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出境医 / 临床实验 / Diet and Exercise Interventions Among Men With Prostate Cancer (Prostate 8-II)

Diet and Exercise Interventions Among Men With Prostate Cancer (Prostate 8-II)

Study Description
Brief Summary:
The Prostate 8-II study is a 2-year randomized controlled trial of testing different combinations of educational and supportive tools related to diet and exercise to evaluate biological, clinical, and quality of life outcomes in men choosing radical prostatectomy as treatment for prostate cancer.

Condition or disease Intervention/treatment Phase
Prostate Cancer Behavioral: Exercise and Diet Not Applicable

Detailed Description:
This is a PI initiated, randomized controlled trial of four exercise and diet interventions among 200 men opting for radical prostatectomy for prostate cancer. The Prostate 8-II study enrolls men up to 8 weeks prior to surgery and participants remain on study for 24 cycles after surgery (1 cycle=28 days). After obtaining written informed consent, enrolled subjects will be scheduled for the baseline assessments. All participants will receive Group A educational materials and tools, but these will be distributed at different times based on group assignment. The other 3 groups will receive different combinations of exercise (Group B), diet (Group C) and exercise and diet (Group D) tools. Men in all arms will be asked to complete questionnaires at baseline, pre-surgery, and at cycles 6 12 & 24 post-surgery, and complete blood and urine collection, diet recall, and accelerometer measurement at select time points. Specimens from biopsy and radical prostatectomy will be reviewed by the investigators' collaborator, GenomeDx, for RNA characterization and assessment of the genomic risk scores. Patients will be followed for 30 days after completion of the 2-year 24-cycle intervention period or removal from the study, or until death, whichever occurs first for any treatment-related adverse events. Following the completion of the intervention, we will follow the patient's treatment and disease status on a yearly basis, for 3 more years.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial of Diet & Exercise Interventions Among Men With Prostate Cancer - II (Prostate 8-II)
Actual Study Start Date : May 11, 2018
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : July 31, 2024
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Arm A: Reference Group
Arm A will receive print educational materials about the benefits of exercise and diet for men with prostate cancer, with recommendations geared at men living with prostate cancer, mailed around the date of surgery. They also receive a 9-week text messaging program focused on recovery after radical prostatectomy surgery.
Behavioral: Exercise and Diet
This Phase 2, open-label, four-arm randomized controlled trial (RCT) will investigate the effects of a 2-year behavioral program providing access to educational materials + clinical texting program (Arm A) + participant portal, text messaging, and coaching (Arms B-D) in 200 men with histologically confirmed low-risk prostate adenocarcinoma who choose radical prostatectomy as treatment.

Experimental: Arm B (Arm A + Exercise)
Arm B receives the following: Arm A material plus access to an online portal with additional educational materials to help improve exercise habits and various tools, such as the ability to track exercise; additional educational print materials on exercise; additional text messages over 2 years that supports healthy exercise habits; and a 1-hour phone session at the start of the study followed by eight 30-minute quarterly phone sessions with an exercise coach over 2 years.
Behavioral: Exercise and Diet
This Phase 2, open-label, four-arm randomized controlled trial (RCT) will investigate the effects of a 2-year behavioral program providing access to educational materials + clinical texting program (Arm A) + participant portal, text messaging, and coaching (Arms B-D) in 200 men with histologically confirmed low-risk prostate adenocarcinoma who choose radical prostatectomy as treatment.

Experimental: Arm C (Arm A + Diet)
Arm C receives the following: Arm A material plus access to an online portal with additional educational materials to help improve diet habits and various tools, such as the ability to track diet; additional educational print materials on diet; additional text messages over 2 years that supports healthy diet habits; and a 1-hour phone session at the start of the study followed by eight 30-minute quarterly phone sessions with a diet coach over 2 years.
Behavioral: Exercise and Diet
This Phase 2, open-label, four-arm randomized controlled trial (RCT) will investigate the effects of a 2-year behavioral program providing access to educational materials + clinical texting program (Arm A) + participant portal, text messaging, and coaching (Arms B-D) in 200 men with histologically confirmed low-risk prostate adenocarcinoma who choose radical prostatectomy as treatment.

Experimental: Arm D (Arm A + Exercise + Diet)
Arm D receives the following: Arm A material plus access to an online portal with additional educational materials to help improve exercise and diet habits and various tools, such as the ability to track exercise and diet; additional educational print materials on exercise and diet; additional text messages over 2 years that supports healthy exercise and diet habits; a 1-hour phone session at the start of the study followed by eight 30-minute quarterly phone sessions with an exercise coach over 2 years; and a 1-hour phone session at the start of the study followed by eight 30-minute quarterly phone sessions with a diet coach over 2 years.
Behavioral: Exercise and Diet
This Phase 2, open-label, four-arm randomized controlled trial (RCT) will investigate the effects of a 2-year behavioral program providing access to educational materials + clinical texting program (Arm A) + participant portal, text messaging, and coaching (Arms B-D) in 200 men with histologically confirmed low-risk prostate adenocarcinoma who choose radical prostatectomy as treatment.

Outcome Measures
Primary Outcome Measures :
  1. Proportion of patients with detectable levels of Prostate-specific antigen (PSA) [ Time Frame: 6 months and 24 months post-surgery ]
    Detectable PSA will be defined based on current practice at the time of analysis. Point estimate and 95% confidence interval of the proportion of detectable PSA at 6 months and 2 years post-surgery for each group will be reported. In addition, Pearson's Chi-square test will be used to test if there are differences in the proportion of detectable PSA at least 6 weeks post-surgery among the groups. If there is a significant difference observed, a 2-sample proportion test to compare Groups B, C, and D, separately, with Group A and one another for each post-intervention time point will be performed. Point estimates and 95% confidence intervals of the recurrence proportion will be obtained for each group

  2. Annual PSA recurrence rate [ Time Frame: 1 year, 2 years and 3 years post surgery ]
    Risk of cancer recurrence (based on current practice) measured using standard criteria using a log- rank test to evaluate the time to recurrence among groups, and multivariate Cox proportional hazards regression to obtain a hazard ratio for the time to recurrence


Secondary Outcome Measures :
  1. Changes in mRNA expression patterns (focusing on change between biopsy and RP) [ Time Frame: From baseline to up to 8 weeks ]
    Effect of intervention on changes in mRNA expression patterns using the 1.4 million marker Affymetrix 1.0 Human Exon Array, in formalin-fixed paraffin-embedded (FFPE) prostate biopsy and prostatectomy tissue to determine which genes are differentially expressed from biopsy to RP within each group. If the expression is significantly different in at least one of the groups, the change of RNA expression level will be compared among all groups by ANOVA. If there is a significant difference observed, we will perform pairwise comparisons among the groups. Multiple testing adjustment will be done by controlling false discovery rate

  2. Decipher score (focusing on change between biopsy and RP) [ Time Frame: From baseline to up to 8 weeks ]
    Assessment of genomic classifiers, using the 1.4 million marker Affymetrix 1.0 Human Exon Array, in FFPE (formalin-fixed paraffin embedded) prostate biopsy and radical prostatectomy tissue. Each score ranges from 0 to 100 and can be interpreted as a probability of progression. The 2-sample proportion test will be used to compare the proportion of reduction in the genomic score between Groups B, C, and D, separately with Group A first. Significant mean changes in the Decipher score will be tested using Analysis of Variance (ANOVA). If there is a significant difference observed, pairwise comparisons among the groups will be performed. A regression model will be built using an indicator for group and stratification factors such as age at diagnosis and surgical parameters (e.g., CAPRA-S) which have been determined to be potential covariates.

  3. Change in sexual function as measured by the Expanded Prostate Cancer Index Composite Short Form (EPIC-26) [ Time Frame: Baseline, and 6 months, 12 months, and 24 months post-surgery ]
    The EPIC-26 will be used to determine the impact of quality of life issues on the sexual function domain. Response options for each EPIC item form a Likert scale, and the raw score of each item is then transformed linearly to a 0-100 scale. Multiple items are combined and then averaged to form the domain scores and total score at each time point also ranging from 0-100, with higher scores representing better health related quality of life (HRQOL).

  4. Change in urinary function as measured by the EPIC-26 [ Time Frame: Baseline, and 6 months, 12 months, and 24 months post-surgery ]
    The EPIC-26 will be used to determine the impact of quality of life issues on the urinary function domain. Response options for each EPIC item form a Likert scale, and the raw score of each item is then transformed linearly to a 0-100 scale. Multiple items are combined and then averaged to form the domain scores and total score at each time point also ranging from 0-100, with higher scores representing better health related quality of life (HRQOL).

  5. Change in scores on the general anxiety scale of the Patient-Reported Outcomes Measurement Information System (PROMIS) [ Time Frame: Baseline, and 6 months, 12 months, and 24 months post-surgery ]
    General anxiety items usually has five response options ranging in value from one to five with a higher value indicating a greater degree of anxiety. The total raw score is the sum the values of the response to each question, and then converted to a scaled T-score for each participant. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10.

  6. Change in scores on the Memorial Anxiety Scale for Prostate Cancer (MAX-PC) [ Time Frame: Baseline, and 6 months, 12 months, and 24 months post-surgery ]
    Memorial Anxiety Scale for Prostate Cancer (MAX-PC) - 18 items assessing prostate cancer anxiety, PSA anxiety, and fear of recurrence; range 0-54; smaller number is better.

  7. Change in scores on the general depression scale of the Patient-Reported Outcomes Measurement Information System (PROMIS) [ Time Frame: Baseline, and 6 months, 12 months, and 24 months post-surgery ]
    General depression items usually has five response options ranging in value from one to five with a higher value indicating a greater degree of depression. The total raw score is the sum the values of the response to each question, and then converted to a scaled T-score for each participant. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10.

  8. Change in scores on the SF-12 [ Time Frame: Baseline, and 6 months, 12 months, and 24 months post-surgery ]
    The SF-12 is a 12-item questionnaire used to assess generic health outcomes from the patient's perspective. The SF-12 consists of a subset of 12 items from the SF-36® Health Survey (SF-36) and measures two composite outcomes assessing mental health composite score (MCS) and physical health composite scores (PCS). The PCS & MCS are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The absolute change in item score by group from baseline up to 12 months was used to assess the quality of life/psychosocial impact on the patients with a larger scores indicating a greater degree of change on physical and mental health.

  9. Change in physical activity over time [ Time Frame: Baseline, and 6 months, 12 months, and 24 months post-surgery ]
    Patients will wear an Actigraph GT3X+ accelerometer on their wrist for 7 consecutive days to measure physical activity

  10. Change in scores on the Godin-Shephard Leisure-Time Physical Activity Questionnaire [ Time Frame: Baseline, and 6 months, 12 months, and 24 months post-surgery ]
    The Godin-Shephard Leisure-Time Physical Activity Questionnaire measures the frequency and duration of various types of physical activity (strenuous, moderate, light) and each is weighted by multiplying the frequency by a corresponding multiplier (x9, x5, x3 respectively) during a typical 7-Day period. The weekly leisure activity score = (9 × Strenuous) + (5 × Moderate) + (3 × Light). A score of 24 units or more indicates a status of "Active", 14 - 23 units "Moderately Active" and < 14 units "Insufficiently Active/Sedentary".

  11. Change in Harvard Food Frequency Questionnaire (FFQ) over time [ Time Frame: Baseline, and 6 months, 12 months, and 24 months post-surgery ]
    The FFQ is a self-administered questionnaire to assess intake of various nutrients. Nutrient intakes are computed by assigning a daily frequency weight

  12. Diet recall [ Time Frame: Baseline, and 6 months, 12 months, and 24 months post-surgery ]
    Two online 24-hour diet recalls as recommended by the National Cancer Institute's Diet Assessment Primer

  13. Intervention feasibility and acceptability (intervention arms) [ Time Frame: Baseline, and 6 months, 12 months, and 24 months post-surgery ]
    Various metrics for study feasibility (e.g., text message, portal, and coaching use) will be measured over time. Study acceptability will be evaluated by survey and in a subset, by phone interview. Descriptive data of these metrics across arms will be reported

  14. Self/efficacy confidence in adopting healthy behaviors over time [ Time Frame: Baseline, and 6 months, 12 months, and 24 months post-surgery ]
    Confidence scores in adopting dietary and physical activity behaviors at for each group using descriptive statistics, such as means, medians, and interquartile range will be reported using descriptive statistics.

  15. Changes in scores on the Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Baseline, and 6 months, 12 months, and 24 months post-surgery ]
    In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality

  16. Changes in perceived social support [ Time Frame: Baseline, and 6 months, 12 months, and 24 months post-surgery ]
    Social support will be measured using published measures from University of California, San Diego (http://sallis.ucsd.edu/measure_socialsupport.html


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age >=18 years
  2. Diagnosed with non-metastatic prostate cancer and choose radical prostatectomy (RP) as primary treatment.
  3. Able to speak and read English
  4. Regular access to the Internet (via a computer, tablet, or phone) and text messaging capabilities on the phone
  5. Ability to understand a written informed consent document, and the willingness to sign it
  6. Cleared by their physician to participate in unsupervised physical activity, if patient has certain health conditions or symptoms, outlined in exclusion criteria

Exclusion Criteria:

  1. Cannot have adjuvant radiation or hormone therapy planned prior to surgery at time of enrollment (if enrolling >4 weeks prior to RP)
  2. Men who have contraindications to exercise based the American College of Sports Medicine 2016 Exercise pre-participation screening criteria (https://www.ncbi.nlm.nih.gov/pubmed/26473759), and who do not receive a physician clearance to participate in the moderate to vigorous intensity physical activity with one or more of the following self-reported conditions:

    1. Heart attack
    2. Heart surgery, cardiac catheterization, or coronary angioplasty
    3. Pacemaker/implantable cardiac defibrillator/rhythm disturbance
    4. Heart valve disease
    5. Heart failure
    6. Heart transplantation
    7. Congenital heart disease
    8. Diabetes
    9. Kidney (renal) disease
    10. Chest discomfort with exertion
    11. Unreasonable breathlessness
    12. Dizziness, fainting, or blackouts
    13. Ankle swelling
    14. Unpleasant awareness of forceful, rapid or irregular heart rate
    15. Burning or cramping sensations in your lower legs when walking short distance
  3. Men already meeting aerobic AND resistance exercise recommendations. To be eligible, must not meet at least one of the following: (1) 150 minutes per week of planned moderate aerobic exercise or 75 minutes per week of planned vigorous aerobic exercise or combination;(2) Two or more days per week of resistance exercise; (3) Eight or more resistance exercises per session
  4. Men who are already meeting all of the 7 prostate-specific dietary recommendations
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Stacey Kenfield, DSc (415) 476-5392 Stacey.Kenfield@ucsf.edu

Locations
Layout table for location information
United States, California
University of California, San Francisco (UCSF) Recruiting
San Francisco, California, United States, 94143
Contact: Imelda Tenggara    415-353-7348    Imelda.tenggara@ucsf.edu   
Sub-Investigator: Peter Carroll, MD, MPH         
Sub-Investigator: Matthew Cooperberg, MD, MPH         
Sub-Investigator: June Chan, ScD         
Sub-Investigator: Erin Van Blarigan, ScD         
Sub-Investigator: Rebecca Graff, ScD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
Layout table for investigator information
Principal Investigator: Stacey Kenfield, DSc University of California, San Francisco
Tracking Information
First Submitted Date  ICMJE June 21, 2019
First Posted Date  ICMJE June 26, 2019
Last Update Posted Date August 20, 2020
Actual Study Start Date  ICMJE May 11, 2018
Estimated Primary Completion Date July 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2020)
  • Proportion of patients with detectable levels of Prostate-specific antigen (PSA) [ Time Frame: 6 months and 24 months post-surgery ]
    Detectable PSA will be defined based on current practice at the time of analysis. Point estimate and 95% confidence interval of the proportion of detectable PSA at 6 months and 2 years post-surgery for each group will be reported. In addition, Pearson's Chi-square test will be used to test if there are differences in the proportion of detectable PSA at least 6 weeks post-surgery among the groups. If there is a significant difference observed, a 2-sample proportion test to compare Groups B, C, and D, separately, with Group A and one another for each post-intervention time point will be performed. Point estimates and 95% confidence intervals of the recurrence proportion will be obtained for each group
  • Annual PSA recurrence rate [ Time Frame: 1 year, 2 years and 3 years post surgery ]
    Risk of cancer recurrence (based on current practice) measured using standard criteria using a log- rank test to evaluate the time to recurrence among groups, and multivariate Cox proportional hazards regression to obtain a hazard ratio for the time to recurrence
Original Primary Outcome Measures  ICMJE
 (submitted: June 25, 2019)
Genomic signature changes [ Time Frame: From baseline to up to 8 weeks ]
Assessment of genomic classifiers, using the 1.4 million marker Affymetrix 1.0 Human Exon Array, in FFPE (formalin-fixed paraffin embedded) prostate biopsy and radical prostatectomy tissue. Each score ranges from 0 to 100 and can be interpreted as a probability of progression.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2020)
  • Changes in mRNA expression patterns (focusing on change between biopsy and RP) [ Time Frame: From baseline to up to 8 weeks ]
    Effect of intervention on changes in mRNA expression patterns using the 1.4 million marker Affymetrix 1.0 Human Exon Array, in formalin-fixed paraffin-embedded (FFPE) prostate biopsy and prostatectomy tissue to determine which genes are differentially expressed from biopsy to RP within each group. If the expression is significantly different in at least one of the groups, the change of RNA expression level will be compared among all groups by ANOVA. If there is a significant difference observed, we will perform pairwise comparisons among the groups. Multiple testing adjustment will be done by controlling false discovery rate
  • Decipher score (focusing on change between biopsy and RP) [ Time Frame: From baseline to up to 8 weeks ]
    Assessment of genomic classifiers, using the 1.4 million marker Affymetrix 1.0 Human Exon Array, in FFPE (formalin-fixed paraffin embedded) prostate biopsy and radical prostatectomy tissue. Each score ranges from 0 to 100 and can be interpreted as a probability of progression. The 2-sample proportion test will be used to compare the proportion of reduction in the genomic score between Groups B, C, and D, separately with Group A first. Significant mean changes in the Decipher score will be tested using Analysis of Variance (ANOVA). If there is a significant difference observed, pairwise comparisons among the groups will be performed. A regression model will be built using an indicator for group and stratification factors such as age at diagnosis and surgical parameters (e.g., CAPRA-S) which have been determined to be potential covariates.
  • Change in sexual function as measured by the Expanded Prostate Cancer Index Composite Short Form (EPIC-26) [ Time Frame: Baseline, and 6 months, 12 months, and 24 months post-surgery ]
    The EPIC-26 will be used to determine the impact of quality of life issues on the sexual function domain. Response options for each EPIC item form a Likert scale, and the raw score of each item is then transformed linearly to a 0-100 scale. Multiple items are combined and then averaged to form the domain scores and total score at each time point also ranging from 0-100, with higher scores representing better health related quality of life (HRQOL).
  • Change in urinary function as measured by the EPIC-26 [ Time Frame: Baseline, and 6 months, 12 months, and 24 months post-surgery ]
    The EPIC-26 will be used to determine the impact of quality of life issues on the urinary function domain. Response options for each EPIC item form a Likert scale, and the raw score of each item is then transformed linearly to a 0-100 scale. Multiple items are combined and then averaged to form the domain scores and total score at each time point also ranging from 0-100, with higher scores representing better health related quality of life (HRQOL).
  • Change in scores on the general anxiety scale of the Patient-Reported Outcomes Measurement Information System (PROMIS) [ Time Frame: Baseline, and 6 months, 12 months, and 24 months post-surgery ]
    General anxiety items usually has five response options ranging in value from one to five with a higher value indicating a greater degree of anxiety. The total raw score is the sum the values of the response to each question, and then converted to a scaled T-score for each participant. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10.
  • Change in scores on the Memorial Anxiety Scale for Prostate Cancer (MAX-PC) [ Time Frame: Baseline, and 6 months, 12 months, and 24 months post-surgery ]
    Memorial Anxiety Scale for Prostate Cancer (MAX-PC) - 18 items assessing prostate cancer anxiety, PSA anxiety, and fear of recurrence; range 0-54; smaller number is better.
  • Change in scores on the general depression scale of the Patient-Reported Outcomes Measurement Information System (PROMIS) [ Time Frame: Baseline, and 6 months, 12 months, and 24 months post-surgery ]
    General depression items usually has five response options ranging in value from one to five with a higher value indicating a greater degree of depression. The total raw score is the sum the values of the response to each question, and then converted to a scaled T-score for each participant. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10.
  • Change in scores on the SF-12 [ Time Frame: Baseline, and 6 months, 12 months, and 24 months post-surgery ]
    The SF-12 is a 12-item questionnaire used to assess generic health outcomes from the patient's perspective. The SF-12 consists of a subset of 12 items from the SF-36® Health Survey (SF-36) and measures two composite outcomes assessing mental health composite score (MCS) and physical health composite scores (PCS). The PCS & MCS are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The absolute change in item score by group from baseline up to 12 months was used to assess the quality of life/psychosocial impact on the patients with a larger scores indicating a greater degree of change on physical and mental health.
  • Change in physical activity over time [ Time Frame: Baseline, and 6 months, 12 months, and 24 months post-surgery ]
    Patients will wear an Actigraph GT3X+ accelerometer on their wrist for 7 consecutive days to measure physical activity
  • Change in scores on the Godin-Shephard Leisure-Time Physical Activity Questionnaire [ Time Frame: Baseline, and 6 months, 12 months, and 24 months post-surgery ]
    The Godin-Shephard Leisure-Time Physical Activity Questionnaire measures the frequency and duration of various types of physical activity (strenuous, moderate, light) and each is weighted by multiplying the frequency by a corresponding multiplier (x9, x5, x3 respectively) during a typical 7-Day period. The weekly leisure activity score = (9 × Strenuous) + (5 × Moderate) + (3 × Light). A score of 24 units or more indicates a status of "Active", 14 - 23 units "Moderately Active" and < 14 units "Insufficiently Active/Sedentary".
  • Change in Harvard Food Frequency Questionnaire (FFQ) over time [ Time Frame: Baseline, and 6 months, 12 months, and 24 months post-surgery ]
    The FFQ is a self-administered questionnaire to assess intake of various nutrients. Nutrient intakes are computed by assigning a daily frequency weight
  • Diet recall [ Time Frame: Baseline, and 6 months, 12 months, and 24 months post-surgery ]
    Two online 24-hour diet recalls as recommended by the National Cancer Institute's Diet Assessment Primer
  • Intervention feasibility and acceptability (intervention arms) [ Time Frame: Baseline, and 6 months, 12 months, and 24 months post-surgery ]
    Various metrics for study feasibility (e.g., text message, portal, and coaching use) will be measured over time. Study acceptability will be evaluated by survey and in a subset, by phone interview. Descriptive data of these metrics across arms will be reported
  • Self/efficacy confidence in adopting healthy behaviors over time [ Time Frame: Baseline, and 6 months, 12 months, and 24 months post-surgery ]
    Confidence scores in adopting dietary and physical activity behaviors at for each group using descriptive statistics, such as means, medians, and interquartile range will be reported using descriptive statistics.
  • Changes in scores on the Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Baseline, and 6 months, 12 months, and 24 months post-surgery ]
    In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality
  • Changes in perceived social support [ Time Frame: Baseline, and 6 months, 12 months, and 24 months post-surgery ]
    Social support will be measured using published measures from University of California, San Diego (http://sallis.ucsd.edu/measure_socialsupport.html
Original Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2019)
  • mRNA expression patterns changes [ Time Frame: From baseline to up to 8 weeks ]
    Effect of intervention on mRNA expression patterns using the 1.4 million marker Affymetrix 1.0 Human Exon Array, in FFPE prostate biopsy and prostatectomy tissue.
  • Prostate-specific antigen (PSA) level [ Time Frame: 6 months, 12 months, and 24 months post-surgery ]
    PSA level will be measured in blood
  • Annual PSA recurrence rate [ Time Frame: From date of surgery to one year post-surgery, to 2 years post-surgery, etc. ]
    Recurrence rate measured using standard criteria
  • Sexual function [ Time Frame: Baseline, and 6 months, 12 months, and 24 months post-surgery ]
    Expanded Prostate Cancer Index Composite-26 (EPIC-26)
  • Urinary function [ Time Frame: Baseline, and 6 months, 12 months, and 24 months post-surgery ]
    Expanded Prostate Cancer Index Composite-26 (EPIC-26)
  • Physical activity [ Time Frame: Baseline, and 6 months, 12 months, and 24 months post-surgery ]
    Actigraph GT3X+ accelerometer on their wrist for 7 consecutive days
  • Diet [ Time Frame: Baseline, and 6 months, 12 months, and 24 months post-surgery ]
    Food frequency questionnaire
  • Diet [ Time Frame: Baseline, and 6 months, 12 months, and 24 months post-surgery ]
    Diet recall
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: June 25, 2019)
  • General quality of life [ Time Frame: Baseline, and 6 months, 12 months, and 24 months post-surgery ]
    SF-12
  • General anxiety [ Time Frame: Baseline, and 6 months, 12 months, and 24 months post-surgery ]
    Patient-Reported Outcomes Measurement Information System (PROMIS) measure
  • Prostate cancer-specific anxiety [ Time Frame: Baseline, and 6 months, 12 months, and 24 months post-surgery ]
    Memorial Anxiety Scale for Prostate Cancer (MAX-PC) - 18 items assessing prostate cancer anxiety, PSA anxiety, and fear of recurrence; range 0-54; smaller number is better.
  • General depression [ Time Frame: Baseline, and 6 months, 12 months, and 24 months post-surgery ]
    Patient-Reported Outcomes Measurement Information System (PROMIS) measure
 
Descriptive Information
Brief Title  ICMJE Diet and Exercise Interventions Among Men With Prostate Cancer
Official Title  ICMJE A Randomized Controlled Trial of Diet & Exercise Interventions Among Men With Prostate Cancer - II (Prostate 8-II)
Brief Summary The Prostate 8-II study is a 2-year randomized controlled trial of testing different combinations of educational and supportive tools related to diet and exercise to evaluate biological, clinical, and quality of life outcomes in men choosing radical prostatectomy as treatment for prostate cancer.
Detailed Description This is a PI initiated, randomized controlled trial of four exercise and diet interventions among 200 men opting for radical prostatectomy for prostate cancer. The Prostate 8-II study enrolls men up to 8 weeks prior to surgery and participants remain on study for 24 cycles after surgery (1 cycle=28 days). After obtaining written informed consent, enrolled subjects will be scheduled for the baseline assessments. All participants will receive Group A educational materials and tools, but these will be distributed at different times based on group assignment. The other 3 groups will receive different combinations of exercise (Group B), diet (Group C) and exercise and diet (Group D) tools. Men in all arms will be asked to complete questionnaires at baseline, pre-surgery, and at cycles 6 12 & 24 post-surgery, and complete blood and urine collection, diet recall, and accelerometer measurement at select time points. Specimens from biopsy and radical prostatectomy will be reviewed by the investigators' collaborator, GenomeDx, for RNA characterization and assessment of the genomic risk scores. Patients will be followed for 30 days after completion of the 2-year 24-cycle intervention period or removal from the study, or until death, whichever occurs first for any treatment-related adverse events. Following the completion of the intervention, we will follow the patient's treatment and disease status on a yearly basis, for 3 more years.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Prostate Cancer
Intervention  ICMJE Behavioral: Exercise and Diet
This Phase 2, open-label, four-arm randomized controlled trial (RCT) will investigate the effects of a 2-year behavioral program providing access to educational materials + clinical texting program (Arm A) + participant portal, text messaging, and coaching (Arms B-D) in 200 men with histologically confirmed low-risk prostate adenocarcinoma who choose radical prostatectomy as treatment.
Study Arms  ICMJE
  • Active Comparator: Arm A: Reference Group
    Arm A will receive print educational materials about the benefits of exercise and diet for men with prostate cancer, with recommendations geared at men living with prostate cancer, mailed around the date of surgery. They also receive a 9-week text messaging program focused on recovery after radical prostatectomy surgery.
    Intervention: Behavioral: Exercise and Diet
  • Experimental: Arm B (Arm A + Exercise)
    Arm B receives the following: Arm A material plus access to an online portal with additional educational materials to help improve exercise habits and various tools, such as the ability to track exercise; additional educational print materials on exercise; additional text messages over 2 years that supports healthy exercise habits; and a 1-hour phone session at the start of the study followed by eight 30-minute quarterly phone sessions with an exercise coach over 2 years.
    Intervention: Behavioral: Exercise and Diet
  • Experimental: Arm C (Arm A + Diet)
    Arm C receives the following: Arm A material plus access to an online portal with additional educational materials to help improve diet habits and various tools, such as the ability to track diet; additional educational print materials on diet; additional text messages over 2 years that supports healthy diet habits; and a 1-hour phone session at the start of the study followed by eight 30-minute quarterly phone sessions with a diet coach over 2 years.
    Intervention: Behavioral: Exercise and Diet
  • Experimental: Arm D (Arm A + Exercise + Diet)
    Arm D receives the following: Arm A material plus access to an online portal with additional educational materials to help improve exercise and diet habits and various tools, such as the ability to track exercise and diet; additional educational print materials on exercise and diet; additional text messages over 2 years that supports healthy exercise and diet habits; a 1-hour phone session at the start of the study followed by eight 30-minute quarterly phone sessions with an exercise coach over 2 years; and a 1-hour phone session at the start of the study followed by eight 30-minute quarterly phone sessions with a diet coach over 2 years.
    Intervention: Behavioral: Exercise and Diet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 25, 2019)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2024
Estimated Primary Completion Date July 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age >=18 years
  2. Diagnosed with non-metastatic prostate cancer and choose radical prostatectomy (RP) as primary treatment.
  3. Able to speak and read English
  4. Regular access to the Internet (via a computer, tablet, or phone) and text messaging capabilities on the phone
  5. Ability to understand a written informed consent document, and the willingness to sign it
  6. Cleared by their physician to participate in unsupervised physical activity, if patient has certain health conditions or symptoms, outlined in exclusion criteria

Exclusion Criteria:

  1. Cannot have adjuvant radiation or hormone therapy planned prior to surgery at time of enrollment (if enrolling >4 weeks prior to RP)
  2. Men who have contraindications to exercise based the American College of Sports Medicine 2016 Exercise pre-participation screening criteria (https://www.ncbi.nlm.nih.gov/pubmed/26473759), and who do not receive a physician clearance to participate in the moderate to vigorous intensity physical activity with one or more of the following self-reported conditions:

    1. Heart attack
    2. Heart surgery, cardiac catheterization, or coronary angioplasty
    3. Pacemaker/implantable cardiac defibrillator/rhythm disturbance
    4. Heart valve disease
    5. Heart failure
    6. Heart transplantation
    7. Congenital heart disease
    8. Diabetes
    9. Kidney (renal) disease
    10. Chest discomfort with exertion
    11. Unreasonable breathlessness
    12. Dizziness, fainting, or blackouts
    13. Ankle swelling
    14. Unpleasant awareness of forceful, rapid or irregular heart rate
    15. Burning or cramping sensations in your lower legs when walking short distance
  3. Men already meeting aerobic AND resistance exercise recommendations. To be eligible, must not meet at least one of the following: (1) 150 minutes per week of planned moderate aerobic exercise or 75 minutes per week of planned vigorous aerobic exercise or combination;(2) Two or more days per week of resistance exercise; (3) Eight or more resistance exercises per session
  4. Men who are already meeting all of the 7 prostate-specific dietary recommendations
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Stacey Kenfield, DSc (415) 476-5392 Stacey.Kenfield@ucsf.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03999151
Other Study ID Numbers  ICMJE 175513-HDFCCC
NCI-2018-02347 ( Registry Identifier: NCI Clinical Trials Reporting Program (CTRP) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stacey Kenfield, DSc University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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