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出境医 / 临床实验 / Health and Energy Through Active Living Every Day (HEALED) After Cancer Pilot Intervention for Cancer Survivors

Health and Energy Through Active Living Every Day (HEALED) After Cancer Pilot Intervention for Cancer Survivors

Study Description
Brief Summary:
The proposed pilot study will test the acceptability, feasibility, and safety of a twelve-week, two-arm randomized control intervention embedded within the Cancer Prevention Study-3 (CPS-3), a prospective cohort study of cancer incidence and mortality initiated by the American Cancer Society. The proposed Health and Energy through Active Living Every Day (HEALED) intervention is intended for survivors of a cancer with a 5-year survival (at Stage I and II) of at least 65% that has a strong level of evidence for association with physical inactivity according to the 2018 PA Guidelines Advisory Committee Report (breast, colon, endometrium, kidney, and bladder). In line with social cognitive theory behavior change techniques, participants will be provided information and skills necessary to be more physically active and less sedentary after a cancer diagnosis. New materials will be disseminated monthly through a website open only to participants, and include: at-home exercise demonstration videos, research news, discussion boards, success stories, infographics for exercise recommendations, etc. This intervention will add to the very minimal evidence base for PA interventions for diverse cancer survivors in a cost-effective manner.

Condition or disease Intervention/treatment Phase
Cancer Quality of Life Fatigue Behavioral: Physical activity Not Applicable

Detailed Description:

The Health and Energy through Active Living Every Day (HEALED) after cancer pilot study is a randomized consent, parallel assignment twelve-week physical activity behavioral intervention. HEALED is intended for survivors of a cancer with a 5-year survival (at Stage I and II) of at least 65% that is categorized as having a strong level of evidence for association with physical inactivity according to the 2018 Physical Activity Guidelines Advisory Committee Report, which includes: breast, colon, endometrium, kidney, and bladder.(11) HEALED has a two-arm design, including an experimental group (n=50) and a wait-listed control group (n=50) which will be instructed to continue behavior "as-usual".

Participants will be recruited through the Cancer Prevention Study-3 (CPS-3). CPS-3 is a prospective cohort study of cancer incidence and mortality initiated by the American Cancer Society (ACS). Over 254,000 CPS-3 participants aged 30 to 65 years with no history of cancer (except for basal or squamous cell skin cancer) completed a baseline survey at enrollment and are sent repeat surveys every three years to update exposure information.(17) All CPS-3 participants will be followed up for cancer incidence and mortality from any cause for at least 20 years. Between enrollment and 2015, there were over 6100 cancer cases in the CPS-3 cohort.

Eligibility for HEALED will be determined based on existing data from CPS-3 2015 and 2018 surveys. Inclusion criteria require: 1) response to 2018 CPS-3 English survey, 2) a self-reported pre- or postmenopausal breast, colon, endometrium, kidney, or bladder cancer, 3) an e-mail address on record, and 4) less than 150 minutes MVPA/week and/or no strength training reported on 2018 survey. Participants will be excluded if they: 1) are not community-dwelling, 2) are not able to walk, or 3) are currently undergoing treatment for a cancer recurrence.

Participants will be invited via email. Based on the CPS-3 physical activity sub-study, in which participants were required to wear an accelerometer for two seven-day periods and complete four seven-day diaries over a one-year period, a 20% response rate is expected. Interested participants will complete a short online screener questionnaire and provide online consent if eligible. The screening questionnaire will include items regarding stage at diagnosis and recurrence, and a physical activity readiness questionnaire (PAR-Q). Participants responding 'yes' to one or more of any of the following items will be excluded from the HEALED intervention to rule-out survivors for whom unsupervised physical activity may be unsafe: a) Has your doctor ever said that you have a heart condition and that you should only perform physical activity recommended by a doctor?, b) Do you lose your balance because of dizziness or do you ever lose consciousness?, c) Do you have a bone or joint problem that could be made worse by a change in your physical activity?, or d) Do you know of any other reason why you should not engage in physical activity? Once an eligible participant provides consent, they will be sent an accelerometer (including instructions for wear and return shipping materials) along with a 4-page survey.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Health and Energy Through Active Living Every Day After Cancer: The HEALED Pilot Intervention for Cancer Survivors in CPS-3
Actual Study Start Date : May 15, 2019
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : October 1, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: Intervention
Aspects of the HEALED intervention are based on various components of successful interventions for breast cancer survivors and older adults, NCI funding priorities, CPS-3 survivor preferences discussed in prior focus groups and survivorship research from other cohorts. As such, HEALED participants will receive monthly motivational e-mails, based on prior studies of the most effective delivery time intervals for interventions involving cancer survivors, with links to a web-based platform which will provide: physical activity information (largely consisting of publicly available evidence-based resources), at-home exercise demonstrations/videos for survivors of all fitness levels, personal survivor stories, physical activity/sitting recommendations (based on National Guidelines and ACS guidelines for survivors), positive messaging, a space for SMART goal setting, a platform for physical activity tracking, a discussion board, etc.
Behavioral: Physical activity
Access to website created to teach cancer survivors to live more active lives, with monthly email reminders/website updates. Intervention participants will also receive exercise bands for at-home resistance training.

No Intervention: Wait-list control
Wait-listed control group will be instructed to continue behavior "as-usual". They will receive access to the HEALED website at the end of the 12-week intervention period.
Outcome Measures
Primary Outcome Measures :
  1. System Usability Scale [ Time Frame: 12 weeks ]

    Assesses usability of the HEALED intervention website. 5-point Likert scale strongly disagree to strongly agree. The participant's scores for each question are converted to numbers 0-4, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. Though the scores are 0-100, these are not percentages and should be considered only in terms of their percentile ranking. Based on research, a SUS score above a 68 would be considered above average.

    Based on research, a SUS score above a 68 would be considered above average and anything below 68 is below average, however the best way to interpret your results involves "normalizing" the scores to produce a percentile ranking.


  2. Physical activity [ Time Frame: 12 weeks ]
    Objectively-measured moderate-vigorous physical activity, light physical activity, and sedentary time

  3. Number of exercise-related adverse events (self-reported musculoskeletal injuries, falls, etc.) [ Time Frame: 12 weeks ]
    Safety of HEALED intervention


Secondary Outcome Measures :
  1. Fatigue Symptom Inventory [ Time Frame: 12 weeks ]
    Physical and mental fatigue, 14 items. Items use an 11-point, Likert-type scale that ranges from one fatigue-related extreme to another (lower points on the scale denote less acute problems with fatigue). A global score can be obtained for items 1-13. Question 14 is meant to provide qualitative data only.

  2. PROMIS Sleep Disturbance (short form 6a) [ Time Frame: 12 weeks ]
    Sleep disturbances and overall sleep quality, 6 items. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 6 to 30 with higher scores indicating greater severity of sleep disturbance.

  3. University of Minnesota Cognitive Function Survey [ Time Frame: 12 weeks ]
    Survey-assessed cognitive function from the Long-Term Follow-Up Study. 25 items with three-point Likert-type scale ranging from "Never a problem" to "Often a problem". Scores range from 25-75, with scores above 50 indicating issues with cognitive function (largely problem-solving).


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Response to 2018 CPS-3 English survey
  • Stage I or II pre- or postmenopausal breast, colon, endometrium, kidney, or bladder cancer
  • E-mail address on record
  • Less than 150 minutes MVPA/week and/or no strength training reported on 2018 survey

Exclusion Criteria:

  • Not community-dwelling
  • Unable to walk
  • Currently undergoing treatment for a cancer recurrence
  • "Yes" response to PAR-Q items
Contacts and Locations

Locations
Layout table for location information
United States, Georgia
American Cancer Society
Atlanta, Georgia, United States, 30303
Sponsors and Collaborators
American Cancer Society, Inc.
Tracking Information
First Submitted Date  ICMJE June 5, 2019
First Posted Date  ICMJE June 12, 2019
Last Update Posted Date June 12, 2019
Actual Study Start Date  ICMJE May 15, 2019
Estimated Primary Completion Date October 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2019)
  • System Usability Scale [ Time Frame: 12 weeks ]
    Assesses usability of the HEALED intervention website. 5-point Likert scale strongly disagree to strongly agree. The participant's scores for each question are converted to numbers 0-4, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. Though the scores are 0-100, these are not percentages and should be considered only in terms of their percentile ranking. Based on research, a SUS score above a 68 would be considered above average. Based on research, a SUS score above a 68 would be considered above average and anything below 68 is below average, however the best way to interpret your results involves "normalizing" the scores to produce a percentile ranking.
  • Physical activity [ Time Frame: 12 weeks ]
    Objectively-measured moderate-vigorous physical activity, light physical activity, and sedentary time
  • Number of exercise-related adverse events (self-reported musculoskeletal injuries, falls, etc.) [ Time Frame: 12 weeks ]
    Safety of HEALED intervention
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2019)
  • Fatigue Symptom Inventory [ Time Frame: 12 weeks ]
    Physical and mental fatigue, 14 items. Items use an 11-point, Likert-type scale that ranges from one fatigue-related extreme to another (lower points on the scale denote less acute problems with fatigue). A global score can be obtained for items 1-13. Question 14 is meant to provide qualitative data only.
  • PROMIS Sleep Disturbance (short form 6a) [ Time Frame: 12 weeks ]
    Sleep disturbances and overall sleep quality, 6 items. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 6 to 30 with higher scores indicating greater severity of sleep disturbance.
  • University of Minnesota Cognitive Function Survey [ Time Frame: 12 weeks ]
    Survey-assessed cognitive function from the Long-Term Follow-Up Study. 25 items with three-point Likert-type scale ranging from "Never a problem" to "Often a problem". Scores range from 25-75, with scores above 50 indicating issues with cognitive function (largely problem-solving).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Health and Energy Through Active Living Every Day (HEALED) After Cancer Pilot Intervention for Cancer Survivors
Official Title  ICMJE Health and Energy Through Active Living Every Day After Cancer: The HEALED Pilot Intervention for Cancer Survivors in CPS-3
Brief Summary The proposed pilot study will test the acceptability, feasibility, and safety of a twelve-week, two-arm randomized control intervention embedded within the Cancer Prevention Study-3 (CPS-3), a prospective cohort study of cancer incidence and mortality initiated by the American Cancer Society. The proposed Health and Energy through Active Living Every Day (HEALED) intervention is intended for survivors of a cancer with a 5-year survival (at Stage I and II) of at least 65% that has a strong level of evidence for association with physical inactivity according to the 2018 PA Guidelines Advisory Committee Report (breast, colon, endometrium, kidney, and bladder). In line with social cognitive theory behavior change techniques, participants will be provided information and skills necessary to be more physically active and less sedentary after a cancer diagnosis. New materials will be disseminated monthly through a website open only to participants, and include: at-home exercise demonstration videos, research news, discussion boards, success stories, infographics for exercise recommendations, etc. This intervention will add to the very minimal evidence base for PA interventions for diverse cancer survivors in a cost-effective manner.
Detailed Description

The Health and Energy through Active Living Every Day (HEALED) after cancer pilot study is a randomized consent, parallel assignment twelve-week physical activity behavioral intervention. HEALED is intended for survivors of a cancer with a 5-year survival (at Stage I and II) of at least 65% that is categorized as having a strong level of evidence for association with physical inactivity according to the 2018 Physical Activity Guidelines Advisory Committee Report, which includes: breast, colon, endometrium, kidney, and bladder.(11) HEALED has a two-arm design, including an experimental group (n=50) and a wait-listed control group (n=50) which will be instructed to continue behavior "as-usual".

Participants will be recruited through the Cancer Prevention Study-3 (CPS-3). CPS-3 is a prospective cohort study of cancer incidence and mortality initiated by the American Cancer Society (ACS). Over 254,000 CPS-3 participants aged 30 to 65 years with no history of cancer (except for basal or squamous cell skin cancer) completed a baseline survey at enrollment and are sent repeat surveys every three years to update exposure information.(17) All CPS-3 participants will be followed up for cancer incidence and mortality from any cause for at least 20 years. Between enrollment and 2015, there were over 6100 cancer cases in the CPS-3 cohort.

Eligibility for HEALED will be determined based on existing data from CPS-3 2015 and 2018 surveys. Inclusion criteria require: 1) response to 2018 CPS-3 English survey, 2) a self-reported pre- or postmenopausal breast, colon, endometrium, kidney, or bladder cancer, 3) an e-mail address on record, and 4) less than 150 minutes MVPA/week and/or no strength training reported on 2018 survey. Participants will be excluded if they: 1) are not community-dwelling, 2) are not able to walk, or 3) are currently undergoing treatment for a cancer recurrence.

Participants will be invited via email. Based on the CPS-3 physical activity sub-study, in which participants were required to wear an accelerometer for two seven-day periods and complete four seven-day diaries over a one-year period, a 20% response rate is expected. Interested participants will complete a short online screener questionnaire and provide online consent if eligible. The screening questionnaire will include items regarding stage at diagnosis and recurrence, and a physical activity readiness questionnaire (PAR-Q). Participants responding 'yes' to one or more of any of the following items will be excluded from the HEALED intervention to rule-out survivors for whom unsupervised physical activity may be unsafe: a) Has your doctor ever said that you have a heart condition and that you should only perform physical activity recommended by a doctor?, b) Do you lose your balance because of dizziness or do you ever lose consciousness?, c) Do you have a bone or joint problem that could be made worse by a change in your physical activity?, or d) Do you know of any other reason why you should not engage in physical activity? Once an eligible participant provides consent, they will be sent an accelerometer (including instructions for wear and return shipping materials) along with a 4-page survey.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Cancer
  • Quality of Life
  • Fatigue
Intervention  ICMJE Behavioral: Physical activity
Access to website created to teach cancer survivors to live more active lives, with monthly email reminders/website updates. Intervention participants will also receive exercise bands for at-home resistance training.
Study Arms  ICMJE
  • Experimental: Intervention
    Aspects of the HEALED intervention are based on various components of successful interventions for breast cancer survivors and older adults, NCI funding priorities, CPS-3 survivor preferences discussed in prior focus groups and survivorship research from other cohorts. As such, HEALED participants will receive monthly motivational e-mails, based on prior studies of the most effective delivery time intervals for interventions involving cancer survivors, with links to a web-based platform which will provide: physical activity information (largely consisting of publicly available evidence-based resources), at-home exercise demonstrations/videos for survivors of all fitness levels, personal survivor stories, physical activity/sitting recommendations (based on National Guidelines and ACS guidelines for survivors), positive messaging, a space for SMART goal setting, a platform for physical activity tracking, a discussion board, etc.
    Intervention: Behavioral: Physical activity
  • No Intervention: Wait-list control
    Wait-listed control group will be instructed to continue behavior "as-usual". They will receive access to the HEALED website at the end of the 12-week intervention period.
Publications * Rees-Punia E, Leach CR, Westmaas JL, Dempsey LF, Roberts AM, Nocera JR, Patel AV. Pilot Randomized Controlled Trial of Feasibility, Acceptability, and Preliminary Efficacy of a Web-Based Physical Activity and Sedentary Time Intervention for Survivors of Physical Inactivity-Related Cancers. Int J Behav Med. 2021 May 6. doi: 10.1007/s12529-021-09999-5. [Epub ahead of print]

*   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 Unknown status
Actual Enrollment  ICMJE
 (submitted: June 10, 2019)
98
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2019
Estimated Primary Completion Date October 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Response to 2018 CPS-3 English survey
  • Stage I or II pre- or postmenopausal breast, colon, endometrium, kidney, or bladder cancer
  • E-mail address on record
  • Less than 150 minutes MVPA/week and/or no strength training reported on 2018 survey

Exclusion Criteria:

  • Not community-dwelling
  • Unable to walk
  • Currently undergoing treatment for a cancer recurrence
  • "Yes" response to PAR-Q items
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03983083
Other Study ID Numbers  ICMJE HEALED_CPS3
Has Data Monitoring Committee No
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 Erika Rees-Punia, American Cancer Society, Inc.
Study Sponsor  ICMJE American Cancer Society, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account American Cancer Society, Inc.
Verification Date June 2019

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

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