Condition or disease | Intervention/treatment | Phase |
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Breast Cancer Colorectal Cancer Endometrial Cancer Kidney Cancer Multiple Myeloma Ovary Cancer Prostate Cancer | Behavioral: Adapting MultiPLe Behavior Interventions That eFfectively Improve (AMPLIFI) Cancer Survivor Health Other: Diet-Exercise Other: Exercise-Diet Other: Wait-list Control- Combined Diet and Exercise | Not Applicable |
For this web-based behavioral intervention trial aimed at improving lifestyle behaviors of individuals at higher risk for cancer, other comorbidities and functional decline, 652 cancer survivors (a large proportion of whom will be age 65 or over, rural, and of minority status) will be enrolled and randomly assigned to one of the following study arms: 1) A diet and exercise intervention which would begin immediately, with the first 6 months focused on promoting healthful changes in diet consistent with the American Institute for Cancer Research Guidelines and designed to invoke an average weight loss of one pound per week, and the second 6 months focused on increasing physical activity. The 163 cancer survivors assigned to this arm would be evaluated at baseline, 6-, 12- and 18-months; 2) An exercise and diet intervention which would begin immediately, with the first 6 months focused on increasing physical activity, and the second 6 months focused on promoting healthful changes in diet consistent with the American Institute for Cancer Research Guidelines and designed to invoke an average weight loss of one pound per week. The 163 cancer survivors assigned to this arm would be evaluated at baseline, 6-, 12- and 18-months; and 3) A 12-month combined diet and exercise intervention focused on promoting healthful changes in diet consistent with the American Institute for Cancer Research Guidelines and designed to invoke an average weight loss of one pound per week, while at the same time promoting physical activity. The 326 cancer survivors assigned to this arm would receive the intervention after a 6-month delay and will be evaluated at baseline, 6-, 12-, 18- and 24-months. Weight status, waist circumference, body composition, diet quality, physical activity, physical performance, quality of life, comorbidity, and health utilities will be measured at baseline and each follow-up time point, as will mediators of behavior change, e.g., social support, self-efficacy and barriers. Additionally, phlebotomy will be performed and biospecimens stored for future analysis.
It is hypothesized that cancer survivors assigned to all three of these study arm will experience significant improvements in weight status, body composition, diet quality, physical activity, physical performance, and quality of life. These improvements also will translate into lower health utility scores and prove cost effective. It also is anticipated that analyses will uncover significant mediators, such as self-efficacy, and moderators, such as level of educational attainment associated with program efficacy. Finally, we hypothesize that while all study arms will experience significant benefit, the sequenced arm participants (arms 1 and 2) will have significantly greater odds of achieving improved diet quality, weight loss, and moderate intensity aerobic physical activity of at least 150 minutes a week as measured by accelerometer) post-intervention than survivors randomized to the simultaneous arm.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 652 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Participants will participate in one of three arms:
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Masking: | Triple (Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | Single blinded trial in which the study participant and select individuals in the research team (i.e., interventionists) will be aware of randomization status, but the assessors and investigators will not. |
Primary Purpose: | Supportive Care |
Official Title: | Adapting MultiPLe Behavior Interventions That eFfectively Improve (AMPLIFI) Cancer Survivor Health |
Actual Study Start Date : | March 2, 2020 |
Estimated Primary Completion Date : | July 1, 2024 |
Estimated Study Completion Date : | July 1, 2024 |
Arm | Intervention/treatment |
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Experimental: Project 1: Diet-Exercise
Participants will receive and participate in web-based sessions that focus on diet for 6 months, followed by exercise for another 6 months. Participants will be encouraged to track their diet and weight for the first 6 months and to log their data in the intervention website, during the second 6 months they will be asked to log their physical activity data (minutes and step counts). Tailored feedback and goal recommendations will be provided through the website. Participants will also receive access to resources for relevant behavioral topics. All participants will be invited to participate in the secret Facebook group for the project (though participation is optional).
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Behavioral: Adapting MultiPLe Behavior Interventions That eFfectively Improve (AMPLIFI) Cancer Survivor Health
AMPLIFI will provide participants with a secure website where they receive and participate in educational sessions tailored to their assigned topics for the intervention arm. The website will provide a resource library for static documents, tips of the day, tracking of health behaviors, and goal-setting.
Other Name: AiM, Plan and act on LIFestYles: AMPLIFY Survivor Health
Other: Wait-list Control- Combined Diet and Exercise Wait-list Control- Combined Diet and Exercise
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Experimental: Project 2: Exercise-Diet
Participants will receive and participate in web-based sessions that focus on diet for 6 months, followed by exercise for another 6 months. Participants will be encouraged to track their diet and weight for the first 6 months and to log their data in the intervention website, during the second 6 months they will be asked to log their physical activity data (minutes and step counts). Tailored feedback and goal recommendations will be provided through the website. Participants will also receive access to resources for relevant behavioral topics. All participants will be invited to participate in the secret Facebook group for the project (though participation is optional).
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Behavioral: Adapting MultiPLe Behavior Interventions That eFfectively Improve (AMPLIFI) Cancer Survivor Health
AMPLIFI will provide participants with a secure website where they receive and participate in educational sessions tailored to their assigned topics for the intervention arm. The website will provide a resource library for static documents, tips of the day, tracking of health behaviors, and goal-setting.
Other Name: AiM, Plan and act on LIFestYles: AMPLIFY Survivor Health
Other: Wait-list Control- Combined Diet and Exercise Wait-list Control- Combined Diet and Exercise
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Experimental: Project 3: Wait-list Control- Combined Diet and Exercise
For the first six months of the study, participants will be in the wait-list control group, where they receive health information on topics other than diet and exercise. Participants will then join the intervention, receiving the diet and exercise content simultaneously in combined web-based sessions. Participants will receive and participate in web-based sessions that focus on diet and exercise for 12 months. Participants will be encouraged to track their diet, weight and physical activity data (minutes and step counts). Tailored feedback and goal recommendations will be provided through the website. Participants will also receive access to resources for relevant behavioral topics. All participants will be invited to participate in the secret Facebook group for the project (though participation is optional).
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Behavioral: Adapting MultiPLe Behavior Interventions That eFfectively Improve (AMPLIFI) Cancer Survivor Health
AMPLIFI will provide participants with a secure website where they receive and participate in educational sessions tailored to their assigned topics for the intervention arm. The website will provide a resource library for static documents, tips of the day, tracking of health behaviors, and goal-setting.
Other Name: AiM, Plan and act on LIFestYles: AMPLIFY Survivor Health
Other: Diet-Exercise Diet-Exercise
Other: Exercise-Diet Exercise-Diet
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Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Wendy Demark-Wahnefried, PhD, RD | 833-535-7934 | AMPLIFY@UABMC.EDU |
United States, Alabama | |
University of Alabama at Birmingham | Recruiting |
Birmingham, Alabama, United States, 35294 | |
Contact: Wendy Demark-Wahnefried, PhD, RD 833-535-7934 AMPLIFY@UAMBC.EDU | |
Sub-Investigator: Kevin Fontaine, PhD | |
Sub-Investigator: Dorothy Pekmezi, PhD | |
Sub-Investigator: Laura Rogers, MD | |
Sub-Investigator: Maria Pisu, PhD | |
Sub-Investigator: Yu-Mei Schoenberger, PhD | |
Sub-Investigator: Kelly Kenzik, PhD | |
Sub-Investigator: Robert Oster, PhD | |
Sub-Investigator: Nataliya Ivankova, PhD | |
United States, Tennessee | |
University of Tennessee Health Science Center | Recruiting |
Memphis, Tennessee, United States, 38163 | |
Contact: Michelle Martin, PhD 901-448-2383 mmart126@uthsc.edu | |
Contact: Dana Guerrero, BS (901) 448-3174 dguerre2@uthsc.edu |
Principal Investigator: | Wendy Demark-Wahnefried, PhD, RD | University of Alabama at Birmingham |
Tracking Information | |||||||||||||||||||
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First Submitted Date ICMJE | June 21, 2019 | ||||||||||||||||||
First Posted Date ICMJE | June 27, 2019 | ||||||||||||||||||
Last Update Posted Date | June 8, 2021 | ||||||||||||||||||
Actual Study Start Date ICMJE | March 2, 2020 | ||||||||||||||||||
Estimated Primary Completion Date | July 1, 2024 (Final data collection date for primary outcome measure) | ||||||||||||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||
Descriptive Information | |||||||||||||||||||
Brief Title ICMJE | Adapting Multiple Behavior Interventions That Effectively Improve Cancer Survivor Health Cancer Survivor Health | ||||||||||||||||||
Official Title ICMJE | Adapting MultiPLe Behavior Interventions That eFfectively Improve (AMPLIFI) Cancer Survivor Health | ||||||||||||||||||
Brief Summary | This research study will test the efficacy of interactive, web-based interventions that improve diet, physical activity and weight management changes among early stage survivors of breast, prostate, colorectal, endometrial, renal, and ovarian cancers. Overarching outcomes also include physical function and performance, muscle mass, quality of life, and health utilities. | ||||||||||||||||||
Detailed Description |
For this web-based behavioral intervention trial aimed at improving lifestyle behaviors of individuals at higher risk for cancer, other comorbidities and functional decline, 652 cancer survivors (a large proportion of whom will be age 65 or over, rural, and of minority status) will be enrolled and randomly assigned to one of the following study arms: 1) A diet and exercise intervention which would begin immediately, with the first 6 months focused on promoting healthful changes in diet consistent with the American Institute for Cancer Research Guidelines and designed to invoke an average weight loss of one pound per week, and the second 6 months focused on increasing physical activity. The 163 cancer survivors assigned to this arm would be evaluated at baseline, 6-, 12- and 18-months; 2) An exercise and diet intervention which would begin immediately, with the first 6 months focused on increasing physical activity, and the second 6 months focused on promoting healthful changes in diet consistent with the American Institute for Cancer Research Guidelines and designed to invoke an average weight loss of one pound per week. The 163 cancer survivors assigned to this arm would be evaluated at baseline, 6-, 12- and 18-months; and 3) A 12-month combined diet and exercise intervention focused on promoting healthful changes in diet consistent with the American Institute for Cancer Research Guidelines and designed to invoke an average weight loss of one pound per week, while at the same time promoting physical activity. The 326 cancer survivors assigned to this arm would receive the intervention after a 6-month delay and will be evaluated at baseline, 6-, 12-, 18- and 24-months. Weight status, waist circumference, body composition, diet quality, physical activity, physical performance, quality of life, comorbidity, and health utilities will be measured at baseline and each follow-up time point, as will mediators of behavior change, e.g., social support, self-efficacy and barriers. Additionally, phlebotomy will be performed and biospecimens stored for future analysis. It is hypothesized that cancer survivors assigned to all three of these study arm will experience significant improvements in weight status, body composition, diet quality, physical activity, physical performance, and quality of life. These improvements also will translate into lower health utility scores and prove cost effective. It also is anticipated that analyses will uncover significant mediators, such as self-efficacy, and moderators, such as level of educational attainment associated with program efficacy. Finally, we hypothesize that while all study arms will experience significant benefit, the sequenced arm participants (arms 1 and 2) will have significantly greater odds of achieving improved diet quality, weight loss, and moderate intensity aerobic physical activity of at least 150 minutes a week as measured by accelerometer) post-intervention than survivors randomized to the simultaneous arm. |
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Study Type ICMJE | Interventional | ||||||||||||||||||
Study Phase ICMJE | Not Applicable | ||||||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Participants will participate in one of three arms:
Masking Description: Single blinded trial in which the study participant and select individuals in the research team (i.e., interventionists) will be aware of randomization status, but the assessors and investigators will not. Primary Purpose: Supportive Care
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||||
Recruitment Status ICMJE | Recruiting | ||||||||||||||||||
Estimated Enrollment ICMJE |
652 | ||||||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||||||||
Estimated Study Completion Date ICMJE | July 1, 2024 | ||||||||||||||||||
Estimated Primary Completion Date | July 1, 2024 (Final data collection date for primary outcome measure) | ||||||||||||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 50 Years and older (Adult, Older Adult) | ||||||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||||||||||||
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Administrative Information | |||||||||||||||||||
NCT Number ICMJE | NCT04000880 | ||||||||||||||||||
Other Study ID Numbers ICMJE | IRB-300002068 1P01CA229997 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Yes | ||||||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Wendy Demark-Wahnefried, PhD, University of Alabama at Birmingham | ||||||||||||||||||
Study Sponsor ICMJE | University of Alabama at Birmingham | ||||||||||||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | University of Alabama at Birmingham | ||||||||||||||||||
Verification Date | October 2020 | ||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |