Adapting Multiple Behavior Interventions That Effectively Improve Cancer Survivor Health Cancer Survivor Health

Study Overview
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Brief Summary
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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, thyroid, and ovarian cancers, as well as multiple myeloma and non-Hodgkin Lymphoma. Overarching outcomes also include physical function and performance, muscle mass, quality of life, and health utilities.

Detailed Description
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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 will be evaluated at baseline, 6-, 12-, and 18-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, dried blood spots obtained from fingersticks will be analyzed for cytokines (IL-6 and hsCRP) and biomarkers of gluco- and lipid regulation, i.e., glucose, and blood lipids (TG) and insulin. It is hypothesized that cancer survivors assigned to all three of these study arms 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.

Official Title
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Adapting MultiPLe Behavior Interventions That eFfectively Improve (AMPLIFI) Cancer Survivor Health

Conditions
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Endometrial Cancer, Breast Cancer, Colorectal Cancer, Kidney Cancer, Multiple Myeloma, Ovary Cancer, Prostate Cancer, Thyroid Cancer, Non-Hodgkin Lymphoma

Intervention / Treatment
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* Behavioral: Adapting MultiPLe Behavior Interventions That eFfectively Improve (AMPLIFI) Cancer Survivor Health
* Other: Diet-Exercise
* Other: Exercise-Diet
* Other: Combined Diet and Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 50 years or older Resident of the continental United States Diagnosed with multiple myeloma, non-Hodgkin lymphoma, or localized kidney or ovarian cancer; or [localized (includes in situ) through regional] breast, colorectum, endometrium, thyroid, or prostate cancer. Completed primary treatment (surgery, radiation or chemotherapy). Active surveillance among men with prostate cancer or women with ductal carcinoma in situ is acceptable. Completion of the 8th grade of school. Able to read and write English. Normal blood pressure or those with high blood pressure for whom physician permission was granted. Community dwelling. Reside in an area that receives wireless coverage. Have an active email address or be willing to have one created for the study. Current body mass index of greater than or equal to 25 kg/m2, but less than 50 kg/m2. Current physical activity level is less than 150 minutes of moderate-to-vigorous exercise per week. Exclusion Criteria: Participation in another diet and exercise program. Evidence of progressive cancer of the eligible types. Recurrence of the eligible cancer types (exceptions are biochemical recurrence of prostate cancer). A physician has provided instruction to limit current physical activity. Pre-existing medical conditions that preclude adherence to an unsupervised weight loss intervention (e.g., pregnancy, severe orthopedic conditions, impending hip or knee replacement (within 6 months), end-stage renal disease, paralysis, dementia, blindness, unstable angina, untreated stage 3 hypertension, or recent history of heart attack, congestive heart failure or pulmonary conditions that required oxygen or hospitalization within 6 months). Second primary cancers, with the exception of non-melanoma skin cancer, or if the initial and second cancers are both deemed eligible cancers. Reside in a skilled nursing or assisted living facility.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will participate in one of three arms: Diet followed by Exercise intervention Exercise followed by Diet intervention Combined Diet and Exercise intervention
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Project 1: Diet-Exercise<br>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). | Behavioral: Adapting MultiPLe Behavior Interventions That eFfectively Improve (AMPLIFI) Cancer Survivor Health<br>* 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.<br>* Other names: AiM, Plan and act on LIFestYles: AMPLIFY Survivor Health;Other: Combined Diet and Exercise<br>* Combined Diet and Exercise<br>|
| Experimental: Project 2: Exercise-Diet<br>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). | Behavioral: Adapting MultiPLe Behavior Interventions That eFfectively Improve (AMPLIFI) Cancer Survivor Health<br>* 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.<br>* Other names: AiM, Plan and act on LIFestYles: AMPLIFY Survivor Health;Other: Combined Diet and Exercise<br>* Combined Diet and Exercise<br>|
| Experimental: Project 3: Combined Diet and Exercise<br>Participants will receive 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). | Behavioral: Adapting MultiPLe Behavior Interventions That eFfectively Improve (AMPLIFI) Cancer Survivor Health<br>* 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.<br>* Other names: AiM, Plan and act on LIFestYles: AMPLIFY Survivor Health;Other: Diet-Exercise<br>* Diet-Exercise<br>Other: Exercise-Diet<br>* Exercise-Diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in dietary quality and intake (Patient reported outcome). | Participants will complete two dietary recalls (one weekday and one weekend day) | Baseline | 
| Change in dietary quality and intake (Patient reported outcome). | Participants will complete two dietary recalls (one weekday and one weekend day) | 6 months | 
| Change in dietary quality and intake (Patient reported outcome). | Participants will complete two dietary recalls (one weekday and one weekend day) | 12 months | 
| Change in dietary quality and intake (Patient reported outcome). | Participants will complete two dietary recalls (one weekday and one weekend day) | 18 months | 
| Change in dietary quality and intake (Patient reported outcome). | Participants will complete two dietary recalls (one weekday and one weekend day) | 24 months | 
| Change in body weight | Participant body weight will be measured during an in-person or remote (Zoom) visit | Baseline | 
| Change in body weight | Participant body weight will be measured during an in-person or remote (Zoom) visit | 6 months | 
| Change in body weight | Participant body weight will be measured during an in-person or remote (Zoom) visit | 12 months | 
| Change in body weight | Participant body weight will be measured during an in-person or remote (Zoom) visit | 18 months | 
| Change in body weight | Participant body weight will be measured during an in-person or remote (Zoom) visit | 24 months | 
| Change in physical activity and sleep (Measured by actigraphy) | Physical activity and sleep will be measured objectively via blank screen accelerometers which are small devices (1x2 inches) that will be worn at the waist during waking hours and switched to a wrist band during sleep for a 7-day period at each assessment point. | Baseline | 
| Change in physical activity and sleep (Measured by actigraphy) | Physical activity and sleep will be measured objectively via blank screen accelerometers which are small devices (1x2 inches) that will be worn at the waist during waking hours and switched to a wrist band during sleep for a 7-day period at each assessment point. | 6 months | 
| Change in physical activity and sleep (Measured by actigraphy) | Physical activity and sleep will be measured objectively via blank screen accelerometers which are small devices (1x2 inches) that will be worn at the waist during waking hours and switched to a wrist band during sleep for a 7-day period at each assessment point. | 12 months | 
| Change in physical activity and sleep (Measured by actigraphy) | Physical activity and sleep will be measured objectively via blank screen accelerometers which are small devices (1x2 inches) that will be worn at the waist during waking hours and switched to a wrist band during sleep for a 7-day period at each assessment point. | 18 months | 
| Change in physical activity and sleep (Measured by actigraphy) | Physical activity and sleep will be measured objectively via blank screen accelerometers which are small devices (1x2 inches) that will be worn at the waist during waking hours and switched to a wrist band during sleep for a 7-day period at each assessment point. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in waist circumference | Waist circumference will be measured using unmarked tapes at the level of the umbilicus during the in-person or remote assessments. | Baseline | 
| Change in waist circumference | Waist circumference will be measured using an unmarked tape at the level of the umbilicus during the in-person or remote assessments. | 6 months | 
| Change in waist circumference | Waist circumference will be measured using an unmarked tape at the level of the umbilicus during in-person or remote assessments. | 12 months | 
| Change in waist circumference | Waist circumference will be measured using an marked tape at the level of the umbilicus during the in-person or remote assessments. | 18 months | 
| Change in waist circumference | Waist circumference will be measured using an unmarked tape at the level of the umbilicus during the in-person or remote assessments. | 24 months | 
| Change in muscle mass (Measured by the D3 creatine dilution method) | To assess muscle mass, participants will take a capsule containing deuterium-labelled creatine [creatine is a substance commonly found in protein-containing foods and deuterium is a naturally-occurring element], the administration of which is proven as safe with several studies conducted in humans across the lifespan from pre-term infants to elders and will use a urine test strip 3 days later on their 2nd void of the day | Baseline | 
| Change in muscle mass (Measured by the D3 creatine dilution method) | To assess muscle mass, participants will take a capsule containing deuterium-labelled creatine [creatine is a substance commonly found in protein-containing foods and deuterium is a naturally-occurring element], the administration of which is proven as safe with several studies conducted in humans across the lifespan from pre-term infants to elders and will use a urine test strip 3 days later on their 2nd void of the day | 6 months | 
| Change in muscle mass (Measured by the D3 creatine dilution method) | To assess muscle mass, participants will take a capsule containing deuterium-labelled creatine [creatine is a substance commonly found in protein-containing foods and deuterium is a naturally-occurring element], the administration of which is proven as safe with several studies conducted in humans across the lifespan from pre-term infants to elders and will use a urine test strip 3 days later on their 2nd void of the day | 12 months | 
| Change in muscle mass (Measured by the D3 creatine dilution method) | To assess muscle mass, participants will take a capsule containing deuterium-labelled creatine [creatine is a substance commonly found in protein-containing foods and deuterium is a naturally-occurring element], the administration of which is proven as safe with several studies conducted in humans across the lifespan from pre-term infants to elders and will use a urine test strip 3 days later on their 2nd void of the day | 18 months | 
| Change in muscle mass (Measured by the D3 creatine dilution method) | To assess muscle mass, participants will take a capsule containing deuterium-labelled creatine [creatine is a substance commonly found in protein-containing foods and deuterium is a naturally-occurring element], the administration of which is proven as safe with several studies conducted in humans across the lifespan from pre-term infants to elders and will use a urine test strip 3 days later on their 2nd void of the day | 24 months | 
| Change in physical performance | Participants will complete the Senior Fitness Battery during the in-person or remote assessments, which includes chair stands, 3m walk, 8' up and go, balance testing (side-by-side, semi-tandem and tandem stances), reaching (stretching exercises of the arms and legs, and the 2-minute step test. | Baseline | 
| Change in physical performance | Participants will complete the Senior Fitness Battery during the in-person or remote assessments, which includes chair stands, 3m walk, 8' up and go, balance testing (side-by-side, semi-tandem and tandem stances), reaching (stretching exercises of the arms and legs, and the 2-minute step test. | 6 Months | 
| Change in physical performance | Participants will complete the Senior Fitness Battery during the in-person or remote assessments, which includes chair stands, 3m walk, 8' up and go, balance testing (side-by-side, semi-tandem and tandem stances), reaching (stretching exercises of the arms and legs, and the 2-minute step test. | 12 months | 
| Change in physical performance | Participants will complete the Senior Fitness Battery during the in-person or remote assessments, which includes chair stands, 3m walk, 8' up and go, balance testing (side-by-side, semi-tandem and tandem stances), reaching (stretching exercises of the arms and legs, and the 2-minute step test. | 18 months | 
| Change in physical performance | Participants will complete the Senior Fitness Battery during the in-person or remote assessments, which includes chair stands, 3m walk, 8' up and go, balance testing (side-by-side, semi-tandem and tandem stances), reaching (stretching exercises of the arms and legs, and the 2-minute step test. | 24 months | 
| Change in physical activity (Patient reported outcome) | Physical activity will be measured via validated questionnaires (e.g., the Godin Leisure Time Physical Activity and the Global Physical Activity Questionnaires). | Baseline | 
| Change in physical activity (Patient reported outcome) | Physical activity will be measured via validated questionnaires (e.g., the Godin Leisure Time Physical Activity and the Global Physical Activity Questionnaires). | 3 months | 
| Change in physical activity (Patient reported outcome) | Physical activity will be measured via validated questionnaires (e.g., the Godin Leisure Time Physical Activity and the Global Physical Activity Questionnaires). | 6 months | 
| Change in physical activity (Patient reported outcome) | Physical activity will be measured via validated questionnaires (e.g., the Godin Leisure Time Physical Activity and the Global Physical Activity Questionnaires). | 9 months | 
| Change in physical activity (Patient reported outcome) | Physical activity will be measured via validated questionnaires (e.g., the Godin Leisure Time Physical Activity and the Global Physical Activity Questionnaires). | 12 months | 
| Change in physical activity (Patient reported outcome) | Physical activity will be measured via validated questionnaires (e.g., the Godin Leisure Time Physical Activity and the Global Physical Activity Questionnaires). | 15 months | 
| Change in physical activity (Patient reported outcome) | Physical activity will be measured via validated questionnaires (e.g., the Godin Leisure Time Physical Activity and the Global Physical Activity Questionnaires). | 18 months | 
| Change in physical activity (Patient reported outcome) | Physical activity will be measured via validated questionnaires (e.g., the Godin Leisure Time Physical Activity and the Global Physical Activity Questionnaires). | 21 months | 
| Change in physical activity (Patient reported outcome) | Physical activity will be measured via validated questionnaires (e.g., the Godin Leisure Time Physical Activity and the Global Physical Activity Questionnaires). | 24 months | 
| Change in quality of life (Patient reported outcome) | Participants will complete questionnaires (PROMIS Cancer-Related Item Bank and Short Form 12) to self-report quality of life. | Baseline | 
| Change in quality of life (Patient reported outcome) | Participants will complete questionnaires (PROMIS Cancer-Related Item Bank and Short Form 12) to self-report quality of life. | 3 Months | 
| Change in quality of life (Patient reported outcome) | Participants will complete questionnaires (PROMIS Cancer-Related Item Bank and Short Form 12) to self-report quality of life. | 6 Months | 
| Change in quality of life (Patient reported outcome) | Participants will complete questionnaires (PROMIS Cancer-Related Item Bank and Short Form 12) to self-report quality of life. | 9 Months | 
| Change in quality of life (Patient reported outcome) | Participants will complete questionnaires (PROMIS Cancer-Related Item Bank and Short Form 12) to self-report quality of life. | 12 months | 
| Change in quality of life (Patient reported outcome) | Participants will complete questionnaires (PROMIS Cancer-Related Item Bank and Short Form 12) to self-report quality of life. | 15 months | 
| Change in quality of life (Patient reported outcome) | Participants will complete questionnaires (PROMIS Cancer-Related Item Bank and Short Form 12) to self-report quality of life. | 18 months | 
| Change in quality of life (Patient reported outcome) | Participants will complete questionnaires (PROMIS Cancer-Related Item Bank and Short Form 12) to self-report quality of life. | 21 months | 
| Change in quality of life (Patient reported outcome) | Participants will complete questionnaires (PROMIS Cancer-Related Item Bank and Short Form 12) to self-report quality of life. | 24 months | 
| Change in healthcare utilization (Patient reported outcome) | Participants will complete a healthcare utilization survey to capture physician and emergency room visits, and hospitalizations. | Baseline | 
| Change in healthcare utilization (Patient reported outcome) | Participants will complete a healthcare utilization survey to capture physician and emergency room visits, and hospitalizations. | 3 months | 
| Change in healthcare utilization (Patient reported outcome) | Participants will complete a healthcare utilization survey to capture physician and emergency room visits, and hospitalizations. | 6 months | 
| Change in healthcare utilization (Patient reported outcome) | Participants will complete a healthcare utilization survey to capture physician and emergency room visits, and hospitalizations. | 9 months | 
| Change in healthcare utilization (Patient reported outcome) | Participants will complete a healthcare utilization survey to capture physician and emergency room visits, and hospitalizations. | 12 months | 
| Change in healthcare utilization (Patient reported outcome) | Participants will complete a healthcare utilization survey to capture physician and emergency room visits, and hospitalizations. | 15 months | 
| Change in healthcare utilization (Patient reported outcome) | Participants will complete a healthcare utilization survey to capture physician and emergency room visits, and hospitalizations. | 18 months | 
| Change in healthcare utilization (Patient reported outcome) | Participants will complete a healthcare utilization survey to capture physician and emergency room visits, and hospitalizations. | 21 months | 
| Change in healthcare utilization (Patient reported outcome) | Participants will complete a healthcare utilization survey to capture physician and emergency room visits, and hospitalizations. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer survivor, Lifestyle behaviors, Web-based intervention, Diet, Exercise, Weight Control, Physical Activity, Distance Medicine, Rural, Older, Minority, African American