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

Overview

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.

Full Title of Study: “Adapting MultiPLe Behavior Interventions That eFfectively Improve (AMPLIFI) Cancer Survivor Health”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 31, 2023

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.

Interventions

  • 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: Diet-Exercise
    • Diet-Exercise
  • Other: Exercise-Diet
    • Exercise-Diet
  • Other: Wait-list Control- Combined Diet and Exercise
    • Wait-list Control- Combined Diet and Exercise

Arms, Groups and Cohorts

  • 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).
  • 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).
  • 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).

Clinical Trial Outcome Measures

Primary Measures

  • Change in dietary quality and intake (Patient reported outcome).
    • Time Frame: Change from baseline to 12-months
    • Participants will complete the NCI-developed ASA24.
  • Change in body weight (Measured by study staff)
    • Time Frame: Change from baseline to 12-months
    • Participant body weight will be measured during an in-person visit with a digital scale.
  • Change in physical activity and sleep (Measured by actigraphy)
    • Time Frame: Change from baseline to 12-months
    • Physical activity and sleep will be measured objectively via blank screen accelerometers which are small devices (1×2 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.

Secondary Measures

  • Change in waist circumference (Measured by study staff)
    • Time Frame: Change from baseline to 12-months
    • Waist circumference will be measured using a measuring tape at the level of the umbilicus during the in-person assessments.
  • Change in muscle mass (Measured by the D3 creatine dilution method)
    • Time Frame: Change from baseline to 12-months
    • To assess muscle mass, three days prior to the home assessment 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.
  • Change in physical performance (Measured by study staff)
    • Time Frame: Change from baseline to 12-months
    • Participants will complete the Senior Fitness Battery during the in-person assessments, which includes chair stands, 3m walk, sit-to-stand, reaching (stretching exercises of the arms and legs, and the 2-minute step test.
  • Change in physical activity (Patient reported outcome)
    • Time Frame: Change from baseline to 12-months
    • Physical activity will be measured via validated questionnaires (e.g., the Godin Leisure Time Exercise Questionnaire).
  • Change in quality of life (Patient reported outcome)
    • Time Frame: Change from baseline to 12-months
    • Participants will complete questionnaires (PROMIS Cancer-Related Item Bank and Short Form 12) to self-report quality of life.
  • Change in healthcare utilization (Patient reported outcome)
    • Time Frame: Change from baseline to 12-months
    • Participants will complete a healthcare utilization survey to capture physician and emergency room visits, and hospitalizations.

Participating in This Clinical Trial

Inclusion Criteria

  • Age 50 years or older
  • Resident of Alabama, Mississippi, North Carolina, or Tennessee in the United States
  • Diagnosed with multiple myeloma or localized kidney or ovarian cancer; or [localized (includes in situ) through regional] breast, colorectum, endometrium, 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.
  • Higher risk for functional decline, such that self reported health "now limits them" to some degree in either "climbing several flights of stairs" or "walking more than a mile".
  • 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.
  • Consuming <2.5 cups of combined fruits and vegetables per day.
  • 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.

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Alabama at Birmingham
  • Collaborator
    • University of Tennessee Health Science Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Wendy Demark-Wahnefried, PhD, Professor – University of Alabama at Birmingham
  • Overall Official(s)
    • Wendy Demark-Wahnefried, PhD, RD, Principal Investigator, University of Alabama at Birmingham
  • Overall Contact(s)
    • Wendy Demark-Wahnefried, PhD, RD, 833-535-7934, AMPLIFY@UABMC.EDU

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