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

  • STATUS
    Recruiting
  • End date
    Jul 1, 2024
  • participants needed
    652
  • sponsor
    University of Alabama at Birmingham
Updated on 31 July 2021
body mass index
cancer
hypertension
carcinoma
carcinoma in situ
chemotherapy regimen
cancer chemotherapy
ovarian cancer
ductal carcinoma in situ
ductal carcinoma
cancer of the ovary

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.

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.

Details
Condition Malignant neoplasm of prostate, urinary tract neoplasm, Ovarian disorder, Colorectal Cancer, Endometrial Carcinoma, Multiple Myeloma, Malignant neoplasm of kidney, Rectal disorder, Nephropathy, Uterine Cancer, Prostatic disorder, Breast Cancer, Ovarian Cancer, Lymphoproliferative Disorder, Prostate Disorders, Kidney Disease (Pediatric), Colon Cancer Screening, Prostate Cancer, Early, Recurrent, Rectal Disorders, Colon cancer; rectal cancer, Ovarian Function, Breast Cancer Diagnosis, Recurrent Ovarian Cancer, Kidney Cancer, Endometrial Cancer, Prostate Cancer, Kidney Disease, Renal Cancer, Lymphoproliferative disorders, Urologic Cancer, breast carcinoma, colorectal neoplasm, prostate carcinoma, ovarian carcinomas, cancer, ovarian, cancer ovarian, cancer of the ovary, cancer, breast, colorectal cancers, multiple myeloma (mm), ovarian tumors, cancer, renal, prostate cancers, cancer, colorectal, colorectal tumor, tumors, colorectal
Treatment Adapting MultiPLe Behavior Interventions That eFfectively Improve (AMPLIFI) Cancer Survivor Health, Diet-Exercise, Exercise-Diet, Wait-list Control- Combined Diet and Exercise, Survivorship Topics - Combined Diet and Exercise
Clinical Study IdentifierNCT04000880
SponsorUniversity of Alabama at Birmingham
Last Modified on31 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 50 years or older
Resident of the continental 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
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
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