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

University of Alabama at Birmingham603 enrolled

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, 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.

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 (pre-intervention), 6-, 12 (post-intervention)- 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 (pre-intervention), 6-, 12 (post-intervention)-, 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.

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Dietary Quality (Healthy Eating Index)

Participants completed two dietary recalls (one weekday and one weekend day) via telephone using a multipass method and the Nutrition Data Systems for Research (NDSR) software. The software averages the 2-day resulting data and calculates the Healthy Eating Index (HEI)-2015. The HEI indicates how closely someone's diet follows the Dietary Guidelines for Americans. The index range is 0 to 100 with an index closer to 100 indicating a healthier, well-balanced diet.

Time frame: Pre-intervention (Baseline), 12-month post-intervention

Body Weight

Participant body weight will be measured during an in-person or remote (Zoom) visit

Time frame: Pre-intervention (Baseline), 12-month post-intervention

Physical Activity (Measured by Actigraphy)

Physical activity 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.

Time frame: Pre-intervention (Baseline), 12-month post-intervention

Secondary Outcomes

Waist Circumference

Waist circumference will be measured using unmarked tapes at the level of the umbilicus during the in-person or remote assessments.

Time frame: Pre-intervention (Baseline),12-month post-intervention

Muscle Mass With Spillage Correction

Participants are provided with a 30 mg capsule of D3Cr and instructed to take the capsule 3 days prior to their assessment date. The night prior to assessment, they begin fasting and continue fasting until they produce the second urinary void of the day. During this void, a test strip is used. The strip is frozen (0 C or below) until analyzed. The outcome measure indicates kg of muscle mass.

Time frame: Pre-intervention (Baseline), 12-month post-intervention

Percentage Muscle Mass With Spillage Correction

Time frame: Pre-intervention (Baseline), 12-month post-intervention

30 Second Chair Stand

In this physical performance test the participant is instructed to sit and stand as many times as they can while crossing their arms against their shoulders for 30 seconds. the outcomes measure is the number of times participants sit and stand in 30 seconds.

Time frame: Pre-intervention (Baseline), 12-month post-intervention

8' Get up and go

In this performance test we instruct participants to start from a seated position, cross their arms against their shoulder, then, when instructed, they stand walk around the cone and come back to a seated position. The outcome measure is the number of seconds from start to end of the walk

Time frame: Pre-intervention (Baseline), 12-month post-intervention

2-minute Step Test

In this performance test, participants are instructed to step in place for 2 minutes. The outcomes measure is the number of steps within the two minutes that reach a certain height. This height is determined measuring first the distance from hip joint to top of knee, taking the half of that distance and applying it from the floor marking a that height on a wall or door frame with a sticker. Assessors spot and count steps that reach or exceed the sticker mark on the wall (every other step is counted)

Time frame: Pre-intervention (Baseline), 12-month post-intervention

Chair Sit and Reach

This physical performance test is done as follows: * Participant sits on the edge of a chair, with one leg is extended straight forward with the heel on the floor and ankle at \~90°.(The other leg remains bent with the foot flat on the floor). * Participant's hands are placed one on top of the other, and participant slowly reaches forward toward the toes of the extended leg (the test is performed on both legs, and assessor selects the most flexible side) * The outcome measure is the distance in cm from the closest finger and toe. 0 inches → fingertips touch the toe Negative (-) → Participant cannot reach toes Positive (+) → Participant reaches past toes

Time frame: Pre-intervention (Baseline), 12-month post-intervention

Back Scratch

This physical performance test of flexibility is done as follows: \- Participant stands upright and reach one hand over the shoulder and the other up the middle of the back, attempting to touch or overlap middle fingers (both sides are tried - right over left, then left over right). Outcome measure is the distance between the closest fingers (most flexible side is recorded) Scoring: 0 inches → fingertips just touch Negative (-) → fingers do not touch (gap distance) Positive (+) → fingers overlap (amount of overlap)

Time frame: Pre-intervention (Baseline), 12-month post-intervention

Physical Activity - Godin (Patient Reported Outcome)

This physical activity outcome is measured using the Godin Leisure Time Physical Activity Questionnaire which asks frequency and duration of various levels of physical activity in a week period. The resulting outcome measure (minutes per week) is the Adjusted Godin Moderate-to-Vigorous Physical Activity (MVPA) score, calculated based on reported frequency and duration of moderate and strenuous (vigorous) leisure-time activities as follows: Adjusted Godin MVPA= (frequency \* duration of moderate activity) + 2 (frequency \* duration of vigorous activity)

Time frame: Pre-intervention (Baseline), 12-month post-intervention

Quality of Life - Physical

Quality of life - physical is assessed using the PROMIS global health subscales measuring self-reported overall physical health, including physical functioning, fatigue, pain, and general health perceptions. The outcome measure is the resulting T-scores, standardized to the U.S. general population Range: (0-100) Higher T-scores indicate better global physical health The Global Physical Health score is calculated by combining responses from survey questionnaire -- raw scores are converted to T-scores via scoring manuals.

Time frame: Pre-intervention (Baseline), 12-month post-intervention

Quality of Life - Mental

Quality of life - mental is assessed using the PROMIS global health subscales measuring self-reported overall mental health, including emotional distress, psychological well-being, social satisfaction, and quality of life perceptions. The outcome measure is the resulting T-score standardized to the U.S. general population Range: (0-100) Higher T-scores indicate better global mental health

Time frame: Pre-intervention (Baseline), 12-month post-intervention

Healthcare Utilization "Any ER or Hospital Visit" (Patient Reported Outcome)

Participants will complete a healthcare utilization survey to capture physician and emergency room visits, and hospitalizations.

Time frame: Pre-intervention (Baseline), 12-month post-intervention

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

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes