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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04000880
Acronym
AMPLIFY
Enrollment
603
Registered
2019-06-27
Start date
2020-03-04
Completion date
2025-09-29
Last updated
2026-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Cancer survivor, Lifestyle behaviors, Web-based intervention, Diet, Exercise, Weight Control, Physical Activity, Distance Medicine, Rural, Older, Minority, African American

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, 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

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.

Interventions

BEHAVIORALAdapting 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.

OTHERDiet-Exercise

Diet-Exercise

OTHERExercise-Diet

Exercise-Diet

OTHERCombined Diet and Exercise

Combined Diet and Exercise

Sponsors

University of Alabama at Birmingham
Lead SponsorOTHER
University of Tennessee
CollaboratorOTHER
National Cancer Institute (NCI)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Caregiver, 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.

Intervention model description

Participants will participate in one of three arms: 1. Diet followed by Exercise intervention 2. Exercise followed by Diet intervention 3. Combined Diet and Exercise intervention

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Dietary Quality (Healthy Eating Index)Pre-intervention (Baseline), 12-month post-interventionParticipants 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.
Body WeightPre-intervention (Baseline), 12-month post-interventionParticipant body weight will be measured during an in-person or remote (Zoom) visit
Physical Activity (Measured by Actigraphy)Pre-intervention (Baseline), 12-month post-interventionPhysical 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.

Secondary

MeasureTime frameDescription
Waist CircumferencePre-intervention (Baseline),12-month post-interventionWaist circumference will be measured using unmarked tapes at the level of the umbilicus during the in-person or remote assessments.
Muscle Mass With Spillage CorrectionPre-intervention (Baseline), 12-month post-interventionParticipants 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.
Percentage Muscle Mass With Spillage CorrectionPre-intervention (Baseline), 12-month post-interventionParticipants 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 percentage of body weight that is muscle mass.
30 Second Chair StandPre-intervention (Baseline), 12-month post-interventionIn 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.
8' Get up and goPre-intervention (Baseline), 12-month post-interventionIn 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
2-minute Step TestPre-intervention (Baseline), 12-month post-interventionIn 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)
Chair Sit and ReachPre-intervention (Baseline), 12-month post-interventionThis 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
Back ScratchPre-intervention (Baseline), 12-month post-interventionThis 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)
Physical Activity - Godin (Patient Reported Outcome)Pre-intervention (Baseline), 12-month post-interventionThis 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)
Quality of Life - PhysicalPre-intervention (Baseline), 12-month post-interventionQuality 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.
Quality of Life - MentalPre-intervention (Baseline), 12-month post-interventionQuality 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
Healthcare Utilization "Any ER or Hospital Visit" (Patient Reported Outcome)Pre-intervention (Baseline), 12-month post-interventionParticipants will complete a healthcare utilization survey to capture physician and emergency room visits, and hospitalizations.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORWendy Demark-Wahnefried, PhD, RD

University of Alabama at Birmingham

Baseline characteristics

Characteristic
Age, Continuous63.10 years
STANDARD_DEVIATION 7.41
Race/Ethnicity, Customized
Non-Hispanic Black
40 participants
Race/Ethnicity, Customized
Non-Hispanic White
427 participants
Race/Ethnicity, Customized
Other
24 participants
Region of Enrollment
United States
151 participants
Sex: Female, Male
Female
121 Participants
Sex: Female, Male
Male
30 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 1511 / 1510 / 301
other
Total, other adverse events
47 / 15141 / 15146 / 301
serious
Total, serious adverse events
9 / 1516 / 15110 / 301

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 3, 2026