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Breast CancerAMPLIFYNCT04000880

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

A study testing Adapting MultiPLe Behavior Interventions That eFfectively Improve (AMPLIFI) Cancer Survivor Health, Diet-Exercise and Exercise-Diet in people with Breast Cancer and Colorectal Cancer, run by University of Alabama at Birmingham at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
Adapting MultiPLe Behavior Interventions That eFfectively Improve (AMPLIFI) Cancer Survivor Health, Diet-Exercise and Exercise-Diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
603 participants
Where
2 sitesUnited States
Study dates
4 Mar 2020to 29 Sep 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 11Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • University of Tennessee Health Science Center

    Memphis, Tennessee, 38163

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Adapting MultiPLe Behavior Interventions That eFfectively Improve (AMPLIFI) Cancer Survivor Health, Diet-Exercise, Exercise-Diet, Combined Diet and Exercise
Keywords
Cancer survivor, Lifestyle behaviors, Web-based intervention, Diet, Exercise, Weight Control, Physical Activity, Distance Medicine, Rural, Older, Minority, African American
Medical subject headings
Breast Neoplasms, Colorectal Neoplasms, Endometrial Neoplasms, Kidney Neoplasms, Multiple Myeloma, Ovarian Neoplasms, Prostatic Neoplasms, Thyroid Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called AiM, Plan and act on LIFestYles: AMPLIFY 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.

  • Diet-ExerciseOther

    Diet-Exercise

  • Exercise-DietOther

    Exercise-Diet

  • Combined Diet and ExerciseOther

    Combined Diet and Exercise

Study groups in NCT04000880
Study groupRoleWhat they receive
Project 1: Diet-ExerciseExperimentalParticipants 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).
Receives: Behavioral: Adapting MultiPLe Behavior Interventions That eFfectively Improve (AMPLIFI) Cancer Survivor Health; Other: Combined Diet and Exercise
Project 2: Exercise-DietExperimentalParticipants 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).
Receives: Behavioral: Adapting MultiPLe Behavior Interventions That eFfectively Improve (AMPLIFI) Cancer Survivor Health; Other: Combined Diet and Exercise
Project 3: Combined Diet and ExerciseExperimentalParticipants 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).
Receives: Behavioral: Adapting MultiPLe Behavior Interventions That eFfectively Improve (AMPLIFI) Cancer Survivor Health; Other: Diet-Exercise; Other: Exercise-Diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Pre-intervention (Baseline), 12-month post-intervention

  2. Body Weight

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

    Measured: Pre-intervention (Baseline), 12-month post-intervention

  3. 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.

    Measured: Pre-intervention (Baseline), 12-month post-intervention

Secondary outcomes (12)

  1. Waist Circumference

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

    Measured: Pre-intervention (Baseline),12-month post-intervention

  2. 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.

    Measured: Pre-intervention (Baseline), 12-month post-intervention

  3. Percentage 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 percentage of body weight that is muscle mass.

    Measured: Pre-intervention (Baseline), 12-month post-intervention

  4. 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.

    Measured: Pre-intervention (Baseline), 12-month post-intervention

  5. 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

    Measured: Pre-intervention (Baseline), 12-month post-intervention

  6. 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)

    Measured: Pre-intervention (Baseline), 12-month post-intervention

  7. 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

    Measured: Pre-intervention (Baseline), 12-month post-intervention

  8. 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)

    Measured: Pre-intervention (Baseline), 12-month post-intervention

  9. 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)

    Measured: Pre-intervention (Baseline), 12-month post-intervention

  10. 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.

    Measured: Pre-intervention (Baseline), 12-month post-intervention

  11. 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

    Measured: Pre-intervention (Baseline), 12-month post-intervention

  12. 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.

    Measured: Pre-intervention (Baseline), 12-month post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2019
  2. Study start4 Mar 2020
  3. Primary completion1 Apr 2025
  4. Study completion29 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
603 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04000880
Sponsor's protocol ID
IRB-300002068
Other IDs
1P01CA229997
Acronym
AMPLIFY
Status last verified
May 2026
First submitted
21 Jun 2019
Last updated
2 Jul 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: We agree to share any remaining biospecimens, including plasma, sera, and buffy coat (some stored in RNAlater® and some stored alone). Samples will be accompanied by a limited dataset of deidentified participant data that investigators need for analyses. To facilitate the data sharing, we plan to build a central archive that will allow public access to data dictionaries and limited-access anonymized datasets. We will develop a single password protected Share Point web system so that all data dictionaries, documentation, and data accessibility will have a consistent user interface. All datasets will conform to the "Standards for Privacy of Individually Identifiable Health Information" rule of the Health Insurance Portability and Accountability Act (HIPAA). Data will be made available as either a SAS export dataset, or as a tab-delimited ASCII file.

Publications

  • Pekmezi D, Fontaine K, Rogers LQ, Pisu M, Martin MY, Schoenberger-Godwin YM, Oster RA, Kenzik K, Ivankova NV, Demark-Wahnefried W. Adapting MultiPLe behavior Interventions that eFfectively Improve (AMPLIFI) cancer survivor health: program project protocols for remote lifestyle intervention and assessment in 3 inter-related randomized controlled trials among survivors of obesity-related cancers. BMC Cancer. 2022 Apr 29;22(1):471. doi: 10.1186/s12885-022-09519-y.

    PubMed 35488238

  • Ivankova NV, Rogers LQ, Herbey II, Martin MY, Pisu M, Pekmezi D, Thompson L, Schoenberger-Godwin YM, Oster RA, Fontaine K, Anderson JL, Kenzik K, Farrell D, Demark-Wahnefried W. Features That Middle-aged and Older Cancer Survivors Want in Web-Based Healthy Lifestyle Interventions: Qualitative Descriptive Study. JMIR Cancer. 2021 Oct 6;7(4):e26226. doi: 10.2196/26226.

    PubMed 34612832

  • Pisu M, Omairi I, Hoenemeyer T, Halilova KI, Schoenberger YM, Rogers LQ, Kenzik KM, Oster RA, Ivankova NV, Pekmezi D, Fontaine K, Demark-Wahnefried W, Martin MY. Developing a virtual assessment protocol for the AMPLIFI Randomized Controlled Trial due to COVID-19: From assessing participants' preference to preparing the team. Contemp Clin Trials. 2021 Dec;111:106604. doi: 10.1016/j.cct.2021.106604. Epub 2021 Oct 29.

    PubMed 34757221

  • Rogers LQ, Pekmezi D, Schoenberger-Godwin YM, Fontaine KR, Ivankova NV, Kinsey AW, Hoenemeyer T, Martin MY, Pisu M, Farrell D, Wall J, Waugaman K, Oster RA, Kenzik K, Winters-Stone K, Demark-Wahnefried W. Using the TIDieR checklist to describe development and integration of a web-based intervention promoting healthy eating and regular exercise among older cancer survivors. Digit Health. 2023 Jun 26;9:20552076231182805. doi: 10.1177/20552076231182805. eCollection 2023 Jan-Dec.

    PubMed 37434730

  • Agnew H, Kitson S, Crosbie EJ. Interventions for weight reduction in obesity to improve survival in women with endometrial cancer. Cochrane Database Syst Rev. 2023 Mar 27;3(3):CD012513. doi: 10.1002/14651858.CD012513.pub3.

    PubMed 36971688

Questions about this trial

What is this clinical trial studying?

A study testing Adapting MultiPLe Behavior Interventions That eFfectively Improve (AMPLIFI) Cancer Survivor Health, Diet-Exercise and Exercise-Diet in people with Breast Cancer and Colorectal Cancer, run by University of Alabama at Birmingham at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dietary Quality (Healthy Eating Index) (time frame: Pre-intervention (Baseline), 12-month post-intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04000880, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.

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