Adapting Multiple Behavior Interventions That Effectively Improve Cancer Survivor Health Cancer Survivor Health
AMPLIFY
Adapting MultiPLe Behavior Interventions That eFfectively Improve (AMPLIFI) Cancer Survivor Health
2 other identifiers
interventional
603
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Mar 2020
Longer than P75 for not_applicable breast-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 21, 2019
CompletedFirst Posted
Study publicly available on registry
June 27, 2019
CompletedStudy Start
First participant enrolled
March 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 29, 2025
CompletedResults Posted
Study results publicly available
July 2, 2026
CompletedJuly 2, 2026
May 1, 2026
5.1 years
June 21, 2019
March 27, 2026
June 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
Pre-intervention (Baseline), 12-month post-intervention
Body Weight
Participant body weight will be measured during an in-person or remote (Zoom) visit
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.
Pre-intervention (Baseline), 12-month post-intervention
Secondary Outcomes (12)
Waist Circumference
Pre-intervention (Baseline),12-month post-intervention
Muscle Mass With Spillage Correction
Pre-intervention (Baseline), 12-month post-intervention
Percentage Muscle Mass With Spillage Correction
Pre-intervention (Baseline), 12-month post-intervention
30 Second Chair Stand
Pre-intervention (Baseline), 12-month post-intervention
8' Get up and go
Pre-intervention (Baseline), 12-month post-intervention
- +7 more secondary outcomes
Other Outcomes (9)
Levels of Stress (Patient Reported Outcome)
Pre-intervention (Baseline), 12-month post-intervention
Circulating Biomarkers "Cholesterol"
Pre-intervention (Baseline), 12-month post-intervention
Circulating Biomarkers "HDL"
Pre-intervention (Baseline), 12-month post-intervention
- +6 more other outcomes
Study Arms (3)
Project 1: Diet-Exercise
EXPERIMENTALParticipants 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).
Project 2: Exercise-Diet
EXPERIMENTALParticipants 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).
Project 3: Combined Diet and Exercise
EXPERIMENTALParticipants 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).
Interventions
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.
Combined Diet and Exercise
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Alabama at Birminghamlead
- University of Tennesseecollaborator
- National Cancer Institute (NCI)collaborator
Study Sites (2)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
University of Tennessee Health Science Center
Memphis, Tennessee, 38163, United States
Related Publications (5)
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.
PMID: 35488238BACKGROUNDIvankova 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.
PMID: 34612832RESULTPisu 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.
PMID: 34757221RESULTRogers 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.
PMID: 37434730RESULTAgnew 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.
PMID: 36971688DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Maria Pisu
- Organization
- University of Alabama at Birmingham
Study Officials
- PRINCIPAL INVESTIGATOR
Wendy Demark-Wahnefried, PhD, RD
University of Alabama at Birmingham
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 21, 2019
First Posted
June 27, 2019
Study Start
March 4, 2020
Primary Completion
April 1, 2025
Study Completion
September 29, 2025
Last Updated
July 2, 2026
Results First Posted
July 2, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Data and samples will be made available to outside investigators after all aims of the P01 and all primary outcomes papers have been published (consonant with the NIH definition of "timely fashion." Requests for data or biologic samples will be handled on a case-by-case basis, and in consultation with the P01 principal investigators (Dr. Demark-Wahnefried) and other members of the investigative team.
- Access Criteria
- Requests for data or biologic samples will be handled on a case-by-case basis, and in consultation with the P01 principal investigators (Dr. Demark-Wahnefried) and other members of the investigative team. Individuals in receipt of data and samples must produce proof of human subjects and HIPAA training. For the transfer of biospecimens, Human Materials and Data Transfer Agreements will be established between UAB and the requesting institution. Publications resulting from the transfer of samples or data must credit the P01 grant. For data only, requesting users will be required to sign a data-use sharing agreement.
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.