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

Abstract

Background Scalable, multiple behavior change interventions are needed to address poor diet, inactivity, and excess adiposity among the rising number of cancer survivors. Efficacy-tested diet (RENEW) and exercise (BEAT Cancer) programs were adapted for web delivery among middle-aged and older cancer survivors for the AMPLIFI study, a National Cancer Institute-funded, multi-site, program project. Methods Throughout the continental U.S., survivors of several obesity-related cancers are being recruited for three interconnected randomized controlled trials (RCTs). Projects 1 and 2 test 6-month diet or exercise interventions versus a wait-list control condition. Upon completion of the 6-month study period, the intervention participants receive the next behavior change sequence (i.e., diet receives exercise, exercise receives diet) and the wait-list control arm initiates a 12-month combined diet and exercise intervention. Project 3 tests the efficacy of the sequential versus simultaneous interventions. Assessments occur at baseline and semi-annually for up to 2-years and include: body mass index, health behaviors (diet quality, accelerometry-assessed physical activity/sleep), waist circumference, D3 creatine-assessed muscle mass, physical performance, potential mediators/moderators of treatment efficacy, biomarkers of inflammation and metabolic regulation, health care utilization, cost, and overall health. Four shared resources support AMPLIFI RCTs: 1) Administrative; 2) Adaptation, Dissemination and Implementation; 3) Recruitment and Retention; and 4) Assessment and Analysis. Discussion Representing a new generation of RCTs, AMPLIFI will exclusively use remote technologies to recruit, intervene and assess the efficacy of the newly-adapted, web-based diet and exercise interventions and determine whether sequential or combined delivery works best for at-risk (older, rural, racial minority) cancer survivors. Trial registration ClinicalTrials.gov, NCT04000880. Registered 27 June 2019.

Physical activity in older adults with metastatic gastrointestinal cancer: a pilot and feasibility study

“…Moreover, during the COVID-19 pandemic, virtual physical functioning assessments were validated for cancer survivors, 62 and the implementation of these methods may improve the accessibility of clinical trials to older adults. 63 …”

Using the TIDieR checklist to describe development and integration of a web-based intervention promoting healthy eating and regular exercise among older cancer survivors

“…This intervention is currently being tested in three inter-related randomized controlled trials led by the University of Alabama at Birmingham and is recruiting nationwide across the United States. 14 We provide, in this Educational Piece, new methods related to development and integration of multiple behavior web-based interventions for older cancer survivors. By providing a comprehensive description of the AMPLIFY intervention design, processes, modifications, and interface with nonintervention research activities, this report complements our prior randomized study design publication.…”

“…reliable information from content experts, interactive/tailoring, flexibility regarding time and frequency of participation, privacy) informed the design of the AiM, Plan, and act on LIFestYles (AMPLIFY) Survivor Health web-based intervention. 13 , 14 …”

“…As previously described, AMPLIFY efficacy testing includes three inter-related randomized controlled trials testing the effects of a: (1) diet only module, (2) exercise only module, and (3) diet and exercise modules delivered in sequence (diet then exercise or vice versa), or concurrently (combined module) on body weight, diet quality, physical activity, and related outcomes in cancer survivors 50 years of age or older. 14 The purpose of this article is to describe the rationale, development, and content of the web-based intervention modules for AMPLIFY and, in so doing, complement our prior randomized trial description. Reporting intervention details offers an important opportunity for future researchers and intervention developers to replicate and improve upon current designs.…”

Development of the prediction model based on clinical-imaging omics: molecular typing and sentinel lymph node metastasis of breast cancer

“…Breast cancer has the highest mortality and morbidity of all tumors and cancers among women ( 1 ). Breast cancer can be divided into 4 molecular types based on gene expression profiles, and biomarkers, and the differences between the molecular types results in different clinical treatment plans and prognoses ( 2 ).…”