Optimization of an mHealth lifestyle intervention for families with hereditary cancer syndromes: Study protocol for a multiphase optimization strategy feasibility study

Authors: BASEN-ENGQUIST, KAREN - Md Anderson Cancer Center; RABER, MARGARET - Children'S Nutrition Research Center (CNRC); STRONG, LARKIN - Md Anderson Cancer Center; SCHEMBRE, SUSAN - Md Anderson Cancer Center; LI, LIANG - Md Anderson Cancer Center; ARUN, BANU - Md Anderson Cancer Center; LU, KAREN - Md Anderson Cancer Center; YOU, NANCY - Md Anderson Cancer Center; VILAR, EDUARDO - Md Anderson Cancer Center; LYNCH, PATRICK - Md Anderson Cancer Center; FARES, SARA - Md Anderson Cancer Center; PETERSON, SUSAN - Md Anderson Cancer Center

Submitted to: Contemporary Clinical Trials
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 12/20/2021
Publication Date: 12/28/2021
Citation: Basen-Engquist, K., Raber, M., Strong, L.L., Schembre, S., Li, L., Arun, B., Lu, K., You, N., Vilar, E., Lynch, P., Fares, S., Peterson, S.K. 2021. Optimization of an mHealth lifestyle intervention for families with hereditary cancer syndromes: Study protocol for a multiphase optimization strategy feasibility study. Contemporary Clinical Trials. https://doi.org/10.1016/j.cct.2021.106662.
DOI: https://doi.org/10.1016/j.cct.2021.106662

Interpretive Summary: Many worry about one day being diagnosed with cancer, but some families are genetically predisposed to higher cancer risk. While we cannot change our genes, those with hereditary mutations may reduce cancer risk and improve prognosis through healthy eating and adequate exercise. These families are often already under healthcare surveillance, so it is important to determine which types of interventions will be most effective at improving lifestyle behaviors without adding undue burden. We developed a series of intervention strategies (social networking, coaching, text messaging, self-monitoring) to improve the diet and exercise behaviors of individuals with hereditary mutations that increase cancer risk (such as BRCA1/2). This paper details each of these strategies, the way we plan to assess them individually, and how many people have joined our study so far. Using clinical databases and social media, we enrolled 104 participants with hereditary pathogenic mutations in our study. These individuals then nominated family members to participate with them, resulting in 102 family member participants. This recruitment success suggests member of this community are highly motivated to participate in healthy living interventions and we plan to use the outcomes of this first study to eventually create diet and exercise programs tailored for those with hereditary cancer risk.

Technical Abstract: Individuals at increased hereditary risk of cancer are an important target for health promotion and cancer prevention interventions. Health-4-Families uses the Multiphase Optimization STrategy (MOST) framework and is designed to pilot digital delivery strategies for a distance-based, 16-week intervention to promote weight management, healthy diet, and increased physical activity among individuals with BRCA1/BRCA2 or DNA mismatch repair (MMR) pathogenic germline variants. This communication describes participant recruitment and the design of the Health-4-Families pilot study. Health-4-Families is a full-factorial (16 condition) randomized pilot study of four lifestyle intervention components: social networking, telephone or email coaching, text messaging, and self-monitoring. The primary outcome was feasibility and satisfaction with these study components. Participants with pathogenic germline variants were identified via clinic surveillance lists and advocacy organizations and were invited to participate with family members. All participants had to report meeting at least one of the following criteria: (1) having a BMI >= 25 kg/m2, (2) consuming <5 servings of fruit and vegetables per day, or (3) getting <150 min of moderate-to-vigorous intensity activity per week. The majority of screened potential participants with pathogenic variants (83%) were eligible; 86% of those eligible provided informed consent and 79% (n=104) completed baseline. A total of 206 family members were nominated by study participants and 49% (n=102) completed baseline. Recruitment data suggest that individuals with pathogenic germline variants, who are at increased risk for hereditary cancers, are motivated to participate in digital lifestyle interventions. This recruitment success highlights the importance of identifying and prioritizing effective and efficient intervention components for hereditary cancer families. We intend to use the outcomes of our pilot study to inform a fully-powered factorial study for this community.