Optimization of an mHealth lifestyle intervention for families with hereditary cancer syndromes: Study protocol for a multiphase optimization strategy feasibility study.
Behavior modification
Hereditary breast cancer
Hereditary ovarian cancer
Lynch syndrome
Multiphase optimization strategy
Telemedicine
Journal
Contemporary clinical trials
ISSN: 1559-2030
Titre abrégé: Contemp Clin Trials
Pays: United States
ID NLM: 101242342
Informations de publication
Date de publication:
02 2022
02 2022
Historique:
received:
23
07
2021
revised:
19
12
2021
accepted:
20
12
2021
pubmed:
1
1
2022
medline:
1
4
2022
entrez:
31
12
2021
Statut:
ppublish
Résumé
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/m 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.
Sections du résumé
BACKGROUND
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.
METHODS
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/m
RESULTS
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.
DISCUSSION
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.
Identifiants
pubmed: 34971795
pii: S1551-7144(21)00398-0
doi: 10.1016/j.cct.2021.106662
pii:
doi:
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
106662Subventions
Organisme : NCI NIH HHS
ID : P30 CA016672
Pays : United States
Informations de copyright
Copyright © 2022 Elsevier Inc. All rights reserved.