RESUMO
BACKGROUND: Individuals diagnosed with melanoma before the age of 40 years (young-onset melanoma survivors) and their first-degree relatives (FDRs) are a growing population at risk for developing recurrent melanoma or new melanomas. Regular surveillance using clinical skin examination (CSE) and skin self-examination (SSE) and engagement in preventive behaviors including sun protection are recommended. Given the growing population of survivors and their families who are at increased risk, it is surprising that no behavioral interventions have been developed and evaluated to improve risk-reduction behaviors. OBJECTIVE: We describe the rationale and methodology for a randomized controlled trial evaluating the efficacy of a Facebook intervention providing information, goal setting, and peer support to increase CSE, SSE, and sun protection for young-onset melanoma survivors and their FDRs. METHODS: Overall, 577 survivors and 577 FDRs will be randomly assigned to either the Young Melanoma Family Facebook Group or the Melanoma Family Healthy Lifestyle Facebook Group condition. Participants will complete measures of CSE, SSE, and sun protection, and mediator measures of attitudes and beliefs before and after the intervention. The primary aim is to evaluate the impact of the Young Melanoma Family Facebook intervention versus the Melanoma Family Healthy Lifestyle Facebook intervention on CSE, SSE frequency and comprehensiveness, and sun protection among FDRs. The secondary aims examine the efficacy of the Young Melanoma Family Facebook intervention on survivors' SSE frequency and comprehensiveness and sun protection behaviors and mechanisms of intervention efficacy for intervention impact on FDR and survivor outcomes. The exploratory aim is to evaluate the efficacy of the 2 interventions on perceived stress, physical activity, and healthy eating. RESULTS: This project was funded by the National Institutes of Health (R01CA221854). The project began in May 2018, and recruitment started in January 2019. We anticipate completing enrollment by November 2023. Power calculations recommended a sample size of 577 survivors and 577 FDRs. Multilevel modeling treating family as the upper-level sampling unit and individual as the lower-level sampling unit will be the primary data analytic approach. Fixed effect predictors in these models will include condition, role, sex, all 2- and 3-way interactions, and covariates. CONCLUSIONS: The Young Melanoma Family Facebook intervention aims to improve primary and secondary skin cancer prevention for young-onset melanoma survivors and their family members. The intervention's delivery via a popular, freely available social media platform increases its impact because of the potential for dissemination in many contexts. If efficacious, this program could be disseminated by dermatologist practices, public health or nonprofit organizations focused on melanoma, and existing melanoma and skin cancer Facebook groups, thereby expanding its reach. This project will produce a content library of posts and a moderation guide for others. TRIAL REGISTRATION: ClinicalTrials.gov NCT03677739; https://clinicaltrials.gov/ct2/show/NCT03677739. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/39640.
RESUMO
BACKGROUND: Survivors of oral cavity and oropharyngeal cancer frequently experience difficulties in swallowing; tasting; speaking; chewing; and maintaining comfortable movements of the head, neck, and shoulder. Engagement in regular self-care can reduce further loss of function and mitigate late effects. Despite the substantial self-care requirements, there are no empirically based interventions to enhance the skills and confidence of these survivors in managing their ongoing care. OBJECTIVE: The aim of this study is to describe the rationale and methodology for a randomized controlled trial evaluating Empowered Survivor (ES) versus Springboard Beyond Cancer, a general web-based program for cancer survivors, on self-efficacy in managing care, preparedness for managing survivorship, and health-related quality of life (QOL). METHODS: This study will recruit a total of 600 individuals who were diagnosed with oral cavity or oropharyngeal cancer in the past 3 years and are currently cancer free primarily from state cancer registries; these individuals will be randomly assigned to either the ES or Springboard Beyond Cancer condition. The participants complete measures of self-efficacy in managing care, preparedness for survivorship, health-related QOL, and engagement in oral self-examination and head and neck strengthening and flexibility exercises at baseline and 2 and 6 months after baseline. The primary aim of this study is to evaluate the impact of ES versus Springboard Beyond Cancer on self-efficacy, preparedness, and health-related QOL. The secondary aim is to examine the mediators and moderators of ES's impact on self-efficacy in managing care, preparedness, and health-related QOL at 6 months. The exploratory aim is to conduct a process evaluation of ES to identify potential oncology or community settings for future implementation. RESULTS: Multilevel modeling will be used to examine whether there are significant differences between the ES and Springboard Beyond Cancer interventions over time. Mediational models will evaluate the indirect effects of ES on outcomes. Quantitative analyses will evaluate the predictors of ES use, and qualitative analyses will evaluate the preferred timing and settings for the implementation of ES. CONCLUSIONS: This randomized controlled trial evaluates a completely web-based intervention, ES, versus a general web-based program for cancer survivors, Springboard Beyond Cancer, on self-efficacy in managing care, preparedness for managing survivorship, and health-related QOL and identifies the putative mediators and moderators of the intervention's effects. If an effect on the primary outcomes is illustrated, the next step could be an implementation trial to evaluate the intervention's uptake in and impact on an oncology care setting or nonprofit organizations. TRIAL REGISTRATION: ClincalTrials.gov NCT04713449; https://clinicaltrials.gov/ct2/show/NCT04713449. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/39996.
