An adapted enhanced social prescribing intervention vs. usual care in the treatment of loneliness in cancer survivors: Study protocol for a feasibility pilot randomized controlled trial

INTRODUCTION: Loneliness has increased substantially in the past decade and adversely affects the health and wellbeing of cancer survivors. Cancer diagnosis and treatment can lead to profound negative changes in health status and social support. In addition to prevention and detection of recurrence and new cancers, survivorship care also requires attention to managing financial, psychological, and physical wellbeing after cancer treatment. Multiple efficacious interventions exist for loneliness, including Social Prescribing, a UK-based model that supports individuals in improving their social connections. However, none have been adapted to meet the needs and preferences of cancer survivors. DESIGN: This feasibility study protocol is reported according to the SPIRIT 2013 and 2025 statements. We adapted an efficacious Social Prescribing intervention to target loneliness in adult cancer survivors, using the ADAPT-ITT process. This protocol describes plans to conduct a feasibility study in preparation for a randomized controlled trial of the Enhanced Social Prescribing intervention. Participants will be randomized on a 1:1 ratio to usual care (brochure) or Enhanced Social Prescribing (intervention). We will recruit 36 participants from two rural and rural-serving primary care practices in the Northwest U.S.. Eligible individuals are age 18 or older, screen positive for loneliness on the 3-item UCLA Loneliness Scale, received a diagnosis of cancer in the past seven years, and speak English. The Enhanced Social Prescribing intervention meets one hour weekly for nine weeks. The primary outcome is participant-reported loneliness as measured by the UCLA Loneliness Scale. Secondary outcomes include participant reported social connection, self-efficacy, quality of life. Self-reported receipt of guideline concordant cancer survivorship care is an exploratory outcome. We will also measure Reach, Implementation, and Acceptability/Appropriateness of the Enhanced Social Support intervention. Using an intent to treat analysis, participants will be analyzed according to their assigned group. We will use linear mixed models to estimate differences between the intervention arm and control arm, and changes in outcomes over the study period. This study protocol is registered at clinicaltrials.gov (NCT07418437). ANTICIPATED RESULTS: We anticipate successful recruitment of 36 participants and delivery of the Enhanced Social Prescribing intervention to 18 participants. DISCUSSION: This study will demonstrate the feasibility of testing the Enhanced Social Prescribing intervention and provide preliminary data and procedures for a larger-scale randomized controlled trial to test the effectiveness and study the implementation of Enhanced Social Prescribing.