Grant Number:	1R01CA282682-01A1 Interpret this number
Primary Investigator:	Wagner, Lynne
Organization:	Univ Of North Carolina Chapel Hill
Project Title:	Randomized Controlled Trial of Fortitude: Targeted Ehealth Intervention to Reduce Fear of Recurrence Among Breast Cancer Survivors in Community Oncology Settings
Fiscal Year:	2024

PROJECT SUMMARY Fear of recurrence (FoR) is a pervasive, distressing concern among breast cancer survivors (BCS) that persists for years after cancer treatment. Long-term survivors identify help with managing FoR as their most pressing unmet need. Effective and scalable FoR interventions are needed to address the salient emotional, cognitive, and behavioral components of FoR. Cognitive behavior therapy (CBT) is well suited to address these components, but patients face many obstacles to psychosocial care due to a lack of available providers, cost, and time constraints. eHealth interventions can overcome these obstacles. We developed, refined, and evaluated FoRtitude 1.0, a 4 week targeted eHealth intervention designed to teach BCS CBT strategies to manage FoR through didactic content and interactive tools. We randomized 196 BCS with moderate or severe FoR to CBT or an attention control (health management content, HMC) and observed a significant reduction in FoR from pre-post intervention among all BCS. While we hypothesized CBT would be superior to HMC, our qualitative data indicate CBT and HMC are mechanistically distinct in reducing FoR. We also found BCS randomized to telephone-based motivational interviewing (telecoaching-MI) had higher eHealth adherence and retention compared to no telecoaching. The FoRtitude 2.0 trial addresses limitations from our last trial by enhancing intervention content through delivering CBT and HMC, adding culturally responsive content, doubling intervention duration (8 week), long- term follow-up, and more rigorously designed control conditions. We added secondary endpoints to assess healthcare utilization and a physiological marker of chronic stress: allostatic load. This phase III, randomized controlled trial (RCT) is designed to evaluate the efficacy of FoRtitude 2.0 augmented by telecoaching-MI to reduce FoR among BCS compared to two controls: an attention control and a usual care control. We will recruit a national, diverse sample of 800 BCS from NCI Community Oncology Research Program (NCORP) Community and Minority/Underserved Sites. We will stratify accrual by race to enroll 300 Black BCS and 500 non-Black BCS (Hispanic and non-Hispanic). Among female BCS with moderate or severe FoR enrolled from NCORP Sites, we propose the following Aims: Aim I. Evaluate the efficacy of FoRtitude 2.0 to reduce FoR at 3 months (1 month post-intervention) compared to attention control and usual care. Aim II. Evaluate the efficacy of FoRtitude 2.0 to improve psychological and behavioral consequences of FoR, including anxiety, depression, HRQL, and health care utilization. Exploratory Aim: Evaluate the efficacy of FoRtitude 2.0 to reduce allostatic load from baseline to 3 months compared to attention control and usual care. Findings will contribute to establishing an evidence-based scalable eHealth intervention targeting FoR that can be widely disseminated at low cost, leading to future research on the dissemination and implementation of FoRtitude among survivors of all cancer types and improving the quality of cancer survivorship.





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