Spots Global Cancer Trial Database for An Informational and Supportive Care Intervention for Patients With Locally Advanced Rectal Cancer

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Trial Identification

Brief Title: An Informational and Supportive Care Intervention for Patients With Locally Advanced Rectal Cancer

Official Title: PATHWAYS: An Informational and Supportive Care Intervention to Enhance Self-Efficacy for Patients With Locally Advanced Rectal Cancer

Study ID: NCT05914766

Conditions

Rectal Cancer

Self Efficacy

Interventions

PATHWAYS

Enhanced usual care

Study Description

Brief Summary: The aim of this study is to evaluate the efficacy of a brief psychoeducational intervention to improve the self-efficacy of patients with locally advanced rectal cancer who are initiating multimodality treatment (e.g., total neoadjuvant therapy).

Detailed Description: This is a randomized control trial that will be split into two phases. Study Phase I will test the feasibility and acceptability of a study evaluating a psychoeducational intervention relative to a control condition for improving self-efficacy in patients with locally advanced rectal cancer who are initiating multimodality treatment. It is expected that this phase will enroll 20 participants. Study Phase II will test the efficacy of the psychoeducational intervention after it has been refined using findings from Study Phase I. It is expected this phase will enroll 100 participants. In this study, participants will complete survey questions and will be randomly assigned to either receive the intervention (consisting of 4 coaching sessions with a study clinician, a comprehensive patient education guidebook, and a coaching session workbook) or enhanced usual care (consisting of an information resource guide for navigating information online). It is expected that about 120 people will take part in this research study.