PATHWAYS: An Informational and Supportive Care Intervention for Patients With Locally Advanced Rectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Proportion of participants retained in the intervention (feasibility)
研究概览
简要总结
The aim of this study is to evaluate the feasibility and acceptability of conducting a randomized trial of a brief psychoeducational intervention versus enhanced usual care for patients with locally advanced rectal cancer who are initiating neoadjuvant multimodality treatment.
详细描述
This is a randomized controlled trial that is split into two phases. Study Phase I tested 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 initiating multimodality treatment. This phase enrolled 20 participants.
Study Part 2 was initially planned as an adequately powered RCT to evaluate intervention efficacy for enhancing patient self-efficacy for managing treatment-related challenges and maintaining quality of life. Due to the substantial refinements that were made to the PATHWAYS intervention and study procedures after Study Part 1, we have elected to change Study Part 2 to a second pilot randomized controlled trial to evaluate the feasibility and acceptability of the refined PATHWAYS study among a larger group of patients (n=60).
Participants in the intervention arm will be invited to receive the PATHWAYS intervention, including 4 coaching sessions with a study clinician focused on information and support related to multimodality treatment for LARC. Participants in the control arm will receive an information resource guide that is tailored for patients with LARC.
It is expected that about 80 people will take part in this research study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥18 years
- •Within 8 weeks after documented decision to pursue multi-modality therapy for newly diagnosed LARC (i.e., stage II or III disease)
- •Able to complete study procedures English or with the assistance of an interpreter
排除标准
- •Comorbid health condition that would interfere with study participation, as identified by cancer care team
- •Has undergone treatment for a prior colorectal cancer
结局指标
主要结局
Proportion of participants retained in the intervention (feasibility)
时间窗: 4 weeks
The primary outcome will be feasibility, defined as ≥60% retention of participants over the four-week intervention.
次要结局
- Proportion of patients enrolled on the study (feasibility)(12 weeks)
- Proportion of participants reporting acceptability of the intervention (acceptability)(12 weeks)
研究者
Kelsey S. Lau-Min, MD
Principal Investigator
Massachusetts General Hospital