An Informational and Supportive Care Intervention for Patients With Locally Advanced Rectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PATHWAYS, Enhanced usual care.
- Who it may be relevant to
- Registry conditions: Rectal Cancer, Self Efficacy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
PATHWAYS: An Informational and Supportive Care Intervention for Patients With Locally Advanced Rectal Cancer
Overview
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.
Detailed description
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.
Interventions
- Behavioral PATHWAYS
The PATHWAYS intervention is a psychoeducational intervention comprised of four behavioral coaching sessions and a patient education guidebook. - Other Enhanced usual care
The enhanced usual care condition consists of an information resource guide.
Primary outcome measures
- Proportion of participants retained in the intervention (feasibility) [Time frame: 4 weeks]
Secondary outcome measures (2)
- Proportion of patients enrolled on the study (feasibility) [Time frame: 12 weeks]
- Proportion of participants reporting acceptability of the intervention (acceptability) [Time frame: 12 weeks]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Comorbid health condition that would interfere with study participation, as identified by cancer care team
- Has undergone treatment for a prior colorectal cancer
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 2 centers
- Massachusetts General Hospital — Boston
- Dana-Farber Cancer Institute — Boston
Identifiers
NCT: NCT05914766 · 23-115