Rectal Cancer, Self Efficacy
Conditions
Keywords
total neoadjuvant therapy, locally advanced rectal cancer, self efficacy, psychoeducational, multimodality treatment
Brief summary
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
BEHAVIORALPATHWAYS
The PATHWAYS intervention is a psychoeducational intervention comprised of four behavioral coaching sessions and a patient education guidebook.
OTHEREnhanced usual care
The enhanced usual care condition consists of an information resource guide.
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Participants will be randomized to either the intervention or enhanced usual care. Randomization will be stratified by treatment sequence (e.g., chemotherapy first vs. concurrent chemoradiation first).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age≥18 years 2. Within 8 weeks after documented decision to pursue multi-modality therapy for newly diagnosed LARC (i.e., stage II or III disease) 3. Able to complete study procedures English or with the assistance of an interpreter
Exclusion criteria
1. Comorbid health condition that would interfere with study participation, as identified by cancer care team 2. Has undergone treatment for a prior colorectal cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants retained in the intervention (feasibility) | 4 weeks | The primary outcome will be feasibility, defined as ≥60% retention of participants over the four-week intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients enrolled on the study (feasibility) | 12 weeks | A secondary feasibility outcome will be defined as ≥60% enrollment among all eligible patients |
| Proportion of participants reporting acceptability of the intervention (acceptability) | 12 weeks | A secondary outcome of acceptability will be defined as ≥80% of participants in the intervention arm reporting Client Satisfaction Questionnaire (CSQ-8) scores of ≥20 (scale from 8-32, higher scores indicate higher satisfaction). |
Countries
United States
Contacts
Primary ContactKelsey Lau-Min, MD, MSCE
Outcome results
None listed