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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Rectal Cancer, Self Efficacy

Intervention / Treatment
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* Behavioral: PATHWAYS
* Other: Enhanced usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age≥18 years Within 4 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Phase I: PATHWAYS Intervention<br>Participants assigned to the PATHWAYS Intervention will receive: 1) four coaching sessions, 2) a comprehensive patient education guidebook, and 3) a coaching session workbook. | Behavioral: PATHWAYS<br>* The PATHWAYS intervention is a psychoeducational intervention comprised of three components.<br>|
| Active Comparator: Study Phase I: Enhanced Usual Care<br>Participants assigned to the enhanced usual care will receive: 1) an information resource guide for navigating information online. | Other: Enhanced usual care<br>* The enhanced usual care condition consists of an information resource guide.<br>|
| Experimental: Study Phase II: PATHWAYS Intervention<br>Participants assigned to the PATHWAYS Intervention will receive: 1) four coaching sessions, 2) a comprehensive patient education guidebook, and 3) a coaching session workbook. | Behavioral: PATHWAYS<br>* The PATHWAYS intervention is a psychoeducational intervention comprised of three components.<br>|
| Active Comparator: Study Phase II: Enhanced Usual Care<br>Participants assigned to the enhanced usual care will receive: 1) an information resource guide for navigating information online. | Other: Enhanced usual care<br>* The enhanced usual care condition consists of an information resource guide.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants retained in the intervention (feasibility) | The primary outcome for Study Phase I will be feasibility, defined as ≥60% retention of participants over the four-week intervention. | 4 weeks (study phase I only) | 
| Self-Efficacy (CASE-Cancer) | The primary outcome for Study Phase II will be self-efficacy, assessed using the Communication and Attitudinal Self-Efficacy Scale for Cancer (CASE-Cancer). CASE-Cancer scores range from 12-48, with higher scores indicating greater self-efficacy. | 12 weeks (study phase II only) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants reporting acceptability of the intervention (acceptability) | The secondary outcome for Study Phase II will be acceptability of the intervention, defined as ≥80% of participants reporting Client Satisfaction Questionnaire (CSQ-8) scores of ≥20 (scale from 8-32, higher scores indicate higher satisfaction). | 12 weeks (study phase I only) | 
| Self-Efficacy (PROMIS) | A secondary outcome for Study Phase II will be a different measure of self-efficacy, assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy Measures for Managing Chronic Conditions. PROMIS scores range from 8-40, with higher scores indicating greater self-efficacy. | 12 weeks (study phase II only) | 
| Coping | A secondary outcome for Study Phase II will be coping, assessed using the Brief Cope (B-COPE). B-COPE scores range from 28-112, with higher scores indicating greater coping ability. | 12 weeks (study phase II only) | 
| Resilience | A secondary outcome for Study Phase II will be resilience, assessed using the Brief Resilience Scale (BRS). BRS scores range from 6-30, with higher scores indicating greater resilience. | 12 weeks (study phase II only) | 
| Social Isolation | A secondary outcome for Study Phase II will be social isolation, assessed using the Patient-Reported Outcomes Measurement Information System Social Isolation (PROMIS SI). PROMIS SI scores range from 4-20, with higher scores indicating greater social isolation. | 12 weeks (study phase II only) | 
| Decisional Regret | A secondary outcome for Study Phase II will be decisional regret, assessed using the Decision Regret Scale (DRS). DRS scores range from 5-25, with higher scores indicating greater decisional regret. | 12 weeks (study phase II only) | 
| Symptom Burden | Assessed using the Edmonton Symptom Assessment Scale (ESAS). ESAS scores range from 0-90, with higher scores indicating greater symptom burden. | 12 weeks (study phase II only) | 
| Psychological Distress | A secondary outcome for Study Phase II will be psychological distress, assessed using the Patient Health Questionnaire (PHQ-4). ESAS scores range from 0-12, with higher scores indicating greater psychological distress. | 12 weeks (study phase II only) | 
| Quality of Life (FACT-C) | A secondary outcome for Study Phase II will be quality of life, assessed using the Functional Assessment of Cancer Therapy-Colorectal (FACT-C). FACT-C scores range from 0-136, with higher scores indicating greater quality of life. | 12 weeks (study phase II only) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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total neoadjuvant therapy, locally advanced rectal cancer, self efficacy, psychoeducational, multimodality treatment