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

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05914766
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 3.3

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Rectal Cancer; Self Efficacy	Behavioral: PATHWAYS; Other: Enhanced usual care	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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).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)
• Primary Purpose: Supportive Care
• Official Title: PATHWAYS: An Informational and Supportive Care Intervention to Enhance Self-Efficacy for Patients With Locally Advanced Rectal Cancer
• Anticipated Study Start Date: Jun 1, 2023
• Anticipated Primary Completion Date: Jun 1, 2026
• Anticipated Study Completion Date: Jun 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study Phase I: PATHWAYS Intervention 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; The PATHWAYS intervention is a psychoeducational intervention comprised of three components.
Active Comparator: Study Phase I: Enhanced Usual Care Participants assigned to the enhanced usual care will receive: 1) an information resource guide for navigating information online.	Other: Enhanced usual care; The enhanced usual care condition consists of an information resource guide.
Experimental: Study Phase II: PATHWAYS Intervention 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; The PATHWAYS intervention is a psychoeducational intervention comprised of three components.
Active Comparator: Study Phase II: Enhanced Usual Care Participants assigned to the enhanced usual care will receive: 1) an information resource guide for navigating information online.	Other: Enhanced usual care; The enhanced usual care condition consists of an information resource guide.

Outcome Measures

Primary Outcome Measures

1. Proportion of participants retained in the intervention (feasibility) [4 weeks (study phase I only)]

   The primary outcome for Study Phase I will be feasibility, defined as ≥60% retention of participants over the four-week intervention.

2. Self-Efficacy (CASE-Cancer) [12 weeks (study phase II only)]

   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 0-130, with higher scores indicating greater self-efficacy.

Secondary Outcome Measures

1. Proportion of participants reporting acceptability of the intervention (acceptability) [12 weeks (study phase I only)]

   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).

2. Self-Efficacy (PROMIS) [12 weeks (study phase II only)]

   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.

3. Coping [12 weeks (study phase II only)]

   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.

4. Resilience [12 weeks (study phase II only)]

   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.

5. Social Isolation [12 weeks (study phase II only)]

   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.

6. Decisional Regret [12 weeks (study phase II only)]

   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.

7. Symptom Burden [12 weeks (study phase II only)]

   Assessed using the Edmonton Symptom Assessment Scale (ESAS). ESAS scores range from 0-90, with higher scores indicating greater symptom burden.

8. Psychological Distress [12 weeks (study phase II only)]

   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.

9. Quality of Life (FACT-C) [12 weeks (study phase II only)]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Age≥18 years

2. Within 4 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts General Hospital

Investigators

• Principal Investigator: Kelsey Lau-Min, MD, MSCE, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kelsey S. Lau-Min, MD, Principal Investigator, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT05914766
• Other Study ID Numbers: 23-115
• First Posted: Jun 22, 2023
• Last Update Posted: Jun 26, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Kelsey S. Lau-Min, MD, Principal Investigator, Massachusetts General Hospital: total neoadjuvant therapy; locally advanced rectal cancer; self efficacy; psychoeducational; multimodality treatment
• Additional relevant MeSH terms: Rectal Neoplasms

Study Results

No Results Posted as of Jun 26, 2023