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

Rectal Cancer Clinical Trial

— PATHWAYS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05914766
• Other study ID #: 23-115
• Status: Recruiting
• Phase: N/A
• Start date: September 21, 2023
• Est. completion date: September 2026

Study information

• Verified date: December 2023
• Source: Massachusetts General Hospital
• Contact: Kelsey Lau-Min, MD, MSCE
• Phone: 617-724-4000
• Email: klau-min[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms
• Self Efficacy

Intervention

Behavioral:
• PATHWAYS
The PATHWAYS intervention is a psychoeducational intervention comprised of three components.

Other:
• Enhanced usual care
The enhanced usual care condition consists of an information resource guide.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)