Recruiting

Psychoeducational Intervention

Sponsor:

Massachusetts General Hospital

Code:

NCT05914766

Conditions

Rectal Cancer

Self Efficacy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PATHWAYS

Enhanced usual care

Study Details

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.

Conditions

Rectal Cancer

Self Efficacy

Study ID

NCT05914766

Start date

Sep 21, 2023

Status verified date

May, 2025

Completion date

Dec, 2028

Anticipated

Primary completion date

May 21, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Ageā‰„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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

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.

experimental: Study Phase II: PATHWAYS Intervention

Participants assigned to the PATHWAYS Intervention will receive: 1) four coaching sessions and 2) a comprehensive patient education guidebook. The intervention has been modified and refined based on feedback from Study Phase I.

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.

Interventions

PATHWAYS

The PATHWAYS intervention is a psychoeducational intervention comprised of four behavioral coaching sessions and a patient education guidebook.

Enhanced usual care

The enhanced usual care condition consists of an information resource guide.

Primary outcome measure

  • Proportion of participants retained in the intervention (feasibility) [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Kelsey Lau-Min, MD, MSCE

617-724-4000klau-min@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Kelsey Lau-Min, MD, MSCE

617-724-4000klau-min@mgh.harvard.edu

Principal Investigator:

Kelsey Lau-Min, MD, MSCE

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Christo Manz, MD, MSHP

617-632-3315christopher_manz@dfci.harvard.edu

Principal Investigator:

Christopher Manz, MD, MSHP

More Information

Sponsor

Massachusetts General Hospital

Last update posted

May 18, 2025

Last verified

May, 2025

Keywords

  • total neoadjuvant therapy
  • locally advanced rectal cancer
  • self efficacy
  • psychoeducational
  • multimodality treatment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-05-18.