An Informational and Supportive Care Intervention for Patients With Locally Advanced Rectal Cancer
PATHWAYS
PATHWAYS: An Informational and Supportive Care Intervention for Patients With Locally Advanced Rectal Cancer
1 other identifier
interventional
80
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2023
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2023
CompletedFirst Posted
Study publicly available on registry
June 22, 2023
CompletedStudy Start
First participant enrolled
September 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 21, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
May 18, 2025
May 1, 2025
4.7 years
June 13, 2023
May 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of participants retained in the intervention (feasibility)
The primary outcome will be feasibility, defined as ≥60% retention of participants over the four-week intervention.
4 weeks
Secondary Outcomes (2)
Proportion of patients enrolled on the study (feasibility)
12 weeks
Proportion of participants reporting acceptability of the intervention (acceptability)
12 weeks
Study Arms (4)
Study Phase I: PATHWAYS Intervention
EXPERIMENTALParticipants assigned to the PATHWAYS Intervention will receive: 1) four coaching sessions, 2) a comprehensive patient education guidebook, and 3) a coaching session workbook.
Study Phase I: Enhanced Usual Care
ACTIVE COMPARATORParticipants assigned to the enhanced usual care will receive: 1) an information resource guide for navigating information online.
Study Phase II: PATHWAYS Intervention
EXPERIMENTALParticipants 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.
Study Phase II: Enhanced Usual Care
ACTIVE COMPARATORParticipants assigned to the enhanced usual care will receive: 1) an information resource guide for navigating information online.
Interventions
The PATHWAYS intervention is a psychoeducational intervention comprised of four behavioral coaching sessions and a patient education guidebook.
The enhanced usual care condition consists of an information resource guide.
Eligibility Criteria
You may qualify if:
- Age≥18 years
- Within 8 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
You may not qualify if:
- Comorbid health condition that would interfere with study participation, as identified by cancer care team
- Has undergone treatment for a prior colorectal cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kelsey Lau-Min, MD, MSCE
Massachusetts General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 13, 2023
First Posted
June 22, 2023
Study Start
September 21, 2023
Primary Completion (Estimated)
May 21, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
May 18, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Partners Innovations team at link below
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.