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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT05914766
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PATHWAYS — BEHAVIORAL
    The PATHWAYS intervention is a psychoeducational intervention comprised of four behavioral coaching sessions and a patient education guidebook.
  • Enhanced usual care — OTHER
    The enhanced usual care condition consists of an information resource guide.

Study Details

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.

Key Dates

Start date
Sep 21, 2023
Status verified
May 2025
Primary completion
May 21, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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.

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02215
Christo Manz, MD, MSHP
[email protected]
617-632-3315
Christopher Manz, MD, MSHP (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Kelsey Lau-Min, MD, MSCE
[email protected]
617-724-4000
Kelsey Lau-Min, MD, MSCE (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
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By specialty
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By research site
Dana-Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MA

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