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

ConditionsRectal CancerSelf Efficacy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Comorbid health condition that would interfere with study participation, as identified by cancer care team

Has undergone treatment for a prior colorectal cancer

Trial design

Design model

Parallel

Treatments tested in this trial

  • PATHWAYS

    Behavioral

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

  • Enhanced usual care

    Other intervention

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

Treatment groups

80 Participants
are divided into 4 treatment groups
Group A: Study Phase I: PATHWAYS InterventionExperimental treatment 1 intervention
Group B: Study Phase I: Enhanced Usual CareActive comparator 1 intervention
Group C: Study Phase II: PATHWAYS InterventionExperimental treatment 1 intervention
Group D: Study Phase II: Enhanced Usual CareActive comparator 1 intervention

Trial outcomes

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.

Time frame
4 weeks

Secondary outcomes

1

Proportion of patients enrolled on the study (feasibility)

A secondary feasibility outcome will be defined as ≥60% enrollment among all eligible patients

Time frame
12 weeks
2

Proportion of participants reporting acceptability of the intervention (acceptability)

A secondary outcome of acceptability will be defined as ≥80% of participants in the intervention arm reporting Client Satisfaction Questionnaire (CSQ-8) scores of ≥20 (scale from 8-32, higher scores indicate higher satisfaction).

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

Source ClinicalTrials.gov
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