MedTrace Logo

Randomized Controlled Trial of the Meaning-Making Intervention (MMi) In Newly Diagnosed Advanced Cancer

NCT02583932 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 179

Last updated 2021-01-08

No results posted yet for this study

Summary

To test whether the Meaning-Making intervention (MMi)(Lee, 2004) plus usual care increases the sense of meaning in life in people newly diagnosed with any type of advanced cancer, compared to similar people who receive 1) usual care alone or 2) usual care plus visits from an empathic visitor, at 2 months after randomization to one of these treatments. The investigators will also evaluate whether any effect is present at 4 and 6 months post-randomization, and the MMi's impact on anxiety/depression, quality of life, existential wellbeing, and posttraumatic growth. To answer our research questions 471 newly diagnosed (\<6 months) advanced cancer patients (stages III or IV) will be studied.

Conditions

Interventions

DRUG

Meaning-Making intervention (MMi)

The MMi is a brief, individualized and manualized therapeutic approach based on post-trauma literature and designed to facilitate a search for meaning following a cancer diagnosis.

BEHAVIORAL

Empathic Visitor

They will provide the basic ingredients for fostering a good therapeutic relationship (i.e., trust, warmth, empathy, neutrality and authenticity) without further intervention or probing.

Sponsors & Collaborators

  • McGill University Health Centre/Research Institute of the McGill University Health Centre

    collaborator OTHER

  • Jewish General Hospital

    lead OTHER

Principal Investigators

  • Melissa Henry, Ph.D. · Jewish General Hospital

  • Robin Cohen, Ph.D. · Jewish General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2020-08-31
Completion
2020-08-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02583932 on ClinicalTrials.gov