Completed

Randomized Controlled Trial of the Meaning-Making Intervention (MMi) in Patients Newly Diagnosed With Advanced Cancer: A Pilot Study

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What is being tested

Meaning-Making intervention (MMi)

+ Empathic visitor

Behavioral
Who is being recruted

See all eligibility criteria
How is the trial designed

Supportive Care Study

Placebo-ControlledPhase 1
Interventional
Study Start: October 2012
See protocol details

Summary

Principal SponsorJewish General Hospital
Last updated: July 10, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2012

Actual date on which the first participant was enrolled.

See above

Principal SponsorJewish General Hospital
Last updated: July 10, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

Inclusion Criteria: 1) Diagnosed with advanced cancer (stage III or IV --TNM classification system; 117); first occurrence, progression or recurrence) of any type of solid tumour <2 months at referral and <6 months at randomization. 2) Willing to participate in weekly MMi or AC sessions. 3) >18 years. 4) Alert and capable of giving free and informed consent. 5) Able to speak and read English or French. Exclusion Criteria: 1) Karnofsky Performance Status (KPS) score <60 (rated by referring oncologists/nurses or Research Coordinator (RC)) or expected survival <6 months according to clinical judgment. 2) Currently receiving radiotherapy (Rx) treatment (although these patients can be reassessed after Rx). Patients will only be included in the study when they have recovered from severe side-effects from Rx and when they feel they can participate in the study. Severe side-effects are defined as a score of 3 or 4 on any of the site-specific toxicity markers of the Eastern Cooperative Oncology Group (ECOG) Common Toxicity Criteria or with more than 3 markers with a score of 2 (moderate side-effects), as evaluated by the treating physician (in consultation with the radiotherapist. 3) Suicidal. Present a score of ≥2 on the Beck Depression Inventory (BDI) suicide item (item #9), administered by the RC or RA during the consent meeting. 4) Known diagnosis of schizophrenia or schizoaffective disorder. 5) Planning a trip within 2 months that would interrupt delivery of the MMi or AC.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Patients in this arm will be receiving the Meaning-Making intervention (MMi) as per intervention manual (Lee, 2006).

Group II

Placebo
This person will provide the basic ingredients fostering a good therapeutic relationship (i.e., trust, warmth, empathy, neutrality and authenticity) without further intervention or probing. The empathic visitor will be specifically instructed to avoid initiating discussions about meaning (e.g., how the patient interprets his feelings and thoughts, understands his/her illness and meaning in life), and focus discussions on what is currently happening (rather than on the interface between past and present).

Group III

No Intervention
Patients in this group will only be receiving treatment as usual.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

McGill University Health Centre

Montreal, CanadaOpen McGill University Health Centre in Google Maps

Jewish General Hospital

Montreal, Canada
Completed2 Study Centers