Randomized Controlled Trial of the Meaning-Making Intervention (MMi) in Patients Newly Diagnosed With Advanced Cancer: A Pilot Study
Meaning-Making intervention (MMi)
+ Empathic visitor
Supportive Care Study
Summary
Study start date: October 1, 2012
Actual date on which the first participant was enrolled.See above
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.60 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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.3 intervention groups are designated in this study
33.333% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboGroup III
No InterventionStudy 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
Jewish General Hospital
Montreal, Canada