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

Phase 1
Open (Enrolling)
Advanced Cancer

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Trial Information

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

See above

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.

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Outcome Measure:


Outcome Description:

Can we recruit a sufficient number (i.e., 60 patients over 9 months or 6.7 per month) of newly diagnosed advanced cancer patients? AND Can we retain a sufficient proportion of both men and women (i.e., at least 80%) with advanced cancer in all 3 trial arms to allow completion of a full study in 4 years?

Outcome Time Frame:

2 months post randomization

Safety Issue:


Principal Investigator

Melissa Henry, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Lady Davis Institute for Medical Research, Jewish General Hospital; and McGill University


Canada: Canadian Institutes of Health Research

Study ID:




Start Date:

October 2012

Completion Date:

January 2014

Related Keywords:

  • Advanced Cancer
  • Neoplasms