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

• Status: Completed
• Trial end date: 2020-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jewish General Hospital
• Collaborator: McGill University Health Centre/Research Institute of the McGill University Health Centre

Criteria

Inclusion Criteria:

1. Diagnosed with advanced cancer (stage III or IV --TNM classification system); first occurrence, progression or recurrence of any type of solid tumour <4 months at referral and <4 months at randomization, as well as Hodgkin's and non-Hodgkin's lymphoma

2. Physically able (referring clinician- and self-perceived) and willing to participate in weekly MMi or attention control sessions.

3. >18 years old.

4. Alert and capable of giving free and informed consent according to the referring clinician.

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) or expected survival <6 months according to clinical judgment of physicians and/or nurses.

2. Currently experiencing severe radiotherapy side-effects. These patients will only be included in the study when they will have recovered from these severe side-effects and when they feel they can participate in the study. Severe radiotherapy 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 > 3 markers with a score of 2, as evaluated by the treating physician (in consultation with the radiotherapist).

3. Currently suicidal (present a score ≥2 on the Beck Depression Inventory suicide item, or self-reported chronic suicidal ideations in the pre-cancer diagnosis period, assessed by the Research Coordinator or Research Assistant (RA) during the consent meeting.

4. Known diagnosis of schizophrenia or schizoaffective disorder.

5. Planning a trip within 2 months that would interrupt intervention delivery.

6. Current or former therapy with Dr. Henry (the PI who already does meaning-based interventions at the Jewish General Hospital).

7. Attending or planning to attend either of the MUHC CanSupport workshops entitled " You are stronger than you think" or "Vous êtes plus fort que vous ne le pensez: Donnez un sens au cancer".

8. Previously receiving any version of the "Reflections Workbook : A self care guide to understanding the experience of cancer".