Clinical trial · Interventional
Randomized Controlled Trial of the Meaning-Making Intervention (MMi) In Newly Diagnosed Advanced Cancer
Randomized Controlled Trial of the Meaning-Making Intervention (MMi) In People Newly Diagnosed With Advanced Cancer: Full Trial
NCT02583932CI-TRIAL-00049319completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Empathic Visitor | Behavioral | — | UNRESOLVED |
| Meaning-Making intervention (MMi) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Meaning-Making intervention (MMi)
- description
- 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. The MMi consists of 3-4 weekly sessions of 30-90 min each with an intervener (psychologist, social worker, or nurse) who provides the necessary ingredients to foster a good therapeutic alliance (i.e., trust, warmth, empathy, neutrality, and authenticity), encourages self-exploration and systematically addresses different levels of meaning (i.e., situational, global, existential, historical).
- interventionNames
- Drug: Meaning-Making intervention (MMi)
- type
- PLACEBO_COMPARATOR
- label
- Empathic Visitor (EV)
- description
- Empathic visitors will meet with patients over 3-4 weekly sessions of 30-90 minutes as in the experimental group. 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. The empathic listener will be specifically instructed to avoid initiating discussions about meaning (e.g., perspective-taking, how the patient interprets his/her 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). If the patient initiates discussions about these topics, the visitor will simply listen without further intervening.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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".
References
Publications (0)
Data not yet available
No reference posted for this study.