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

NCT02583932 | Completed Phase 3

• 1 other identifier: MM-JGH-15-100
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Advanced Cancer

Keywords

Randomized controlled trial; Psychological; Meaning; Existential; Quality of life; Intervention; Cancer; Advanced disease; New diagnosis

Outcome Measures

Primary Outcomes (1)

• Meaning in life measured by Facit-Sp-12 meaning subscale

  Facit-Sp-12 meaning subscale

  2 months post-randomization

Secondary Outcomes (4)

• Existential Wellbeing measured by McGill Quality of Life (MQOL) Existential Wellbeing subscale

  2 months post-randomization

• Anxiety and depression measured by Hospital Anxiety and Depression Scale (HADS) Total score

  2 months post-randomization

• Quality of life measured by McGill Quality of Life (MQOL) Total score

  2 months post-randomization

• Post-traumatic growth measured by Post-Traumatic Growth Inventory (PTGI) Total score

  2 months post-randomization

Other Outcomes (1)

• All of the abovementioned outcomes

  4 and 6 months post-randomization

Study Arms (3)

Meaning-Making intervention (MMi)

EXPERIMENTAL

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).

Drug: Meaning-Making intervention (MMi)

Empathic Visitor (EV)

PLACEBO COMPARATOR

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.

Behavioral: Empathic Visitor

Usual Care Control Group

NO INTERVENTION

Treatment as usual in tertiary care hospital, typically medically-focused. All participants will be free to use hospital- or community-based supports, which will be tracked in all groups throughout the study by questionnaire and through a chart review. Both recruiting centres include well established psychosocial oncology services including psychiatrists, psychologists and social workers.

Interventions

Meaning-Making intervention (MMi) DRUG

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.

Also known as: MMi

Meaning-Making intervention (MMi)

Empathic Visitor BEHAVIORAL

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.

Also known as: Attention-Control

Empathic Visitor (EV)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Physically able (referring clinician- and self-perceived) and willing to participate in weekly MMi or attention control sessions.
• \>18 years old.
• Alert and capable of giving free and informed consent according to the referring clinician.
• Able to speak and read English or French.

You may not qualify if:

• 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.
• 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).
• 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.
• Known diagnosis of schizophrenia or schizoaffective disorder.
• Planning a trip within 2 months that would interrupt intervention delivery.
• Current or former therapy with Dr. Henry (the PI who already does meaning-based interventions at the Jewish General Hospital).
• 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".
• Previously receiving any version of the "Reflections Workbook : A self care guide to understanding the experience of cancer".

Sponsors & Collaborators

• Jewish General Hospital: lead
• McGill University Health Centre/Research Institute of the McGill University Health Centre: collaborator

Study Sites (2)

Jewish General Hospital

Montreal, Quebec, H3T 1E8, Canada

Location

McGill University Health Centre (MUHC)

Montreal, Quebec, H4A 3J1, Canada

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Melissa Henry, Ph.D.

  Jewish General Hospital

  PRINCIPAL INVESTIGATOR

• Robin Cohen, Ph.D.

  Jewish General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: Investigators and care providers are masked as to group assignment
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician-Scientist

Study Record Dates

• First Submitted: October 16, 2015
• First Posted: October 22, 2015
• Study Start: October 1, 2015
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: January 8, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)