Clinical trial NCT02583932: Randomized Controlled Trial of the Meaning-Making Intervention (MMi) In Newly Diagnosed Advanced Cancer
Official title: Randomized Controlled Trial of the Meaning-Making Intervention (MMi) In People Newly Diagnosed With Advanced Cancer: Full Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Advanced Cancer
Keywords: Randomized controlled trial
Psychological
Meaning
Existential
Quality of life
Intervention
Cancer
Advanced disease
New diagnosis
Lead sponsor: Jewish General Hospital
Sponsor class: OTHER
Collaborators: name: McGill University Health Centre/Research Institute of the McGill University Health Centre
First posted: 2015-10-22
Enrollment: 179
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Background: Psychosocial interventions are effective for all types of cancer in preventing and addressing distress and enhancing quality of life. However, most neglect existential issues. Issues of meaning and meaninglessness are especially important existential concerns for advanced cancer patients and crucial in determining their quality of life. Adaptation can be promoted and current and/or future existential crises curtailed by an early, psychologically growth-promoting intervention such as the Meaning-Making intervention (MMi)(Lee, 2006), helping patients adapt more quickly or fully, and preparing them for stormy periods ahead such as the end of life. However, it is not known whether: 1) the MMi can help patients newly diagnosed with advanced cancer; 2) it increases a sense of meaning in life; 3) its impact lasts beyond the end of the intervention; and 4) the effect shown is due to the MMi or a similar effect could be obtained by having someone listen empathically for the same amount of time as it takes to administer the MMi.

The investigators now want to test its efficacy in a full 3-arm randomized controlled trial for newly diagnosed advanced cancer patients. They will roll in the feasibility pilot study data (n=60) since it demonstrated that the initial protocol was feasible and the investigators therefore did not view or analyze the outcome data (it was viewed only by the research coordinator) and the design stayed the same (ClinicalTrials.gov Identifier: NCT01693991). .

Primary Hypothesis: Adding the MMi to usual care (experimental group) enhances meaning in life on the FACIT-Sp-12 meaning subscale among newly diagnosed advanced cancer patients, compared with those receiving usual care plus meetings with an empathic non-professional visitor (i.e., attention-control group) or usual care alone, at 2 months post-randomization. "Meaning in life" (primary outcome) is defined as the belief that one's life has significance and purpose (i.e., global meaning) and "newly diagnosed advanced cancer patient" is defined as the 6 months after first occurrence of, progression to, or recurrence of stage III or IV cancer.

Secondary hypotheses: The Experimental Group will have decreased anxiety and depression (Hospital Anxiety and Depression Scale), increased overall quality of life (McGill Quality of Life Questionnaire (MQOL) Total), existential wellbeing (MQOL Existential Wellbeing), and posttraumatic growth (Post-Traumatic Growth Inventory), compared to the Attention-Control and Usual Care groups at 2 months post-randomization. Furthermore, the MMi effects are present at 4 and 6 months post-randomization. Additional analyses: The investigators plan subgroup analyses of effect modifiers such as gender, degree of baseline perceived life-threat, initial level of psychological distress, initial level of meaning in life, and degree of experienced physical wellbeing.

Design and method: RCT with 471 newly diagnosed advanced cancer patients assigned randomly to the Experimental Group, Attention-Control, or Usual Care. Patients will complete self-report questionnaires measuring outcomes at baseline, 2, 4 and 6 months post-randomization.

Significance of the research: Advanced cancer patients are confronted with the possibility of imminent death and consequently struggle to search for meaning in their plight. An early, psychologically growth-promoting intervention is especially important for these patients to prevent further distress within a lifespan that is likely to be limited. Interventions designed to promote psychological wellbeing and enhance quality of life usually fail to address this important existential dimension and pathway to improved wellbeing. The MMi offers a promising avenue to help advanced cancer patients adjust to their diagnosis and improve their quality of life, helping them to adapt more quickly or fully. If the results of this RCT are positive, focus groups and interviews with key stakeholders indicate that it will be integrated into routine cancer care, with outreach activities designed to equip the oncology healthcare community to address meaning and existential issues in clinical practice.

Eligibility 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".

Primary outcomes:
measure: Meaning in life measured by Facit-Sp-12 meaning subscale
timeFrame: 2 months post-randomization
Secondary outcomes:
measure: Existential Wellbeing measured by McGill Quality of Life (MQOL) Existential Wellbeing subscale
timeFrame: 2 months post-randomization
measure: Anxiety and depression measured by Hospital Anxiety and Depression Scale (HADS) Total score
timeFrame: 2 months post-randomization
measure: Quality of life measured by McGill Quality of Life (MQOL) Total score
timeFrame: 2 months post-randomization
measure: Post-traumatic growth measured by Post-Traumatic Growth Inventory (PTGI) Total score
timeFrame: 2 months post-randomization
Other outcomes:
measure: All of the abovementioned outcomes
timeFrame: 4 and 6 months post-randomization
Locations:
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre (MUHC)
state: Quebec
Study officials:
affiliation: Jewish General Hospital
name: Melissa Henry, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Jewish General Hospital
name: Robin Cohen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: