Randomized Controlled Trial of the Meaning-Making Intervention (MMi)

Summary

Research questions: Pilot study research questions: Primary: 1)Can we recruit a sufficient number (i.e., at least 60 patients over 9 months) and retain a sufficient proportion of both men and women (i.e., at least 80% at 2, 4, or 6 months post-randomization) with advanced cancer in all 3 trial arms to allow completion of a full study in 4 years?; 2)Is MMi acceptable: to a general ACP? to both men and women?; Secondary: 1)Is it feasible to complete the intervention in 3-4 weeks? 2)How long is it feasible to test MMi effects: 2, 4 or 6 months post-randomization(retention rate=80%)? 3)Which recruitment strategies are most helpful? 4)What sample size is needed for a full study? Full-study research questions: Primary: Does adding the MMi to usual care (experimental group or EG) enhance meaning in life among newly diagnosed ACP, compared with those receiving usual care plus meetings with an empathic non-professional visitor (i.e., attention-control group or AC) or usual care alone (UC), at x months post-randomization? (time determined in pilot) "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 ACP" is defined as the 6 months after first occurrence of, progression toward, or recurrence of stage III or IV cancer (TNM classification system). Secondary: In our future full-study, we plan to evaluate MMi effects on secondary outcomes such as existential wellbeing (MQOL existential wellbeing) and posttraumatic growth (Post-Traumatic Growth Inventory). We also plan to test a theoretical model where sense of meaning in life has a protective (moderating) effect on tertiary outcomes such as physical QoL (MQOL physical subscale), anxiety and depression (Hospital Anxiety and Depression Scale (HADS)), and overall QoL (MQOL Total) in EG patients. Methodology: RCT pilot study with 60 newly diagnosed ACP (stages III or IV) within 2 months of referral and 6 months of randomization, assigned randomly to: (1) EG, (2) AC, or (3) UC. Patients will complete self-report questionnaires (including outcome measures, as well as sociodemographic and medical variables) at 2, 4 and 6 months post-randomization.

Conditions

• Advanced Cancer

Interventions

BEHAVIORAL

Meaning-Making intervention (MMi)

MMi and attention control sessions will take place weekly for 3 weeks at the patient's home or hospital, as the patient prefers. We will try to limit delays to no more than 1 week if needed (e.g., for recovery from treatment side-effects), but because the feasibility of this schedule is one of the research questions, if more flexibility is required we will not withdraw people from the study if the delay is longer, since a longer intervention period could be incorporated in a full-scale RCT. Dates and duration of each session will be tracked. MMi sessions will be conducted by 2 bilingual mental health professionals (nurse, social worker, or psychologist) with at least 1 year of clinical oncology experience and will be initiated within 1 week after randomization.

BEHAVIORAL

Empathic visitor

This person will provide the basic ingredients fostering a good therapeutic relationship (i.e., trust, warmth, empathy, neutrality and authenticity) without further intervention or probing. The empathic visitor will be specifically instructed to avoid initiating discussions about meaning (e.g., how the patient interprets his 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).

Sponsors & Collaborators

• Jewish General Hospital

  lead OTHER

Principal Investigators

• Melissa Henry, Ph.D. · Lady Davis Institute for Medical Research, Jewish General Hospital; and McGill University

• S Robin Cohen, Ph.D. · Lady Davis Institute for Medical Research, Jewish General Hospital; and McGill University

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

SINGLE_GROUP

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-10-31

Primary Completion

2013-12-31

Completion

2013-12-31

Countries

• Canada

Study Locations