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

Advanced Cancer Clinical Trial

Official title:

Randomized Controlled Trial of the Meaning-Making Intervention (MMi) in Patients Newly Diagnosed With Advanced Cancer: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01693991
• Other study ID #: 258431
• Status: Completed
• Phase: Phase 1
• First received: September 18, 2012
• Last updated: July 9, 2014
• Start date: October 2012
• Est. completion date: December 2013

Study information

• Verified date: July 2014
• Source: Jewish General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

See above

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria: 1) Diagnosed with advanced cancer (stage III or IV --TNM classification system; 117); first occurrence, progression or recurrence) of any type of solid tumour <2 months at referral and <6 months at randomization. 2) Willing to participate in weekly MMi or AC sessions. 3) >18 years. 4) Alert and capable of giving free and informed consent. 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 (RC)) or expected survival <6 months according to clinical judgment. 2) Currently receiving radiotherapy (Rx) treatment (although these patients can be reassessed after Rx). Patients will only be included in the study when they have recovered from severe side-effects from Rx and when they feel they can participate in the study. Severe 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 more than 3 markers with a score of 2 (moderate side-effects), as evaluated by the treating physician (in consultation with the radiotherapist. 3) Suicidal. Present a score of =2 on the Beck Depression Inventory (BDI) suicide item (item #9), administered by the RC or RA during the consent meeting. 4) Known diagnosis of schizophrenia or schizoaffective disorder. 5) Planning a trip within 2 months that would interrupt delivery of the MMi or AC.

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Advanced Cancer

Intervention

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.
• 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).

Locations

Country	Name	City	State
Canada	Jewish General Hospital	Montreal	Quebec
Canada	McGill University Health Centre	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Jewish General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility	Can we recruit a sufficient number (i.e., 60 patients over 9 months or 6.7 per month) of newly diagnosed advanced cancer patients? AND; Can we retain a sufficient proportion of both men and women (i.e., at least 80%) with advanced cancer in all 3 trial arms to allow completion of a full study in 4 years?	2 months post randomization	No
Primary	Acceptability	Is the MMi acceptable to at least 80% of men and women with advanced cancer, as indicated by 80% positive responses on the Pilot-Study Questionnaire (PSQ; adapted from the CSQ-8; Attkisson & Zwick, 1982) Q#7 (score 3 or 4), Q#8, and Q#9 (score 5, 6 or 7).; PSQ Q#7: Would you recommend those types of meetings to other people in your situation? 1= no, definitively not; 2= no, I don't think so; 3= yes, I think so; 4= yes, definitively PSQ Q#8: Were the meetings acceptable? PSQ Q#9: On the whole, how positive or negative was your experience of the meetings? 1= Totally negative; 2= Very negative; 3= A little negative; 4= Neutral; 5= A little positive; 6= Very positive; 7= Totally positive	2 months post-randomization	No
Secondary	Timing of the intervention	Will at least 95% of EG and AC patients complete the intervention in 3-4 weeks?	2 month post-randomization	No
Secondary	Primary evaluation time	Which evaluation time should be primary, 2, 4 or 6 months post-randomization, based on an acceptable retention rate of 80%?	6 months post-randomization	No
Secondary	Recruitment strategies	Which recruitment strategies are most effective, defined as the strategies recruiting the largest % of participants. Strategies recruiting <5% of participants will be considered unhelpful. All participants will be queried as to how they found out about the study. Recruitment strategies will include: being recruiting directly through the treating team, posted ads in recruiting oncology clinics, use of local media (newspaper and radio interviews), and creation of a website linked with the Jewish General Hospital and the McGill University Health Centre.	2 months post-randomization	No
Secondary	Sample size calculation for the full study	What is the 80% upper confidence interval for the standard deviation at baseline?	2 months post-randomization	No