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Advanced CancerPhase 1NCT01693991

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

A Phase 1 study testing Meaning-Making intervention (MMi) and Empathic visitor in people with Advanced Cancer, run by Jewish General Hospital at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Advanced Cancer
What is being tested?
Meaning-Making intervention (MMi) and Empathic visitor
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
2 sitesCanada
Study dates
Oct 2012to Dec 2013
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • McGill University Health Centre

    Montreal, Quebec, H3G 1A4

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E8

Other trials in Canada

About this study

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

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.

Read the detailed description

See above

Conditions
Advanced Cancer
Being tested
Meaning-Making intervention (MMi), Empathic visitor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Meaning-Making intervention (MMi)Behavioural

    Also called 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 visitorBehavioural

    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).

Study groups in NCT01693991
Study groupRoleWhat they receive
Meaning-Making intervention (MMi)ExperimentalPatients in this arm will be receiving the Meaning-Making intervention (MMi) as per intervention manual (Lee, 2006).
Receives: Behavioral: Meaning-Making intervention (MMi)
Empathic visitorPlacebo comparatorThis 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).
Receives: Behavioral: Empathic visitor
Control GroupNo interventionPatients in this group will only be receiving treatment as usual.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility

    1. 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
    2. 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?

    Measured: 2 months post randomization

  2. 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

    Measured: 2 months post-randomization

Secondary outcomes (4)

  1. Timing of the intervention

    Will at least 95% of EG and AC patients complete the intervention in 3-4 weeks?

    Measured: 2 month post-randomization

  2. Primary evaluation time

    Which evaluation time should be primary, 2, 4 or 6 months post-randomization, based on an acceptable retention rate of 80%?

    Measured: 6 months post-randomization

  3. 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.

    Measured: 2 months post-randomization

  4. Sample size calculation for the full study

    What is the 80% upper confidence interval for the standard deviation at baseline?

    Measured: 2 months post-randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01693991
Sponsor's protocol ID
258431
Status last verified
Jul 2014
First submitted
18 Sep 2012
Last updated
10 Jul 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Meaning-Making intervention (MMi) and Empathic visitor in people with Advanced Cancer, run by Jewish General Hospital at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility (time frame: 2 months post randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01693991.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2014.

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