Clinical trial NCT02353546: CALM Phase 2b Pilot
Official title: Managing Cancer and Living Meaningfully (CALM): Phase 2b Pilot Randomized Psychotherapy Trial in Patients With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: affective symptoms
cancer
depression
palliative care
pilot trial
psychotherapy
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2015-02-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Managing Cancer And Living Meaningfully (CALM) is a brief psychotherapy designed to alleviate distress in advanced cancer. In an earlier intervention-only pilot trial, CALM was associated with reductions in depressive symptoms and death anxiety and an increase in spiritual wellbeing. The purpose of this study is to assess the feasibility of a large-scale randomized controlled trial (RCT) of CALM and to identify preliminary effects in advanced cancer. This phase 2b pilot RCT employed intervention and usual care arms with 3 and 6 month follow-ups. The primary outcome was depressive symptoms (PHQ-9) and secondary outcomes included diagnosis of major depression (SCID), death anxiety, attachment security and spiritual wellbeing. Multilevel regression was used to compare change over time between groups. 60 patients with advanced cancer will be recruited from the Princess Margaret Cancer Centre, Toronto, Canada, and equally randomized into intervention and usual care conditions.

Detailed description: Abstract

Background Managing Cancer And Living Meaningfully (CALM) is a brief individual psychotherapy for patients with advanced cancer. In an intervention-only phase 2a trial, CALM showed promising results, leading to the present 2b pilot, which introduces procedures for randomisation and improved rigour in preparation for a phase 3 randomised controlled trial (RCT).

Aims To test trial methodology and assess feasibility of a confirmatory RCT.

Design A parallel-arm RCT (intervention vs usual care) with 3 and 6-month follow-ups. Assessment of feasibility included rates of consent, randomisation, attrition, intervention non-compliance and usual care contamination. Primary outcome: depressive symptoms (Patient Health Questionnaire-9; PHQ-9). Secondary outcomes: major depressive disorder (MDD), generalised anxiety, death anxiety, spiritual well-being, attachment anxiety and avoidance, self-esteem, experiential avoidance, quality of life and post-traumatic growth. Bayesian conjugate analysis was used in this low-powered setting.

Setting/participants 60 adult patients with advanced cancer from the Princess Margaret Cancer Centre.

Trial registration number NCT02353546.

http://dx.doi.org/10.1136/bmjspcare-2015-000866

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Fluent in English
* Confirmed diagnosis of Stage IIIB or IV lung cancer, Stage III or IV ovarian cancer, Stage IV endocrine, breast, gastrointestinal, genitourinary or gynecologic cancer, or pancreatic cancer at any stage

Exclusion Criteria:

* Short Orientation-Memory-Concentration Test (score of \<20)
* Individuals receiving in-hospital psychiatric or psychological treatment at the time of recruitment

Primary outcomes:
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 6-months
Secondary outcomes:
measure: Major Depression Structured Clinical Interview for DSM Disorders (SCID)
timeFrame: 6-months
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: 6-months
measure: Death and Dying Distress Scale (DADDS)
timeFrame: 6-months
measure: Functional Assessment of Chronic Illness Therapy-Spiritual Well-being Scale (FACIT-Sp-12)
timeFrame: 6-months
measure: Modified Experiences in Close Relationships (ECR M-16)
timeFrame: 6-months
measure: Rosenberg Self-esteem Scale (RSES)
timeFrame: 6-months
measure: Acceptance and Action Questionnaire-II (AAQ-II)
timeFrame: 6-months
measure: Quality of Life at the End of Life-Cancer Scale (QUAL-EC)
timeFrame: 6-months
measure: Posttraumatic Growth Inventory (PTGI)
timeFrame: 6-months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Gary Rodin
role: PRINCIPAL_INVESTIGATOR
affiliation: University Health Network, Toronto
name: Sarah Hales
role: PRINCIPAL_INVESTIGATOR
affiliation: University Health Network, Toronto
name: Chris Lo
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lo C, Hales S, Chiu A, Panday T, Malfitano C, Jung J, Rydall A, Li M, Nissim R, Zimmermann C, Rodin G. Managing Cancer And Living Meaningfully (CALM): randomised feasibility trial in patients with advanced cancer. BMJ Support Palliat Care. 2019 Jun;9(2):209-218. doi: 10.1136/bmjspcare-2015-000866. Epub 2016 Jan 19.