Clinical trial NCT04499690: Global CALM Implementation Study
Official title: Managing Cancer and Living Meaningfully (CALM): A Global Initiative
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Depression
Keywords: Psychosocial
Behavioural Intervention
Implementation Science
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinicians who are participating in the Global CALM Training Program.

Brief summary: This study seeks to evaluate the implementation of the Managing Cancer and Living Meaningfully (CALM) Program in diverse cultural settings, including its feasibility, fidelity, and acceptability. It will also assess the cross-cultural generalizability of the CALM intervention with a particular focus on patient-reported outcomes with regard to psychological well-being and quality of life.

Detailed description: CALM is a semi-structured, manualized, individual psychotherapy designed for patients with advanced cancer and their loved ones. Research conducted over the past decade has shown that CALM is a feasible, acceptable, and effective therapy for patients with advanced or metastatic cancer.

The CALM Training Program was developed to train oncology clinicians in the delivery of CALM. The training program consists of: 1) introductory workshops, which provide foundational training in the intervention; 2) advanced workshops, which support the development of advanced therapeutic skills; and 3) ongoing case supervision, delivered in small-group format, either in-person or online, which provides an opportunity for continuing improvement and refinement in the delivery of CALM.

To evaluate the implementation of the CALM Program at the clinician and organization levels, we will approach clinicians engaging in the CALM Training Program and invite them to participate in this research study, which includes completion of quantitative measures at baseline, 1 year (primary endpoint) and 2 years (study endpoint), participation in qualitative interviews, and collection of feasibility data. Implementation science frameworks will be applied to assess participants' perceived individual- and contextual-level barriers and facilitators to implementing CALM through qualitative interviews.

Sites involved in the Global CALM Program will conduct pilot studies of CALM in their setting to evaluate CALM at the patient- and caregiver-levels. We will not be involved in the collection of prospective patient- and caregiver-level data, however data will be pooled and analyzed to assess the cross-cultural generalizability of the CALM intervention.

Eligibility criteria: Inclusion Criteria:

The research team will approach clinicians who:

* have expressed interest in taking part in the Global CALM Program;
* able to deliver psychotherapeutic care according to the legislation/organizational policy that regulates their profession;
* ≥18 years of age;
* able to provide informed consent;
* fluent in English (or other language(s) in which training and supervision will be offered);
* fluent in the main language spoken in the country where their centre is located (to be able to deliver CALM sessions); and
* willing/able to engage with training in the CALM therapy and attend in-person or online supervision meetings (based on feasibility).

Exclusion Criteria:

-

Primary outcomes:
measure: Change in Site Feasibility Metrics
timeFrame: Throughout study completion, every 12 months
measure: Change in Confidence in Therapy - Oncology Questionnaire
timeFrame: Changes from baseline, 1 Year, and 2 Years
measure: Change in Supervision Evaluation Questionnaire
timeFrame: Changes from baseline, 1 Year and 2 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Gary Rodin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Health Network, Toronto
name: Sarah Hales, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: