Global CALM Implementation Study

Depression Clinical Trial

— Global CALM  

Official title:

Managing Cancer and Living Meaningfully (CALM): A Global Initiative

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04499690
• Other study ID #: 18-5670
• Status: Active, not recruiting
• Start date: June 17, 2019
• Est. completion date: December 1, 2024

Study information

• Verified date: December 2023
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Depression

Intervention

Behavioral:
• Managing Cancer and Living Meaningfully
A brief, individual, manualized psychosocial intervention for patients with advanced and metastatic cancer

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Site Feasibility Metrics	The Global CALM Program's site lead will complete site feasibility metrics, which include measures of reach (e.g. # clinicians engaged in CALM training, # of CALM-related research projects), effectiveness (e.g. CALM treatment integrity and supervision evaluation ratings), adoption (e.g. # of patients being seen for CALM), implementation (e.g. # of completed CALM cases, # CALM certified therapists), and maintenance. This measure is completed annually throughout the site's engagement in the CALM Program.	Throughout study completion, every 12 months
Primary	Change in Confidence in Therapy - Oncology Questionnaire	The Confidence with Therapy - Oncology Questionnaire (CTO) is a 14-item Likert-type questionnaire used to assess a therapists' level of confidence in the delivery of psychotherapy to patients who are living with advanced cancer. This questionnaire will be administered to participating clinicians who partake in case supervision, at baseline, 1 year, and 2 years.	Changes from baseline, 1 Year, and 2 Years
Primary	Change in Supervision Evaluation Questionnaire	The CALM Supervision Evaluation Questionnaire is a 30-item questionnaire evaluating CALM supervision meetings. Adapted from the works of Spiegel and Spira (1991), Arcinue (2002), Winstanley (2000), and Cliffe et al. (2016), this questionnaire evaluates the perceived feasibility, acceptability and efficacy of supervision, the extent to which the supervision adhered to CALM therapy protocol, and the overall experience of participating in group supervision. This questionnaire will be administered to clinicians who partake in case supervision, at the 1- and 2-year time points.	Changes from baseline, 1 Year and 2 Years