Global CALM Implementation Study

NCT ID: NCT04499690

Last Updated: 2025-07-17

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-06-17
• Study Completion Date: 2022-12-23

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.

Conditions

Depression

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Global CALM Training Program Clinicians

Clinicians engaging in the CALM Training Program.

Managing Cancer and Living Meaningfully

Intervention Type: BEHAVIORAL

A brief, individual, manualized psychosocial intervention for patients with advanced and metastatic cancer

Interventions

Managing Cancer and Living Meaningfully

A brief, individual, manualized psychosocial intervention for patients with advanced and metastatic cancer

Intervention Type: BEHAVIORAL

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

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gary Rodin, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Sarah Hales, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

18-5670

Identifier Type: -

Identifier Source: org_study_id