Global CALM Implementation Study

Status Active, not recruiting

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Depression

Clinical Trial Details

NCT number	NCT04499690
Study type	Observational
Source	University Health Network, Toronto
Contact
Status	Active, not recruiting
Phase
Start date	June 17, 2019
Completion date	December 1, 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Global CALM Implementation Study — Global CALM

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms