Global CALM Implementation Study (Global CALM)
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|ClinicalTrials.gov Identifier: NCT04499690|
Recruitment Status : Enrolling by invitation
First Posted : August 5, 2020
Last Update Posted : August 5, 2020
|Condition or disease||Intervention/treatment|
|Depression||Behavioral: Managing Cancer and Living Meaningfully|
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 Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Managing Cancer and Living Meaningfully (CALM): A Global Initiative|
|Actual Study Start Date :||June 17, 2019|
|Estimated Primary Completion Date :||June 17, 2023|
|Estimated Study Completion Date :||June 17, 2023|
Global CALM Training Program Clinicians
Clinicians engaging in the CALM Training Program.
Behavioral: Managing Cancer and Living Meaningfully
A brief, individual, manualized psychosocial intervention for patients with advanced and metastatic cancer
- Change in Site Feasibility Metrics [ Time Frame: Throughout study completion, every 12 months ]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.
- Change in Confidence in Therapy - Oncology Questionnaire [ Time Frame: Changes from baseline, 1 Year, and 2 Years ]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.
- Change in Supervision Evaluation Questionnaire [ Time Frame: Changes from baseline, 1 Year and 2 Years ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04499690
|Princess Margaret Cancer Centre|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Gary Rodin, MD||University Health Network, Toronto|
|Principal Investigator:||Sarah Hales, MD PhD||University Health Network, Toronto|