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Global CALM Implementation Study (Global CALM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04499690
Recruitment Status : Enrolling by invitation
First Posted : August 5, 2020
Last Update Posted : August 5, 2020
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

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.

Condition or disease Intervention/treatment
Depression Behavioral: Managing Cancer and Living Meaningfully

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Clinicians who are participating in the Global CALM Training Program.
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:

-


Information from the National Library of Medicine

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


Locations
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Canada, Ontario
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Gary Rodin, MD University Health Network, Toronto
Principal Investigator: Sarah Hales, MD PhD University Health Network, Toronto
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT04499690    
Other Study ID Numbers: 18-5670
First Posted: August 5, 2020    Key Record Dates
Last Update Posted: August 5, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University Health Network, Toronto:
Psychosocial
Behavioural Intervention
Implementation Science
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms