DepressionGlobal CALMNCT04499690

Global CALM Implementation Study

An observational study of Depression, run by University Health Network, Toronto at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Depression
What is being tested?: Managing Cancer and Living Meaningfully
Type of treatment: Lifestyle or therapy programme
How many people: 40 participants
Where: 1 siteCanada
Study dates: 17 Jun 2019to 23 Dec 2022
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Clinicians who are participating in the Global CALM Training Program.

Who may be able to join

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).

Who cannot join

Trial locations and contacts

1 site in 1 country.

Canada1 site

Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

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

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.

Read the 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
Being tested: Managing Cancer and Living Meaningfully
Keywords: Psychosocial, Behavioural Intervention, Implementation Science
Medical subject headings: Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Managing Cancer and Living MeaningfullyBehavioural
A brief, individual, manualized psychosocial intervention for patients with advanced and metastatic cancer

Study groups in NCT04499690
Study group	Role	What they receive
Global CALM Training Program Clinicians		Clinicians engaging in the CALM Training Program. Receives: Behavioral: Managing Cancer and Living Meaningfully

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Throughout study completion, every 12 months
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.
Measured: Changes from baseline, 1 Year, and 2 Years
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.
Measured: Changes from baseline, 1 Year and 2 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Jun 201923 Dec 2022

First posted5 Aug 2020
Study start17 Jun 2019
Primary completion23 Dec 2022
Study completion23 Dec 2022

Why it stopped: Study recruitment \& data collection ceased in Dec 2022 in part due to funding shortages and the impact of the COVID-19 Pandemic. 40 clinician-participants consented; 35 completed measures; no data were analyzed or published; REB was closed Nov 2024.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for DepressionStudies of the same condition, open and under way.
More trials run by University Health Network, TorontoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04499690
Sponsor's protocol ID: 18-5670
Acronym: Global CALM
Status last verified: Jul 2025
First submitted: 24 Jul 2020
Last updated: 17 Jul 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Managing Cancer and Living Meaningfully (CALM): A Global Initiative
ClinicalTrials.gov ID: NCT04499690
Acronym / sponsor ID: Global CALM / 18-5670
Conditions: Depression
Keywords: Psychosocial, Behavioural Intervention, Implementation Science
Study type: Observational
Recruitment status: TerminatedReason stopped: Study recruitment \& data collection ceased in Dec 2022 in part due to funding shortages and the impact of the COVID-19 Pandemic. 40 clinician-participants consented; 35 completed measures; no data were analyzed or published; REB was closed Nov 2024.
Enrolment: 40 participants (actual)
Lead sponsor: University Health Network, TorontoUniversity, hospital or other
Study start: 17 Jun 2019 (actual)
Primary completion: 23 Dec 2022 (actual)
Study completion: 23 Dec 2022 (actual)
First posted: 5 Aug 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Global CALM Training Program Clinicians	–	Behavioral: Managing Cancer and Living MeaningfullyClinicians engaging in the CALM Training Program.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Clinicians who are participating in the Global CALM Training Program.

Key inclusion criteria (8 listed)

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);

Key exclusion criteria (1 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Managing Cancer and Living MeaningfullyA brief, individual, manualized psychosocial intervention for patients with advanced and metastatic cancer	Behavioural	Global CALM Training Program Clinicians

Primary outcome

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.

Results and safety

The study was stopped early (reason given: Study recruitment \& data collection ceased in Dec 2022 in part due to funding shortages and the impact of the COVID-19 Pandemic. 40 clinician-participants consented; 35 completed measures; no data were analyzed or published; REB was closed Nov 2024.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.

Related trials for Depression

Recruiting
A Pilot Study to Examine the Efficacy of Internet-Delivered Skills Training in Affective and Interpersonal Regulation (i-STAIR) for Individuals With Adverse Childhood Experiences and Subsyndromal Depression
Subthreshold Depression
Recruiting
Our Voices Matter: Intervention for Depression in Youth
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Active, not recruitingPhase 4
Neural Circuit Effects of Ketamine in Depression
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Recruiting
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Not yet recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gary Rodin, MD principal investigator

University Health Network, Toronto

Sarah Hales, MD PhD principal investigator

University Health Network, Toronto

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Depression, run by University Health Network, Toronto at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Site Feasibility Metrics (time frame: Throughout study completion, every 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04499690.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.