Clinical trialPhase 3Completed
Managing Cancer and Living Meaningfully (CALM): A Study to Evaluate the Effectiveness of a Psychological Intervention for Cancer Patients
Managing Cancer and Living Meaningfully (CALM): A Randomized Controlled Trial of a Psychotherapeutic Intervention for Patients With Metastatic Cancer
- Outcome
- Finished, no results posted
- Phase
- Phase 3
- Status
- Completed
- Study type
- Interventional
- Start
- January 2012
- Expected end
- October 2016
- Enrollment
- 305 participants
- Sites
- 1
- Primary outcomes
- Patient Health Questionnaire-9 (PHQ-9)
- Sponsor
- Other
- Results posted
- No
- Last update
- 27 September 2019
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Brief summary public domain (ClinicalTrials.gov)
The purpose of this study is to test the effectiveness of a brief manualized individual psychotherapy, called Managing Cancer and Living Meaningfully (CALM), to reduce distress and promote psychological well-being in patients with various types of cancer, including metastatic disease.
Detailed description public domain (ClinicalTrials.gov)
We have developed and pilot-tested a brief manualized individual psychotherapy, called Managing Cancer and Living Meaningfully (CALM), to reduce distress in patients with various types of cancer, including metastatic disease. We propose to conduct a two-arm randomized controlled trial (RCT) to test the effectiveness of CALM against usual care (UC) for the reduction of distress in patients with various types of cancer, including metastatic disease. Usual care at our center includes routine screening for depression and other distress in oncology outpatient clinics, communication of screening information to the medical treatment team, and referral as needed for non-standardized, and primarily instrumental, psychosocial care and psychiatric assessment and treatment. The design will be an unblinded RCT consisting of two conditions (CALM and UC), with a baseline assessment and follow-ups at three and six months. The trial will take place in Princess Margaret Cancer Centre, University Health Network, a comprehensive cancer center in Toronto, Canada. Participants will be outpatients with various types of cancer, including metastatic disease.
Papers 3
- Registry-listed results paperManaging Cancer and Living Meaningfully (CALM): A Randomized Controlled Trial of a Psychological Intervention for Patie… DOI 10.1200/jco.2017.77.1097↗
- Builds on itDeath talk and relief of death-related distress in patients with advanced cancer. DOI 10.1136/bmjspcare-2016-001277↗
- BackgroundManaging Cancer And Living Meaningfully (CALM): randomised feasibility trial in patients with advanced cancer. DOI 10.1136/bmjspcare-2015-000866↗
The registry lists these as results papers; in a hand check of 27 such links about 78% reported the trial’s results, so read the paper before treating it as the outcome.