Pancreatic Cancer Research

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

These are registry fields. A trial card, with population, design, endpoints and result direction each tied to a quote, is not in the data yet.

Ask this document

Answers come only from this document’s own text, as highlighted quotes. If it doesn’t say, you are told so instead of given a guess.

Try

Source text

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.