Managing Cancer and Living Meaningfully (CALM): A Randomized Controlled Trial of a Psychotherapeutic Intervention for Patients With Metastatic Cancer
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 305
- Locations
- 1
- Primary Endpoint
- Patient Health Questionnaire-9 (PHQ-9)
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •≥18 years of age
- •Fluency in English
- •Confirmed diagnosis of stage III or IV lung cancer; any stage of pancreatic cancer, unresectable cholangiocarcinoma, unresectable liver cancer, unresectable ampullary/peri-ampullary cancer, or other stage IV (metastatic) gastrointestinal cancer; stage III or IV ovarian and fallopian tube cancers, or other stage IV gynecological cancers; and stage IV breast, genitourinary, sarcoma, melanoma or endocrine cancers (all with expected survival of 12-18 months)
Exclusion Criteria
- •Major communication difficulties (including language barriers)
- •Inability to commit to the required 3-6 psychotherapy sessions
- •Cognitive impairment indicated in the medical record, or by the attending oncologist, or as indicated by a score < 20 on the Short Orientation-Memory-Concentration test, unless deemed suitable at the recruiter's discretion
- •Actively seeing a psychiatrist or psychologist in the Department of Supportive Care (formerly the Department of Psychosocial Oncology and Palliative Care) at Princess Margaret Cancer Centre at the time of study approach
Arms & Interventions
Usual Care
Usual care 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.
CALM
Patients assigned to the intervention arm will receive 3-6 CALM therapy sessions over 3-6 months delivered by a trained therapist at our center.
Intervention: CALM (Behavioral)
Outcomes
Primary Outcomes
Patient Health Questionnaire-9 (PHQ-9)
Time Frame: 6-months
A reliable and valid 9-item measure of depression that has been used widely with advanced cancer patients.
Secondary Outcomes
- Death and Dying Distress Scale (DADDS)(6-months)
- Clinical Evaluation Questionnaire (CEQ)(6-months)
- Quality of Life at the End of Life-Cancer Scale (QUAL-EC)(6-months)
- Posttraumatic Growth Inventory (PTGI)(6-months)
- Structured Clinical Interview for DSM Disorders (SCID)-Research Version(6-months)
- Generalized Anxiety Disorders-7 (GAD-7)(6-months)
- Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp)(6-months)
- Demoralization Scale (DS)(6-months)
- Experiences in Close Relationships Inventory Modified Short Form Version (ECR-M-16)(6-months)
- Couple Communication Scale (CCS)(6-months)