Managing Cancer and Living Meaningfully (CALM): A Study to Evaluate the Effectiveness of a Psychological Intervention for Cancer Patients
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Managing Cancer and Living Meaningfully (CALM): A Randomized Controlled Trial of a Psychotherapeutic Intervention for Patients With Metastatic Cancer|
- Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: 6-months ] [ Designated as safety issue: No ]A reliable and valid 9-item measure of depression that has been used widely with advanced cancer patients.
- Structured Clinical Interview for DSM Disorders (SCID)-Research Version [ Time Frame: 6-months ] [ Designated as safety issue: No ]A semi-structured interview that allows researchers to make clinical diagnoses according to DSM criteria. Portions of the Mood Disorders and Optional Disorders modules will be administered: major depressive episode and minor depressive disorder.
- Generalized Anxiety Disorders-7 (GAD-7) [ Time Frame: 6-months ] [ Designated as safety issue: No ]A widely used and validated 7-item self-report measure designed to screen and assess the severity of GAD symptoms.
- Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp) [ Time Frame: 6-months ] [ Designated as safety issue: No ]A 12-item self-report measure of spiritual well-being, assessing spiritual meaning and peace, and faith, that has been widely used in palliative care research.
- Posttraumatic Growth Inventory (PTGI) [ Time Frame: 6-months ] [ Designated as safety issue: No ]A 21-item self-report scale that measures positive psychological changes after trauma. It has been used as a measure of psychological growth in cancer and as an outcome measure for intervention studies.
- Quality of Life at the End of Life-Cancer Scale (QUAL-EC) [ Time Frame: 6-months ] [ Designated as safety issue: No ]A measure of quality of life in patient populations near the end of life.
- Death and Dying Distress Scale (DADDS) [ Time Frame: 6-months ] [ Designated as safety issue: No ]A recently developed, 15-item measure assessing death anxiety in patients with advanced cancer.
- Demoralization Scale (DS) [ Time Frame: 6-months ] [ Designated as safety issue: No ]A 24-item self-report measure that assesses one aspect of existential distress, which includes loss of meaning and purpose, disheartenment and helplessness.
- Experiences in Close Relationships Inventory Modified Short Form Version (ECR-M-16) [ Time Frame: 6-months ] [ Designated as safety issue: No ]A 16-item self-report measure of attachment security.
- Couple Communication Scale (CCS) [ Time Frame: 6-months ] [ Designated as safety issue: No ]A measure for participants who are married, common-law, or in a long-term relationship. This measure is concerned with an individual's feelings, beliefs, and attitudes about the communication in his/her relationship.
- Clinical Evaluation Questionnaire (CEQ) [ Time Frame: 6-months ] [ Designated as safety issue: No ]A 7-item measure evaluating the extent to which patients felt emotionally supported by the clinical services provided.
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
|No Intervention: Usual Care|
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.
We have developed and pilot-tested a brief manualized individual psychotherapy, called Managing Cancer and Living Meaningfully (CALM), to reduce distress in cancer patients with advanced 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 metastatic cancer. 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 Hospital, University Health Network, a comprehensive cancer center in Toronto, Canada. Participants will be outpatients with metastatic cancer.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01506492
|Contact: Aubrey Chiu||(416) 340-4800 ext email@example.com|
|Contact: Tania Panday||(416) firstname.lastname@example.org|
|Princess Margaret Hospital||Recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Contact: Aubrey Chiu (416) 340-4800 ext 2708 email@example.com|
|Contact: Tania Panday (416) 340-4828 firstname.lastname@example.org|
|Principal Investigator: Gary Rodin, MD, FRCPC|
|Principal Investigator: Sarah Hales, MD, FRCPC|
|Principal Investigator:||Gary Rodin, MD, FRCPC||University Health Network, Toronto|
|Principal Investigator:||Sarah Hales, MD, FRCPC||University Health Network, Toronto|