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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
305
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.
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Patient Health Questionnaire-9 (PHQ-9)
A reliable and valid 9-item measure of depression that has been used widely with advanced cancer patients.
Time frame: 6-months
Structured Clinical Interview for DSM Disorders (SCID)-Research Version
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.
Time frame: 6-months
Generalized Anxiety Disorders-7 (GAD-7)
A widely used and validated 7-item self-report measure designed to screen and assess the severity of GAD symptoms.
Time frame: 6-months
Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp)
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.
Time frame: 6-months
Posttraumatic Growth Inventory (PTGI)
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.
Time frame: 6-months
Quality of Life at the End of Life-Cancer Scale (QUAL-EC)
A measure of quality of life in patient populations near the end of life.
Time frame: 6-months
Death and Dying Distress Scale (DADDS)
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A recently developed, 15-item measure assessing death anxiety in patients with advanced cancer.
Time frame: 6-months
Demoralization Scale (DS)
A 24-item self-report measure that assesses one aspect of existential distress, which includes loss of meaning and purpose, disheartenment and helplessness.
Time frame: 6-months
Experiences in Close Relationships Inventory Modified Short Form Version (ECR-M-16)
A 16-item self-report measure of attachment security.
Time frame: 6-months
Couple Communication Scale (CCS)
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.
Time frame: 6-months
Clinical Evaluation Questionnaire (CEQ)
A 7-item measure evaluating the extent to which patients felt emotionally supported by the clinical services provided.
Time frame: 6-months