Managing Cancer and Living Meaningfully (CALM): A Study to Evaluate the Effectiveness of a Psychological Intervention for 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.

• 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.

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 cancer patients with advanced disease.

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.

• No Intervention: Usual Care
• Experimental: CALM
  Intervention: Behavioral: CALM

Inclusion Criteria:

• ≥18 years of age
• Fluency in English
• No cognitive impairment indicated in the medical record or by the attending oncologist
• Confirmed diagnosis of "wet" stage IIIB (those not treated with curative intent) or IV lung cancer; any stage of pancreatic 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
• A score <20 on the Short Orientation-Memory-Concentration (SOMC) test, indicating cognitive impairment unless deemed suitable at recruiter's discretion
• Actively seeing a psychiatrist in the Psychosocial Oncology and Palliative Care Department at Princess Margaret Hospital at the time of study approach