stage IV malignancy. Cancer that is metastasized to other organs
Conditions
Interventions
CALM includes 3-6 individual sessions of psychotherapy, each approximately 50
minutes in length, delivered over 3-6 months.
During these sessions, four themes are covered: 1) symptom management and
2) changes in self and relations with
close others
3) spiritual well-being, or sense of meaning and purpose
and 4)
preparing for the future, sustaining hope and facing mortality.
Sponsors
Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - >18 years of age - Fluency in Dutch or English - No cognitive impairment indicated in the medical record or by the treating clinician - Able to provide informed consent - diagnosis of Stage IV cancer with expected survival of 6-18 months - OR a diagnosis of stage IV non-small cell lung carcinoma with a response after 12 weeks of treatment with first line immunotherapy or targeted therapy with or without chemotherapy OR a stage IV melanoma with a response after 12 weeks of treatment with immunotherapy. Response after 12 weeks is assessed/determined by the treating physician
Exclusion criteria
Exclusion criteria: - Patients with a primary psychotic disorder or suicidal intents - Concurrent psychological or psychiatric treatment elsewhere - Lack of interest in treatment for their distress - Major communication difficulties - Inability to commit to the required 3-6 psychotherapy sessions (e.g., too ill to participate, lack of transportation, insufficient motivation to participate, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Feasibility to implement CALM and acceptability assessed with: a. the percentage of patients that consent to participate b. the percentage of patients that complete at least 3 sessions of CALM therapy after consent and complete study measures c. qualitative interviews | — |
Secondary
| Measure | Time frame |
|---|---|
| 2. Preliminary effectiveness of CALM in Dutch setting: a. Primary effectiveness outcome: Change in depressive symptoms assessed with the Patient Health Questionnaire-9 (PHQ-9) measured at baseline and at three months and six months b. The clinical evaluation questionnaire (CEQ-2) at three and six months and qualitative interviews 3. Change in psychological well-being and quality of life assessed with the Death and Dying Distress Scale (DADDS), the Experiences in Close Relationships Inventory Modified Short Term Version (ECR-M16), the Quality of Life at the End of Life-Cancer Scale (QUAL-EC), the Hospital Anxiety and Depression Scale (HADS), and the Brief Illness Perception Questionnaire (Brief IPQ). All measures are collected at the start of the intervention (baseline), at three and six months. 4. Long-term effects will be assessed in the subgroup of participants with melanoma or lung carcinoma and a favorable response on immunotherapy after 1 year with the PHQ-9, DADDS, ECR-M16, QUAL-EC, HADS and Brief IPQ. | — |
Countries
Netherlands
Outcome results
None listed