This study aims to 1. Assess the feasibility to implement CALM in a Dutch setting of a specialized oncology hospital, a university hospital and a psycho-oncology centre2. Research its preliminary effectiveness in these settings. 3. Explore the…
ID
Source
Brief title
Condition
- Metastases
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Psychological well-being is challenged in individuals with metastatic cancer
because of the diverse stressors and burdens associated with it, which may
result in depression, anxiety and demoralization, well before the end of life.
To address the lack of evidence-based individual therapies tailored for this
population, a brief, individual psychotherapeutic intervention has been
developed, to alleviate depression and distress and promote psychological
growth. The intervention is named Managing Cancer and Living Meaningfully
(CALM), and was shown to be more effective than care as usual in diminishing
depressive symptoms in patients with stage IV cancer.
A subgroup of patients with stage IV cancer that are treated with immunotherapy
or targeted therapy now show partial or complete remission of cancer and thus
live significantly longer than was possible only a couple of years ago.
However, the disease course remains uncertain and the patients seem to
experience distress that is in many ways similar to patients with a short life
expectancy. We hypothesize that these patients can benefit from CALM as well.
Study objective
This study aims to
1. Assess the feasibility to implement CALM in a Dutch setting of a specialized
oncology hospital, a university hospital and a psycho-oncology centre
2. Research its preliminary effectiveness in these settings.
3. Explore the possibilities to apply CALM to a group of patients with a more
chronic course of illness.
Study design
The study is designed as a feasibility study to implement an existing
psychotherapeutic intervention. A mixed methods design will be used for data
collection: a combination of quantitative and qualitative data are collected.
Intervention
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
communication with health care providers; 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.
Study burden and risks
The risk associated with participation in this study can be considered as
negligible. The burden of the study is filling out questionnaires at three time
points, which will take approximately 35 minutes at each time point. Four of
these questionnaires are directly used to monitor treatment results and to
guide the therapy. Three questionnaires are added for research purposes only
(the CEQ-2, the HADS and the IPQ). A subgroup of patients will be asked to
participate in an interview of maximum one hour, scheduled according to the
participants convenience and to fill out the same set of questionnaires after
12 months. A possible benefit of participating is to be offered CALM, which has
been shown to reduce symptoms of depression in studies conducted elsewhere. A
possible benefit of a qualitative interview is, that additional time is
allocated to reflect on the CALM therapy.
Plesmanlaan 121
Amsterdam 1066CX
NL
Plesmanlaan 121
Amsterdam 1066CX
NL
Listed location countries
Age
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
- 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL67265.031.18 |