To test the effects of a problem-solving therapy to reduce distress and increase quality of life in patients with cancer. Also to test the mechanisms of change of the therapy.
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Level of distress, measured with the Hopkins Symptom Checklist (HSCL-25)
Secondary outcome
Quality of Life, measured with the RSCL and the WHO-5
Mediating effects, i.e. to see wether improvements in problem solving capacity,
perceived control, coping, social support and loss processing are associated
with better outcome on distress in both groups.
Another aspect of the study will be a process evaluation. Videotapes of
treatment sessions will give information about treatment integrity of the
sessions and about (verbal and non-verbal) working elements of the treatment.
Background summary
We have found that approximately 25% (for male patients) to 35% (females) of
cancer patients report clinically significant distress and this is remarkable
stable across sites and severities. In our study, we therefore aim at treating
these cancer patients to cope more adequately with the stress they encounter.
Given the fact that there is quite some scepticism concerning the alleged
efficacy of psychosocial interventions focusing on lowering distress among
cancer patients, there is a pressing need to carry out well-designed effect
studies. In addition, since the majority of studies have been carried out in
the USA, it is important to replicate findings of these studies in the Dutch
healthcare system, so that generalizability of findings to the Netherlands can
be assured. Thereby, our study will replicate and extend on a study of Nezu et
al. (2003) which has shown positive results and which was carried out on the
basis of a well documented treatment protocol.
Study objective
To test the effects of a problem-solving therapy to reduce distress and
increase quality of life in patients with cancer. Also to test the mechanisms
of change of the therapy.
Study design
A prospective, randomised, controlled multicentre trial. Duration of the
follow-up will be 9 months.
Intervention
Problem solving therapy, aimed at improving problem solving capacity. 10
sessions of each 1 hour will be held.
Study burden and risks
Patients in the intervention group will get 10 sessions PST of 1 hour weekly.
Both groups will have four measurements with short questionnaires, which will
take about 45 min- 1 hour.
A. Deusinglaan 1
9713 AV Groningen
NL
A. Deusinglaan 1
9713 AV Groningen
NL
Listed location countries
Age
Inclusion criteria
1) a diagnosis of cancer, 2) a survival rate of 50% or greater (in the following five years) as deemed by the treating physician, 3) age 18-65
Exclusion criteria
1) not being able to speak Dutch, 2) a serious psychiatric disorder existing prior to the diagnosis of cancer which may complicate the treatment, 3) acute suicidal behaviour or 4) receiving psychotherapy for emotional psychological problems.
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 | NL20781.042.07 |