To obtain insight in the usefulness and efficacy of psychosocial intervention for HNC patients and their spouses by performing a pilot study.
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
- Adjustment disorders (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Hospital Anxiety and Depression Scale (HADS).
Secondary outcome
Health-related quality of life questionnaires:
EORTC QLQ-C30 and QLQ-H&N35 for the patients
the SF36 for the partners
Background summary
In the Netherlands approximately 2500 patients are diagnosed with primary head
and neck cancer (HNC) every year. HNC patients have to deal with severe side
effects of treatment: in addition to complaints as pain and fatigue and fear
for tumour recurrence, patients are often confronted with changes in facial
appearance, speech or swallowing problems and related psychological distress.
A recent study at our Department revealed that approximately 30% of the
patients and 20% of their spouses have clinical levels of distress and
adaptation problems after treatment. Psychosocial intervention has proved to be
beneficial in patients treated for cancer at various sites. Evidence on the
efficacy of intervention in HNC patients is limited. Information on the
efficacy of intervention in spouses of HNC patients is lacking completely.
Because of the specific problems of head and neck cancer patients and their
spouses, a tailored psychosocial intervention program is needed.
Study objective
To obtain insight in the usefulness and efficacy of psychosocial intervention
for HNC patients and their spouses by performing a pilot study.
Study design
non-randomised prospective pilot study
Intervention
Psychosocial intervention: a course "Living with head and neck cancer"
6 sessions of 1 1/2 - 2 hours per session.
Study burden and risks
Patients and spouses will be asked to fill in questionnaires on distress and
health related quality of life. If the intervention proves to be effective,
patients and spouses will benefit immediately by improving their quality of
life.
postbus 7057
1007 MB Amsterdam
Nederland
postbus 7057
1007 MB Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
head and neck cancer
treatment > 3 months
psychological distress
Exclusion criteria
cognitive dysfunction
not speaking dutch
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 | NL11674.029.06 |