To evaluate cost-effectiveness of a stepped care strategy to improve symptoms of depression or anxiety in patients treated for head and neck cancer or lung cancer.
ID
Source
Brief title
Condition
- Other condition
- Respiratory and mediastinal neoplasms malignant and unspecified
- Anxiety disorders and symptoms
Synonym
Health condition
psychische stoornissen: angststoornissen en -symptomen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is the Hospital Anxiety and Depression Scale (HADS) and costs
(health care utilization and work loss (TIC-P and PRODISQ modules)).
Secondary outcome
Secondary outcome measures are quality of life questionnaires (EORTC QLQ-C30,
EORTC QLQ-HN35, EORTC QLQ-LC13) and patient satisfaction with care (EORTC
QLQ-PATSAT).
Background summary
In the Netherlands over 10.000 patients are diagnosed with lung cancer (LC) or
head and neck cancer (HNC) every year of whom 25-50% have comorbid anxiety or
depression after treatment. Although there is evidence on efficacy of
psychosocial cancer care in general, patients with poor survival rates (LC) or
less prevalent tumours (HNC) are often not involved, while these patients are
among the most distressed patients. Barriers to admission to psychosocial care
are a lack of adequate screening instruments in oncology settings, and that
traditional models of the delivery of psychosocial care do not meet current
demands. A stepped care approach including a web-based self-help intervention
has the potential to improve the efficiency of psychosocial care.
Study objective
To evaluate cost-effectiveness of a stepped care strategy to improve symptoms
of depression or anxiety in patients treated for head and neck cancer or lung
cancer.
Study design
Randomised controlled trial. Follow up at 3, 6, 9 and 12 months.
Intervention
Stepped care model with 4 evidence based steps: 1. Watchful waiting, 2.
Internet-based self-help, 3. Problem Solving Therapy applied by a nurse, and 4.
Specialised psychological interventions and/or antidepressant medication.
Control group patients receive care as usual which most often is no
intervention or referral to specialised intervention.
Study burden and risks
Risks are negligible and burden is low. In case of positive results,
participating patients will benefit immediately from the stepped care approach.
De Boelelaan 1118
Amsterdam 1007 MB
NL
De Boelelaan 1118
Amsterdam 1007 MB
NL
Listed location countries
Age
Inclusion criteria
Treatment for UICC stage I-IV lung or head and neck carcinoma: ICD-10 C00-C14 (lip, oral cavity and pharynx), C32 (larynx), C33 (trachea), C34 (lung); psychological distress or possible or probable cases of depression or anxiety as assessed by the Hospital Anxiety Depression Scale (HADS-Anxiety subscale score > 7 and/or HADS-Depression subscale score > 7, or total score on HADS > 14). For more details, see page 11 of the researchprotocol.
Exclusion criteria
Other (neurological) diseases causing cognitive dysfunction; no motivation to undergo psychosocial therapy; current treatment for a depressive or anxiety disorder; end of treatment for a psychiatric disorder less than two months ago, high suicide risk; psychotic and/or manic signs; too little knowledge of the Dutch language to fill out the questionnaires.
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 | NL28142.029.09 |