The effect of comprehensive counseling by a nurse specialist on depressive symptoms and quality of life: a prospective randomised study in patients with head and neck cancer
| ISRCTN | ISRCTN06768231 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN06768231 |
| Protocol serial number | UU 2003-2782; NTR257 |
| Sponsor | University Medical Centre Utrecht (UMCU) (Netherlands) |
| Funder | The National Cancer Fund (Koningin Wilhelmina Fonds [KWF]) (The Netherlands) |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 10/04/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
University Medical Center Utrecht
Department of Nursing Science
Res. Group Psychology of Health and Illness
P.O. Box 80036
Utrecht
3508 TA
Netherlands
| Phone | +31 (0)30 253 8879 |
|---|---|
| J.R.J.deLeeuw@umcutrecht.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, active controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | NUCAI |
| Study objectives | After treatment, patients of the experimental group will show: 1. Less depression 2. Better quality of life 3. Less uncertainty 4. Less concern for cancer recurrence one year after the start of treatment |
| Ethics approval(s) | Received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Head cancer, neck cancer, tumour |
| Intervention | Comprehensive counselling will be given by a nurse specialist, specially trained for this purpose. The patient will be referred for a short contact before the start of surgery or before the start of primary radiotherapy. All patients who receive a combined treatment are also seen by the nurse specialist at two weeks after surgery, prior to post-operative radiotherapy. Furthermore, all patients are shortly seen by the nurse, two weeks after the overall completion of treatment. The nurse specialist will see the patient every 2 months during the year after the completion of treatment. The duration of each session 45 to 60 minutes and all sessions will be combined with a regular medical check-up at the outpatient clinic. At 12 months after the completion of treatment, the intervention will be discontinued, but the nurse specialist remains available for the patients. To guarantee continuity of available support in the experimental group, patients of the experimental group will be urged to contact the nurse specialist when in need of additional information or support. During the second year, the patient will receive the same type of care as the patients in the control arm. The aim of the counselling intervention by the specialised nurse is to help the patient to deal with physical symptoms and impairments, to reduce emotional distress and to improve morale, coping ability and sense of control. The intervention consists of six sessions during the period of one year. |
| Intervention type | Other |
| Primary outcome measure(s) |
Depression will be measured with the Center for Epidemiological Studies-Depression Scale (CES-D). The CES-D consists of 20 items with a 4-point Likert scale, resulting in a total score ranging from 0 to 60. A high score reflects a high level of depression. A cut-off point of 16 can be used, patients with a score of 16 or more being classified as being a possible case of depression. This questionnaire has been developed for research in the general, non-psychiatric population, it contains 20 items and has been used in Dutch cancer research. |
| Key secondary outcome measure(s) |
1. Quality of Life with the EORTC Core Questionnaire (QLQ-C30, version 3.0) and the EORTC Head and Neck Module (QLQ-H&N35). The QLQ-C30 contains five functional scales, three symptom scales, a global QoL scale and six sin-gle-items. It has been tested in an international study in which Dutch patients participated, contains 33 items concerning global quality of life, functional capacity, physical and psychological symptoms, and daily activities. The QLQ-H&N35 measures tumour-specific and treatment related symptoms. This questionnaire has also been tested in an international study in which Dutch patients participated and contains seven symptom scales (pain, swallowing, senses (taste/smell), speech, social eating, social con-tacts, and sexuality) and six single items (teeth problems, trismus, dry mouth, sticky saliva, cough, and feeling ill). |
| Completion date | 01/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 154 |
| Key inclusion criteria | 1. Patients with squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, receiving treatment with surgery and/or radiotherapy with curative intent 2. No previous or synchronous malignancies, with the exception of: 2.1. Adequately treated squamous cell or basal cell carcinoma of the skin or in situ carcinoma of the cervix 2.2. Synchronous second squamous cell carcinoma of oral cavity, pharynx or larynx Which can also be treated with curative intent 3. Ability to complete the questionnaire and expected cooperation of the patient, as reflected by a completed baseline questionnaire |
| Key exclusion criteria | Does not comply with the above inclusion criteria |
| Date of first enrolment | 01/12/2003 |
| Date of final enrolment | 01/12/2009 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
3508 TA
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 04/02/2014 | Yes | No |
