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
Secondary identifying numbers	UU 2003-2782; NTR257

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Dr J R J de Leeuw
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
Email	J.R.J.deLeeuw@umcutrecht.nl

Study information

Study design	Randomised, active controlled, parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study acronym	NUCAI
Study hypothesis	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
Condition	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	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.
Secondary outcome measures	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). 2. Concern with recurrence of cancer will be measured with the Worry of Cancer Scale. This questionnaire contains five items measuring the fear of cancer recurrence. 3. Uncertainty is measured with the Uncertainty in Illness Scale, containing 30 items measuring ambiguity and unpredictability
Overall study start date	01/12/2003
Overall study end date	01/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	154
Participant 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
Participant exclusion criteria	Does not comply with the above inclusion criteria
Recruitment start date	01/12/2003
Recruitment end date	01/12/2009

Locations

Countries of recruitment

Netherlands

Study participating centre

University Medical Center Utrecht

Utrecht
3508 TA
Netherlands

Sponsor information

University Medical Centre Utrecht (UMCU) (Netherlands)
University/education

PO Box 85500
Utrecht
3508 GA
Netherlands

Website	http://www.umcutrecht.nl/zorg/
"ROR"	https://ror.org/04pp8hn57

Funders

Funder type

Charity

The National Cancer Fund (Koningin Wilhelmina Fonds [KWF]) (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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