Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr J R J de Leeuw


Contact details

University Medical Center Utrecht
Department of Nursing Science
Res. Group Psychology of Health and Illness
P.O. Box 80036
3508 TA
+31 (0)30 253 8879

Additional identifiers

EudraCT number number

Protocol/serial number

UU 2003-2782; NTR257

Study information

Scientific title



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

Received from the local medical ethics committee

Study design

Randomised, active controlled, parallel group trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet


Head cancer, neck cancer, tumour


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



Not Specified

Drug names

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 trial start date


Overall trial end date


Reason abandoned (if study stopped)


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 type


Age group




Target number of participants


Participant exclusion criteria

Does not comply with the above inclusion criteria

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

University Medical Center Utrecht
3508 TA

Sponsor information


University Medical Centre Utrecht (UMCU) (Netherlands)

Sponsor details

PO Box 85500
3508 GA

Sponsor type




Funder type


Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

2014 results in:

Publication citations

  1. Results

    van der Meulen IC, May AM, de Leeuw JR, Koole R, Oosterom M, Hordijk GJ, Ros WJ, Long-term effect of a nurse-led psychosocial intervention on health-related quality of life in patients with head and neck cancer: a randomised controlled trial., Br. J. Cancer, 2014, 110, 3, 593-601, doi: 10.1038/bjc.2013.733.

Additional files

Editorial Notes