Contact information
Type
Scientific
Primary contact
Dr J R J de Leeuw
ORCID ID
Contact details
University Medical Center Utrecht
Department of Nursing Science
Res. Group Psychology of Health and Illness
P.O. Box 80036
Utrecht
3508 TA
Netherlands
+31 (0)30 253 8879
J.R.J.deLeeuw@umcutrecht.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
UU 2003-2782; NTR257
Study information
Scientific title
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
Received from the local medical ethics committee
Study design
Randomised, active controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
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
Phase
Not Specified
Drug names
Primary outcome measures
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
01/12/2003
Overall trial end date
01/12/2009
Reason abandoned
Eligibility
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
Patient
Age group
Adult
Gender
Both
Target number of participants
154
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
Trial participating centre
University Medical Center Utrecht
Utrecht
3508 TA
Netherlands
Sponsor information
Organisation
University Medical Centre Utrecht (UMCU) (Netherlands)
Sponsor details
PO Box 85500
Utrecht
3508 GA
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
The National Cancer Fund (Koningin Wilhelmina Fonds [KWF]) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Results - basic reporting
Publication summary
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24280999
Publication citations
-
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.