A randomised controlled trial of the effectiveness of a coping strategies intervention for people with head and neck cancer

ISRCTN	ISRCTN26202234
DOI	https://doi.org/10.1186/ISRCTN26202234
Protocol serial number	MCT-75475
Sponsor	McGill University (Canada)
Funder	Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-75475)

Submission date: 16/11/2005
Registration date: 16/11/2005
Last edited: 10/12/2007

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Paul John Allison
Scientific

Faculty of Dentistry
McGill University
Rm 238D
Strathcona Building
3640, University St.
Montreal
H3A 2B2
Canada

Phone	+1 514 398 7203 (00045)
Email	paul.allison@mcgill.ca

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Psychological distress in people with head and neck cancer. Those receiving the test intervention will have reduced psychological distress compared to those in the control group. To test the effectiveness of the test intervention in reducing symptoms of psychological distress in people with head and neck cancer.
Ethics approval(s)	Ethics approval received from the Institutional Review Board of McGill University, Montreal, Canada on the 25 July 2005.
Health condition(s) or problem(s) studied	Head and neck cancer
Intervention	The test intervention is the 'Nucare program'; a psycho-educational intervention designed to teach cancer patients strategies to help them cope with having their disease. The intervention is a structured training package, delivered by trained therapists during 2-3 one-two hour sessions. The control intervention is an attention placebo in which individuals are invited to talk with the therapists concerning any problems they have with their cancer and treatment. Trial details received 12 Sept 2005
Intervention type	Other
Primary outcome measure(s)	Psychological distress symptoms as indicated by the depression scale of the Hospital Anxiety and Depression Scale (HADS) at 4 months following randomisation.
Key secondary outcome measure(s)	1. Mean HADS anxiety and depression scale scores (measured at 8 weeks, 4, 8 months) 2. Quality of life, measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) Core 30 and Head and Neck (H&N35) module 3. Coping strategies (measured using the Ways of Coping Checklist) 4. Smoking and alcohol consumption behaviours 5. 2 year post-diagnosis survival 6. Recurrent head and neck cancer incidence 7. New head and neck cancer incidence 8. Cost per depression averted
Completion date	31/03/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	250
Key inclusion criteria	1. Are diagnosed with a primary cancer of the head and neck region (International Statistical Classification of Diseases and Related Health Problems [ICD-9] 140-149 and 161; lip, salivary glands, tongue, floor of mouth, other mouth, oropharynx, nasopharynx, other pharynx and larynx) 2. Age 18 years and older, either sex 3. Were diagnosed 6 - 12 months previously 4. Scored greater than 7 on one or both of the anxiety and depression scales of the Hospital Anxiety and Depression Scale (HADS) 5. Are able to understand and complete either English or French language questionnaires 6. Have signed a consent form
Key exclusion criteria	1. Are undergoing palliative or terminal care only 2. Have a previous history of malignant disease affecting other parts of their body 3. Have been diagnosed with depression and are currently undergoing any anti-depressive therapy 4. Live beyond 90 minutes traveling time by car/taxi from the site where they are recruited AND are unable or unwilling to travel to the recruitment hospital to receive the intervention as an alternative. This exclusion criterion will be used because a small proportion of patients at these clinics travel considerable distances for treatment and a limit must be made concerning the traveling time necessary for the therapists in the study.
Date of first enrolment	01/04/2005
Date of final enrolment	31/03/2009

Locations

Countries of recruitment

Canada

Study participating centre

Faculty of Dentistry

Montreal
H3A 2B2
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan