Contact information
Type
Scientific
Primary contact
Dr Paul John Allison
ORCID ID
Contact details
Faculty of Dentistry
McGill University
Rm 238D
Strathcona Building
3640
University St.
Montreal
H3A 2B2
Canada
+1 514 398 7203 (00045)
paul.allison@mcgill.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MCT-75475
Study information
Scientific title
Acronym
Study hypothesis
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
Ethics approval received from the Institutional Review Board of McGill University, Montreal, Canada on the 25 July 2005.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
Psychological distress symptoms as indicated by the depression scale of the Hospital Anxiety and Depression Scale (HADS) at 4 months following randomisation.
Secondary outcome measures
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
Overall trial start date
01/04/2005
Overall trial end date
31/03/2009
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
250
Participant 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.
Recruitment start date
01/04/2005
Recruitment end date
31/03/2009
Locations
Countries of recruitment
Canada
Trial participating centre
Faculty of Dentistry
Montreal
H3A 2B2
Canada
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-75475)
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