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ISRCTN
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ISRCTN26202234
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ClinicalTrials.gov identifier
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Public title
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A randomised controlled trial of the effectiveness of a coping strategies intervention for people with head and neck cancer
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Scientific title
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Acronym
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N/A
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Serial number at source
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MCT-75475
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Ethics approval received from the Institutional Review Board of McGill University, Montreal, Canada on the 25 July 2005.
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Study design
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Randomised controlled trial
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Countries of recruitment
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Canada
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Disease/condition/study domain
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Head and neck cancer
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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.
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Anticipated start date
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01/04/2005
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Anticipated end date
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31/03/2009
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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250
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Interventions
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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
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Primary outcome measure(s)
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Psychological distress symptoms as indicated by the depression scale of the Hospital Anxiety and Depression Scale (HADS) at 4 months following randomisation.
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Secondary outcome measure(s)
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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
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Sources of funding
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Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-75475)
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Trial website
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Publications
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Contact name
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Dr
Paul John
Allison
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Address
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Faculty of Dentistry
McGill University
Rm 238D
Strathcona Building
3640, University St.
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City/town
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Montreal
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Zip/Postcode
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H3A 2B2
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Country
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Canada
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Tel
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+1 514 398 7203 (00045)
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Fax
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+1 514 398 8242
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Email
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paul.allison@mcgill.ca
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Sponsor
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McGill University (Canada)
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Address
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3640 University St.
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City/town
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Montreal
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Zip/Postcode
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H3A 2B2
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Country
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Canada
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Date applied
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16/11/2005
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Last edited
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10/12/2007
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Date ISRCTN assigned
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16/11/2005
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