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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN26202234
Enrollment
250
Registered
2005-11-16
Start date
2005-04-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and neck cancer Cancer Head and neck

Interventions

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 ther

Sponsors

McGill University (Canada)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Psychological distress symptoms as indicated by the depression scale of the Hospital Anxiety and Depression Scale (HADS) at 4 months following randomisation.

Secondary

MeasureTime frame
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

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026