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

Completed

Conditions: Head and neck cancer
Cancer
Head and neck

Registration Number: ISRCTN26202234

Lead Sponsor: McGill University (Canada)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 250

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
1. Mean HADS anxiety and depression scale scores (measured at 8 weeks, 4, 8 months)<br>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<br>3. Coping strategies (measured using the Ways of Coping Checklist) <br>4. Smoking and alcohol consumption behaviours<br>5. 2 year post-diagnosis survival<br>6. Recurrent head and neck cancer incidence<br>7. New head and neck cancer incidence <br>8. Cost per depression averted