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 |
| Secondary identifying numbers | 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
Scientific
Faculty of Dentistry
McGill University
Rm 238D
Strathcona Building
3640, University St.
Montreal
H3A 2B2
Canada
| Phone | +1 514 398 7203 (00045) |
|---|---|
| paul.allison@mcgill.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 01/04/2005 |
| Completion date | 31/03/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
H3A 2B2
Canada
Sponsor information
McGill University (Canada)
Not defined
Not defined
3640 University St.
Montreal
H3A 2B2
Canada
"ROR" |
https://ror.org/01pxwe438 |
|---|
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-75475)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
