Condition category
Cancer
Date applied
16/11/2005
Date assigned
16/11/2005
Last edited
10/12/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

McGill University (Canada)

Sponsor details

3640 University St.
Montreal
H3A 2B2
Canada

Sponsor type

Not defined

Website

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

Publication citations

Additional files

Editorial Notes