Study Stopped
This study is currently terminated due to low recruitment rate.
Enhancing Coping Skills in Patients With Cancer
1 other identifier
interventional
1
1 country
1
Brief Summary
- Approximately 30% of all patients with cancer report levels of psychological distress indicative of the need for psychological intervention.
- Research suggests that learning more adaptive coping strategies improves psychological adjustment to cancer.
- It is imperative to develop cost-efficient, feasible psychosocial interventions.
- The aim is to test the efficacy of the self administered format of a psycho-educational intervention (NUCARE) in reducing distress and enhancing adaptive coping strategies for cancer patients. It is hypothesized that:
- patients would show significant reductions in distress (i.e., depression and anxiety) over the 6-week treatment period, and that treatment would produce superior results compared to wait-list; patients would maintain or even increase their improvement up to 3 months following treatment.
- the treatment would enhance more adaptive coping strategies.
- greater self-reported adherence to the treatment/homework would be associated with symptom improvement, more autonomous self-regulation and higher perceived competence for adhering to the coping intervention program.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable cancer
Started Jun 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2011
CompletedFirst Posted
Study publicly available on registry
May 24, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedAugust 22, 2012
August 1, 2012
1.2 years
May 20, 2011
August 21, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in The Health Education Impact Questionnaire from pre to post intervention, at 6 weeks post intervention, and 3 months post intervention
pre-intervention (week 0), post intervention (week 6), 6 weeks post intervention, 3 months post intervention
Secondary Outcomes (1)
Change in coping strategies & distress from pre to post intervention, at 6 weeks post intervention, and 3 months post intervention
pre-intervention (week 0), post intervention (week 6), 6 week post intervention, 3 month post intervention
Study Arms (2)
Immediate Intervention Treatment
EXPERIMENTALWait list
EXPERIMENTALInterventions
The self administered coping intervention (i.e. NUCARE workbook) aims to teach individuals how to cope with their cancer. The intervention embraces two major areas: (i) the enhancement of a sense of personal control; and (ii) the learning of emotional and instrumental coping responses. The approach emphasizes training in problem-solving, relaxation techniques, cognitive coping skills, goal setting, communication, social support and lifestyle factors. The didactic material of the Nucare program is comprised of a workbook containing 12 chapters addressing the above mentioned aspects.
Eligibility Criteria
You may qualify if:
- + years of age,
- able to read English,
- a cancer patient presenting at the McGill University Health Centre (MUHC) interested in participating,
- willing to receive minimal therapist contact (by telephone) and self administered therapy,
- able to give their own consent.
You may not qualify if:
- currently receiving psychological/psychiatric treatment/counselling,
- indicate at the time of recruitment that they intend to seek psychological treatment elsewhere during the study period,
- a history of psychosis or bipolar disorder,
- substance abuse/dependence in last 6 months,
- taking psychotropic medication with altering dosages in the past 3 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
McGill University Health Centre - Melanoma Clinic & Cedars CanSupport
Montreal, Quebec, H3A 1A1, Canada
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Annett Koerner, PhD
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Member, Psychosocial Oncology Program
Study Record Dates
First Submitted
May 20, 2011
First Posted
May 24, 2011
Study Start
June 1, 2011
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
August 22, 2012
Record last verified: 2012-08