Enhancing Coping Skills in Patients With Cancer

Cancer Clinical Trial

Official title:

Enhancing Coping Skills in Patients With Cancer - a Randomized Controlled Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01359072
• Other study ID #: 10-327-PSY
• Status: Terminated
• Phase: N/A
• First received: May 20, 2011
• Last updated: August 21, 2012
• Start date: June 2011
• Est. completion date: August 2012

Study information

• Verified date: August 2012
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18+ 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• Self administered coping intervention
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.

Locations

Country	Name	City	State
Canada	McGill University Health Centre - Melanoma Clinic & Cedars CanSupport	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
McGill University Health Center	Louise Granofsky-Psychosocial Oncology Program, Segal Cancer Centre, Montreal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in coping strategies & distress from pre to post intervention, at 6 weeks post intervention, and 3 months post intervention	Measured with The Ways of Coping Questionnaire - Cancer Version scale and the Hospital Anxiety and Depression Scale	pre-intervention (week 0), post intervention (week 6), 6 week post intervention, 3 month post intervention	No