Enhancing Coping Skills in Patients With Cancer

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

  • 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.

Study Overview

Status

Terminated

Conditions

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Quebec
      • Montreal, Quebec, Canada, H3A 1A1
        • McGill University Health Centre - Melanoma Clinic & Cedars CanSupport

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate Intervention Treatment
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.
Experimental: Wait list
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in The Health Education Impact Questionnaire from pre to post intervention, at 6 weeks post intervention, and 3 months post intervention
Time Frame: pre-intervention (week 0), post intervention (week 6), 6 weeks post intervention, 3 months post intervention
pre-intervention (week 0), post intervention (week 6), 6 weeks post intervention, 3 months post intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in coping strategies & distress from pre to post intervention, at 6 weeks post intervention, and 3 months post intervention
Time Frame: pre-intervention (week 0), post intervention (week 6), 6 week post intervention, 3 month 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Annett Koerner, PhD, McGill University Health Centre/Research Institute of the McGill University Health Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

May 20, 2011

First Submitted That Met QC Criteria

May 20, 2011

First Posted (Estimate)

May 24, 2011

Study Record Updates

Last Update Posted (Estimate)

August 22, 2012

Last Update Submitted That Met QC Criteria

August 21, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • 10-327-PSY

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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