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Enhancing Coping Skills in Patients With Cancer

This study has been terminated.
(This study is currently terminated due to low recruitment rate.)
Sponsor:
Collaborator:
Louise Granofsky-Psychosocial Oncology Program, Segal Cancer Centre, Montreal
Information provided by (Responsible Party):
Dr. Annett Korner, PhD, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01359072
First received: May 20, 2011
Last updated: August 21, 2012
Last verified: August 2012
History of Changes
  Purpose
  • 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.

Condition Intervention
Cancer
 Other: Self administered coping intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Enhancing Coping Skills in Patients With Cancer - a Randomized Controlled Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Measured with The Ways of Coping Questionnaire - Cancer Version scale and the Hospital Anxiety and Depression Scale


Enrollment: 1
Study Start Date: June 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Immediate Intervention Treatment 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.
Experimental: Wait list 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01359072

Locations
Canada, Quebec
McGill University Health Centre - Melanoma Clinic & Cedars CanSupport
Montreal, Quebec, Canada, H3A 1A1
Sponsors and Collaborators
McGill University Health Center
Louise Granofsky-Psychosocial Oncology Program, Segal Cancer Centre, Montreal
Investigators
Principal Investigator: Annett Koerner, PhD McGill University Health Center
  More Information

No publications provided

Responsible Party: Dr. Annett Korner, PhD, Associate Member, Psychosocial Oncology Program, McGill University Health Center
ClinicalTrials.gov Identifier: NCT01359072     History of Changes
Other Study ID Numbers: 10-327-PSY
Study First Received: May 20, 2011
Last Updated: August 21, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by McGill University Health Center:
coping
psychological distress
self-administered intervention

ClinicalTrials.gov processed this record on June 17, 2013