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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014