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

May 20, 2011
August 21, 2012
June 2011
August 2012   (final data collection date for primary outcome measure)
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 ]
The Health Education Impact Questionnaire [ Time Frame: pre-intervention, post intervention, 6 weeks post intervention, 3 months post intervention ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01359072 on ClinicalTrials.gov Archive Site
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
coping strategies & distress [ Time Frame: pre-intervention, post intervention, 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
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Cancer
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: Immediate Intervention Treatment
    Intervention: Other: Self administered coping intervention
  • Experimental: Wait list
    Intervention: Other: Self administered coping intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
August 2012
August 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01359072
10-327-PSY
No
Dr. Annett Korner, PhD, McGill University Health Center
McGill University Health Center
Louise Granofsky-Psychosocial Oncology Program, Segal Cancer Centre, Montreal
Principal Investigator: Annett Koerner, PhD McGill University Health Center
McGill University Health Center
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP