Clinical trial NCT01359072: Enhancing Coping Skills in Patients With Cancer
Official title: Enhancing Coping Skills in Patients With Cancer - a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cancer
Keywords: coping
psychological distress
self-administered intervention
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Louise Granofsky-Psychosocial Oncology Program, Segal Cancer Centre, Montreal
First posted: 2011-05-24
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Change in The Health Education Impact Questionnaire from pre to post intervention, at 6 weeks post intervention, and 3 months post intervention
timeFrame: pre-intervention (week 0), post intervention (week 6), 6 weeks post intervention, 3 months post intervention
Secondary outcomes:
measure: Change in coping strategies & distress from pre to post intervention, at 6 weeks post intervention, and 3 months post intervention
timeFrame: pre-intervention (week 0), post intervention (week 6), 6 week post intervention, 3 month post intervention
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University Health Centre - Melanoma Clinic & Cedars CanSupport
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Annett Koerner, PhD
role: PRINCIPAL_INVESTIGATOR
References: