NCT01359072

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 24, 2011

Completed
8 days until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

August 22, 2012

Status Verified

August 1, 2012

Enrollment Period

1.2 years

First QC Date

May 20, 2011

Last Update Submit

August 21, 2012

Conditions

Keywords

copingpsychological distressself-administered intervention

Outcome Measures

Primary Outcomes (1)

  • Change in The Health Education Impact Questionnaire from pre to post intervention, at 6 weeks post intervention, and 3 months post intervention

    pre-intervention (week 0), post intervention (week 6), 6 weeks post intervention, 3 months post intervention

Secondary Outcomes (1)

  • Change in coping strategies & distress from pre to post intervention, at 6 weeks post intervention, and 3 months post intervention

    pre-intervention (week 0), post intervention (week 6), 6 week post intervention, 3 month post intervention

Study Arms (2)

Immediate Intervention Treatment

EXPERIMENTAL
Other: Self administered coping intervention

Wait list

EXPERIMENTAL
Other: Self administered coping intervention

Interventions

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.

Immediate Intervention TreatmentWait list

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • + 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McGill University Health Centre - Melanoma Clinic & Cedars CanSupport

Montreal, Quebec, H3A 1A1, Canada

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Annett Koerner, PhD

    McGill University Health Centre/Research Institute of the McGill University Health Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Member, Psychosocial Oncology Program

Study Record Dates

First Submitted

May 20, 2011

First Posted

May 24, 2011

Study Start

June 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

August 22, 2012

Record last verified: 2012-08

Locations