Skip to main content
Clinical Trials/NCT01555645
NCT01555645
Completed
Not Applicable

How Can Health Care Help Female Breastcancer Patients Reduce Their Stress Symptoms? A Randomized Intervention Study With Stepped-care

Uppsala University0 sites466 target enrollmentMay 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Uppsala University
Enrollment
466
Primary Endpoint
Psychosocial aspect
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

The purpose of this study within Caring sciences is to identify women with breast cancer who have stress symptoms and to offer these women appropriate care to reduce stress and increase well-being. This will be achieved by

  1. Studying the prevalence of stress related symptoms in female patients with breast cancer
  2. Testing the use of two short screening instruments to identify women at risk for developing long-standing stress symptoms
  3. Studying the level and intensity of stress management interventions required to achieve increased well-being, using a stepped-care approach.
  4. Studying the effects of interventions based on cognitive behavior therapy, delivered individually or in a group format.

The hypothesis is that half of the individuals assigned to a low intensity intervention will be significantly improved after treatment. For individuals who continue to have symptoms after low intensity treatment it is hypothesized that continued treatment in a group setting with high intensity interventions will be more cost-effective. In addition the assumption is that reduction of stress symptoms in women with breast cancer will lead to a reduction in socio-economic costs.

Registry
clinicaltrials.gov
Start Date
May 2009
End Date
September 2014
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Uppsala University
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • over the age of 18
  • a recent diagnosis of breast cancer
  • scheduled for adjuvant treatment in Falun, Gävle or Uppsala (Sweden)

Exclusion Criteria

  • ongoing psychiatric condition
  • language deficiencies in Swedish

Outcomes

Primary Outcomes

Psychosocial aspect

Time Frame: Changes in psychosocial aspects from baseline to 12 months post diagnosis

Intrusion, Avoidance, Anxiety, Depression, Quality of life, Fatigue, Daily stress

Secondary Outcomes

  • Cost-Utility Analysis(12 month)
  • Patient satisfaction(3 month, after intensive intervention and 12 month)

Similar Trials