Stress Management in Breast Cancer Patients

Not Applicable

Completed

• Conditions: Breast Cancer; Stress

• Registration Number: NCT01555645
• Lead Sponsor: Uppsala University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2012-02-28
• Study First Submitted QC: 2012-03-14
• Study First Posted: 2012-03-15
• Primary Completion: 2014-03
• Study Completion: 2014-09
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-03
• Last Update Posted: 2015-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 466

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Psychosocial aspect	Changes in psychosocial aspects from baseline to 12 months post diagnosis	Intrusion, Avoidance, Anxiety, Depression, Quality of life, Fatigue, Daily stress

Secondary Outcome Measures

Name	Time	Method
Cost-Utility Analysis	12 month
Patient satisfaction	3 month, after intensive intervention and 12 month