NCT01555645

Stress Management in Breast Cancer Patients

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 466 (actual)
• Sponsor: Uppsala University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer
• Stress

Interventions

Type	Name	Description
BEHAVIORAL	Stress management, in two steps	All patients start at the first step of the intervention program with a two hours psychoeducation in stress management. Patients, who don't report a decrease in stress related symptoms, after the first step will be offered an intensive stress management, either in individual or group format. Components included in the intervention concern 1) basic knowledge about cancer, treatment, healthy living and stress reactions, 2) self-awareness with help of diary for thoughts, feelings and behavior 3) instruction in various techniques on how to express negative feelings, how to communicate with others more effectively, how to change behaviors related to stress 4) training these techniques in real-life situations 5) cognitive restructuring 6) spirituality, derived from cognitive behavior therapy.

Timeline

• Start date: 2009-05-01
• Primary completion: 2014-03-01
• Completion: 2014-09-01
• First posted: 2012-03-15
• Last updated: 2015-12-04

Locations

3 sites across 1 country: Sweden