Stress Management in Breast Cancer Patients

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01555645
• Other study ID #: K2010-70X-21412-01-3
• Secondary ID: CAN 2009/25CAN 2
• Status: Completed
• Phase: N/A
• First received: February 28, 2012
• Last updated: December 3, 2015
• Start date: May 2009
• Est. completion date: September 2014

Study information

• Verified date: December 2015
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 466
• Est. completion date: September 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Stress

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychosocial aspect	Intrusion, Avoidance, Anxiety, Depression, Quality of life, Fatigue, Daily stress	Changes in psychosocial aspects from baseline to 12 months post diagnosis	No
Secondary	Cost-Utility Analysis		12 month	No
Secondary	Patient satisfaction		3 month, after intensive intervention and 12 month	No