Stress Management in Breast Cancer Patients

Uppsala University

Status: Completed

Conditions: Breast Cancer; Stress

Treatments: Behavioral: Stress management, in two steps

Study type: Interventional

Funder types: Other

Identifiers

NCT01555645

CAN 2009/25 (Other Grant/Funding Number)

CAN 2011/08 (Other Grant/Funding Number)

K2010-70X-21412-01-3

Details and patient eligibility

About

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.

Enrollment: 466 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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466 participants in 2 patient groups

Stress management Individual format

Experimental group

Description:

The methods and techniques will be the same as those used in the group intervention. The first session will be used for a detailed assessment of the individual's psychosocial problems, as used in earlier studies. The sessions will last 45 - 60 minutes. The number of sessions will depend on the individual patient's problems and the joint assessment made by the patient and nurse together. The total number of sessions will be at least 4, with a maximum of 8. The contents of the sessions are Session 1: Assessment, Session 2: Analysis of diary (self-registration) and suggestions for problem management, Session 3: Evaluation of problem management skills Session 4: Follow-up and conclusion of the intervention. When necessary Sessions 5 -8 will address specific obstacles and continued practice.

Treatment:

Behavioral: Stress management, in two steps

Stress management Group format

Experimental group

Description:

Participants will meet for 2 hours every week for a total of 20 hours. In the intervals between the group meetings patients will be asked to do homework. Homework entails practicing problem-solving techniques, keeping a diary, practicing relaxation or physical activities. Each group meeting has a specific subject, i.e. What is stress and stress behaviors, Stress related symptoms, How to manage anger and negative thoughts, Self-registrations and behavioral changes, Future perspectives, Cancer, stress and relations, Expectations and demands, Body, pleasure and sexuality.

Treatment:

Behavioral: Stress management, in two steps