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Stress Management in Breast Cancer Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Uppsala University
ClinicalTrials.gov Identifier:
NCT01555645
First received: February 28, 2012
Last updated: March 14, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention
Breast Cancer
Stress
 Behavioral: Stress management, in two steps

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: How Can Health Care Help Female Breastcancer Patients Reduce Their Stress Symptoms? A Randomized Intervention Study With Stepped-care

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Uppsala University:

Primary Outcome Measures:
  • Psychosocial aspect [ Time Frame: Changes in psychosocial aspects from baseline to 12 months post diagnosis ] [ Designated as safety issue: No ]
    Intrusion, Avoidance, Anxiety, Depression, Quality of life, Fatigue, Daily stress


Secondary Outcome Measures:
  • Cost-Utility Analysis [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  • Patient satisfaction [ Time Frame: 3 month, after intensive intervention and 12 month ] [ Designated as safety issue: No ]

Enrollment: 466
Study Start Date: May 2009
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stress management Individual format
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.
 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.
Experimental: Stress management Group format
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.
 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01555645

Locations
Sweden
Falun, Sweden
Gävle, Sweden
Uppsala, Sweden
Sponsors and Collaborators
Uppsala University
Investigators
Principal Investigator: Karin Nordin, Prof Uppsala University
  More Information

No publications provided by Uppsala University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT01555645     History of Changes
Other Study ID Numbers: K2010-70X-21412-01-3, CAN 2009/25, CAN 2011/08
Study First Received: February 28, 2012
Last Updated: March 14, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Uppsala University:
Breast cancer
Stress management
Stepped care
Randomized

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 21, 2013