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OpenTrials
Completed

NCT Number: NCT01555645

Stress Management in Breast Cancer Patients

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Stress

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Falun, Sweden

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stress management, in two steps

Behavioral

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.

Primary outcomes

  1. Psychosocial aspect

    Time frame: Changes in psychosocial aspects from baseline to 12 months post diagnosis

    Intrusion, Avoidance, Anxiety, Depression, Quality of life, Fatigue, Daily stress

Secondary outcomes

  1. Cost-Utility Analysis

    Time frame: 12 month

  2. Patient satisfaction

    Time frame: 3 month, after intensive intervention and 12 month

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Mar 15, 2012
Registry last updated
Dec 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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