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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01555645
Enrollment
466
Registered
2012-03-15
Start date
2009-05-31
Completion date
2014-09-30
Last updated
2015-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Stress

Keywords

Breast cancer, Stress management, Stepped care, Randomized

Brief 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.

Interventions

BEHAVIORALStress 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.

Sponsors

Uppsala University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Psychosocial aspectChanges in psychosocial aspects from baseline to 12 months post diagnosisIntrusion, Avoidance, Anxiety, Depression, Quality of life, Fatigue, Daily stress

Secondary

MeasureTime frame
Cost-Utility Analysis12 month
Patient satisfaction3 month, after intensive intervention and 12 month

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026