Clinical trial NCT01555645: Stress Management in Breast Cancer Patients
Official title: How Can Health Care Help Female Breastcancer Patients Reduce Their Stress Symptoms? A Randomized Intervention Study With Stepped-care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Stress
Keywords: Breast cancer
Stress management
Stepped care
Randomized
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2012-03-15
Enrollment: 466
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Psychosocial aspect
timeFrame: Changes in psychosocial aspects from baseline to 12 months post diagnosis
Secondary outcomes:
measure: Cost-Utility Analysis
timeFrame: 12 month
measure: Patient satisfaction
timeFrame: 3 month, after intensive intervention and 12 month
Other outcomes:
Locations:
city: Falun
country: Sweden
city: Gävle
country: Sweden
city: Uppsala
country: Sweden
Study officials:
affiliation: Uppsala University
name: Karin Nordin, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hellerstedt-Borjesson S, Nordin K, Fjallskog ML, Holmstrom IK, Arving C. Women Treated for Breast Cancer Experiences of Chemotherapy-Induced Pain: Memories, Any Present Pain, and Future Reflections. Cancer Nurs. 2016 Nov/Dec;39(6):464-472. doi: 10.1097/NCC.0000000000000322.
citation: Nordin K, Rissanen R, Ahlgren J, Burell G, Fjallskog ML, Borjesson S, Arving C. Design of the study: how can health care help female breast cancer patients reduce their stress symptoms? A randomized intervention study with stepped-care. BMC Cancer. 2012 May 4;12:167. doi: 10.1186/1471-2407-12-167.