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Clinical Trials/NCT01108224
NCT01108224
Completed
N/A

Psychosocial Group Intervention to Patients With Primary Breast Cancer - Psychosocial and Survival Outcome From a Randomised Study

Danish Cancer Society0 sites210 target enrollmentJanuary 2004
ConditionsBreast Cancer

Overview

Phase
N/A
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Danish Cancer Society
Enrollment
210
Primary Endpoint
Quality of life
Status
Completed
Last Updated
16 years ago

Overview

Brief Summary

The purpose of this study is to determine whether an intervention to breast cancer patients including psycho-education and group psychotherapy can enhance quality of life and survival.

Detailed Description

PURPOSE: This randomized study included patients diagnosed with breast cancer who participated in an intervention including education and group psychotherapy lasting 10 weeks after surgery. The purpose of the study was to enhance Quality of Life, coping and social relations and to support the women when going through treatment. PATIENTS AND METHODS: We randomly assigned 210 patients with primary breast cancer to a control or an intervention group. Patients in the intervention group were offered 2 weekly 6-hour sessions of psycho-education and eight weekly 2-hour sessions of group psychotherapy. Participants and nonparticipants were followed up for QoL, coping and social relations after one, six and twelve months post intervention and on vital status 5 years after surgical treatment.

Registry
clinicaltrials.gov
Start Date
January 2004
End Date
December 2006
Last Updated
16 years ago
Study Type
Interventional
Study Design
Factorial
Sex
Female

Investigators

Eligibility Criteria

Inclusion Criteria

  • Eligible patients were 18-70 years of age with stage I-IIIA primary breast cancer

Exclusion Criteria

  • Distant metastasis
  • Not speaking or understanding Danish
  • Over 71 years
  • Other life-threatening diseases
  • Brain-damaged

Outcomes

Primary Outcomes

Quality of life

Time Frame: 12 months post intervention

Does Quality of Life enhance among a group of primary breast cancer patients who participate in a psychosocial group intervention compared to a control group of primary breast cancer patients who do not recieve any psychosocial intervention?

Secondary Outcomes

  • Survival(5 years post surgery)

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