Psychotherapy to Patients With Primary Breast Cancer - Psycho-social and Survival Outcome From a Randomised Trial

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Behavioral: Psychosocial support

• Registration Number: NCT01108224
• Lead Sponsor: Danish Cancer Society

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.

Study Timeline

• Status Verified: 2004-01
• Study Start: 2004-01
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Study First Submitted: 2010-02-16
• Study First Submitted QC: 2010-04-20
• Last Update Submitted: 2010-04-20
• Study First Posted: 2010-04-21
• Last Update Posted: 2010-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 210

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Psychosocial support	Psychosocial support	-

Primary Outcome Measures

Name	Time	Method
Quality of life	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 Outcome Measures

Name	Time	Method
Survival	5 years post surgery	Does primary breast cancer patients who participate in a psychosocial intervention survive for longer time compared to a control group of primary cancer patients who do not participate in any intervention?