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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Psychosocial support


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psychosocial support<br> | Behavioral: Psychosocial support<br>* Psycho-social group intervention including patient-education for 6 h per week for 2 weeks and group therapy 2½ h for 8 weeks<br>* Other names: Patient-education and group therapy;|
| No Intervention: Control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | 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? | 12 months post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | 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? | 5 years post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality of life, Coping, Social relations, Survival, Psychotherapy