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

Danish Cancer Society

Status: Completed

Conditions: Breast Cancer

Treatments: Behavioral: Psychosocial support

Study type: Interventional

Funder types: Other

Identifiers

NCT01108224

Camma 2003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 210 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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210 participants in 2 patient groups

Psychosocial support

Experimental group

Treatment:

Behavioral: Psychosocial support

Control group

No Intervention group