Psychotherapy to Patients With Primary Breast Cancer - Psycho-social and Survival Outcome From a Randomised Trial
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Psychosocial Group Intervention to Patients With Primary Breast Cancer - Psychosocial and Survival Outcome From a Randomised Study|
- Quality of life [ Time Frame: 12 months post intervention ] [ Designated as safety issue: No ]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?
- Survival [ Time Frame: 5 years post surgery ] [ Designated as safety issue: No ]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?
|Study Start Date:||January 2004|
|Study Completion Date:||December 2006|
|Primary Completion Date:||December 2006 (Final data collection date for primary outcome measure)|
|Experimental: Psychosocial support||
Behavioral: Psychosocial support
Psycho-social group intervention including patient-education for 6 h per week for 2 weeks and group therapy 2½ h for 8 weeks
Other Name: Patient-education and group therapy
|No Intervention: Control group|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01108224
|Principal Investigator:||Ellen H Boesen, MSc, Phd||Institute of Cancer Epidemiology, Danish Cancer Society, Strandboulevarden 49, DK-2100|
|Study Chair:||Christoffer Johansen, DSc (Med)||Institute of Cancer Epidemiology, Danish Cancer Society, Strandboulevarden 49, DK-2100|