Effectiveness of a Rehabilitation Programme for Mothers With Breast Cancer and Their Children
About 1/3 of newly diagnosed breast cancer patients are mothers of children who still live at home. They face additional challenges and stress, their children are also affected by the mother's illness. The oncological rehabilitation programme "getting better together" focuses on these special family needs. This waiting-control-group study examines the effectiveness of the intervention by...
Brief Summary
Official Title: “Effectiveness of a Family-oriented Rehabilitation Programme for Mothers With Breast Cancer and Their Children - Quality of Life and Psychological Health of Mothers and Their Children”
About 1/3 of newly diagnosed breast cancer patients are mothers of children who still live at home. They face additional challenges and stress, their children are also affected by the mother's illness. The oncological rehabilitation programme "getting better together" focuses on these special family needs. This waiting-control-group study examines the effectiveness of the intervention by accompanying the patients and their children over the course of a year and assessing their quality of life and psychological health.
- Study Type: Interventional
- Study Design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: July 2010
Detailed Clinical Trial Description
About 1/3 of newly diagnosed breast cancer patients are mothers of children who still live at home. They face additional challenges and stress, their children are also affected by the mother's illness. The oncological rehabilitation programme "getting better together", administered by the Rexrodt von Fircks Foundation and the Clinic Ostseedeich in Groemitz, Germany, focuses on these special family needs. This waiting-control-group-study, designed and executed at the Philipps University Marburg Medical Center, Department of Child and Adolescent Psychiatry, examines the effectiveness of the intervention by accompanying the patients and their children over the course of a year and assessing their quality of life and psychological health.
The primary outcome measure for mothers is the health related quality of life as assessed by the EORTC QLQ-C30 and BR-23; children's adaptation is assessed with the ILK (Inventory for the Assessment of Quality of Life of Children and Adolescents) as well as the Strengths and Difficulties Questionnaire (SDQ)
Intervention(s) in this Clinical Trial
- Behavioral: rehabilitation programme "getting better together"
- Mothers and their children (age 0-16) take part in a 3-week, family-oriented oncological rehabilitation programme which consists of medical, psychological and psychooncological treatments for mothers and children.
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 3-week family oriented rehabprogramme
- waiting control group
Outcome Measures for this Clinical Trial
Primary Measures
- Mothers' and children's Quality of Life (EORTC OLQ-C30, QLQ-BR23; ILK)
- Time Frame: 4 weeks before, at the beginning & post treatment, 3 and 12 months follow-up
Safety Issue?: No
- Time Frame: 4 weeks before, at the beginning & post treatment, 3 and 12 months follow-up
Secondary Measures
- Children's psychological difficulties (SDQ)
- Time Frame: 4 weeks before, at the beginning & post treatment, 3 and 12 months follow-up
Safety Issue?: No
- Time Frame: 4 weeks before, at the beginning & post treatment, 3 and 12 months follow-up
- Mothers' Depressive Symptoms (BDI)
- Time Frame: 4 weeks before, at the beginning and post treatment, 3 and 12 months follow up
Safety Issue?: No
- Time Frame: 4 weeks before, at the beginning and post treatment, 3 and 12 months follow up
- Mother's Life Satisfaction
- Time Frame: 4 weeks before, at the beginning & post treatment, 3 and 12 months follow up
Safety Issue?: No
- Time Frame: 4 weeks before, at the beginning & post treatment, 3 and 12 months follow up
- Mothers' and children's Treatment Satisfaction
- Time Frame: Post Treatment
Safety Issue?: No
- Time Frame: Post Treatment
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- participants of the rehabilitation programme "getting better together"
- mothers of children up to the age of 16
- have been diagnosed with and treated for breast cancer for the first time in their lives
- chemotherapy or radiation therapy ended no less than 6 weeks ago
Exclusion Criteria:
- metastases
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: N/A
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Philipps University Marburg Medical Center Other
Overall Clinical Trial Officials and Contacts
Fritz Mattejat, PhD Study Director Philipps University Marburg Medical Center, Dept. of Child and Adolescent Psychiatry
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00916825
Study ID Number: RvF01 - 135/07
ClinicalTrials.gov Identifier: NCT00916825
Health Authority: Germany: Ethics Commission
The homepage of the foundation who initiated the oncological rehab-programme
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00916825
