Effectiveness of a Rehabilitation Programme for Mothers With Breast Cancer and Their Children
Recruitment status was: Active, not recruiting
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|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|
- 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 ]
- Children's psychological difficulties (SDQ) [ 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 ]
- Mother's Life Satisfaction [ 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 ]
|Study Start Date:||January 2009|
|Estimated Study Completion Date:||July 2010|
|Estimated Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
Experimental: 3-week family oriented rehabprogramme
waiting control group
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.
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)
Please refer to this study by its ClinicalTrials.gov identifier: NCT00916825
|23473 Groemitz, Germany|
|Study Director:||Fritz Mattejat, PhD||Philipps University Marburg Medical Center, Dept. of Child and Adolescent Psychiatry|
|Principal Investigator:||Katja J John, DP (MA)||Philipps University Marburg Medical Center, Dept. of Child and Adolescent Psychiatry|