Effectiveness of a Rehabilitation Programme for Mothers With Breast Cancer and Their Children
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00916825|
Recruitment Status : Unknown
Verified February 2010 by Philipps University Marburg Medical Center.
Recruitment status was: Active, not recruiting
First Posted : June 10, 2009
Last Update Posted : February 3, 2010
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Behavioral: rehabilitation programme "getting better together"||Not Applicable|
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)
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||750 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 2009|
|Estimated Primary Completion Date :||July 2010|
|Estimated Study Completion Date :||July 2010|
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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|