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| Sponsor: | Philipps University Marburg Medical Center |
|---|---|
| Collaborators: |
Dept. of Child and Adolescent Psychiatry, Philipps University Marburg Rexrodt von Fircks Foundation |
| Information provided by: | Philipps University Marburg Medical Center |
| ClinicalTrials.gov Identifier: | NCT00916825 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Behavioral: rehabilitation programme "getting better together" |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Single Group Assignment |
| 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 |
| Estimated Enrollment: | 750 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
3-week family oriented rehabprogramme: Experimental
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)
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Germany | |
| Klinik Ostseedeich | |
| 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 |
More Information
| Responsible Party: | Philipps University Marburg Medical Center, Dept. of Child and Adolescent Psychiatry ( Mattejat, PhD ) |
| Study ID Numbers: | RvF01 - 135/07 |
| Study First Received: | June 9, 2009 |
| Last Updated: | February 2, 2010 |
| ClinicalTrials.gov Identifier: | NCT00916825 History of Changes |
| Health Authority: | Germany: Ethics Commission |
|
breast cancer quality of life children of somatically ill parents psychological adaptation |
|
Neoplasms Neoplasms by Site Skin Diseases Breast Neoplasms Breast Diseases |