Impact of a Rehabilitation Programme for Mothers With Breast Cancer and Their Children

Breast Cancer Clinical Trial

Official title:

Impact 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00916825
• Other study ID #: RvF01 - 135/07
• Status: Completed
• Phase: N/A
• Start date: January 2009
• Est. completion date: July 2013

Study information

• Verified date: February 2010
• Source: Philipps University Marburg Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 801
• Est. completion date: July 2013
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Germany	Klinik Ostseedeich	Grömitz

Sponsors (3)

Lead Sponsor	Collaborator
Philipps University Marburg Medical Center	Dept. of Child and Adolescent Psychiatry, Philipps University Marburg, Rexrodt von Fircks Foundation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mothers' and children's Quality of Life (EORTC OLQ-C30, QLQ-BR23; ILK)		4 weeks before, at the beginning & post treatment, 3 and 12 months follow-up
Secondary	Children's psychological difficulties (SDQ)		4 weeks before, at the beginning & post treatment, 3 and 12 months follow-up
Secondary	Mothers' Depressive Symptoms (BDI)		4 weeks before, at the beginning and post treatment, 3 and 12 months follow up
Secondary	Mother's Life Satisfaction		4 weeks before, at the beginning & post treatment, 3 and 12 months follow up
Secondary	Mothers' and children's Treatment Satisfaction		Post Treatment

External Links

•   Study homepage
•   The homepage of the foundation who initiated the oncological rehab-programme