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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Behavioral: rehabilitation programme "getting better together"

• Registration Number: NCT00916825
• Lead Sponsor: Philipps University Marburg Medical Center

Brief 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.

Detailed 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)

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-06-09
• Study First Submitted QC: 2009-06-09
• Study First Posted: 2009-06-10
• Status Verified: 2010-02
• Primary Completion: 2010-07
• Study Completion: 2013-07
• Last Update Submitted: 2019-04-15
• Last Update Posted: 2019-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 801

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
3-week family oriented rehabprogramme	rehabilitation programme "getting better together"	waiting control group

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Mothers' Depressive Symptoms (BDI)	4 weeks before, at the beginning and post treatment, 3 and 12 months follow up
Mothers' and children's Treatment Satisfaction	Post Treatment
Children's psychological difficulties (SDQ)	4 weeks before, at the beginning & post treatment, 3 and 12 months follow-up
Mother's Life Satisfaction	4 weeks before, at the beginning & post treatment, 3 and 12 months follow up

Trial Locations

Locations (1)

Klinik Ostseedeich; 🇩🇪 Grömitz, Germany