Overview

This trial is active, not recruiting.

Condition breast cancer
Treatment rehabilitation programme "getting better together"
Sponsor Philipps University Marburg Medical Center
Collaborator Dept. of Child and Adolescent Psychiatry, Philipps University Marburg
Start date January 2009
End date July 2010
Trial size 750 participants
Trial identifier NCT00916825, RvF01 - 135/07

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
waiting control group
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.

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Eligibility Criteria

Female participants of any age.

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

Additional Information

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
Principal investigator Katja J John, DP (MA)
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)
Trial information was received from ClinicalTrials.gov and was last updated in February 2010.
Information provided to ClinicalTrials.gov by Philipps University Marburg Medical Center.