Clinical trial NCT00916825: Impact of a Rehabilitation Programme for Mothers With Breast Cancer and Their Children
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
quality of life
children of somatically ill parents
psychological adaptation
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
Collaborators: name: Dept. of Child and Adolescent Psychiatry, Philipps University Marburg
name: Rexrodt von Fircks Foundation
First posted: 2009-06-10
Enrollment: 801
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)

Eligibility criteria: 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

Primary outcomes:
measure: Mothers' and children's Quality of Life (EORTC OLQ-C30, QLQ-BR23; ILK)
timeFrame: 4 weeks before, at the beginning & post treatment, 3 and 12 months follow-up
Secondary outcomes:
measure: Children's psychological difficulties (SDQ)
timeFrame: 4 weeks before, at the beginning & post treatment, 3 and 12 months follow-up
measure: Mothers' Depressive Symptoms (BDI)
timeFrame: 4 weeks before, at the beginning and post treatment, 3 and 12 months follow up
measure: Mother's Life Satisfaction
timeFrame: 4 weeks before, at the beginning & post treatment, 3 and 12 months follow up
measure: Mothers' and children's Treatment Satisfaction
timeFrame: Post Treatment
Other outcomes:
Locations:
city: Grömitz
country: Germany
facility: Klinik Ostseedeich
Study officials:
affiliation: Philipps University Marburg Medical Center, Dept. of Child and Adolescent Psychiatry
name: Fritz Mattejat, PhD
role: STUDY_DIRECTOR
affiliation: Philipps University Marburg Medical Center, Dept. of Child and Adolescent Psychiatry
name: Katja J John, DP (MA)
role: PRINCIPAL_INVESTIGATOR
References:
citation: John K, Becker K, Mattejat F. Impact of family-oriented rehabilitation and prevention: an inpatient program for mothers with breast cancer and their children. Psychooncology. 2013 Dec;22(12):2684-92. doi: 10.1002/pon.3329. Epub 2013 Jun 13.