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

Study Overview
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Brief Summary
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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
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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)

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: rehabilitation programme getting better together


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3-week family oriented rehabprogramme<br>waiting control group | Behavioral: rehabilitation programme getting better together<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Children's psychological difficulties (SDQ) |  | 4 weeks before, at the beginning & post treatment, 3 and 12 months follow-up | 
| Mothers' Depressive Symptoms (BDI) |  | 4 weeks before, at the beginning and 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 | 
| Mothers' and children's Treatment Satisfaction |  | Post Treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, quality of life, children of somatically ill parents, psychological adaptation