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

April 15, 2019 updated by: Philipps University Marburg Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

801

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Grömitz, Germany, 23473
        • Klinik Ostseedeich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 3-week family oriented rehabprogramme
waiting control group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
4 weeks before, at the beginning & post treatment, 3 and 12 months follow-up

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philipps University Marburg Medical Center

Collaborators

Dept. of Child and Adolescent Psychiatry, Philipps University Marburg
Rexrodt von Fircks Foundation

Investigators

  • Study Director: Fritz Mattejat, PhD, Philipps University Marburg Medical Center, Dept. of Child and Adolescent Psychiatry
  • Principal Investigator: Katja J John, DP (MA), Philipps University Marburg Medical Center, Dept. of Child and Adolescent Psychiatry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

June 9, 2009

First Submitted That Met QC Criteria

June 9, 2009

First Posted (Estimate)

June 10, 2009

Study Record Updates

Last Update Posted (Actual)

April 17, 2019

Last Update Submitted That Met QC Criteria

April 15, 2019

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RvF01 - 135/07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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