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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2010 by Philipps University Marburg Medical Center.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00916825
First Posted: June 10, 2009
Last Update Posted: February 3, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Dept. of Child and Adolescent Psychiatry, Philipps University Marburg
Rexrodt von Fircks Foundation
Information provided by:
Philipps University Marburg Medical Center
  Purpose
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.

Condition Intervention
Breast Cancer Behavioral: rehabilitation programme "getting better together"

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Philipps University Marburg Medical Center:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Estimated Enrollment: 750
Study Start Date: January 2009
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00916825


Locations
Germany
Klinik Ostseedeich
23473 Groemitz, Germany
Sponsors and Collaborators
Philipps University Marburg Medical Center
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
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mattejat, PhD, Philipps University Marburg Medical Center, Dept. of Child and Adolescent Psychiatry
ClinicalTrials.gov Identifier: NCT00916825     History of Changes
Other Study ID Numbers: RvF01 - 135/07
First Submitted: June 9, 2009
First Posted: June 10, 2009
Last Update Posted: February 3, 2010
Last Verified: February 2010

Keywords provided by Philipps University Marburg Medical Center:
breast cancer
quality of life
children of somatically ill parents
psychological adaptation

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases