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Completed

NCT Number: NCT00916825

Impact of a Rehabilitation Programme for Mothers With Breast Cancer 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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Klinik Ostseedeich

Grömitz, 23473, Germany

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rehabilitation programme "getting better together"

Behavioral

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

  1. 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

  1. Children's psychological difficulties (SDQ)

    Time frame: 4 weeks before, at the beginning & post treatment, 3 and 12 months follow-up

  2. Mothers' Depressive Symptoms (BDI)

    Time frame: 4 weeks before, at the beginning and post treatment, 3 and 12 months follow up

  3. Mother's Life Satisfaction

    Time frame: 4 weeks before, at the beginning & post treatment, 3 and 12 months follow up

  4. Mothers' and children's Treatment Satisfaction

    Time frame: Post Treatment

Sponsors and collaborators

Lead sponsor

Philipps University Marburg

Other

Collaborators

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

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2013
First posted
Jun 10, 2009
Registry last updated
Apr 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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