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

NCT ID: NCT00916825

Last Updated: 2019-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

801 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2013-07-31

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)

Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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3-week family oriented rehabprogramme

waiting control group

Group Type EXPERIMENTAL

rehabilitation programme "getting better together"

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Dept. of Child and Adolescent Psychiatry, Philipps University Marburg

OTHER

Sponsor Role collaborator

Rexrodt von Fircks Foundation

UNKNOWN

Sponsor Role collaborator

Philipps University Marburg

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fritz Mattejat, PhD

Role: STUDY_DIRECTOR

Philipps University Marburg Medical Center, Dept. of Child and Adolescent Psychiatry

Katja J John, DP (MA)

Role: PRINCIPAL_INVESTIGATOR

Philipps University Marburg Medical Center, Dept. of Child and Adolescent Psychiatry

Locations

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Klinik Ostseedeich

Grömitz, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 23760766 (View on PubMed)

Related Links

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http://www.rvfs.de

The homepage of the foundation who initiated the oncological rehab-programme

Other Identifiers

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RvF01 - 135/07

Identifier Type: -

Identifier Source: org_study_id

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