NCT00916825

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
801

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Jan 2009

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 10, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

April 17, 2019

Status Verified

February 1, 2010

Enrollment Period

1.5 years

First QC Date

June 9, 2009

Last Update Submit

April 15, 2019

Conditions

Breast Cancer

Keywords

breast cancerquality of lifechildren of somatically ill parentspsychological adaptation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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

Study Arms (1)

3-week family oriented rehabprogramme

EXPERIMENTAL

waiting control group

Behavioral: rehabilitation programme "getting better together"

Interventions

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.

3-week family oriented rehabprogramme

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • metastases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik Ostseedeich

Grömitz, 23473, Germany

Location

Related Publications (1)

  • 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.

    PMID: 23760766DERIVED

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Fritz Mattejat, PhD

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

    STUDY DIRECTOR

  • Katja J John, DP (MA)

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2009

First Posted

June 10, 2009

Study Start

January 1, 2009

Primary Completion

July 1, 2010

Study Completion

July 1, 2013

Last Updated

April 17, 2019

Record last verified: 2010-02

Locations

DE(1)