Breast CancerNCT00916825
Impact of a Rehabilitation Programme for Mothers With Breast Cancer and Their Children
A study testing rehabilitation programme "getting better together" in people with Breast Cancer, run by Philipps University Marburg at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- rehabilitation programme "getting better together"
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 801 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2009to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- metastases
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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)
- Conditions
- Breast Cancer
- Being tested
- rehabilitation programme "getting better together"
- Keywords
- breast cancer, quality of life, children of somatically ill parents, psychological adaptation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rehabilitation programme "getting better together"Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 3-week family oriented rehabprogramme | Experimental | waiting control group Receives: Behavioral: rehabilitation programme "getting better together" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mothers' and children's Quality of Life (EORTC OLQ-C30, QLQ-BR23; ILK)
Measured: 4 weeks before, at the beginning & post treatment, 3 and 12 months follow-up
Secondary outcomes (4)
Children's psychological difficulties (SDQ)
Measured: 4 weeks before, at the beginning & post treatment, 3 and 12 months follow-up
Mothers' Depressive Symptoms (BDI)
Measured: 4 weeks before, at the beginning and post treatment, 3 and 12 months follow up
Mother's Life Satisfaction
Measured: 4 weeks before, at the beginning & post treatment, 3 and 12 months follow up
Mothers' and children's Treatment Satisfaction
Measured: Post Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2009 (estimated)
- Study startJan 2009
- Primary completionJul 2010
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 801 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Collaborators
- Dept. of Child and Adolescent Psychiatry, Philipps University Marburg, Rexrodt von Fircks Foundation
- Responsible party
- Sponsor
- Investigators
- Fritz Mattejat, PhD, Study director, Philipps University Marburg Medical Center, Dept. of Child and Adolescent PsychiatryKatja J John, DP (MA), Principal investigator, Philipps University Marburg Medical Center, Dept. of Child and Adolescent Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00916825
- Sponsor's protocol ID
- RvF01 - 135/07
- Status last verified
- Feb 2010
- First submitted
- 9 Jun 2009
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23760766
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00916825
- Acronym / sponsor ID
- RvF01 - 135/07
- Conditions
- Breast Cancer
- Keywords
- breast cancer, quality of life, children of somatically ill parents, psychological adaptation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 801 participants (actual)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Collaborators
- Dept. of Child and Adolescent Psychiatry, Philipps University Marburg, Rexrodt von Fircks Foundation
- Study start
- Jan 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 10 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3-week family oriented rehabprogramme | Experimental | Behavioral: rehabilitation programme "getting better together"waiting control group |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- metastases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | 3-week family oriented rehabprogramme |
Primary outcome
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 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Derived from this study: PubMed 23760766John 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.
- Study homepageLink provided by the sponsor.
- The homepage of the foundation who initiated the oncological rehab-programmeLink provided by the sponsor.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fritz Mattejat, PhD study director
Philipps University Marburg Medical Center, Dept. of Child and Adolescent Psychiatry
Katja J John, DP (MA) principal investigator
Philipps University Marburg Medical Center, Dept. of Child and Adolescent Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rehabilitation programme "getting better together" in people with Breast Cancer, run by Philipps University Marburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00916825, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.