Families With Minor Children and One Parent Suffering From CancerF-SCOUTNCT04186923
Familien-SCOUT: Comprehensive Support for Families With a Parent Suffering From Cancer
A study testing F-SPOKE in people with Families With Minor Children and One Parent Suffering From Cancer, run by RWTH Aachen University at 3 sites in Germany.
Trial summary
When a parent with minor children falls ill with cancer, it is extremely stressful for all of the family members, including the partner and children. Familiar everyday routines are often disrupted even at an early stage, and for a prolonged period. Read more about this study
- Who is it for?
- Ages 8 years and olderHealthy volunteers can take part
- Conditions the study is for
- Families With Minor Children and One Parent Suffering From Cancer
- What is being tested?
- F-SPOKE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 472 participants
- Where
- 3 sitesGermany
- Study dates
- 1 Oct 2019to 1 Jun 2022
- 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 8 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Confirmed ICD diagnosis of cancer in one parent
- Custody of at least one underage child
- Adequate knowledge of German
- Availability of informed consent to participate in the study from the patient and/or healthy parent and linkage to questionnaire data and routine data
Who cannot join
- Withdrawal of consent by the ill or healthy parent
- Relevant cognitive limitation, advanced dementia
- Individuals who are in relationships of dependence or employment to the project managers or their representatives
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Department of Hematology, Oncology, Hemostaseology and Stem Cell Transplantation, Faculty of Medicine, RWTH Aachen University
Aachen
Department of Psychosomatic Medicine and Psychotherapy, University Hospital Bonn
Bonn
Clinical Institute of Psychosomatic Medicine and Psychotherapy, Heinrich-Heine-University Duesseldorf
Düsseldorf
About this study
When a parent with minor children falls ill with cancer, it is extremely stressful for all of the family members, including the partner and children. Familiar everyday routines are often disrupted even at an early stage, and for a prolonged period. Financial difficulties, the threat represented by the uncertain course of the disease, and worries about the children's future have a cumulative effect. The affected families are thereby pushed to their limits organizationally and emotionally. The burden involved tends to be underestimated, and secondary psychological conditions often develop among all the family members. They often do not have adequate access to support.
The aim of this project is to establish a care management system that provides support for families with underage children in which one parent is seriously ill. In order to reduce the burden on families, "family SCOUTS" are to be used who can provide advice and information at an early stage. They are intended to encourage families to discuss things openly, and they should also facilitate access to all the support services available.
The project will evaluate whether the use of family SCOUTS reduces the burden on the family in comparison with families who do not have a family SCOUT. For this purpose, investigations will be carried out before and after the family SCOUTS are deployed. Standardized questionnaires, interviews, and routine data from the participating health-insurance companies will provide the basic data.
- Being tested
- F-SPOKE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F-SPOKEOther
This project includes communicative, emotional, and also organizational support with outreach across different sectors and phases (F-SPOKE - family-centered, cross-sector and cross-phase organizational, communicative, and emotional support).
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (IG) | Experimental | Families receive permanent contact persons to support in the organisation of everyday life, financial applications, during emotional coping with illness and open communication within the family. Receives: Other: F-SPOKE |
| Control Group | No intervention | In the control group the families are treated according to the standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Anxiety and Depression Scale (HADS
HADS is used to record anxiety and depression in patients with physical diseases or psychogenic physical symptoms.Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. The HADS uses a scale and therefore the data returned from the HADS is ordinal.
Measured: Change from Baseline HADS at 9 months
Secondary outcomes (9)
Distress Thermometer (DT)
DT is a screening instrument developed by the National Comprehensive Cancer Network (NCCN) for registering psychosocial stress in oncological patients. It consists of a scale from 0 to 10 and a list of problems, providing a scheme for referral to the relevant professional services.
Measured: baseline & 9 month
Parenting Concerns Questionnaire (PCQ)
PCQ is used to record concerns among parents who have developed cancer. It includes 15 items with a 5-level response scale.
Measured: baseline and 9 month
HLS-EU-Q16
HLS-EU-Q16 measures health competenceliteracy, using 16 items and a four-level response scale.
Measured: 3 month
PA-F-P-KF
The short form of the Fear of Progression Anxiety Questionnaire for Partners (PA-F-P-KF) records anxieties regarding progression fear of progression in healthy partners of individuals with chronic disease. The scale includes 12 items, each with a 5-level scale of response categories.
Measured: baseline & 9 month
CaPIN
The Cancer Patient Information Needs (CaPIN) scale measures information needs on various topics among cancer patients. The scale consists of 22 items with binary-coded response categories (yes/no).
Measured: 3 & 9 Month
MOS-SS
This instrument is a subscale of the validated "Medical Outcomes Study Social Support (MOS-SS) survey. The eight items on the subscale record emotional and informational social support. The response categories have a five-level scale.
Measured: 3 month
FAD
The Family Assessment Device (FAD)is based on the McMaster Model of Family Functioning (MMFF), a clinically oriented conceptualization of families. It is a screening instrument only consisting of 53-items. The model identifies six dimensions of family functioning. Scores range from 1 to 4 with 1 reflecting healthy functioning and 4 reflecting unhealthy functioning. The FAD is made up of seven scales.
Measured: baseline & 9 month
EQ-5D-5L
The EuroQoL Group (EQ)-5D is a generic measurement instrument that uses a standardized, preference-based procedure to describe and investigate health-related quality of life.The EQ-5D-5L is composed of the EQ-5D-5L descriptive system and the EQ Visual Analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Each level corresponds to 1-digit number expressing the level selected for that dimension.
Measured: baseline, 3 & 9 month
KIDSCREEN-10:
The KIDSCREEN questionnaire for children is used to record health-related quality of life (HRQoL). The scale ranges from 5 to 50, with a higher score indicating a better quality of life.
Measured: baseline & 9 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start1 Oct 2019
- Primary completion1 Sep 2021
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Families With Minor Children and One Parent Suffering From 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 472 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tim H. Brümmendorf, Prof. Dr., Principal investigator, Department of Hematology, Oncology, Hemostaseology, RWTH Aachen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04186923
- Sponsor's protocol ID
- 18-033
- Acronym
- F-SCOUT
- Status last verified
- Oct 2022
- First submitted
- 2 Dec 2019
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Holsteg S, Klett MK, Kisic AM, Horbach-Bremen R, Brune M, Dohmen M, Drueke B, Ernstmann N, Geiser F, Heier L, Heuser C, Icks A, Panse J, Petermann-Meyer A, Viehmann A, Karger A. Psychological burden, quality of life, problems, and parental concerns of single mothers with cancer: a cross-sectional comparison. Support Care Cancer. 2025 Feb 11;33(3):173. doi: 10.1007/s00520-025-09225-y.
PubMed 39932595Heuser C, Ernstmann N, Heier L, Nakata H, Geiser F, Karger A, Icks A, Brune M, Haastert B, Horbach-Bremen R, Brummendorf T, Petermann-Meyer A. Health-Related Quality of Life and Experiences of Minor Children With Parental Cancer-A Family-Based Multilevel Analysis of Determinants. Psychooncology. 2024 Nov;33(11):e70029. doi: 10.1002/pon.70029.
PubMed 39562832Ernstmann N, Nakata H, Heier L, Heuser C, Dohmen M, Bremen R, Geiser F, Holsteg S, Karger A, Viehmann A, Brune M, Icks A, Haastert B, Brummendorf TH, Petermann-Meyer A. Feasibility of a complex psychosocial intervention for families with parental cancer: acceptability, suitability, implementability, and perceived support. J Cancer Res Clin Oncol. 2024 Oct 17;150(10):464. doi: 10.1007/s00432-024-05946-5.
PubMed 39414623Heuser C, Schneider JN, Heier L, Ernstmann N, Nakata H, Petermann-Meyer A, Bremen R, Karger A, Icks A, Brummendorf TH, Geiser F. Family resilience of families with parental cancer and minor children: a qualitative analysis. Front Psychol. 2024 Jan 19;14:1251049. doi: 10.3389/fpsyg.2023.1251049. eCollection 2023.
PubMed 38314254Dohmen M, Petermann-Meyer A, Blei D, Bremen R, Brock-Midding E, Brune M, Geiser F, Haastert B, Halbach SM, Heuser C, Holsteg S, Heier L, Icks A, Karger A, Montalbo J, Nakata H, Panse J, Rottmann TP, Sattler K, Viehmann A, Vomhof M, Ernstmann N, Brummendorf TH. Comprehensive support for families with parental cancer (Family-SCOUT), evaluation of a complex intervention: study protocol for a non-randomized controlled trial. Trials. 2021 Sep 15;22(1):622. doi: 10.1186/s13063-021-05577-y.
PubMed 34526078
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Familien-SCOUT: Comprehensive Support for Families With a Parent Suffering From Cancer
- ClinicalTrials.gov ID
- NCT04186923
- Acronym / sponsor ID
- F-SCOUT / 18-033
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 472 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 5 Dec 2019 (actual)
- 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.
When a parent with minor children falls ill with cancer, it is extremely stressful for all of the family members, including the partner and children. Familiar everyday routines are often disrupted even at an early stage, and for a prolonged period. Financial difficulties, the threat represented by the uncertain course of the disease, and worries about the children's future have a cumulative effect. The affected families are thereby pushed to their limits organizationally and emotionally. The burden involved tends to be underestimated, and secondary psychological conditions often develop among all the family members. They often do not have adequate access to support.
The aim of this project is to establish a care management system that provides support for families with underage children in which one parent is seriously ill. In order to reduce the burden on families, "family SCOUTS" are to be used who can provide advice and information at an early stage. They are intended to encourage families to discuss things openly, and they should also facilitate access to all the support services available.
The project will evaluate whether the use of family SCOUTS reduces the burden on the family in comparison with families who do not have a family SCOUT. For this purpose, investigations will be carried out before and after the family SCOUTS are deployed. Standardized questionnaires, interviews, and routine data from the participating health-insurance companies will provide the basic data.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group (IG) | Experimental | Other: F-SPOKEFamilies receive permanent contact persons to support in the organisation of everyday life, financial applications, during emotional coping with illness and open communication within the family. |
| Control Group | No intervention | –In the control group the families are treated according to the standard of care. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed ICD diagnosis of cancer in one parent
- Custody of at least one underage child
- Adequate knowledge of German
- Availability of informed consent to participate in the study from the patient and/or healthy parent and linkage to questionnaire data and routine data
Key exclusion criteria (3 listed)
- Withdrawal of consent by the ill or healthy parent
- Relevant cognitive limitation, advanced dementia
- Individuals who are in relationships of dependence or employment to the project managers or their representatives
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 |
|---|---|---|
| F-SPOKEThis project includes communicative, emotional, and also organizational support with outreach across different sectors and phases (F-SPOKE - family-centered, cross-sector and cross-phase organizational, communicative, and emotional support). | Other | Intervention group (IG) |
Primary outcome
Hospital Anxiety and Depression Scale (HADS
Time frame: Change from Baseline HADS at 9 months
HADS is used to record anxiety and depression in patients with physical diseases or psychogenic physical symptoms.Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. The HADS uses a scale and therefore the data returned from the HADS is ordinal.
9 secondary outcomes
Distress Thermometer (DT)
Time frame: baseline & 9 month
Parenting Concerns Questionnaire (PCQ)
Time frame: baseline and 9 month
HLS-EU-Q16
Time frame: 3 month
PA-F-P-KF
Time frame: baseline & 9 month
CaPIN
Time frame: 3 & 9 Month
MOS-SS
Time frame: 3 month
FAD
Time frame: baseline & 9 month
EQ-5D-5L
Time frame: baseline, 3 & 9 month
KIDSCREEN-10:
Time frame: baseline & 9 month
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 26 Oct 2022.
- Derived from this study: PubMed 39932595Holsteg S, Klett MK, Kisic AM, Horbach-Bremen R, Brune M, Dohmen M, Drueke B, Ernstmann N, Geiser F, Heier L, Heuser C, Icks A, Panse J, Petermann-Meyer A, Viehmann A, Karger A. Psychological burden, quality of life, problems, and parental concerns of single mothers with cancer: a cross-sectional comparison. Support Care Cancer. 2025 Feb 11;33(3):173. doi: 10.1007/s00520-025-09225-y.
- Derived from this study: PubMed 39562832Heuser C, Ernstmann N, Heier L, Nakata H, Geiser F, Karger A, Icks A, Brune M, Haastert B, Horbach-Bremen R, Brummendorf T, Petermann-Meyer A. Health-Related Quality of Life and Experiences of Minor Children With Parental Cancer-A Family-Based Multilevel Analysis of Determinants. Psychooncology. 2024 Nov;33(11):e70029. doi: 10.1002/pon.70029.
- Derived from this study: PubMed 39414623Ernstmann N, Nakata H, Heier L, Heuser C, Dohmen M, Bremen R, Geiser F, Holsteg S, Karger A, Viehmann A, Brune M, Icks A, Haastert B, Brummendorf TH, Petermann-Meyer A. Feasibility of a complex psychosocial intervention for families with parental cancer: acceptability, suitability, implementability, and perceived support. J Cancer Res Clin Oncol. 2024 Oct 17;150(10):464. doi: 10.1007/s00432-024-05946-5.
- Derived from this study: PubMed 38314254Heuser C, Schneider JN, Heier L, Ernstmann N, Nakata H, Petermann-Meyer A, Bremen R, Karger A, Icks A, Brummendorf TH, Geiser F. Family resilience of families with parental cancer and minor children: a qualitative analysis. Front Psychol. 2024 Jan 19;14:1251049. doi: 10.3389/fpsyg.2023.1251049. eCollection 2023.
- Derived from this study: PubMed 34526078Dohmen M, Petermann-Meyer A, Blei D, Bremen R, Brock-Midding E, Brune M, Geiser F, Haastert B, Halbach SM, Heuser C, Holsteg S, Heier L, Icks A, Karger A, Montalbo J, Nakata H, Panse J, Rottmann TP, Sattler K, Viehmann A, Vomhof M, Ernstmann N, Brummendorf TH. Comprehensive support for families with parental cancer (Family-SCOUT), evaluation of a complex intervention: study protocol for a non-randomized controlled trial. Trials. 2021 Sep 15;22(1):622. doi: 10.1186/s13063-021-05577-y.
- Individual participant dataSharing planned: No
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.
Tim H. Brümmendorf, Prof. Dr. principal investigator
Department of Hematology, Oncology, Hemostaseology, RWTH Aachen University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing F-SPOKE in people with Families With Minor Children and One Parent Suffering From Cancer, run by RWTH Aachen University at 3 sites 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 3 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 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Hospital Anxiety and Depression Scale (HADS (time frame: Change from Baseline HADS at 9 months). 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 NCT04186923, which also lists 5 linked publications.
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 26 Oct 2022.