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Familien-SCOUT: Comprehensive Support for Families With a Parent Suffering From Cancer (F-SCOUT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04186923
Recruitment Status : Recruiting
First Posted : December 5, 2019
Last Update Posted : December 5, 2019
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Families With Minor Children and One Parent Suffering From Cancer Other: F-SPOKE Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 560 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Familien-SCOUT: Comprehensive Support for Families With a Parent Suffering From Cancer
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Arm Intervention/treatment
Experimental: Intervention group (IG)
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.
Other: F-SPOKE
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).

No Intervention: Control Group
In the control group the families are treated according to the standard of care.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Distress Thermometer (DT) [ Time Frame: baseline & 9 month ]
    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.

  2. Parenting Concerns Questionnaire (PCQ) [ Time Frame: baseline and 9 month ]
    PCQ is used to record concerns among parents who have developed cancer. It includes 15 items with a 5-level response scale.

  3. HLS-EU-Q16 [ Time Frame: 3 month ]
    HLS-EU-Q16 measures health competenceliteracy, using 16 items and a four-level response scale.

  4. PA-F-P-KF [ Time Frame: baseline & 9 month ]
    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.

  5. CaPIN [ Time Frame: 3 & 9 Month ]
    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).

  6. MOS-SS [ Time Frame: 3 month ]
    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.

  7. FAD [ Time Frame: baseline & 9 month ]
    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.

  8. EQ-5D-5L [ Time Frame: baseline, 3 & 9 month ]
    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.

  9. KIDSCREEN-10: [ Time Frame: baseline & 9 month ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04186923


Contacts
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Contact: Andrea Petermann-Meyer, Dr. +49 241 80 35991 apetermann-meyer@ukaachen.de

Locations
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Germany
Department of Hematology, Oncology, Hemostaseology and Stem Cell Transplantation, Faculty of Medicine, RWTH Aachen University Recruiting
Aachen, Germany
Contact: Tim H. Brümmendorf, Prof. Dr.    +49 241 80 89805    madrian@ukaachen.de   
Contact: Andrea Petermann-Meyer, Dr.    +49 241 80 89805      
Department of Psychosomatic Medicine and Psychotherapy, University Hospital Bonn Recruiting
Bonn, Germany
Contact: Franziska Geiser, Prof. Dr.    +49 228 287 15256    franziska.geiser@ukbonn.de   
Clinical Institute of Psychosomatic Medicine and Psychotherapy, Heinrich-Heine-University Duesseldorf Recruiting
Duesseldorf, Germany
Contact: Andre Karger, Dr.    +49 211 811 6212    andre.karger@med.uni-duesseldorf.de   
Sponsors and Collaborators
RWTH Aachen University
Investigators
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Principal Investigator: Tim H. Brümmendorf, Prof. Dr. Department of Hematology, Oncology, Hemostaseology, RWTH Aachen University

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Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT04186923    
Other Study ID Numbers: 18-033
First Posted: December 5, 2019    Key Record Dates
Last Update Posted: December 5, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stress, Psychological
Behavioral Symptoms