Familien-SCOUT: Comprehensive Support for Families With a Parent Suffering From Cancer (F-SCOUT)
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|ClinicalTrials.gov Identifier: NCT04186923|
Recruitment Status : Recruiting
First Posted : December 5, 2019
Last Update Posted : December 5, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||560 participants|
|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|
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.
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.
- 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.
- 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.
- 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.
- HLS-EU-Q16 [ Time Frame: 3 month ]HLS-EU-Q16 measures health competenceliteracy, using 16 items and a four-level response scale.
- 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.
- 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).
- 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.
- 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.
- 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.
- 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.
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
|Contact: Andrea Petermann-Meyer, Dr.||+49 241 80 email@example.com|
|Department of Hematology, Oncology, Hemostaseology and Stem Cell Transplantation, Faculty of Medicine, RWTH Aachen University||Recruiting|
|Contact: Tim H. Brümmendorf, Prof. Dr. +49 241 80 89805 firstname.lastname@example.org|
|Contact: Andrea Petermann-Meyer, Dr. +49 241 80 89805|
|Department of Psychosomatic Medicine and Psychotherapy, University Hospital Bonn||Recruiting|
|Contact: Franziska Geiser, Prof. Dr. +49 228 287 15256 email@example.com|
|Clinical Institute of Psychosomatic Medicine and Psychotherapy, Heinrich-Heine-University Duesseldorf||Recruiting|
|Contact: Andre Karger, Dr. +49 211 811 6212 firstname.lastname@example.org|
|Principal Investigator:||Tim H. Brümmendorf, Prof. Dr.||Department of Hematology, Oncology, Hemostaseology, RWTH Aachen University|