Clinical trial · Interventional
Home Chemotherapy Intervention for Children With Cancer - a Feasibility Study
Parent-Administered Low-Dose Cytarabine to Children and Adolescents With Cancer at Home - a Feasibility Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Children with cancer undergo intensive treatment with many serious side effects and frequent in- and outpatient visits. Studies show that the frequent hospitalizations are very disruptive to children and their families, who strive to maintain a normal everyday life. The aim of the study is to test a parent-led home-administered low-dose cytarabine intervention that will not compromise the quality of treatment and care, increase the caregiver burden or the experienced symptoms of the children. The methodical approach is based on The Medical Research Council's framework to develop and evaluate complex interventions in health care using both clinical observational methods, participatory methods, surveys and qualitative ethnographic methods. The overall goal of the project is to support and ease the everyday lives of children with cancer and their families during the intensive treatment periods.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Childhood Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
| Supportive Care | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| parent-led home-administered low-dose Cytarabine | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- parent-led home-administered low-dose Cytarabine
- description
- Parents to the included participants are offered to administer the protocolized low-dose bolus (injection) Cytarabine in their children's CVCs at home. The administration procedure is developed as a simple and safe non-touch technique. The parents receive a video and paper-based guideline and information material followed by a 3-step nurse-led education program. The parents can administer the Cytarabine at home when they (and the child/adolescent) feel safe and comfortable managing the procedure and when the nurses are sure that the parents can manage the procedure at home. The first dose of Cytarabine is always administered at the hospital.
- interventionNames
- Other: parent-led home-administered low-dose Cytarabine
Primary outcomes (7)
- measure
- Recruitment rate
- timeFrame
- From day 15 (from protocol start) until the last day with low dose cytarabine treatment which depends on protocol stratification and randomization (mean intervention period = 22 weeks)
- description
- Number of families who consent to participate in the study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 17 Years
Show eligibility criteria text
Inclusion Criteria: \- Children/adolescents diagnosed with ALL, LBL or PH+ ALL Exclusion Criteria: * If their parents did not understand, read and speak Danish * If the parents did not manage the children/adolescents' basic care and treatment needs (CVC care, oral medication, hygiene, nutrition, mobilization, ect.)
References
Publications (1)
- DERIVEDRoug LI, Topperzer MK, Michelsen RT, Jarden M, Wahlberg A, Hjalgrim LL, Hansson H. Development of an intravenous chemotherapy intervention for children and adolescents with cancer administered by their parents at home (INTACTatHome). BMC Health Serv Res. 2023 Jun 20;23(1):664. doi: 10.1186/s12913-023-09613-2. PMID 37340397