Home Chemotherapy Intervention for Children With Cancer - a Feasibility Study

Study Overview
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Brief Summary
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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.

Detailed Description
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This single-arm feasibility study is conducted at Copenhagen University Hospital, Rigshospitalet, in Denmark at the Department of Pediatric Oncology and Hematology.The PI started to recruit participants March 2022. Patients with Acute Lymphoblastic Leukemia (ALL), Philadelphia positive Acute Lymphoblastic Leukemia (PH+ALL) and Lymphoblastic Lymphoma (LBL) are eligible for inclusion if their parents speak and understand Danish or English, able to manage basic treatment and care such as oral medication, mobilization, nutrition, central venous catheter care and practice good personal hygiene. The parents' competences are assessed by the PI in collaboration with a team of project- and ward nurses who know them. Participants are recruited between day 15 and 29 from diagnosis. Parents to eligible participants and adolescents aged 15+ receive oral and written information and provide written informed consent before inclusion. Children and adolescents less than 15 years of age receive oral information and provide oral consent if possible according to their age. 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.

Official Title
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Parent-Administered Low-Dose Cytarabine to Children and Adolescents With Cancer at Home - a Feasibility Study

Conditions
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Supportive Care, Childhood Cancer

Intervention / Treatment
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* Other: parent-led home-administered low-dose Cytarabine


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: parent-led home-administered low-dose Cytarabine<br>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. | Other: parent-led home-administered low-dose Cytarabine<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment rate | Number of families who consent to participate in the study | 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) | 
| Attrition rate | Number of drop-outs during the intervention | From time of obtained consent until end of intervention period (mean intervention period = 22 weeks) | 
| Demand (dose) | Number of parent-led home-administered low-dose Cytarabine (total and average) | From day 38 up to day 167 from protocol start. Four to eight timepoints depending on number of protocolized cytarabine doses (mean intervention period = 22 weeks) | 
| Education time | Time (minutes) nurses spent on education for parents before the intervention | From time of obtained consent until start of intervention (2-4 weeks) | 
| Adverse events | Severe and non-severe events | From recruitment start to end of intervention (mean intervention period = 22 weeks) | 
| Respons rate | Number of responses on PENAT questionnaire | Everyday during each four-day-long chemo-cycle to five days after (one to eight cycles are given depending on the specific protocol).The typical intervention period is 22 weeks | 
| Respons rate | Number of responses on CMCC and SS questionnaires | At the end of each chemo-cycle (day 4, each chemo-cycle is four days). The typical intervention period is 22 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nausea and Vomiting during low-dose Cytarabine treatment (tentative) | Questionnaire (PENAT - measuring chemotherapy induced nausea and vomiting)) | Starting day one of the Cytarabine cycle and stops five days after (9 days). Each Cytarabine cycle is four days. There can be from four to eight cycles of Cytarabine in the Protocol. | 
| Caregiver Demands (tentative) | Questionnaire (CMCC: Care of My Child with Cancer) | Day four (and the last day) of each cycle of Cytarabine (each cycle is four days) | 
| Satisfaction and safety (tentative) | Questionnaire measuring parents and children/adolescents' experience of satisfaction and safety managing the home-administration of Cytarabine) | Day four (and the last day) of each cycle of Cytarabine (each cycle is four days) | 
| The family's experience of the intervention of home-administered Cytarabine | qualitative interviews with parents and children/adolescents | Interviews are conducted after end intervention (approximately day 167 since protocol start) | 
| Adaption, Integration, implementation | Qualitative process evaluation of the feasibility areas: Adaption, integration and implementation | Fieldnotes are collected at various timepoints during the in total study/intervention period = 43 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Home chemotherapy