Clinical trial NCT05372536: Home Chemotherapy Intervention for Children With Cancer - a Feasibility Study
Official title: Parent-Administered Low-Dose Cytarabine to Children and Adolescents With Cancer at Home - a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Supportive Care
Childhood Cancer
Keywords: Home chemotherapy
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2022-05-12
Enrollment: 15
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: 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.)

Primary outcomes:
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)
measure: Attrition rate
timeFrame: From time of obtained consent until end of intervention period (mean intervention period = 22 weeks)
measure: Demand (dose)
timeFrame: 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)
measure: Education time
timeFrame: From time of obtained consent until start of intervention (2-4 weeks)
measure: Adverse events
timeFrame: From recruitment start to end of intervention (mean intervention period = 22 weeks)
measure: Respons rate
timeFrame: 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
measure: Respons rate
timeFrame: At the end of each chemo-cycle (day 4, each chemo-cycle is four days). The typical intervention period is 22 weeks
Secondary outcomes:
measure: Nausea and Vomiting during low-dose Cytarabine treatment (tentative)
timeFrame: 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.
measure: Caregiver Demands (tentative)
timeFrame: Day four (and the last day) of each cycle of Cytarabine (each cycle is four days)
measure: Satisfaction and safety (tentative)
timeFrame: Day four (and the last day) of each cycle of Cytarabine (each cycle is four days)
measure: The family's experience of the intervention of home-administered Cytarabine
timeFrame: Interviews are conducted after end intervention (approximately day 167 since protocol start)
measure: Adaption, Integration, implementation
timeFrame: Fieldnotes are collected at various timepoints during the in total study/intervention period = 43 weeks
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Louise Ingerslev Roug
state: Danmark
Study officials:
affiliation: Rigshospitalet, Denmark
name: Marianne Madsen, Chief nurse
role: STUDY_CHAIR
References: