Home Chemotherapy Intervention for Children With Cancer - a Feasibility Study

Childhood Cancer Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05372536
• Other study ID #: LROU0001-1
• Status: Recruiting
• Phase: N/A
• Start date: March 11, 2022
• Est. completion date: February 28, 2023

Study information

• Verified date: May 2022
• Source: Rigshospitalet, Denmark
• Contact: Louise I Roug, RN, MA
• Phone: +45 20625228
• Email: louise.ingerslev.roug[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: February 28, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 17 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Childhood Cancer
• Supportive Care

Intervention

Other:
• parent-led home-administered low-dose Cytarabine
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.

Locations

Country	Name	City	State
Denmark	Louise Ingerslev Roug	Copenhagen	Danmark

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Attrition rate	Number of drop-outs during the intervention	From time of obtained consent until end of intervention period (mean intervention period = 22 weeks)
Primary	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)
Primary	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)
Primary	Adverse events	Severe and non-severe events	From recruitment start to end of intervention (mean intervention period = 22 weeks)
Primary	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
Primary	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	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.
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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