Home Chemotherapy Intervention for Children With Cancer - a Feasibility Study

NCT05372536 | Completed

• 1 other identifier: LROU0001-1
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Supportive Care; Childhood Cancer

Keywords

Home chemotherapy

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (5)

• Nausea and Vomiting during low-dose Cytarabine treatment (tentative)

  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)

  Day four (and the last day) of each cycle of Cytarabine (each cycle is four days)

• Satisfaction and safety (tentative)

  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

  Interviews are conducted after end intervention (approximately day 167 since protocol start)

• Adaption, Integration, implementation

  Fieldnotes are collected at various timepoints during the in total study/intervention period = 43 weeks

Study Arms (1)

parent-led home-administered low-dose Cytarabine

EXPERIMENTAL

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

Interventions

parent-led home-administered low-dose Cytarabine OTHER

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.

parent-led home-administered low-dose Cytarabine

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \- Children/adolescents diagnosed with ALL, LBL or PH+ ALL

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Louise Ingerslev Roug

Copenhagen, Danmark, 2100, Denmark

Location

Related Publications (1)

• Roug 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 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Cytarabine

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Marianne Madsen, Chief nurse

  Rigshospitalet, Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: May 12, 2022
• Study Start: February 1, 2022
• Primary Completion: October 31, 2022
• Study Completion: April 1, 2023
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)