- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05372536
Home Chemotherapy Intervention for Children With Cancer - a Feasibility Study (INTACTatHome)
May 10, 2022 updated by: Louise Ingerslev Roug, Rigshospitalet, Denmark
Parent-Administered Low-Dose Cytarabine to Children and Adolescents With Cancer at Home - a Feasibility Study
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Louise I Roug, RN, MA
- Phone Number: +45 20625228
- Email: louise.ingerslev.roug@regionh.dk
Study Contact Backup
- Name: Helena Hansson, RN, PHD
- Phone Number: +45 35459400
- Email: helena.hansson@regionh.dk
Study Locations
-
-
Danmark
-
Copenhagen, Danmark, Denmark, 2100
- Recruiting
- Louise Ingerslev Roug
-
Contact:
- Louise I Roug, Nurse, MA
- Phone Number: +45 20625228
- Email: louise.ingerslev.roug@regionh.dk
-
Contact:
- Helena Hansson, Nurse, Ph.D
- Phone Number: 35459400
- Email: helena.hansson@regionh.dk
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recruitment rate
Time Frame: 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)
|
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
Time Frame: From time of obtained consent until end of intervention period (mean intervention period = 22 weeks)
|
Number of drop-outs during the intervention
|
From time of obtained consent until end of intervention period (mean intervention period = 22 weeks)
|
Demand (dose)
Time Frame: 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)
|
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 Frame: From time of obtained consent until start of intervention (2-4 weeks)
|
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
Time Frame: From recruitment start to end of intervention (mean intervention period = 22 weeks)
|
Severe and non-severe events
|
From recruitment start to end of intervention (mean intervention period = 22 weeks)
|
Respons rate
Time Frame: 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
|
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
Time Frame: At the end of each chemo-cycle (day 4, each chemo-cycle is four days). The typical intervention period is 22 weeks
|
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)
Time Frame: 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.
|
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)
Time Frame: Day four (and the last day) of each cycle of Cytarabine (each cycle is four days)
|
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)
Time Frame: Day four (and the last day) of each cycle of Cytarabine (each cycle is four days)
|
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
Time Frame: Interviews are conducted after end intervention (approximately day 167 since protocol start)
|
qualitative interviews with parents and children/adolescents
|
Interviews are conducted after end intervention (approximately day 167 since protocol start)
|
Adaption, Integration, implementation
Time Frame: Fieldnotes are collected at various timepoints during the in total study/intervention period = 43 weeks
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 11, 2022
Primary Completion (Anticipated)
December 31, 2022
Study Completion (Anticipated)
February 28, 2023
Study Registration Dates
First Submitted
April 25, 2022
First Submitted That Met QC Criteria
May 10, 2022
First Posted (Actual)
May 12, 2022
Study Record Updates
Last Update Posted (Actual)
May 12, 2022
Last Update Submitted That Met QC Criteria
May 10, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LROU0001-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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