Feasiblity and Safety of Home-based Intensive Chemotherapy

NCT04904211 | Completed DMC

• 1 other identifier: Home-Based Chemo
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 6

Brief Summary

a multicenter single-arm feasibility and safety study of home-based intensive chemotherapy in patients with newly diagnosed acute myeloid leukemia and their quality of life and psychological wellbeing. This national study included patients from six sites in Denmark who received intensive chemotherapy on programmed CADD Solis infusion pumps through a central venous catheter and were also managed as outpatients during treatment-induced pancytopenia.

Conditions

Acute Leukemia

Outcome Measures

Primary Outcomes (8)

• Recruitment rate

  Number of participants included from eligible patients

  up to 3 years

• Adherence to intervention

  Number of weeks completed out of planned weeks of intervention

  Up to 24 weeks

• Hospital admissions

  Data will be collected from medical charts

  Up to 24 weeks

• Infections (days)

  Data will be collected from medical charts

  Up to 24 weeks

• Infections (type)

  Data will be collected from medical charts

  Up to 24 weeks

• Number of days home during treatment

  Data will be collected from medical charts

  Up to 24 weeks

• Number of contacts to hospital during treatment

  Data will be collected from medical charts

  Up to 24 weeks

• Number of removed CVK

  Data will be collected from medical charts

  Up to 24 weeks

Secondary Outcomes (3)

• Psychological wellbeing

  Change measures (baseline, 12 weeks, 24 and 36 weeks)

• Quality of Life in participants

  Change measures (baseline, 12 weeks, 24 and 36 weeks)

• Quality of Life in participants

  Change measures (baseline, 12 weeks, 24 and 36 weeks)

Study Arms (1)

Feasiblity and Safety

EXPERIMENTAL

All eligible patients will be assigned to this arm

Other: Home-based chemotherapy

Interventions

Home-based chemotherapy OTHER

To investigate the feasibility and safety of home-based intensive chemotherapy in patients with newly diagnosed acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS). Furthermore, we examined the quality of life (QOL) and psychological wellbeing while receiving induction and consolidation chemotherapy at home.

Feasiblity and Safety

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants 18 years or older were included within the first 28 days from diagnosis with AML or high-risk MDS if intensive chemotherapy treatment was planned.

You may not qualify if:

• Patients were excluded if they did not understand, read and speak Danish, suffered from a severe illness requiring hospitalization if they had an unstable medical disease or any cognitive/psychiatric disorders. During the intervention, participants were withdrawn if hospitalized in an intensive care unit for more than two weeks, if they had a psychological condition (delirium or severe depression), or in case of transition to terminal care or if deceased. Moreover, participants were censored if they relapsed or transitioned to hematopoietic stem cell transplantation (HSCT).

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (6)

Aalborg University Hospital

Aalborg, Denmark

Location

Aarhus University Hospital

Aarhus, Denmark

Location

Herlev Hospital

Herlev, 2730, Denmark

Location

Odense University Hospital

Odense, Denmark

Location

Sjællandsuniversitetshospital Roskilde

Roskilde, 4000, Denmark

Location

Rigshospitalet

Copenhagen, Østerbro, 2100, Denmark

Location

Related Publications (1)

• Norskov KH, Fridthjof K, Kampmann P, Dunweber A, Andersen CL, Renaberg T, Schollkopf C, Ahmad SA, Schou K, Jensen CF, Moller P, Lundholm BW, Marcher C, Jepsen L, Orntoft AK, Ommen HB, Andersen L, Behrentzs A, Hasselgren CF, Severinsen M, Grand MK, Jarden M, Moller T, Kjeldsen L. A national Danish proof of concept on feasibility and safety of home -based intensive chemotherapy in patients with acute myeloid leukemia. Leuk Res. 2022 Jan;112:106756. doi: 10.1016/j.leukres.2021.106756. Epub 2021 Nov 22.

  PMID: 34839055 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Nurse Specialist, PhD

Study Record Dates

• First Submitted: May 22, 2021
• First Posted: May 27, 2021
• Study Start: January 1, 2017
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: May 27, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (6)