A national Danish proof of concept on feasibility and safety of home -based intensive chemotherapy in patients with acute myeloid leukemia

Nørskov, Kristina Holmegaard; Fridthjof, Katrine S.; Kampmann, Peter; Dünweber, Anne; Andersen, Christen Lykkegaard; Renaberg, Toni P.; Schöllkopf, Claudia; Ahmad, Syed Azhar; Schou, Katrine; Jensen, Cecilie Fremming; Lundholm, Birgitte Wolf; Marcher, Claus Werenberg; Jepsen, Lene Østergaard; Ørntoft, Anne Katrine; Ommen, Hans Beier; Andersen, Lotte Nygaard; Behrentzs, Anni; Hasselgren, Connie Fruergaard; Severinsen, Marianne Tang; Grand, Mia Klinten; Jarden, Mary; Møller, Tom; Kjeldsen, Lars

doi:10.1016/j.leukres.2021.106756

Cited by 7 publications

(3 citation statements)

References 30 publications

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“…12 Results from recent pilot studies suggested that outpatient induction chemotherapy in acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS) is feasible without compromising patient safety, provided that appropriate support systems are in place. 13 , 14 Pragmatic solutions like this could also be applied in clinical trials to deliver as much experimental therapy as possible near to home.…”

Section: Working Toward Decentralized Trial Designsmentioning

confidence: 99%

“…Thus, a decentralized trial design will require substantial training efforts of local staff and close oversight by the investigator, who retains final responsibility for noncompliance in relation to tasks delegated to third parties at a decentralized trial site 12 . Results from recent pilot studies suggested that outpatient induction chemotherapy in acute myeloid leukemia (AML) and high‐risk myelodysplastic syndrome (MDS) is feasible without compromising patient safety, provided that appropriate support systems are in place 13,14 . Pragmatic solutions like this could also be applied in clinical trials to deliver as much experimental therapy as possible near to home.…”

Section: Working Toward Decentralized Trial Designsmentioning

confidence: 99%

See 1 more Smart Citation

A Lack of Diversity, Equity, and Inclusion in Clinical Research Has Direct Impact on Patient Care

El‐Galaly¹,

Gaidzik²,

Găman³

et al. 2023

HemaSphere

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Section: Working Toward Decentralized Trial Designsmentioning

confidence: 99%

Section: Working Toward Decentralized Trial Designsmentioning

confidence: 99%

A Lack of Diversity, Equity, and Inclusion in Clinical Research Has Direct Impact on Patient Care

El‐Galaly¹,

Gaidzik²,

Găman³

et al. 2023

HemaSphere

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show abstract

“…One department had administered only 5-FU chemotherapy using an elastomeric infusion pump. The other two departments provided multiple chemotherapies and hydrations as home care using an electronic PIP [ 39 , 40 ]. Organizational changes imposed on the two departments, i.e., moving inpatient care to home care managed by the outpatient ambulatory unit, significantly influenced care routines.…”

Section: Development Of the Interventionmentioning

confidence: 99%

Development of an intravenous chemotherapy intervention for children and adolescents with cancer administered by their parents at home (INTACTatHome)

Roug,

Topperzer,

Michelsen

et al. 2023

BMC Health Serv Res

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Background Families of children and adolescents with cancer strive to maintain routines and normalcy during the child’s treatment trajectory that requires frequent hospital visits. Intravenous chemotherapy at home can reduce time spent on the frequent hospital visits and mitigate disruption in daily life. Studies on home chemotherapy for children and adolescents with cancer are limited, as is knowledge of family and health care professionals’ needs, and knowledge required to inform adaptation or replication of interventions in other settings. The aim of this study was to develop and describe an evidence-based home chemotherapy intervention that is feasible and safe for children and adolescents and suitable for future feasibility testing. Methods The Medical Research Council’s guidance for developing complex interventions in health care and the framework of action developed by O’Cathain et al. was used as theoretical frameworks to structure the development process. A literature search, an ethnographic study, and interviews with clinical nurse specialists from adult cancer departments formed the evidence base. Educational learning theory to support and understand the intervention was identified. Stakeholder perspectives were explored in workshops with health care professionals and parent-adolescent interviews. Reporting was qualified using the GUIDED checklist. Results A stepwise educational program to teach parents how to administer low-dose chemotherapy (Ara-C) to their child at home and a simple and safe administration procedure were developed. Key uncertainties were identified, including barriers and facilitators impacting future testing, evaluation, and implementation. Causal assumptions and reasoning for how the intervention leads to short-term outcomes and long-term impact were clarified in a logic model. Conclusions The iterative and flexible framework allowed for integration of existing evidence and new data and was successfully applied to the development process. The detailed report on the development process of the home chemotherapy intervention can enhance adaptation or replication of the intervention to other settings and thereby mitigate family disruption and stress of frequent hospital visits for these treatments. The study has informed the next phase of the research project that aims to test the home chemotherapy intervention in a prospective single-arm feasibility study. Trial registration ClinicalTrials.gov ID: NCT05372536.

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Vascular access device type for systemic anti-cancer therapies in cancer patients: A scoping review

Duggan,

Hernon,

Dunne

et al. 2024

Critical Reviews in Oncology/Hematology

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A national Danish proof of concept on feasibility and safety of home -based intensive chemotherapy in patients with acute myeloid leukemia

Cited by 7 publications

References 30 publications

A Lack of Diversity, Equity, and Inclusion in Clinical Research Has Direct Impact on Patient Care

A Lack of Diversity, Equity, and Inclusion in Clinical Research Has Direct Impact on Patient Care

Development of an intravenous chemotherapy intervention for children and adolescents with cancer administered by their parents at home (INTACTatHome)

Vascular access device type for systemic anti-cancer therapies in cancer patients: A scoping review

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