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

A literature search on intravenous home chemotherapy services for children and adolescents was conducted using the CINAHL and PubMed databases, supplemented by a snowball search strategy. We identified seven studies in which home chemotherapy was delivered by parents or infused by a PIP, in the absence of a nurse [8, 9, 11‐14, 25], and 10 studies in which home chemotherapy was delivered by a nurse [5, 7, 10, 14, 15, 27, 35‐38] (see Additional file 1). The literature search showed that the studies had significant variations in study design, outcomes, and procedures e.g., whether a single drug or more drugs were offered for home treatment. Few studies elaborated on the development process of the services or on considerations for implementation such as facilitators and barriers [5, 6, 8, 25, 35]. Three studies raised attention to the risk of parents perceiving home chemotherapy as a possible burden [6, 8, 25]. One study reported two reasons why home chemotherapy could not be delivered as intended, despite extensive preparation and pilot testing [25]. The first reason was a lack of outpatient care resources while the second related to clinician reluctance to transfer and oversee treatment in an outpatient setting [25]. The literature search resulted in an overview of intravenous home chemotherapy services and pointed to key uncertainties, barriers, and facilitators to consider in the development process as well as the need for clear objectives for an intervention [29, 30].

An ethnographic study was conducted to explore experiences with home care in thirteen families having children with cancer to identify pivotal family needs to consider when developing the intervention [17]. The study showed that parents were willing to manage different home care tasks to avoid hospitalization and that their perspectives on complexity did not always correspond to what health care professionals define as complex e.g., regarding intravenous treatments [17]. The study also demonstrated that families experienced ambiguous expectations of parent caregiving at home and at the hospital from nurses, their children and themselves [17]. Parents’ needs for clear communication on the division of care responsibilities, their need for safety and security while providing care at home, and their individual prerequisites for learning the care tasks were included in the development process. The study is reported in full in a previous publication [17].

Semi-structured interviews were conducted with three clinical nurse specialists from three adult cancer departments with experience in home chemotherapy services to identify relevant intravenous home chemotherapy solutions, benefits, and barriers. The interviews were recorded and transcribed. 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. The clinical nurse specialists informed that since their patients were at home more, they had to reorganize care to deliver all required information and instructions within a shorter timeframe. Ward nurses and clinicians appreciated the comprehensive support from the implementing team when adapting to the new routines of prescribing and administering chemotherapy to the home setting as well as education and regular meetings to discuss their concerns. Initially, clinical nurse specialists met resistance from staff but that decreased when the staff saw how the home chemotherapy services benefitted the patients. None of the home chemotherapy regimens established at the adult cancer departments could be directly adapted to pediatric oncology-hematology. Practical and organizational elements that emanated from the interviews as well as experiences with development and implementation were discussed in the intervention development group and informed the development process and future process evaluation outcomes.

Moving chemotherapy administration from the hospital into a patient’s home entails new nursing care procedures and educational practices for nurses and the parents. Vedtofte [41] suggests a broad didactic model when planning and evaluating education in health care. The model includes eight essential elements: overall goal, specific purpose, participant prerequisites, relationships between those involved in the educational context, content, methods, practicalities, and evaluation [41]. The model was used to development the intervention’s education program. Illeris presents a comprehensive understanding of learning that comprises four types of learning, perspectives on barriers to learning, and internal and external conditions [42, 43]. The didactic model and the learning theory were used as analytical instruments to understand both recipients and provider learning processes in the development phase and will be used when evaluating the parent and the nurse experiences with teaching and learning in the intervention.

Two workshops were conducted with health care professionals (HCP) comprising focus groups [44] combined with elements from the Nominal Group Technique (NGT) [45‐47]. NGT is used to structure an equal consensus building process in a group with different perspectives and controlled by a facilitator [45, 47]. The aim was to explore, discuss and seek consensus on chemotherapy treatments suitable for home chemotherapy in the absence of a nurse, as well as identify potential facilitators and barriers. NGT elements were used, including individual ranking of the chemotherapies, stringently facilitated group discussions that allowed for equal speaking opportunity, and plenum discussion. DPOH nurses and physicians were invited to participate in two workshops. Nine nurses and three physicians attended Workshop 1 (n = 12) while nine nurses and two physicians attended Workshop 2 (n = 11). All participants had pediatric oncology and hematology expertise in chemotherapy management in addition to more than five years of clinical practice at the DPOH. Department management was represented by the chief nurse and chief physician. LIR was the primary facilitator while MKT, RTM, and a research nurse assisted at the workshops. Prior to Workshop 1, the participants received information material on the current home care service at the DPOH to align their knowledge [45]. The material included a list of 13 chemotherapy treatments with low anaphylactic reactions and requiring multiple consecutive infusion days, derived from 211 pediatric cancer protocolss used at the DPOH. The treatments were divided into three categories; short infusions (≤1 hour), longer infusions (>1 hour), and continuous hydration. The participants individually assessed suitability of the specific home chemotherapies by ranking them on a five-point scale before and after the workshop.Each workshop contained nine structured 15-minute focus group sessions, with 4–5 participants in each group. Each participant took part in three focus groups on predetermined themes during a workshop. The participants wrote down ideas, reflections, and conclusions on cardboards during the focus groups. The focus group discussions were recorded and transcribed. Data (transcriptions and cardboard notes) were coded by LIR using NVivo and analyzed deductively to identify suitability of chemotherapy for home treatment including barriers and facilitators. The analysis was subsequently discussed in the intervention development group. Notes from the plenary discussions were included in the data.

The parents (n = 10) and adolescents (n = 4) were interviewed individually (parents) or in dyads (parent-adolescent) to determine needs and preferences related to specific home chemotherapy solutions and educational requirements. A convenience sampling strategy was used, and interviews were conducted during admission to the DPOH. Participants had experience with intravenous antibiotic/antifungal infusions at home with PIP or hospital care with the chemotherapies assessed relevant for home care intervention during the workshops (see Table 1 for participant characteristics). RTM conducted the interviews using a short semi-structured interview guide (see Table 2) and demonstrated the different types of equipment used in home chemotherapy, e.g., electronic PIP, elastomeric PIP, and syringes for chemotherapy injections, after which participants were asked about their personal experiences with any of the equipment and preferences for home use. Questions on treatment solutions and education moved between reflection on prior experiences and hypothetical considerations about preferences. Oral and written consent was obtained from all participants and the interviews were recorded and transcribed verbatim. Data were analyzed by RTM, MKT and LIR using reflexive thematic analysis [48, 49].

Two main themes and fives sub-themes were identified (see Fig. 2). Main themes, sub-themes, and representative quotes are provided in Additional file 2.

Continuous chemotherapy and hydration at home “tests the limit”. Most parents and adolescents found that care tasks during continuous chemotherapies and/or hydrations at home would be demanding and burdening. Some considered the idea of continuous intravenous hydration at home as manageable while simultaneously acknowledging the comprehensive caregiver demand it would imply. Others expressed reluctance to assume the tasks and focused on specific issues, e.g. where to rinse out urinals or how to keep track of pH-values:

” I think there are more challenges to it... because firstly, it's actually a method that requires quite a lot of gadgets (...) we need urinals, we need (...) those pH-sticks... we can easily bring them home..., but then you start accumulating a lot of gear... uhm... I don't know... it could be done, but I think it would be testing our limits...”. (Father to P1, 12 years old).

Finally, some parents and adolescents found the sum of care tasks to be overwhelming but were unable to offer specific explanations. Both parents and adolescents appeared more reluctant to administer chemotherapy at home compared with hydration, which they generally considered less risky.

Worrying about managing side effects at home. Severe and harmful side effects were a constant concern for the parents and adolescents. Similar to findings in the ethnographic study [17], the parents doubted their ability to observe and manage severe treatment related side effects at home during continuous chemotherapy and/or hydration. An adolescent, who had experienced side effects during treatment at the hospital, seemed concerned about whether this would be manageable at home:

"I don't exactly know why, but when [getting hydration and chemotherapy] I really like being in here [at the hospital] … also because then you get nauseous and [experience] all kinds of pain… I've been in pain and stuff like that… then I think it's very good to be in here" (P9, 16 years old).

A mother stated that being a single parent is a challenge when managing harmful side effects during home chemotherapy infusions. Another mother underscored that it can be more difficult to assess symptoms and side effects in a young child.

Short and simple home chemotherapy treatments are appealing. Parents found solutions with chemotherapy administered by syringe and injected into a CVC or infused through elastomeric PIP appealing due to their simplicity and speed and stressed the feeling of independence and normalcy they could provide. However, administering the chemotherapy by syringe also prompted uncertainty: “And you don't get sick receiving it in a really short time span, like you do with that one?” (Mother to P5, 4 years old). One mother reflected on the practical challenges related to administer the chemotherapy by syringe: “(…) It can, of course, be difficult to sit still, when you’re as young as [name of the child] (…)”, (Mother to P7, 1 year old). Parents and adolescents considered the short elastomeric pump infusions and chemotherapy solutions by syringe injected into the CVC as more non-restrictive to daily life than the electronic PIP. However, some parents with elastomeric PIP experience noted that it took some effort to learn the procedure and that they had to keep an eye on the pump to monitor the proper infusion rate and correct position during infusions. None of the participants had experience with injecting medicine directly into the CVC.

Appreciating comprehensive, individualized training at the hospital. Parents and adolescents who had experienced home care with antibiotics or antifungal treatment on a PIP described their appreciation of comprehensive instructions from the HCU nurses including written guidelines and supervised hands-on training. Both parents and adolescents emphasized hands-on training as a pivotal prerequisite to feeling confident in managing medical home care tasks. The parents trusted the nurse’s assessment and decision of when they were ready and competent to manage the care tasks:

“(…) Alpha Omega is that you feel secure. They’re very good at informing that they won't send you home until you’re confident that you can manage it and they’re confident that you can.” (Mother to P7, 1 year old)

However, one mother and her daughter described feeling insecure being supervised during a training session at the hospital while they felt calm and secure practicing the same procedure at home.

In the beginning everything is overwhelming. Readiness and timing were seen as pivotal by the parents and adolescents regarding learning and managing medical care tasks at home. While most participants agreed that learning and managing complex care tasks were sometimes introduced too early, there were different views across and within families on when the right time should be. Parents stated that it was important for them to learn and have experience in administering oral medicines and performing basic care tasks before additionally managing new complex care tasks at home:

“I can understand if someone feels insecure about managing some of those things themselves, but we just haven't felt that way. I'm sure we can learn it [home treatment].” (Father to P8, 2 years old). But it also depends on when in the process you’re introduced to it… [because] at the start everything is overwhelming … you have to learn so much about the tube and stuff like that, but um... later.” (Mother to P8, 2 years old)

In conclusion, the findings showed that parents and adolescents assessed shorter infusions by means of an elastomeric PIP and by injection into CVCs to be manageable, simple, and fast while continuous infusion of hydration and chemotherapy were considered more complex and demanding. For some, the benefits of being at home outweighed the added workload of continuous hydration and chemotherapy, while others remained reluctant to use this solution. There is a need for comprehensive and individualized educational support and hands-on training, the timing of which should be carefully considered by the staff. Findings were discussed in the intervention development group and subsequently incorporated in the intervention development process and evaluation outcome measures.

Evidence-based procedures and guidelines were developed in parallel with and following the workshops and parent-adolescent interviews, and included: 1) non-touch CVC care procedures using a needle-free connector; 2) adaptation of local guidelines for chemotherapy induced nausea and vomiting control in home chemotherapy; 3) procedure for administering Ara-C by injection instead of infusion; 4) delivery procedure of Ara-C from the hospital pharmacy, 5) guidelines for prescribing and documenting parent-administered chemotherapy at home in the electronic patient journal; 6) a nursing guideline on how to teach the parents, ensuring the fidelity of the intervention; 7) a parent guideline on how to perform the procedure providing step-by-step instructios and safety precautions.  A demonstration video showing the procedure was also produced.

We tested the intervention with low-dose Ara-C administered by parents at home to assess safety, educational components, adaptation to clinical care practice, and integration with the electronic patient journal system. Three families were invited to participate using a purposeful sampling strategy. Two of the families were recruited prior to Ara-C treatment and one family was recruited after cycle two of Ara-C. The parents were instructed in critical reading of all information and guidelines. The first child received 11 of 16 doses Ara-C at home with no complications. The second child received 17 of 24 doses of Ara-C at home with five minor complications, and the third child received 14 of 16 doses of Ara-C at home with one minor complication. No severe adverse events occurred during the testing. The types of minor complications were: 1) nurses forgot to inform parents to flush the CVC between treatments; 2) a booking error caused delivery of infusion bags instead of syringes by the pharmacy; 3) incorrect connection of the safety caps on the chemotherapy syringes delivered by the pharmacy; 4) parents forgot to close the CVC tap before disconnecting the injection syringe; 5) nurses forgot to install the needle-free connector before discharging the patient. Adjustments were made and feedback were given to the relevant stakeholders e.g., pharmacists delivering the syringes with cytarabine. Close collaboration with the hospital pharmacy was imperative to quickly adjust preparation and delivery of chemotherapy to align with the requirements of the home care organization. The procedure guidelines and parent information materials were adjusted according to suggestion of the parents. The procedure for home chemotherapy prescription and documentation were refined by the electronic patient journal specialist who reviewed all subsequent prescriptions to ensure their accuracy. Testing the intervention’s educational components revealed that flexibility in delivery time and place was imperative to meet the individual needs of the parents. The test also showed that the families managed more doses of chemotherapy at home than expected.

The intervention development group modelled the final intervention based on the results from all development process components, acknowledging that further refinements may be needed when testing the feasibility [30].