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Ambulatory Toxicity Management (AToM) Pilot: results of a pilot study of a pro-active, telephone-based intervention to improve toxicity management during chemotherapy for breast cancer
- Monika K. Krzyzanowska1, 2Email authorView ORCID ID profile,
- Cassandra MacKay1,
- Heekyung Han1,
- Maria Eberg1,
- Sonal Gandhi3,
- Nicole B. Laferriere4,
- Melanie Powis2,
- Doris Howell2,
- Clare L. Atzema3,
- Kelvin K. W. Chan3, 5,
- Vishal Kukreti2,
- Sandra Mitchell6,
- Marla Nayer7,
- Mark Pasetka3,
- Dafna Knittel-Keren2 and
- Erin Redwood1
© The Author(s). 2019
- Received: 31 August 2018
- Accepted: 18 January 2019
- Published: 8 March 2019
Chemotherapy is associated with a significant risk of toxicity, which often peaks between ambulatory visits to the cancer centre. Remote symptom management support is a tool to optimize self-management and healthcare utilization, including emergency department visits and hospitalizations (ED+H) during chemotherapy. We performed a single-arm pilot study to evaluate the feasibility, acceptability, and potential impact of a telephone symptom management intervention on healthcare utilization during chemotherapy for early stage breast cancer (EBC).
Women starting adjuvant or neoadjuvant chemotherapy for EBC at two cancer centres in Ontario, Canada, received standardized, nurse-led calls to assess common toxicities at two time points following each chemotherapy administration. Feasibility outcomes included patient enrollment, retention, RN adherence to delivering calls per the study schedule, and resource use associated with calls; acceptability was evaluated based on patient and provider feedback. Impact on acute care utilization was evaluated post hoc by linking individual patient records to provincial data holdings to examine ED+H patterns among participating patients compared to contemporaneous controls.
Between September 2013 and December 2014, 77 women were enrolled (mean age 55 years). Most commonly used regimens were AC-paclitaxel (58%) and FEC-docetaxel (16%); 78% of patients received primary granulocyte colony-stimulating factor prophylaxis. 83.8% of calls were delivered per schedule; mean call duration was 9 min. The intervention was well received by both patients and clinicians. Comparison of ED+H rates among study participants versus controls showed that there were fewer ED visits in intervention patients [incidence rate ratio (IRR) (95% CI) = 0.54 (0.36, 0.81)] but no difference in the rate of hospitalizations [IRR (95% CI) = 1.02 (0.59, 1.77)]. Main implementation challenges included identifying eligible patients, fitting the calls into existing clinical responsibilities, and effective communication to the patient’s clinical team.
Telephone-based pro-active toxicity management during chemotherapy is feasible, perceived as valuable by clinicians and patients, and may be associated with lower rates of acute care use. However, attention must be paid to workflow issues for scalability. Larger scale evaluation of this approach is in progress.
- Breast cancer
- Symptom management
- Chemotherapy toxicity
- Telephone case management
- Quality improvement
Systemic therapy can improve the outcomes of patients with cancer, but carries a substantial risk of toxicity, which often peaks between visits to the cancer clinic. Suboptimal management of toxicities can lead to emergency department visits and hospitalizations (ED+H) during treatment. The growing number of studies reporting high rates of acute care utilization during chemotherapy across countries and settings [1, 2] suggests that our current models for managing toxicities among patients receiving chemotherapy in ambulatory settings may be inadequate. By providing patients with self-management strategies or alternatives to the emergency department for further assessment, early intervention can help to address toxicities before they become too severe [3, 4].
Pro-active management of symptoms has been shown to decrease acute care use in chronic diseases such as congestive heart failure . In oncology specifically, studies suggest that remote, often telephone-based, nurse-led symptom-focused interventions are feasible, may improve symptom control and decrease unscheduled emergency room visits and hospitalizations [6–11]. A recently published, single-centre randomized controlled trial of remote web-based patient-reported symptom assessments coupled with automatic provider alerts [12, 13] demonstrated that patients receiving remote monitoring had fewer emergency department visits (34% vs 41%) or hospitalizations (45% vs 49%), remained on chemotherapy longer (8.2 vs 6.3 months), and had better survival relative to patients receiving usual follow-up care. All of these studies, however, have evaluated the impact of these types of interventions in the research setting and have not addressed the additional barriers associated with the implementation and sustainability in routine ambulatory cancer care. As such, further evaluation is needed to inform effective integration of pro-active toxicity management into existing models of care.
The purpose of this single-arm pilot study was to assess the feasibility and acceptability of implementing a nurse-led, pro-active, telephone-based toxicity management into routine clinical practice for patients receiving chemotherapy for early-stage breast cancer and to evaluate potential impact on emergency room visits and hospitalizations during treatment. The goal was to inform larger scale implementation and evaluation. We chose to focus on women with breast cancer as previous population-based studies have reported high rates of treatment-related toxicities and acute care utilization during treatment in this patient population [14–16]. In addition, confounding from symptoms related to advanced cancer is likely to be small in this population given the early stage of disease.
Study design and participants
To evaluate the feasibility and acceptability of implementing a pro-active, telephone-based toxicity management intervention, we undertook a single-arm prospective pilot study in two academic institutions with integrated cancer programs, in Ontario, Canada, that responded to a request to participate. Women newly diagnosed with early-stage breast cancer (stages I–III) who were initiating adjuvant or neoadjuvant chemotherapy, had an adequate command of English to complete questionnaires, and provided individual consent to participate were eligible. Patients receiving treatment with an investigational agent were excluded because the focus of the intervention was on patients treated in routine care. To understand the feasibility of using administrative data to look at acute care utilization during treatment and evaluate the potential impact of the intervention on acute care utilization, an administrative data-based analysis was also undertaken. A contemporaneous control cohort was identified after the study completion from the Activity Level Report (ALR) database, which was linked to other administrative databases to capture information on patient demographic and clinical characteristics, and outcomes. The control cohort consisted of all other patients diagnosed with early-stage breast cancer who were initiating the same chemotherapy regimens as study participants in the two participating institutions during the study intervention period but who did not participate in the prospective pilot (Additional file 1: Figure S1).
Description of the intervention
Educational handouts discussing treatments and management of toxicities dispensed to patients initiating treatment differ by provider and cancer centre. As such, all patients were provided with a standardized symptom self-management guide prior to initiating chemotherapy which included recommendations for self-management of common toxicities. The content of the guide was adapted from information available on the Canadian Cancer Society and American Cancer Society web pages. The guide covered a subset of 9 toxicities from the National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (NCI PRO-CTCAE). These were chosen from the 124-item bank through expert consensus (by the project steering committee) to reflect commonly experienced toxicities by breast cancer patients who are treated with chemotherapy that may lead to ED+H and are amenable to early intervention [17, 18]. The subset of toxicities included the following: nausea, vomiting, mouth and throat sores, pain, aching joints and muscles, loose and watery stools, shivering or shaking chills, constipation, and fatigue.
Analysis of feasibility and acceptability
The primary focus of the evaluation was on the feasibility and acceptability of implementation, for which a target recruitment of up to 100 women was considered sufficient based on the literature [19, 20]. A formal sample size calculation was not undertaken. Feasibility was assessed based on patient enrollment, retention, RN adherence to delivering calls per the study schedule, and resource use (non-pharmacological or pharmacological recommendations, healthcare provider visit or urgent care). Acceptability of the intervention was assessed from the perspectives of patients and providers using end-of-study surveys (patients) and semi-structured interviews (patients and providers). Following the completion of the last cycle of chemotherapy and related calls, all patients were invited to complete an end-of-study survey that sought feedback on the patient symptom self-management guide and the follow-up calls. Feasibility and acceptability findings are reported as a proportion; 95% confidence intervals (95% CI) were calculated to represent variance in the observed proportion. A convenience sample of 17 patients also participated in the end-of-study semi-structured telephone interviews on the patients’ experiences with the intervention. In addition, interviews were conducted with providers involved in delivering the intervention to evaluate the barriers and facilitators of implementation and recommendations for improving intervention delivery. Qualitative data from the interviews was analysed using inductive content analysis to derive themes and sub-themes that were grounded in the experience of patients and clinicians . Whether or not the intervention was considered acceptable and feasible was determined by the project steering committee based on the review of the experience with recruitment, delivery of intervention, and feedback from patients and providers following completion of the study.
Analysis of acute care utilization
An administrative data-based analysis was undertaken to assess the feasibility of using administrative data to look at ED+H, to evaluate sample representativeness, and to compare the rates of acute care visits among pilot study participants against patients receiving care at the participating centres during the same time frame but who did not participate in the pilot (contemporaneous controls). Pilot study participants were identified deterministically in the provincial data holdings. Information on chemotherapy regimen was obtained from the Activity Level Reporting (ALR) database. Information on ED visits and hospitalizations from initiation of chemotherapy until 30 days after the final dose was obtained from the National Ambulatory Care System (NACRS) database and Canadian Institute for Health Information Discharge Abstract Database (CIHI DAD), respectively. Acute care visits were classified as ED visit only or a hospitalization, defined as having experienced either a direct admission or an ED visit resulting in an admission. Demographic and clinical characteristics of the intervention and control cohorts were summarized using descriptive statistics. Standardized differences were assessed between the patients receiving the intervention and the controls. Negative binomial regression with an offset for time was used to estimate the relationship between event rates and the study intervention, overall and stratified by centre. We undertook a stratified analysis by centre due to the differences in regimen, patient characteristics such as cancer stage and age, baseline rates of acute care utilization, and centre characteristics such as rurality which may affect the way patients would seek and receive medical care but could not be adjusted for due to small sample size. We used clinical expertise and statistical evaluation to select the most important variables for adjustment in regression models.
Baseline demographic and clinical characteristics of study participants
Centre 1, n = 56
Centre 2, n = 21
Total, n = 77
Age, mean (SD)
Married, n (%)
Highest level of education, n (%)
Less than college/university
College/university or higher
Prefer not to respond
Combined household income, n (%)
< $60 k
> 100 k
Prefer not to respond
Employment status, n (%)
Employed (working or on sick leave)
Unemployed or retired
Stage, n (%)
Treatment intent, n (%)
Regimen, n (%)
Primary G-CSF prophylaxis, n (%)
Central line, n (%)
Co-morbidities, n (%)
Chronic lung disease
Moderate to severe kidney disease
End-of-study feedback from participants by study site
N = 49 (%)
N = 21 (%)
N = 70 (%)
NCI PRO-CTCAE tool
The NCI PRO is important because it helps my healthcare team and research coordinator know what symptom I am having and how severe they are.
Strongly agree/somewhat agree
The symptom levels made it easier for me to describe how I am physically feeling.
Strongly agree/somewhat agree
Symptom management guide
During your chemotherapy treatment, did you use the symptom management guide provided to you?
How often did you refer to the symptom management Guide? (number of times/chemotherapy cycle)
Greater than 3 times
Did you find the symptom management guide helpful in managing your symptoms related to chemotherapy?
Strongly agree/somewhat agree
Did you feel that the symptom management guide improved your ability to self-manage your chemotherapy side effects?
Strongly agree/somewhat agree
Did you feel that the symptom management guide helped you to understand when to seek medical care?
Strongly agree/somewhat agree
Pro-active, telephone-based symptom management calls
Did you like receiving the follow-up phone calls?
Strongly agree/somewhat agree
Did you find the follow-up phone calls to be a burden?
Strongly agree/somewhat agree
Were the follow-up calls helpful in managing your symptoms?
Strongly agree/somewhat agree
During treatment, my physical symptoms have been controlled to a comfortable level (examples of physical symptoms are nausea, pain, constipation, etc.)
Strongly agree/somewhat agree
During treatment, my emotional symptoms have been controlled to a comfortable level (examples of emotional symptoms are anxiety, depression, etc.)
Strongly agree/somewhat agree
Do you feel that participating in this study prevented you from going to the emergency room as a result of you chemotherapy side effects?
Strongly agree/somewhat agree
Strongly disagree/somewhat disagree
Would you recommend this study protocol (symptom assessment, symptom management, and follow-up phone calls) be adapted to all cancer patients getting chemotherapy?
Strongly agree/somewhat agree
Thematic analysis of end-of-study patient (n = 17) interviews
a) Normalized experience
“The nurse telephone support was crucial, because if I had a question or thought it was a weird symptom or something unusual I could talk to her’. I think the talking it out with her and realizing what I thought was maybe not manageable was manageable” (1-005).
“You do not know is this how I am supposed to be feeling? … Is it normal to feel this way? So by having confirmation, by speaking and reassurance from the study nurse, it did help” (2-054)
b) Confidence for self-care
“After talking to her, I was most confident, I felt so relieved, I feel so comfortable after talking to her”. (2-027).
“After the nurse talked to me, I was so sure of myself that I was going to be just fine, that I did not have to worry about anything.” (2-033).
c) Expert personalized advice
“I live alone. And you, here’s somebody who is concerned about you, who knows my disease, this nurse knew my disease. And, when she gave me any advice it was so helpful. It was like medicine, taking some medicine to relax, to relieve my problem. That’s so helpful, really.” (2-027)
“Having somebody that you can call to say, “Is this normal, I have got this problem, what should I do, who can also give you better advice than just, you know, on the back of a package’. This is not working for me. How am I going to make this work? She gave me really good suggestions. It makes you know you can deal with it. Otherwise you feel like you are flying blind. And that’s kind of scary when you do not feel so good” (2-004).
a) No need to panic
“She would assure you it was normal, so, you know, there is no need to panic over anything”. (2-040)
“So it feels like you are safe because somebody’s asking about you, like somebody from the hospital is calling and saying okay. So I knew … I knew that they were all taking care of me.” (2-033)
b) A lifeline, not on your own
“Just overall knowing that, like I said, that she was checking, that I could rely on her to call. If I had any questions or concerns that on a regular basis, I’d be talking to her.” (1-005)
“I think knowing that I had a nurse call coming gave me peace of mind.” (2-056).
“I could confidently talk to her about what really needed to be addressed, I guess … I found her almost like a lifeline to me some days. I just felt very confident”. (1-014)
Thematic analysis of end-of-study provider interviews (n = 9)
What worked well
a) Patients liked receiving calls
• Overall the intervention was well received by patients who appreciated the personal touch the intervention added to their care.
• Reassurance provided to patients regarding their treatment experience reduced anxiety.
• Patients liked consistent individual performing the calls.
b) Providers liked delivering the intervention
• Providers enjoyed their involvement.
• Orientation provided to staff prior to their involvement
c) Importance of planning
• Screening breast clinic patient lists to identify patients eligible for the study.
• Determining a scheduled time to make the intervention calls to prevent missed calls.
• The use of a thorough and practical tool to provide structure to the telephone calls.
What did not work
a) Fitting the intervention into existing work flow
• Providers struggled to fill calls into their existing work schedule.
• Burden of large amounts of data collection and length of form to be completed during calls.
• Communication between team members and incorporation of NCI PRO-CTCAE into clinic appointments.
• Inconsistent staff performing intervention calls.
• Patients’ confusion regarding who to call if issues arose between calls.
b) Ensuring appropriate experience
• Clinical trial staff may not have sufficient symptom management experience compared with nurses working in the chemotherapy clinic.
Recommendations for improvement
• Develop a tracking tool for the telephone calls.
• Timing of calls: first call for cycle one should be early. After first cycle, one call at days 5–8 may be sufficient.
• Limit number of providers making follow-up calls.
• Track and manage other common symptoms during calls (e.g., insomnia, anxiety, and depression).
b) Staff training
• Further training on symptom management and organization of workload.
c) Communication within circle of care
• Develop process to ensure oncologists and staff are aware of symptom information reported on NCI PRO-CTCAE.
• Develop documentation process to ensure clear communication between team members.
• Reduce amount of data collection.
• Improve patient symptom management guide—make it more illustrative.
Acute care use during chemotherapy
Crude and adjusted emergency department (ED) visits and hospitalization (H) incidence rates in study participants and contemporaneous controls by centre
Number of patients
Total number of person-months
Emergency department visits
Total ED visits
IR for ED visits per month
Crude IRR (95% CI)
Adjusted IRRa (95% CI)
Total H visits
IR for H visits per month
Crude IRR (95% CI)
Adjusted IRRb (95% CI)
0.48 (0.32, 0.73)
0.54 (0.36, 0.81)
1.05 (0.60, 1.85)
1.02 (0.59, 1.77)
0.72 (0.46, 1.11)
0.78 (0.51, 1.21)
0.90 (0.45, 1.80)
0.96 (0.48, 1.95)
0.29 (0.14, 0.62)
0.33 (0.16, 0.67)
1.27 (0.50, 3.19)
1.53 (0.65, 3.59)
Introduction of a standardized, pro-active, telephone-based toxicity management during chemotherapy for early stage breast cancer was feasible, well received by both patients and providers, and demonstrated promising preliminary results on ED utilization as compared to contemporaneous controls identified from the administrative data. Some issues related to recruitment were encountered, which were related to the availability of local resources to deliver the intervention; these can likely be overcome with changes to the implementation process, in particular, appropriate team planning and simplification of the data collection processes.
The intervention was well received by patients who, in both end-of-study surveys and interviews, indicated that they liked the support that the calls provided and especially enjoyed the relationship they developed with the nurses making the calls. The patients indicated that having real-time support to normalize the experience, and help them navigate symptoms, boosted their confidence for self-care and decreased anxiety. Nurses play a key role in supporting cancer patients throughout their illness, including beyond visits to the cancer clinic , but how to deliver effective remote support to patients during treatment is an area of active research. Similar to previous studies, our findings suggest that pro-active, nurse-led telephone management is a promising approach for delivering remote support between clinic visits. Whether other healthcare providers, such as oncology pharmacists  or clerical staff , could be involved in telephone support remains to be explored. While the study was well received by providers, a number of practical implementation challenges were identified that have not been addressed in previous studies, which have focused on efficacy as opposed to effectiveness of telephone-based toxicity management support.
The greatest challenges we encountered were related to identifying eligible patients, incorporating the calls into existing work responsibilities, and determining the best approach to communicate within the circle of care since the intervention nurses were often different than the usual care team. Our findings suggest that embedding pro-active symptom management into routine care requires a fundamental transformation of the “whole system”; simply adding greater expectations to existing practice systems is unlikely to be successful . In a series of two randomized trials by Mooney et al. in ambulatory patients receiving chemotherapy [7, 26], the addition of a dedicated nurse to respond to symptom alerts was associated with improved symptom control, compared to relying on physicians and nurses to respond to the alerts as an add-on to their usual workload. This suggests that either creating a dedicated nursing role or ensuring protected time within an existing role is necessary for successful implementation of remote support programs. Patient identification via electronic health records (EHRs), as well as integrating call outcomes within EHRs, is an area for future study.
The incidence of ED visits during treatment in the patients that participated in the pilot was lower than that in the contemporaneous controls, although the magnitude of the effect varied by centre. While selection bias could explain this finding, telephone-based case management has been shown to decrease re-admissions in chronic diseases, such as heart failure [4, 5], and a recent single centre study of remote symptom management during chemotherapy for patients with advanced cancer also reported lower ED rates and hospitalizations in patients randomized to the intervention . Furthermore, fewer acute care visits have been reported from early evaluations of the oncology patient-centred medical home whose core principles include enhanced remote support for patients receiving chemotherapy [22, 26]. We postulate that the most likely mechanism behind the lower rate of ED utilization in the setting of outpatient chemotherapy delivery is early symptom management, although our findings from patient interviews suggest that a component of benefit may be from decreasing anxiety and normalizing the experience of chemotherapy for patients with just-in-time support and standardized education.
Our study should be interpreted in the context of its limitations. We included two different centres to improve the generalizability of the findings, but the number of participating sites and sample size were limited. Furthermore, since not all patients treated at each of the centres during the intervention period were enrolled, potential for selection bias exists. While the intervention details and supporting tools were created centrally by the project steering committee, the centres were given flexibility in how they wanted to implement the intervention and data collection, and some implementation outcomes such as a recruitment rate were not reliably captured. This highlights the importance of conducting formal pilot studies prior to large-scale implementation trials. Involvement of research personnel facilitated patient identification and data collection, but involvement of clinical personnel is essential for sustainability and spread beyond the research setting which is the cornerstone of implementation science. Figuring out the optimal balance between research and clinical personnel in these types of studies requires additional work. Finally, due to the resource limitations, symptom management calls were not recorded or analysed for content; the quality of the calls could have varied by provider. Although our findings suggest that pro-active symptom management may help to optimize care in ambulatory cancer population, larger scale evaluations are needed to determine impact and sustainability. Selecting patients at higher risk of toxicity or focusing the intervention on high-risk periods, such as early in the chemotherapy course or when there is a change in drug, may help to optimize resource use and facilitate scalability of the intervention [27, 28]; however, a validated prediction model to identify high-risk patients does not currently exist . Further analysis using administrative data and retrospective chart review could help to identify high-risk patients and high-risk periods for intervention.
In summary, our study suggests that pro-active, telephone-based toxicity management during chemotherapy in routine care is feasible, perceived as valuable by patients and providers and may have a positive impact on acute care utilization. Larger-scale evaluations of the impact of this approach on acute care utilization and patient-reported outcomes are warranted, but attention to implementation issues needs to be considered prior to initiation. We are currently conducting a 20-centre cluster-randomized trial of this intervention (NCT02485678).
We would like to thank the pharmacy, nursing and research staff at Sunnybrook Regional Health Sciences Centre and Thunder Bay Regional Health Sciences Centre. We would like to acknowledge Hilary Connor, a nursing student from the Faculty of Nursing at the University of Toronto, for her assistance in coding qualitative data obtained through the patient interviews. We would like to thank all of the patients who participated in this trial.
This pilot study was funded by the Ontario Ministry of Health and Long Term Care through Cancer Care Ontario’s Regional Systemic Treatment Program.
Availability of data and materials
The data that support the findings of this study are available from Cancer Care Ontario and Canadian Institute for Health Information (CIHI) but restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available. Data are however available from the authors upon reasonable request and with permission of Cancer Care Ontario and CIHI.
MKK, SG, NBL, DH, CLA, KKWC, VK, SM, MN, MaP, and ER conceived/designed the study. CM, HH, SG, NBL, DH, MaP, and DKK conducted the data collection. MKK, CM, HH, ME, MeP, and DKK conducted the data analysis. All authors drafted, reviewed, and approved the final manuscript.
Ethics approval and consent to participate
Approval from the institutional research ethics boards at both participating centres was received prior to initiating the study. Patients provided individual, written consent to participate in the study. In addition, patients provided consent to link their study records to provincial administrative healthcare data holdings to evaluate the impact of the intervention on ED+H.
Consent for publication
Aspects of this work have been presented at the American Society of Clinical Oncology Quality Care Symposium, Phoenix, AZ (February 2016); the Applied Research in Cancer Control Conference, Toronto, Ontario (May 2016); and the Multinational Association of Supportive Care in Cancer, Adelaide, Australia (June 2016).
Authors Cassandra MacKay, Heekyung Han, Maria Eberg, and Erin Redwood are or were employees of Cancer Care Ontario, a not-for-profit agency of the Government of Ontario. All other authors declare that they have no competing interests.
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