Oral Self-Management of Palbociclib (Ibrance®) using Mobile Technology Protocol

Abstract

Aim:

This study will test the feasibility and effectiveness of mobile technology intervention on the patients’ self-management of oral anticancer medication. Secondary objectives include acceptability, the usefulness of text messages and satisfaction by participants and nurses

Methods:

This prospective two-arm study will recruit patients (N=220) with metastatic breast cancer and initiating treatment with palbociclib (Ibrance ®). Allowing for attrition, patients will be randomized into the control (N=100) or intervention (N=100) group. Unidirectional text-message reminders will be sent during the treatment cycle through a secure web application using the patient’s smartphone. Self-reported survey responses will be collected at three time points; at consent, end of treatment cycles and the follow-up clinic visit and include a demographic questionnaire, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Post Study assessment and the R-15 Patient Satisfaction Questionnaire. Nurses providing care for study patients will complete the Adaptation of Stamps Nurse Workload questionnaire. Data will be analyzed an intent-to-treat analysis comparing the two arms. Study approval was obtained in December 2019 and funded in January 2020.

Discussion:

Smartphones are globally available and have text messaging capability which is increasingly being used as an intervention in health care studies. This study will test a low-cost, nurse-led intervention that enhances the patient’s experience with oral anti-cancer medications, improves access to care, reduces costs and improves the satisfaction of nurses caring for oncology patients.

Impact:

Despite the ease of administering oral anti-cancer medications, oncology patients may not take them as prescribed and consequently, these factors affect patient outcomes and disease control. Given the importance of taking oral anti-cancer medications and the difficulties patients experience in achieving it, the effective use of mobile technology interventions can actively engage patients in their care and improve medication self-management of anticancer treatment regimens.

1|. Introduction

Smartphones with text messaging capability are increasingly used as an intervention in health care research. Studies have reported that patients who are engaged with their care and communicate efficiently and effectively with their clinicians have improved health outcomes (Buchholz et al., 2012; Breen et al., 2015; DeKoekkoek et al., 2015; Kearney et al., 2009; Krebs et al., 2011; Davis & Oakley-Girvan, 2017; Heiney et al., 2020). Mobile phones are a common form of technology and are used globally across cultures, countries, languages, ages, genders and socioeconomic classes (Park et al., 2014; Thakker et al., 2016). Exploring an alternative low cost, nurse-led interventions may possess the potential for enhancing the patient experience, improving population health, reducing costs and preventing burnout and dissatisfaction within a nursing workforce (Bodenheimer & Sinsky, 2014). The purpose of this study is aimed at evaluating whether text messaging reminders is an effective and feasible method in strengthening oral anticancer medication treatment regimens for patients with metastatic breast cancer and the usefulness and satisfaction of the text messaging intervention.

2. |. Background

Metastatic Breast Cancer is a chronic, progressive condition where the goal of treatment is not curative but minimizes symptoms while controlling the spread of the disease (Nounou et al., 2015). Palbociclib (Ibrance ®) is a well-tolerated oral anticancer drug used to treat metastatic breast cancer as monotherapy or multi-modal in combination with letrozole (Femara) or fulvestrant (Faslodex) as an initial treatment. (Finn et al., 2015; Lynce & Issacs, 2015; Mangini et al., 2015; Morikawa & Henry, 2015; Turner et al., 2015; Wilkes & Barton-Burke, 2019). However, based on the individuals’ metastatic disease progression, subsequent medications, letrozole (Femara), fulvestrant (Faslodex) and/or Palbociclib (Ibrance ®) may be added to a patient’s current treatment regimen. Consequently, patients may have different experiences and difficulties in self-administering multiple treatment and medication regimens. For example, palbociclib (Ibrance ®) is a 28-day treatment and taken for 21 days with 7 days off between cycles whereas letrozole (Femara) is take daily. When Faslodex is used as a multimodal treatment with either letrozole (Femara) or palbociclib (Ibrance ®), fulvestrant (Faslodex) is administered intramuscularly on Day 1, 15 and 29 followed by a once monthly injection at the physician’s office. Patients with metastatic breast disease may be prescribed oral treatment regimens for an unspecified length of time. Therefore, identifying interventions that help patients on oral anticancer therapy to self-manage their treatments, lab appointments and physician visits can ultimately improve the outcomes of their care (Mathes et al., 2012; Smith et al., 2020; Vanwesemael et al., 2017).

Medication self-management is one of the primary concerns surrounding oral anticancer therapy since patients may fail to remember to take medications, complete laboratory tests, or attend doctor visits, which can lead to inappropriate dosing, inadequate laboratory monitoring and a failure to report side effects. Despite the ease of administering oral anticancer agents, the self-management of prescribed medications vary among patients (D’Amato et al., 2008; Mathes et al., 2012 Spoelstra et al., 2013). Self-managing oral anticancer agents presents a host of patient concerns including a lack of knowledge or understanding of the administration regimen, the rationale for therapy, side effects and other components of safe medication self-management.

Since oral anticancer agents are meant to be taken at home, there may be misconceptions among patients that these medications are not as strong as other conventional chemotherapy drugs, which can lead to mismanagement of their medications (Buchholz et al., 2012; DeKoekkoek et al., 2015; Kruse et al., 2015a & 2015b). Krebs et al., (2011) suggest that patient concerns regarding medications could be addressed through targeted messages delivered from credible sources and could be a supportive method for reminding patients to take their medication as prescribed.

Educational instructions regarding self-care activities, diaries and medication calendars alone may not be an effective method of enhancing the patient’s ability to care for themselves (Burhenn & Smuddle, 2015; Riipa et al., 2015). Since approximately 98% of mobile telephones or smartphones have text messaging functionality, customized messages sent by a clinician using the patient’s’ smartphone device can be a feasible and effective intervention platform (Park et al., 2014; Thakker, et al, 2016; Spoelstra et al., 2016). Many mobile applications used to facilitate communication between the patient and the health care team are user-friendly, compatible with electronic health records and compliant with the Health Insurance Portability and Accountability Act (HIPAA). Various technology-based interventions have explored employing mobile applications, text messaging, pager systems and email reminders to aid in medication self-management (Riipa et al, 2015; Schneider et al., 2011; 2014; Sommers et al., 2012; Thakker, et al, 2016; Whittaker et al., 2012). Though the reported literature describing text messaging in breast cancer patients is limited, several studies concluded that mobile technology improves the patient-provider interactivity and can strengthen interventions by augmenting standard patient care with medication reminders, laboratory testing and physician visits (Krebs et al., 2001; Park et al., 2016; Riipa et al., 2015; Stacey et al., 2012; Thakkar et al., 2016;).

2.1 |. Conceptual Model

The Self-Regulation Theory (Johnson et al., 1997) guided this research and posits that health care experiences are unique to each patient whose participation and practice is critical for their health care and outcomes. The model’s propositions for engaging patient’s in their care align with the study’s mobile technology intervention for facilitating medication self-administration of oral anticancer medication.

3.0|. The Study

3.1 |. Aims and Hypotheses

The specific aims of this two-group clinical trial test whether text message reminders will improve the medication self-management of patients with metastatic breast cancer in taking their oral anticancer medications and to evaluate the workload and nurse satisfaction of nurses caring for patients in this clinical trial.

3.1.1. |. Specific aim 1

The primary aim is to assess the feasibility and effectiveness of a unidirectional text messaging intervention for patients diagnosed with metastatic breast cancer and initiating palbociclib (Ibrance®).

Hypothesis 1:

Patients in the intervention group will report that receiving text messaging reminders on their smartphone is a feasible and effective method for supporting self-management of their oral anticancer treatment regimens.

3.1.2 |. Specific aim 2

To compare the following measures between a control group (standard of care) and an intervention group (standard of care + unidirectional text messaging intervention):

SA 2a.

Health-related quality of life (HRQoL)

Hypothesis SA2a.

Improved medication self-administration will lead to an improved health-related quality of life in the intervention group compared with the control group.

SA 2b.

Routine standard of care including laboratory testing

Hypothesis SA2b.

Patients in the intervention group will have improved medication self-management that positively affects lab values and attendance to lab appointments compared with the control group.

SA 2c.

Acceptability

Hypothesis SA2c.

Survey results for patient’s in the intervention group report that text messaging reminders is an acceptable method to augment medication therapies.

SA 2d.

Nursing workload and work satisfaction for office practice nurses of patients in the study

Hypothesis SA 2d.

Nurses report a decreased workload and improved satisfaction for patients receiving text message reminders in the intervention group compared with the control group.

SA 2e.

Report and summarize the usefulness of unidirectional text messaging

Hypothesis SA2e.

Survey results from patients in the intervention group will positively support the usefulness of text messages.

3.2 |. Study Design

This prospective study is a randomized control trial comparing patients on palbociclib (Ibrance®) receiving standard care (control group) to patients receiving standard of care with text messaging (intervention group) (Figure 1). For both groups, treatment will include bi-weekly laboratory testing for the first two months of therapy, medication dosing on a 28-day cycle and monthly physician visits.

Figure 1:|.

Study Schema

3.3|. Participants

3.3.1|. Inclusion Criteria

• Adults 18 years of age or older with a metastatic breast cancer

• Can read and write in English

• Initiating therapy on palbociclib (Ibrance®) for the first time, either as monotherapy or in conjunction with Letrozole (Femara) or Fulvestrant (Faslodex)

• Use a personal smartphone – iPhone or Android

• Agree to download test messaging application on their personal smartphone and receive text message reminders.

• Provide written informed consent

3.3.2 |. Exclusion criteria

• Patients with a history of taking palbociclib (Ibrance®).

• Patients whose caregivers coordinate their health care.

Participants will be removed from the study if: (1) the participant chooses to withdraw consent for continued participation at any time; (2) the participant reports intolerable distress due to study participation; (3) the participant becomes ineligible for study participation as designated by the inclusion/exclusion criteria.

3.4|. Sample Size

The sample size is theoretically derived based on factors that include data from the current literature and the numbers of patients treated with the drug palbociclib (Ibrance ®) at the organization. We expect to randomize 100 patients in the control and intervention group, respectively. We estimate the power of our test by using generic statistical settings due to a lack of historical data. When the difference between the rates from the two groups is 40% of the pooled standard deviation, the power is 0.80 that we will be able to detect such a difference at the significance level of 0.05. If the difference is 60% of the pooled standard deviation, the power is 0.99 for detecting this difference.

3.5 |. Study setting and recruitment

Participants will be recruited from the breast center at a tertiary-care oncology facility in the northeastern United States. Patients who are starting palbociclib (Ibrance®) will be asked to participate. Potential participants will be prescreened using organization reports and referrals from the medical oncologist and the office practice nurses in the research setting. Patients are assessed for eligibility and meeting study criteria. The consenting team will meet with patients in-person or virtually and obtain informed consent.

3.6 |. Randomization

Patients are randomized to either the text-messaging (Intervention) arm or the control (Standard of Care) arm 1:1. Randomization is accomplished by the random permuted blocks method and is stratified into three groups by age (≤45, 46–60, ≥60) and previous treatment regimens (CMF: cyclophosphamide, methotrexate, docetaxel; AC: Adriamycin (doxorubicin) and Cytoxan (cyclophosphamide), AC + paclitaxel (Taxol), AC + docetaxel (Taxotere); other chemotherapy combinations). Once the randomized arm is determined, the study team notifies the research staff and/or investigators at participating sites of the treatment arm and participant identification (ID).

3.7 |. The Interventions

3.7.1 |. The control intervention

In the control group (standard of care) patients receive teaching in the clinic or via telephone regarding medication administration, interval bloodwork and follow-up visits. On initiating treatment, patients are given a paper drug diary, medication calendar and printed drug information. In this study, patients are instructed to bring the drug diary and the empty medication blister packs to each clinic visit.

3.7.2. |. The experimental intervention

Patients in the intervention group receive standard of care plus unidirectional text messages sent through a HIPAA-compliant messaging application downloaded to the patient’s phone. The intervention group receive customized text messages (Table 1) based on the intervention timepoints identified by clinical experts involved with the palbociclib (Ibrance®) treatment regimens as high-risk for medication mismanagement and lab appointments. Patients in the intervention group will be in the study during the first three cycles of palbociclib (Ibrance®), though some patients may continue the treatment for an additional three cycle or longer periods.

Table 1:

Text Messages at Cycle Timepoints

Text Messages: The treatment cycle is 21 days on and 7 days off medication	Cycle 1 & Day	Cycle 2 & Day	Cycle 3 & Day
1 Medication approval/delivery	C1–D00
2 Confirm medication delivery	C1–D0	C2–D0	C3–D0
3 Start medication	C1–D1	C2–D1	C3–D1
4 Check-in	C1–D7	C2–D7	C3–D7
5 CBC Day before the test	C1–D13	C2–D13	No CBC
6 CBC Day of test	C1–D14	C2–D14
7A CBC results/Continue	C1–D15	C2–D15
7B CBC results/Call MD office
8 Last pill in the cycle	C1–D21	C2–D21	C3–D21
9 Start break week	C1–D22	C2–D22	C3–D22

3.7.3.|. Intervention research procedure

Patients of all races and ethnic groups are eligible for participation in this study and recruited for enrollment primarily through referrals from their primary medical oncologist and the office practice nurse at the breast and imaging center. Potential study participants are asked to provide specific health information to determine eligibility before the text-messaging application is downloaded to the patient’s smartphone. All participants meeting the inclusion criteria are informed of the risks and benefits of study. If the patient is willing to participate, a written informed consent document is obtained and stored in the Electronic Medical Record (EMR). The patient is registered for the study and randomized into the control or intervention group.

The office practice nurses working with the medical oncologist provide direct care and education to patients in both the control and intervention groups. In the current office practice workflow, nurses are involved in all patient-initiated and follow-up symptom- or treatment-related calls. For each study patient under their care, the nurses will be asked to complete a brief survey at the end of the patients’ treatment cycle about the nurses’ satisfaction and workload.

3.7.4.|. Intervention fidelity and quality assurance procedures

This study included the following to ensure quality assurance of our text message intervention:

QA1:

The research staff review the study calendar and database daily and identify the patients requiring a text-message reminder and the customized message to be sent the next day.

QA2:

The nurse researcher does not directly care for study participants; however, they will review the medical record before sending a text message.

QA3:

Only the nurse researchers will manually send a text message reminder to the participants in the intervention group.

QA4:

If a patient sends a text reply involving symptoms, the nurse researchers will send an urgent message to the medical oncologists’ office practice nurses who will direct patient care and document the text message in the medical record (Nursing Telephone Triage form).

QA5:

Lab results at mid-cycle of treatment.

• A CBC is collected on Day 14 of the treatment cycle. Pending the CBC results, medication may be dose-reduced or held. Other symptom-related issues may also alter treatment regimens and differ by the individual patient. After a discussion with the medical oncologist, the office practice nurse calls the patient and discusses lab results and any medication dosage changes until the CBC is repeated.

• A verification email correspondence between the research team and medical oncologists’ practice is shared to ensure that all members of the healthcare team are included in a discussion about the treatment plan and medication changes and treatment plan. The text message will be sent to the patient after the verification email is received by the nurse researcher.

3.8 |. Data collection

Self-report surveys will be administered to study participants at three-time points: 1) the beginning of the study after informed consent is obtained but before the beginning of the first treatment cycle; 2) at the end of three treatment cycles (12 weeks); and 3) at the study conclusion and the physician office visit three-months after the end of the first three treatment cycles (24 weeks). An email link to the study’s questionnaires in the patient portal is provided and surveys can be completed using a smartphone or personal computer. Nurses providing care for patients in this study are asked to complete the NDNQI-STAMPS Adapted Index Work Satisfaction questionnaire at 12 weeks for each enrolled patient to assess the perception of their workload impact from this mobile technology.

3.8.1 |. Outcomes variables and measurement instruments

The measures will be collected as noted in Table 2. The primary outcome is the accessibility and effectiveness of text message reminders and medication self-administration. The secondary outcomes are the patient’s quality of life, accessibility and usability and satisfaction of text messages in the intervention group and nurse’s satisfaction and workload.

Table 2:

Aims, timeline and study measures

Measures	Aim	Pre-Screen	Base-line	12 Weeks	24 Weeks
Screening reports, referrals	-	x
Intervention Group Only
Feasibility: Patient Satisfaction Questionnaire R15 [Q10] (Spoelstra et al., 2015)	1				x
Usefulness: Post Study Questionnaire (Total Score EV:3) (Spoelstra et al., 2015)	1				x
Comparisons between control and experimental groups
Effectiveness: All randomized patients will be analyzed, as this is an intent-to-treat analysis comparing the two groups	1				x
Acceptability: Proportion of patients who agreed to participate/number of patients asked to participate	2			x
Drop-out Rate: Proportion of patients who joined but did not complete the study / number who agreed to participate in the study.	2			x
Demographic Baseline Questionnaire	2		x	x	x
Quality of Life: EORTC QLQ-C30 (Bjordal et al., 2000; Young et al 2002)	2		x	x	x
Lab Testing	2		x	x	x
Accuracy Rate [Drug Diary]- Proportion of days hat each study participant accurately self-administers medication	2			x
Nurses caring for patients in both groups for comparison
Nurses Workload and Satisfaction: The STAMPS index (Taunton et al., 2004): Autonomy and Task Requirements Scales	2			x
EORTC QLQ-C30 European organization for research and treatment of cancer quality of life questionnaire; STAMPS: Index of Work Satisfaction Survey-National Database of Nursing Quality Indicators: NDNQI-Adapted Index of Work Satisfaction

3.8. 2 |. Participant measures

3.8.2.1|. EORTC

The EORTC QLQ)-C30 (Bjordal et al., 2000; Yong et al., 2002) is a 30-item quality of life survey used with breast cancer patients (Spranger et al., 1996). It includes five functional scales, three symptom scales, a global health status/QOL scale and six single items. All scales and single-item scores range from 0 to 100. High scores for Global Health Status/QoL scale represent high QoL, high scores for functional scales represent high/healthy levels of functioning. High scores for symptom scales and single items represent elevated levels of symptomatology and/or problems. Version 3.0 has four-point scales for the first five items (QLQ-C30, V3) and coded with the same response categories as items 6–28, as “Not at all”, “A little”, “Quite a bit” and “Very much.” To allow for these categories, question 4 has been re-worded in this study as “Do you have to stay in a bed or a chair during the day?”

3.8 2.2|. The Demographic baseline questionnaire (DBQ)

The DBQ developed by study investigators to obtain participant information about current use of technology and includes five demographic questions, four statements about their uses-of-technology and one treatment-regimen question. Participants check only the statements that apply.

3.8 2.3|. Post Study Questionnaire for text messaging (PostSQ)

The PostSQ (Spoelstra et al., 2015 a; b) (Intervention only) was adopted to determine the patient experiences and usefulness of the unidirectional text messaging intervention. A 5-point Likert Scale format, ranging from 1, “Not Useful”; to 5, “Extremely Useful”, measures the perception of usefulness to knowledge of treatment schedule and unidirectional text messaging intervention for diagnostic lab work, follow-up medication and physician visits.

3.8 2.4|. Patient Satisfaction Questionnaire-R 15 (PSQ15)

The PSQ-15 (Spoelstra, 2015 a; b) (Intervention group only) measures feasibility in this study and was adapted for study use to collect patient information about their perception and opinion on receiving reminder text messages to facilitate their self-management of oral anti-cancer medication. There are 12 statements that are answered in Yes/No format and participants can check all that apply.

3.8 2.5|. The STAMPS Index of Work Satisfaction Survey-National Database of Nursing Quality Indicators: NDNQI-Adapted Index of Work Satisfaction

The STAMPS index (Taunton et al., 2004) measures the workload and satisfaction of nurses between the control and intervention group and uses a 6-point Likert scale format. In this study, 15 questions from the Task Requirements (7 items) and Autonomy (8 items) will be evaluated. The original tool yielded coefficient alphas of .69 - .90. Kendall’s tau estimates of correlation were between .80 and .90. (Taunton et al., 2004).

3.8 2.6|. Drug Diary (Control and Intervention group)

The drug diary is used in conjunction with the medication calendar and medication blister-packs. The drug diary includes a 21-day grid to record daily the dates and times, number of capsules and the dose of the medication taken for each treatment cycle. Information on this document is reconciled with the nurse researcher at follow up clinic visits.

3.8 2.7|. Medication Calendar (Control and Intervention groups)

The medication calendar is a standard of care and used to visually map out the dates for taking all anticancer medications.

3.8 2.8|. Other Participant measurements

Documents used to obtain patient data while on the study and organization-specific documents of daily activities at the organization are found in the EMR and include Nursing Telephone Triage Form, Nursing Encounter forms, The Medication Reconciliation Form, Toxicity Grading Document, the Department of Medicine (DOM) Physician Follow-up Note and the Patient Education Documentation Form (PEDF).

3.8 2.9|. Messaging chat export

The text messaging chats for each study participant in the experimental group is exported from the application and scanned to the EMR.

3.8 2.10|. Data management

The research study team is responsible for project compliance, data collection, abstraction and entry, data reporting, regulatory monitoring, problem resolution and prioritization and coordinating the activities of the protocol study team. Data is de-identified, and participants are assigned unique study identification numbers (ID). All study data is entered into a password-protected database on a secure server. Paper documents are destroyed after they are scanned into patients’ EMR serving as source documentation.

3.9 |. Statistical Analysis

Descriptive statistical analysis will be performed to summarize population characteristics data and the mean, median, range and variances will be calculated for numerical responses. Proportions and confidence intervals will be calculated for categorical responses.

3.9.1 |. Data analysis for the primary aims

For the primary aim of effectiveness, all patients randomized in the study’s control and intervention groups will be analyzed as this is an intent-to-treat analysis comparing the two arms. To analyze the primary aim of feasibility, the responses to question #10 on the Patient Satisfaction study measure will be calculated for the intervention group at the 24-week time point. We will assess effectiveness, in terms of an accuracy rate of a mobile technology intervention, by calculating the proportion of days that each study participant accurately self-administers the medication.

The feasibility of the mobile technology intervention will be evaluated for the intervention arm and is quantified as the percentage of patients who recommend text messages (question 10 in the R15 Patient Satisfaction Questionnaire) at the 24-week time point. We consider the study feasible if the lower bound of the 2-sided, 95% confidence interval of the observed feasibility rate is at least 70%. The sample size of 100 will provide a margin of error (i.e., half of the 95% confidence interval) roughly at 10%. The likelihoods of declaring the mobile technology feasible at various true feasibility rates as/are follows: The True Feasibility (%)/Prob of Declaring Feasible (70% /0.03); (73%/0.12); (76%/ 0.28); (79%/ 0.56); (82%/ 0.82) and (85%/0.96) respectively.

Each patient, from either arm, will provide an accuracy rate that is regarded as a continuous measure and is compared between the two arms using a 2-sided, 2-sample t-test; a Wilcoxon rank-sum test may be used if the rates are found to be skewed.

3.9.2 |. Data analysis for the secondary specific aims

For each of the secondary aims, analyses will be based on available data. That is, evaluable patients will be those who provide measures and endpoints specified for each aim. For the secondary objectives, measures will be collected for both arms except for usefulness, which is a measure for the intervention group.

Post-study HRQoL will be evaluated by EORTC QLQ-C30, summarized and tabulated to examine patterns of change after treatment. We will examine the subscale scores for symptoms, emotions and functioning for both arms. Such continuous measures will be compared again using t-tests or Wilcoxon tests between the two arms.

The laboratory testing results will be identified through the lab system. Results include red blood count (RBC), white blood count (WBC), hemoglobin (Hgb), platelets and absolute neutrophil count (ANC). Such counts will be compared using an analysis of covariance (ANCOVA) model incorporating baseline lab results. A “buffering window” will be included for consistent analysis as patients’ lab tests may be done at slightly different time points. Therefore, 1 month +/− 2 weeks and 3 months +/− 2 weeks. Side effects and symptom profiles will be summarized and tabulated according to type and grade. The frequency of grade 3+ side effects will be compared between the two arms using Fisher exact test.

Acceptability will be calculated as the proportion of patients who agreed to participate in this study divided by the number of patients who were asked to participate. The dropout rate will be calculated as the proportion of patients who joined but did not complete the study divided by the number of who agreed to participate in the study. Confidence intervals will be calculated for acceptability and the dropout rate.

Usefulness will be calculated as the total score of the domain Question EV: 3 of the Post Study Questionnaire for the intervention arm. Nursing workload and work satisfaction will be measured using two subscales of the NDNQI-Adapted Index of Work Satisfaction (STAMPS) tool: Autonomy and Task Requirements. The total scale scores will be calculated and compared using a GEE-based estimation procedure by considering multiple entries contributed by the same nurse (i.e., each nurse will be regarded as a “cluster” and the clustering effect will be considered.

3.10 |. Ethical considerations

Study approval was obtained by the organization’s Institutional Review Board (IRB: 19–458) in December 2019 and is registered as a clinical trial (ClinicalTrials.gov Identifier: NCT04216576). Participation in this study is voluntary and participants may withdraw at any time. No incentives will be provided to study participants and are not reimbursed for the prescribed medications. Confidentiality is guaranteed for all patients. Patient names will not appear on any questionnaire. Only aggregate data will be presented in any presentation or publication. Funding was approved in January 2020.

3.11 |. Data safety monitoring plan

The DSM plans approved by the National Cancer Institute were established and are monitored by the Memorial Sloan Kettering (MSK) Office of Clinical Research. During the protocol development and review process, the protocol was assessed for its level of risk and degree of monitoring required and established the monitoring procedures found in this protocol.

3.12|. Study Rigour: Validity and reliability

Scientific rigor is ensured based on reliability, credibility and safety of study measures and using standard reports for screening and data collection. The research team supports all study phases of the study. Consents will be obtained by one of four nurses known as the consenting professional. A rule-based quality assurance plan was developed to ensure quality and safety for the intervention. A quality assurance review will be conducted quarterly to ensure consistency of study methods. All deviations to consistency, toxicities and side effects occurring on study participants will be collected and reported to the organization’s IRB.

Training manuals were developed for both the intervention and control arms of the study and were presented to staff at the research setting during staff meetings. All staff hired for this study will undergo detailed one-day training to ensure the fidelity of the intervention. The study team attended a training session for the text-messaging application [OhMD, Inc. 2020], with ongoing assistance from the developers.

4.0 |. Discussion

A primary concern for patients on oral anti-cancer therapy is their ability to self-manage their treatment regimen. Self-managing means taking medications on time, proper diagnostic testing and attending scheduled doctor visits. Conversely, patients who do not effectively self-manage may experience inappropriate dosing, inadequate laboratory monitoring, fail to report side effects and further cancer metastases. Since patients with metastatic breast cancer require oral anti-cancer medication for extended periods, it becomes imperative that health care providers find interventions that facilitate access to supportive resources to help patients self-manage their anti-cancer therapy.

In this study, we aim to explore the feasibility and effectiveness of text message intervention in two comparative groups of breast cancer patients. The secondary aims investigate whether patients in the intervention group report that receiving text message reminders is an acceptable and useful measure to self-manage their oral anticancer treatment. Secondary aims for both study groups explore comparisons for the patient’s demographics, quality of life, lab testing and the nurse’s workload in caring for the study patients. Interventions involving education and technology have highlighted the potential to improve patient self-management easily and effectively (Burhenn & Smuddle, 2015; Stacey et al., 2012).

The smartphone is used in many daily activities and may be an untapped resource that can fundamentally improve a patient’s ability to self-manage their oncologic treatment regimens while improving communication and satisfaction with health care providers. The study’s intervention proposes that text messaging support will decrease the necessity for patient-initiated phone conversations and thus more effectively managing nurses’ workload and increasing their satisfaction. Mobile technology actively engages the patient as an equal partner in determining their health care and thus has the potential to change future care delivery models.

4.1|. Limitations

There is bias in favor of participants who may be inclined to use technology. However, given the global use of mobile technology (Park et al., 2014; Thakker et al., 2016), we contend that this study’s intervention is potentially relevant to most individuals from a variety of backgrounds. The study team also recognizes that only English-speaking, reading and writing individuals will be included in this study. Finally, patients taking palbociclib (Ibrance®) alone as opposed to multi-modal in combination with fulvestrant or with letrozole are both current treatments for metastatic breast cancer. A patient may be on a regimen of letrozole initially and subsequently palbociclib (Ibrance®) may be added, which may have different experiences in using unidirectional text messaging intervention to support self-management.

5|. Conclusion

This study will employ a nurse-led text-messaging intervention to test the feasibility and effectiveness of using mobile technology on a patient’s self-management of oral anticancer medication for metastatic breast cancer. The nurse-led, patient-centered intervention will be useful for reminding patients to take oral anticancer medications and lead to improved patient experiences and acceptability of treatment regimens. Our results may also improve the patients’ clinical outcomes and QOL. Office practice nurses caring for patients receiving test message may experience a decrease in nursing workload while improving their work satisfaction