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Research Article

D-CRSE: Diminishing chemotherapy-related side effects through patient education, a mixed-methods pilot study

ORCID Icon, ORCID Icon, , MS ORCID Icon, , ORCID Icon, ORCID Icon, , , ORCID Icon, , , PhD & , MDORCID Icon show all

Abstract

Objectives

Patient education materials regarding self-management of chemotherapy-related side effects are limited, which may result in patients using disreputable sources. We created a brochure that educates patients on common side effects, tools to address problems themselves, and guidance on when to contact their oncologist or seek emergency care. This mixed-methods study conducted at Penn State Cancer Institute evaluates the feasibility of using an educational brochure to improve patient outcomes through education.

Methods

Chemotherapy naïve patients with breast or gastrointestinal (GI) cancer were enrolled in a single-arm clinical trial from December 2021 to 2022. Participants received the educational brochure and were asked to provide their initial impressions. They completed The Emotional Thermometer Scale (ETS) and the Memorial Symptom Assessment Scale (MSAS) to measure changes in patient symptoms and mental health throughout their chemotherapy course at 0, 6, and 12-week intervals. The drop-out rate was recorded as a measure of study feasibility.

Results

The study participants were split between the following cancer types: 77.8% breast and 22.2% GI cancer. A significant decrease in overall mean ETS score was observed between baseline and week 6 (p = 0.001) and 12 (p = 0.0004), respectively. Moreover, the mean MSAS psychological symptoms decreased significantly at week 12 compared to baseline (p = 0.005), while no change was observed in physical symptoms (p = 0.101). Of the 40 participants who completed baseline surveys, 37 had at least one additional visit for a drop-out rate of 7.5%.

Conclusion

This mixed-methods pilot study was successful in demonstrating the feasibility of distributing a standardized educational brochure as an intervention for chemotherapy patients. While participants’ emotional scores and psychological symptoms decreased over time, physical symptoms did not, which aligns with side effect progression from cumulative chemotherapy burden.

Introduction

The diagnosis of cancer is a life-altering event that can cause a large amount of distress for newly diagnosed patients. This distress may be particularly pronounced during the first phase of a patient’s cancer journey, especially when there is difficulty interpreting new medical information and a lack of general medical knowledge.Citation1 In response to a new cancer diagnosis and upon initiating treatment, patients require information regarding the stage of their disease, treatment options, and side effects of treatment.Citation2

Although many patients acquire this information through their oncologist or primary physician, many may also supplement or replace reputable sources with easily accessible, but often less reliable, information via the internet to learn more about their cancer and prepare themselves for their journey.Citation3 One study assessing the quality control of online information for colorectal cancer, found that about 50% of the links available from top search engines on this topic were commercially oriented with an aim to sell a product or service. Notably, <1% of the available information was from professional societies.Citation4

Complementary alternative medicine (CAM) has become another area in cancer treatment that is often riddled with misinformation. CAM treatments, such as acupuncture, meditation, antioxidants, probiotics, and foods like apricot pits and ginger, are commonly promoted online which can lead to some cancer patients seeking them out.Citation5 In contrast to standard chemotherapeutic regimens, CAM treatments lack rigorous scientific backing with few randomized clinical trials available to support the claims that CAM treatments improve patient outcomes. Moreover, CAM treatments are not always favorable, have the potential to severely impact one’s health, and may even decrease the efficacy of a patient’s chemotherapy regimen.Citation6

Other offline sources that patients consult include friends and family members, who may provide recommendations and advice that are not always scientifically supported. Regardless of the source, disreputable resources that misinform patients have the potential to severely impact their health and fight against cancer.

A proposed solution is to incorporate standardized patient education programs and evidence-based educational brochures, which have been shown to significantly increase patient knowledge and satisfaction, as well as encourage lifestyle changes that may improve patient-centered outcomes.Citation7–9 Currently, there is a lack of formal patient education materials available to patients undergoing chemotherapy at Penn State Cancer Institute (PSCI), especially materials that are appropriate for the average health literacy level of the patient population. Resources from organizations, such as the American Cancer Society (ACS) and the National Comprehensive Cancer Network (NCCN) have limitations in their chemotherapy-specific patient education materials. Although these organizations have extremely thorough and comprehensive brochures available, the amount of information can be overwhelming to patients, specifically newly diagnosed cancer patients. There is evidence to suggest that many cancer patients prefer limited amounts of information as opposed to having as much information as possible.Citation10 The NCCN and ACS patient materials have also been perceived as too broad or not specific enough to address patients’ questions and/or concerns. For instance, it has been found that one of the most important questions that cancer patients seek answers to is the specific side effects of chemotherapy.Citation11 Although the NCCN and ACS have some information about side effects embedded in their materials, educating patients about them is not the sole purpose and the content often does not align with the health literacy level of the average patient at PSCI.

To address the knowledge deficit, we created a brochure that educates patients on common side effects, tools to address problems themselves, and guidance on when to contact their oncologist or seek emergency care. Topics addressed in the brochure range from nausea, hair loss, and fatigue to constipation and guidance on safe personal touch.

We hypothesize that providing chemotherapy-naive patients with an evidence-based educational brochure will help them feel more prepared to navigate the unknowns associated with chemotherapy and safely address side effects as they occur. Additionally, we predict that this educational intervention will improve patient-related outcomes and quality of life. Negative emotions, such as distress and anxiety which occur secondary to undergoing chemotherapy, can be mitigated by providing an accurate representation of the side effect profile. Furthermore, the brochure is designed to help patients know when it is necessary to contact their medical oncologist and when it is appropriate to seek emergency care, to ultimately decrease the high amount of potentially preventable hospital visits amongst cancer patients as a result of patient education.Citation12

Research design

This single-arm mixed-methods pilot study was performed at Penn State Cancer Institute in Hershey, Pennsylvania, which is the only comprehensive cancer center in central Pennsylvania. PSCI cared for a total of 3698 cancer registry cases in 2016 alone.Citation13 Despite the large patient volume seen at PSCI, there is a lack of patient education materials regarding cytotoxic chemotherapy side effects that align with the health literacy level of the average patient population. As a result, the evidence-based educational brochure was created (Supplemental File Citation1). With the primary objective of creating a brochure that serves as an effective educational intervention, the Emotional Thermometer Scale (ETS) and the Memorial Symptom Assessment Scale (MSAS) were chosen as data collection tools and administered to patients at regular intervals during their chemotherapy course.Citation14,Citation15

The ETS is a validated tool employed to predict changes in multiple parameters reflecting patients’ mental health pre- and post-chemotherapy treatment, thus enabling quantification of how the educational brochure impacted patients’ mental health during treatment. The ETS includes five dimensions, specifically measuring distress, anxiety, depression, anger, and if a patient needs help. These parameters were continuous variables with scores ranging from 0 (best) and 10 (worst). The MSAS is a patient-rated instrument that provides multidimensional information about a group of common symptoms a patient may experience. This is a validated instrument for the assessment of symptom characteristics, prevalence, and distress, which allowed the team to gauge if the information in the brochure targeted a representative subsection of symptoms experienced by the patients. From a qualitative standpoint, patients were also asked to provide their initial impressions to help determine if the teaching material was understandable and perceived as useful to patients, which helped determine if the brochure itself was an effective educational tool. Given that one of the primary goals of this pilot study was to determine the feasibility of using a brochure-based educational material, a control arm was not designated, and all patients received the brochure.

The protocol was approved by the Penn State Human Research Protection Program under the identification number STUDY00016592. The study protocol was also registered at Clinicaltrials.gov (identifier NCT04694794).

Participant sample

Participants included chemotherapy naïve patients with breast and GI cancer at PSCI. Participants were identified by medical oncologists through interactions in the clinic or through medical record review by members of the study team. In the latter situation, the patient’s primary oncologist was contacted for permission to approach the patient. Study team members screened patients for eligibility based on inclusion criteria utilizing electronic medical records.

To be eligible to participate, prospective participants were required to be chemotherapy naïve or to have started chemotherapy treatment no more than 6 weeks before enrollment. Participants also had to begin treatment no later than 6 weeks after enrollment and be 18 years of age or older with an Eastern Cooperative Oncology Group (ECOG) performance status of 0–3. Lastly, it was required that participants understand and read written English or Spanish without any functional difficulty. Prospective participants were not excluded if they received other cancer treatments, such as immunotherapy, targeted treatment, endocrine therapy, or radiation, as long as they also received concurrent cytotoxic chemotherapy at the time of enrollment. Likewise, participants were allowed to be involved with other cancer trials offered at PSCI.

All prospective participants gave their informed consent for inclusion before they participated in the study. Patients were approached for consent and enrollment by members of the study team either at the first visit with the medical oncologist when a cytotoxic chemotherapy regimen was recommended, or at the first chemotherapy infusion.

Participants were enrolled on a rolling basis with a goal of accruing a total of 35 eligible patients. There was no predetermined percentage of either breast or gastrointestinal cancer that was required to be met when recruiting participants. The team expected to approach about 40 patients and anticipated a 10–15% drop-out rate, which was considered in determining accrual goals.

Methodological approach

At an infusion session occurring within 6 weeks of starting chemotherapy, participants were given the educational brochure and surveys. Infusion sessions were chosen as the time for surveys because it was anticipated that patients would be more willing to participate while already occupied by the infusion. At the baseline visit, the patients were instructed to briefly review the brochure’s content and then immediately record a few sentences about their perceived usefulness and understandability of the brochure. Next, baseline symptom and emotion profiles were collected by administering the MSAS and ETS. The surveys were again administered at two additional time points during follow-up infusion sessions at week 6 and week 12 (±10 days) to capture patient symptoms as their chemotherapy treatment progressed. Notably, the surveys were measured to take 12 minutes or fewer to complete.

A participant’s involvement in the study concluded with the completion of the week 12 (±10 days) survey. The ±10 days were utilized if a patient had to postpone an appointment due to side effects from the chemotherapy, scheduling changes due to COVID-19, or unexpected personal reasons. Study data were collected and managed using Research Electronic Data Capture (REDCap) electronic data capture tools hosted at Penn State Health Milton S. Hershey Medical Center and Penn State College of Medicine.Citation16 REDCap is a secure, web-based application designed to support data capture for research studies, providing: an intuitive interface for validated data entry; audit trails for tracking data manipulation and export procedures; and automated export procedures for seamless data downloads to common statistical package procedures for importing data from external sources.

Statistical methods

The primary outcome variables were the MSAS and ETS scores. The distributions of the survey measurements at different time points were summarized with the sample size, mean, and standard deviation values so the overall change with time could be observed. Paired-sample t-tests were used to compare the differences between baseline measurements to their follow-up visits at week 6 and week 12 (±10 days) with the baseline and week 6 data showing the short-term effect of the educational brochure and week 12 data showing the mid-term effect of the brochure.

The participant drop-out rate after the baseline was designated as the secondary outcome. A drop-out participant was defined as a patient who completed the baseline measurements and failed to complete one of the following visits (week 6 or 12). Due to the limited sample size and predominance of breast cancer patients in the sample, the team did not run the analyses by stratifying the two cancer types, and the data were analyzed as a whole. Ad hoc analyses were performed comparing the selected demographics () to determine any differences within all baseline participants, between those who did and did not complete the week 12 visit using Fischer’s exact tests. All analyses were performed using R programming language version 4.3.2 (R Foundation for Statistical Computing, Vienna, Austria). All tests were two-sided and the statistical significance level used was 0.05. The significance level was not adjusted for multiple testing because of the exploratory nature of this study.

Table 1. Demographics and characteristics for consented patients (n = 45), all baseline patients (n = 40), and comparisons between those who did and did not complete the week 12 visit.

Results

Out of all consented participants (n = 45), 40 completed the baseline surveys and 37 of them attended at least one additional visit. Using the definition stated above, the drop-out rate was 7.5%. Of the participants who completed baseline surveys, 82.2% were female and 17.8% male. Most responders (77.8%) were being treated for breast cancer (81.8% ductal carcinomas, 9.1% lobular carcinomas, 9.1% invasive metaplastic carcinoma, 52.5% ER+, 42.5% PR+, 22.5% HER2+). The remaining patients (22.2%) were treated for colorectal cancer. Additionally, 27.5% of all enrolled patients underwent concurrent therapies with their chemotherapy (). Furthermore, Fisher’s exact tests comparing the demographics of participants who completed both baseline and week 12 surveys with those who did not complete week 12 surveys showed no significant difference in any demographic category ().

The mean ETS components were significantly decreased at week 6 compared to baseline measurements for distress, anxiety, anger, and the overall ETS (p = 0.006, p < 0.0001, p = 0.038, and p = 0.001, respectively). Likewise, the scores for distress, anxiety, anger, and the overall ETS were also significantly decreased at week 12 compared to baseline (p = 0.014, p < 0.0001, p = 0.032, and p = 0.0004, respectively). In contrast, the ETS depression component revealed a significant change from baseline at week 12 only (p = 0.042). The mean MSAS measurements demonstrated a significant decrease in psychological symptoms at week 12 compared to baseline (p = 0.005), while physical symptoms did not change significantly (p = 0.101). Survey component changes between baseline, week 6, and week 12 visits are shown graphically for the ETS and MSAS in and , respectively. summarizes the mean score comparisons from baseline to weeks 6 and 12 for the ETS and MSAS.

Figure 1. Mean ETS component changes between week 0 (baseline), week 6, and week 12 visits.

Figure 1. Mean ETS component changes between week 0 (baseline), week 6, and week 12 visits.

Figure 2. Mean MSAS component changes between week 0 (baseline), week 6, and week 12 visits.

Figure 2. Mean MSAS component changes between week 0 (baseline), week 6, and week 12 visits.

Table 2. Mean score comparisons from baseline to 6 and 12 weeks for the ETS and MSAS.

Qualitative results were recorded for the enrolled participants, which included first impressions of the educational brochure materials. Out of 40 participants, 31 elected to provide comments on their first impressions of the educational brochure. Over half the participants (51.6%) thought that the brochure would be helpful to them. About 20% mentioned that they appreciated the consolidation of this information being found in one place which made referring to it easier. Two comments explicitly mentioned that the information in this booklet would be better to reference than a general internet search. Six comments included suggestions for the brochure which included that future improvements to the brochure should include pictures, better timing of when the brochure was received, and that the breadth of information was intimidating. Some sample first impressions are included in .

Table 3. Qualitative results: assorted first impressions.

Discussion

While participant’s emotional scores and psychological symptoms significantly decreased between baseline and week 12 measurements, physical symptoms did not. The trend of improving psychological but not physical symptoms by the end of the 12 week follow-up visit aligns with side effect progression from cumulative chemotherapy burden. Similarly, the decrease in psychological symptoms correlates with the significant decrease observed in negative emotions captured with the majority of ETS components when comparing baseline measurements to those recorded at weeks 6 and 12, suggesting that emotional scores may improve before psychological symptoms change and continue to improve over time ().

These key findings may be explained by a few different factors. One likely explanation is that exposure to the educational brochure, possibly amongst other supportive factors, did help to ease distressing emotions and consequently psychological symptoms for each visit. However, one major limitation to this conclusion in this pilot study is the lack of a control arm, which does not allow for the assertion that exposure to the educational brochure is directly attributable to the cause of the decrease in psychological and emotional symptoms. Consequently, it is also possible that the psychological and emotional burden of the disease improves organically with time due to supportive factors occurring independently of, or in conjunction with, the educational intervention. By week 12, patients had more time to navigate the health system, orient themselves to their situation, and increase their familiarity with the chemotherapeutic treatment process overall, which likely resulted in an improved ability to cope with the emotional burden of their disease by the end time point of this study.

Evidence suggests that patients who received educational materials reported a greater sense of control over their own learning by limiting the influence of online materials.Citation17 Participants in our study noted that they “feel more comfortable using this [the brochure] instead of Google.” While online information remains widely available to patients, due to the varying reliability of those online sources, there is evidence to support that patients having access to hard-copy educational materials may help improve their own experiences within the health care system and may improve their understanding of their disease.Citation18

Another study reviewed sources that patients would seek online regarding breast cancer. Almost 40% of the participants from that study did seek information on CAM therapies and a sizable number of those patients did intend to discuss those options with their provider.Citation19 A different study monitored patient and provider feedback after supplying patients with an educational brochure regarding CAM therapies relating to their chemotherapy. All participating providers found that the brochure made it easier to discuss CAM with their patients and a majority of the providers felt that the brochure helped save time during the patient encounter.Citation20 When utilized by providers and patients, educational materials may positively impact the patient-physician relationship, highlighting an area that can be capitalized on. Standardizing patient education guides that focus on patient-oriented outcomes, such as quality of life or psychological symptoms, which is a goal the brochure used in this study, will improve care for patients, hospitals, and health systems.

Consequently, the future adaptation of this pilot study to a double-arm randomized controlled clinical trial would allow for the ability to better assert that a self-management educational intervention may help improve a cancer patient’s psychosocial well-being. Additionally, given that the trial drop-out rate was lower than expected at 7.5%, this pilot study does provide evidence that adaptation to a larger randomized controlled trial in the future is feasible. Other limitations of this pilot study are the failure to account for differences in patient socioeconomic factors, such as educational background and familial and financial support, as well as the fact the patients were participating while at infusion visits. Future studies should aim to control these variables, as these factors could impact a patient’s use of and need for educational materials and may represent alternative reasons for emotional and psychological distress or well-being. Additionally, future studies can also implement technological advances, such as utilizing different formats of education materials or survey systems. Although the brochure developed in this study was created to address a notable gap in formal chemotherapy education materials accessible to patients within our institution, future studies should also attempt to clarify standardized educational materials by exploring the diversity of educational approaches among oncologists. This could be achieved through surveys aimed at understanding provider practices at the onset of chemotherapy treatment for patients.

While most patients undergoing cytotoxic chemotherapy typically encounter side effects akin to those observed in our study cohort, the applicability of our findings to broader patient cohorts beyond those with breast and GI cancers treated at Penn State Cancer Institute is constrained. This limitation is especially pertinent when extrapolating results to individuals with hematological malignancies, given the distinct side effect profiles of chemotherapy agents utilized for these conditions compared to those used for other tumor types.

Our study sheds light on the gap in the standardized care of patients receiving chemotherapy, the potential implications to the psychosocial aspect of oncology, and the emotional burden that patients experience from undergoing cytotoxic treatment for cancer. Patients may benefit from standardized educational brochures that aim to prepare them for potential chemotherapy side effects, especially considering that current patient education materials offered by prominent cancer organizations do not include pertinent and detailed information for mitigating the side effects of chemotherapy, and these materials may not be best suited for the average health literacy level of the patient population in a particular hospital or health system. It is imperative that an increased emphasis is placed on creating educational materials that are focused on patient-centered outcomes.

Conclusions

Educational interventions for patients surrounding their experiences with different side effects of chemotherapy remain vital to improving patient care. In this pilot study, chemotherapy patients with breast or GI cancer were given a brochure that educates on common side effects, tools to address problems themselves, and guidance on when to contact their oncologist or seek emergency care. Study participants demonstrated quantitative and qualitative benefits during the follow-up time points. This pilot study demonstrates the feasibility of a larger study and the importance of implementing such educational interventions.

Authors contributions

All authors had full access to all the data in the study and took accountability for all aspects of the work including the integrity of the data and accuracy of the data analysis. Conception and design: MV, JZ, CK, SL, GJ, JB, DM. Patient screening for eligibility and consent: MV, SL, GJ, HD, JB, RK, MC, BF, DM, SH. Acquisition, analysis, interpretation of data, and manuscript writing: All authors. Data analysis: JZ. Study supervision: MV.

Supplemental material

Supplemental Material

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Disclosure statement

MV is a recipient of the Robert A. Winn Diversity in Clinical Trials Career Development Award, funded by Bristol Myers Squibb Foundation. No potential conflict of interest was reported by the author(s).

Data availability statement

The participants of this study did not give written consent for their data to be shared publicly, so due to the sensitive nature of the research supporting data is not available.

Additional information

Funding

The author(s) reported there is no funding associated with the work featured in this article.

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