Improving Cancer Care by Incorporating the Patient's Voice Into On-treatment Symptom Management
Conditions: Cancer, Thoracic Neoplasms, Gastrointestinal Cancer, Lung Cancer
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Official title 
IMPROVE: Improving Cancer Care by Incorporating the Patient’s Voice into 
On-treatment Symptom Management 
 
NCT number 
NCT04589247 
 
Document date 
February 23, 2021 

 
 
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Date: February 23, 2021    
Principal Investigator: Khinh Ranh Voong, MD, MPH 
Application Number: IRB00218263 
 
 
 
JHM IRB - eForm A – Protocol 
 
 
 
 Use the section headings to write the JHM IRB eForm A, inserting the appropriate material 
in each. If a section is not applicable, leave heading in and insert N/A. 
 When submitting JHM IRB eForm A (new or revised), enter the date submitted to the field at 
the top of JHM IRB eForm A. 
 
************************************************************************************** 
 
IMPROVE: Improving Cancer Care by Incorporating the Patient’s Voice into On-treatment 
Symptom Management 
 
1. 
Abstract 
a. Provide no more than a one page research abstract briefly stating the problem, the research 
hypothesis, and the importance of the research. 
 
Physician-reported measures are known to under report important symptoms and toxicities from 
therapy and their associated level of burden on patients1, leading to missed opportunities for 
clinicians to intervene and improve treatment-related outcomes. With the advances in systemic 
therapy and in radiotherapy, definitive-intent radiation is increasingly being offered in concert with 
systemic therapy for patients with locally-advanced and for limited metastatic disease.3-9 however, 
these therapies are not without risk. In a systematic review of 19 randomized trials of patients with 
non-small cell lung cancer (NSCLC) receiving chemoradiation (chemoRT) compared to radiation 
alone, chemoRT improved survival but at a cost of greater toxicity (esophagitis: RR 1.8, 95% CI: 
1.3-2.3; neutropenia: RR 3.53, 95% CI: 1.8-6.7; grade 3 to 4 anemia: RR 3.5, 95% CI: 1.8-6.8).10 
Given the competing medical comorbidities and frailty of cancer patients at presentation, the 
potential risks with aggressive radiation, the ability to optimally understand, monitor, and manage 
cancer treatment toxicity is critical. 
 
Patient-reported outcome measures (PROMs) is an umbrella term that refers to any report on a 
health status measure that is reported directly by the patient, without the influence of clinicians or 
anyone else.11 PROMs have been shown to more closely reflect a patient’s daily health status when 
compared to physician-reported measures.1 Given the disconnect between patient and provider-
assessed toxicity, PROMs can be used to more accurately and consistently characterize the 
detrimental impact of treatment on a patient’s symptom-specific outcomes, functional well-being, 
and overall quality of life. For example, a French randomized trial in stage IV NSCLC patients 
showed a survival benefit (22.5 vs 14.9 months) when using web-based PROMs to guide follow-up 
vs. standard follow-up with imaging every 3 to 6 months.12 However, research is needed to 
evaluate if patient symptom reporting during treatment allows earlier and improved detection of 
treatment toxicity, and leads to individualized interventions which may improve the toxicity 
outcomes for locally-advanced and oligometastatic patients receiving definitive chemoRT. 
 
 
 

 
 
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2. 
Objectives (include all primary and secondary objectives) 
 
a. Primary objective: Describe the proportion of patients with changes in physician-perception of 
treatment-related toxicity that result from routine physician review of PROMs reported during 
definitive radiotherapy. 
 
b. Secondary Objectives: Describe (1) the proportion of patients with changes in the management 
of treatment-related symptoms and (2) the type of management changes that result from routine 
physician review of PROMs reported during definitive radiotherapy. 
 
3. 
Background (briefly describe pre-clinical and clinical data, current experience with procedures, 
drug or device, and any other relevant information to justify the research) 
 
Interest is growing in using PROMs as a tool for improving assessment of patients and to guide 
physician decision making. Historically, PROMs were used for collecting data on patients in 
clinical trials but such data was not shared with the physicians involved in earlier trials to guide 
decision making in the care of patients.  Patient-physician discordance in the rating and perception 
of symptom burden in patients has been demonstrated in studies of cancer patients undergoing 
treatment.13 Use of PROMs by physicians may reduce this discordance and help improve overall 
assessment of the symptomatic burden for patients on-treatment. Recent studies have shown the 
feasibility and usability of PROMs in routine clinical care for cancer patients.14-19  
 
Snyder et al. randomized patients receiving oncological care to three different questionnaires 
assessing quality of life. Patients reported that utilization of PROMs improved the quality of care, 
improved communication with their physicians, and patients felt more in control of their care. 
Although not powered for this purpose, the trial also showed that participants from minority racial 
groups, with lower education levels, and less computer usage were more likely to rate the PROM 
intervention more favorably than their peers, suggesting a benefit for this intervention in addressing 
the needs of vulnerable populations.18 PROMs can also help physicians identify the symptoms that 
patients report as most bothersome,19 which can help clinicians tailor decision making approaches 
to create more beneficial outcomes for patients. There is less evidence to suggest that these 
assessments can lead to changes in management of symptoms and improved symptom burden as a 
result of treatment, though there have been some recent examples.12, 17, 20-21 
 
Lung cancer patients treated at Johns Hopkins currently report individual adverse on-treatment 
symptoms using the National Cancer Institute’s Patient-Reported Outcomes version of the Common 
Terminology Criteria for Adverse Events (PRO-CTCAE, version 1). 22 Our group has demonstrated 
the feasibility of routine real-time collection of PROMs in our clinic for lung cancer patients 
receiving radiation. Over time, we have been able to increase patient PROM completion rates to 
above 80 % (Figure 1).23 
 
This study builds on that clinical collection and review of PROMs by nurses.  We propose a 
prospective pilot study to describe the proportion of patients with a change in their physician’s 
assessment of their overall toxicity burden that result from routine physician review of PROMs 
during radiotherapy. We hypothesize that routine physician review of PROMs during on-treatment 
visits will (1) increase proportion of patients with an increased in their physician’ s assessment of 
their overall toxicity burden during definitive radiotherapy, and (2) correspondingly increase the 
proportion of patients receiving physician-directed interventions for treatment-related symptoms.  
 
Figure 1: Patient PROM completion rates in the thoracic radiation oncology clinic 

 
 
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4. 
Study Procedures 
a. Study design, including the sequence and timing of study procedures (distinguish research 
procedures from those that are part of routine care).   
 
Patient Recruitment: 
We will recruit eligible cancer patients who are about to begin conventional-fractionated 
(chemo-) radiotherapy. Patients will be informed of the study by their physician, clinic staff or 
research staff prior to the day of their first on-treatment visit.  For patients who decide to 
participate, research staff or treating physicians will obtain an informed and written consent 
before or on the first on-treatment visit. 
 
Clinician Recruitment:   
The treating radiation oncologists have expressed a willingness to participate in the study and 
will help with patient recruitment. The radiation oncologists will be recruited at Johns Hopkins 
and at WellSpan Health through emails and will have differing levels of experience.  Once we 
have received IRB approval, we will go through a formal consenting process. Physicians will 
have the option to decide not to participate.  If a physician is willing to participate, she/he will 
be asked to provide written informed consent.   
 
A participating physician may be included a co-investigator in this study. No physician co-
investigator may analyze their own patient’s PROM data included as a part of the study.  There 
is no requirement that to be a co-investigator physician must also be a research participant. 
 
Study Procedures:  
In order to minimize the need for research-only in-person visits, telemedicine visits may be 
substituted for in person clinical trial visits or portions of clinical trial visits where determined to 
be appropriate and where determined by the investigator not to increase the participants risks. 
Prior to initiating telemedicine for study visits the study team will explain to the participant, 
what a telemedicine visit entails and confirm that the study participant is in agreement and able 
to proceed with this method. Telemedicine acknowledgement will be obtained in accordance 
with the Guidance for Use of Telemedicine in Research. In the event telemedicine is not deemed 
feasible, the study visit will proceed as an in-person visit. Telemedicine visits will be conducted 
using HIPAA compliant method approved by the Health System and within licensing 
restrictions. 
 
As part of patients’ routine on-treatment evaluation, patients will report: (1) their symptoms 
using PRO-CTCAE measures for cancer-specific symptoms during on-treatment visits, (2) the 
most bothersome symptom, and (3) effect of their symptoms on their perception of bother and 
role function in terms of interference with daily activities (Appendix A.)  These measures 
should take only 5-10 minutes to complete.  

 
 
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** After signing informed consents - Patients will be asked to complete the measures prior to 
seeing their physician, during each on-treatment visit. Patient Care Technicians (PCT), Clinical 
Ancillary Staff, or Research Staff will provide the PROM forms to the patients and assess the 
forms for completion of questions. If the first three options are not available, a nurse may 
provide the patients the form and confirm with the patients that the PROMs have been 
completed without reviewing the content of the forms.  PROM forms will be completed on an 
electronic tablet. A hard-copy will be used as a back-up measure for patients if electronic 
devices or wireless functioning capabilities are not available at the time. 
 
As a part of the study, treating physicians over-seeing the care of their patients will be asked to 
provide a global burden score.  Lee et al. demonstrated the feasibility of using a global burden 
score to capture the provider’s overall perception of the combined burden of all assessed 
symptoms, using a visual analogue scale demarcating an aggregate score from 0 to 10.  This 
scale uses anchors at 0, 2, 4, 6, 8, and 10 for no, mild, moderate, severe, life-threatening adverse 
events, and death, respectively.24  
 
** During weekly on-treatment visits and prior to reviewing their patient’s PROMs, physicians 
will rate the symptom burden for each of their patients from 0 to 10 using available clinical data. 
Routine available clinical data include: vital signs, laboratory work, physical exam, nursing 
assessment, physician’s clinical judgement. Then after reviewing the patient’s PROMs, 
physicians will re-rate the patient’s symptom burden and report any change in recommended 
interventions due to review of the PROMs.  Management changes include (1) additional 
counseling, (2) medications/interventions changed, (3) referrals to other services, and (4) further 
testing/evaluation (Appendix B). At the end of each patient’s course of radiotherapy, providers 
will complete a Clinician Feedback Form to answer questions regarding the impact of PROM 
review on overall symptom perception and management during treatment (Appendix C). These 
forms were designed to be easy to complete and will take an estimated 5 minutes per patient.   
 
**At the time of enrollment, research staff will collect pertinent patient baseline and 
characteristics through clinical chart review. During each on-treatment visit, research staff 
collect pertinent clinical and treatment variables through chart review (Appendix D).  The 
research staff, if available on site, will also be available to assist patients in completing the 
questionnaires during scheduled visits and to address any issues or concerns patients have in 
completing the questionnaires. 
 
** Marks demarcates interventions that will/may require research staff availability and 
assistance.  
 
b. If your study involves data/biospecimens from participants enrolled under other research studies 
with a written consent or under a waiver of consent, please list the IRB application numbers for 
those studies.  Please note:  Certificate of Confidentiality (CoC) protections applied to the data 
in source studies funded by NIH or CDC will extend to this new study if the funding was active 
in 2016.  If this situation applies, Section 36, question 4 in the application will need to be 
answered “Yes” and “Hopkins Faculty” should be selected in question 7. No other documents 
are required. 
 
Not applicable. 
 
c. Study duration and number of study visits required of research participants. 
 

 
 
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Patients will be enrolled in the study prior to or on their first radiotherapy on-treatment visit and 
will continue through the course of their radiotherapy.  Data will be collected at routine weekly 
on-treatment visits; no study-specific visits are required 
 
d. Blinding, including justification for blinding or not blinding the trial, if applicable. 
 
Blinding will not be possible as the treating physician will need to provide routine care to the 
patients enrolled on this study. In addition, the treating physician will need to appropriately 
assign burden scores, and to report on whether there was a change in management for each of 
their patients who enroll on this study.  
 
e. Justification of why participants will not receive routine care or will have current therapy 
stopped. 
 
Patients will continue to receive their routine care.  This study will not alter nor stop the planned 
radiotherapy treatments. All patients enrolled will undergo routine weekly on-treatment 
evaluation and toxicity management by the treating physician.  
 
f. Justification for inclusion of a placebo or non-treatment group. 
 
There is NO placebo group. This is a pilot study to evaluate whether physician review of 
PROMs during radiotherapy changes the physician’s assessment of a cancer patient’s overall 
toxicity burden and management of treatment-related symptoms. There is insufficient sample 
size to include a placebo group. In future studies building on this, where we have a greater 
sample size, we can randomize patients to 2 arms: with and without routine PROM review.  
 
g. Definition of treatment failure or participant removal criteria. 
 
Patients will be removed if they desire to refrain from answering the PROM questionnaire.  
 
h. Description of what happens to participants receiving therapy when study ends or if a 
participant’s participation in the study ends prematurely. 
 
There will be no change in the patient’s routine care or treatment.   
 
5. 
Inclusion/Exclusion Criteria 
 
Our study population will be treating radiation oncologists and their primary cancer patients 
requiring definitive treatment with radiation with or without concurrent chemotherapy as per the 
inclusion criteria below. Cancer patients receiving stereotactic body radiation therapy or hypo-
fractionated definitive radiation will not be recruited as these patients represent a different treatment 
population with a much lower overall treatment toxicity burden.  
 
Patients: 
Inclusion Criteria: 
 Men and women over 18 years of age 
 Able to read and write in English or able to understand/answer questions with the aid of 
an interpreter 
 Histologically confirmed loco-regional to advanced primary cancer, including but not 
limited to lung cancer, esophageal, or gastro-intestinal cancers at risk of developing 
radiotherapy-related toxicity.    

 
 
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 Receiving definitive conventionally-fractionated radiation treatment with or without 
chemotherapy 
 
Exclusion Criteria: 
 Patients receiving radiation for palliative intent  
 Patients who do not provide informed consent 
 Patients who chose to withdraw from the study  
Radiation Oncologists 
Inclusion criteria: 
 Must be the physician overseeing the care of the patient who answers the PROMS 
 
Exclusion criteria: 
 Have not provided informed consent 
 
6. 
Drugs/ Substances/ Devices 
a. The rationale for choosing the drug and dose or for choosing the device to be used. 
Not applicable.  
 
b. Justification and safety information if FDA approved drugs will be administered for non-FDA 
approved indications or if doses or routes of administration or participant populations are 
changed. 
Not applicable.  
 
c. Justification and safety information if non-FDA approved drugs without an IND will be 
administered.  
Not applicable.  
 
7. 
Study Statistics 
 
 
This is s prospective pilot study.  
 
a. Primary outcome variable(s). 
 
The primary outcome is the proportion of patients with any change in their physicians-assessed burden 
scores for at least one on-treatment visit, along with their exact binomial 95% confidence interval.   
 
b. Secondary outcome variables 
 
The secondary outcome is the proportion of patients with a change in their on-treatment management for at 
least one on-treatment visit, along with the exact binomial 95% confidence interval.   
 
c. Exploratory outcome variables: 
 
We will also summarize the mean change in the physician-assessed burden score across on-treatment-visits, 
and across patients, using mean, standard deviation, median and ranges. We will report the distribution of 
changes (an increase, decrease or no change) in physician burden score after PROM review across all 
visits.  
 

 
 
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We will also summarize the mean change in the physician interventions across on-treatment-visits, and 
across patients, using mean, standard deviation, median and range of cumulative changes in interventions 
made.  We will explore the average cumulative number of management interventions based on each 
specified numerical change in burden score. 
 
Additionally, we will describe differences in mean physician burden score between first half and second 
half of treatment. To describe changes in the physician perception of treatment-related toxicity resulting 
from routine physician review of PROMs, we also will compare the mean change in burden scores for on-
treatment visits 4 to 7 to the mean change in burden scores for visits 1 to 3.  Treatment-related toxicities are 
expected to worsen over time.   If PROM review does not change physician perception of treatment-related 
symptoms, there would no difference between the mean change in burden score across patients in the first 
half of treatment compared to the second half of treatments. Using paired t-tests, we will examine the 
differences between mean physician burden score across patients in the second compared to the first half of 
the treatments. We would expect the changes in burden scores to be greater in later visits since treatment-
related toxicities and corresponding PROMS are expected to worsen over time.  
 
Depending on the proportion of patients with a change in physician burden assessment, we will also 
explore potential variables associated with a change in burden assessment by the physician.  
We will evaluate associations between variables of interest and development of any point as well ≥2 
absolute point change in their physician’s assessed burden scores for at least one on-treatment visit using 
Fisher’s exact test.  Variables may include but are not limited to: PROM question type from the 
corresponding on-treatment visit (symptom type, symptom severity, most bothersome symptom, 
interference on activity of daily living), baseline clinical or demographic information, and/or treatment 
information including treating-physician or disease-site.  We will not adjust for multiple comparison due to 
the exploratory nature of this study.  
 
 
d. Statistical plan including sample size justification and interim data analysis. 
 
The analyses will be descriptive. The statistical plan is written by study objective above. 
Exploratory plots will be made (line graph, bar plots) and used to visualize the distribution of data 
of interest. These plots may include but are not limited to cumulative number of additional 
interventions recommended with time and the distribution of type of additional interventions 
(counseling, medications/interventions, referrals, testing/evaluation). Exploratory tables will 
compare the average burden score change with the average cumulative number of management 
interventions per week.  Secondary analysis will explore ratings on the Clinician Feedback Form.   
 
Annually, 60-80 lung and esophageal cancer patients and 20 gastrointestinal tumors are treated with 
definitive RT over the course of 5-7 weeks at Johns Hopkins. On average >80% of on-treatment 
visits have PROMs completed for lung cancer patients. A sample size of at least 50 patients yields a 
two-sided 95% confidence interval with a width of less than 30% for descriptive analyses. Thus, we 
would be able to estimate the proportion of patients with a change in their physician assessed 
burden score and change in management with a margin of error of 15 % (+/- 15 %).   
 
There will be no interim data analysis.  
 
e. Early stopping rules. 
 
Not applicable.  
 
8. 
Risks 

 
 
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a. Medical risks, listing all procedures, their major and minor risks and expected frequency. 
 
There are minimal risks to patients associated with participation in this study.  PROs will be 
collected as a part of routine clinical care. Patients may become fatigued by completing the PRO 
questionnaire or the study forms and they may be upset by some of the questions (although the 
nature of the items is not generally upsetting).  Patients will be instructed that completion of the 
PRO questionnaire is voluntary and they may decide to stop completing the PRO questionnaire at 
any time.  They will be informed of the approximate length of time it takes to complete the 
questionnaire.  The data collection from clinicians is brief and should not be fatiguing or upsetting. 
 
b. Steps taken to minimize the risks. 
 
Because of the nature of this study, we do not anticipate any adverse events.  However, if a patient 
is upset by completing the study forms or becomes fatigued by completing them, the patient is free 
to stop completing the questionnaire at any time. 
 
c. Plan for reporting unanticipated problems or study deviations. 
 
The principal investigator and Co-investigators at all sites will notify the appropriate regulatory 
agencies of any serious adverse event due to any cause during the course of this investigation. These 
include the Johns Hopkins Cancer Center Data and Safety Monitoring Committee, and the Johns 
Hopkins Medical Institutional Review Board (JHM-IRB) of The Johns Hopkins Medical 
Institutions. We do not expect any fatal events as a result of this study but will notify within 14 days 
regarding unanticipated problems or deviations.  
 
d. Legal risks such as the risks that would be associated with breach of confidentiality:  
 
While data will be stored data in securely locked files (computer files will be password protected 
and any paper records will be stored in the research office at Johns Hopkins and all respective sites 
under lock and key) in which only the research team has access, there is always the risk that 
confidentiality will be lost. Following data analysis, all clinical information will be de-identified. 
Data management strategies will take full consideration of regulations on the security and 
confidentiality of electronic data. Summary data reports will not contain any identifying 
information. Upon completion of the study and data retention period, patient identifiers will be 
deleted in compliance with the Health Insurance Portability and Accountability Act.  
 
e. Financial risks to the participants:  
 
There will be no costs accrued to the patient as a result of completing the PROM questionnaire. We 
will attempt to eliminate additional logistical burdens by scheduling the assessments on days 
patients already have other scheduled clinical appointments.  
 
 
9. 
Benefits 
a. 
Description of the probable benefits for the participant and for society. 
 
Participants will answer PROMs which may improve patient-provider communication, management 
of patient symptoms, and the patient’s experience and satisfaction with treatment.   
 
 
10. 
Payment and Remuneration 

 
 
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a. 
Detail compensation for participants including possible total compensation, proposed bonus, 
and any proposed reductions or penalties for not completing the protocol. 
 
A $10 dollar gift card will be offered to patients enrolled on the protocol.  
 
11. 
Costs 
a. 
Detail costs of study procedure(s) or drug (s) or substance(s) to participants and identify 
who will pay for them. 
 
None. 
 

 
 
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