Development and Usability Testing of Nutrition Algorithms for Cancer Health Outcomes (NACHO) and Quality of Life During Cancer Treatment
Phase: NA
Conditions: Nutrition Poor, Nutritional Deficiency, Quality of Life
Sponsor: Dana-Farber Cancer Institute

PROTOCOL TITLE: Development and Testing of Nutritional Algorithms 
 
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PROTOCOL 
 
 
 
 
 
Study Title: 
Development and Usability Testing of Nutrition Algorithms for Cancer 
Health Outcomes (NACHO) and Quality of Life During Cancer Treatment 
 
DF/HCC IRB Protocol #22-637 
 
NCT05825469 
 
January 29, 2025

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Table of Contents 
1.0 
Objectives ................................................................................................... 3 
2.0 
Background ................................................................................................. 3 
3.0 
Inclusion and Exclusion Criteria .................................................................. 5 
4.0 
Study-Wide Number of Subjects ................................................................. 6 
5.0 
Study-Wide Recruitment Methods............................................................... 6 
6.0 
Multi-Site Research ..................................................................................... 8 
7.0 
Study Timelines........................................................................................... 8 
8.0 
Study Endpoints .......................................................................................... 7 
9.0 
Procedures Involved ................................................................................... 8 
10.0 Data and Specimen Banking ..................................................................... 10 
11.0 Data Management and Confidentiality ...................................................... 13 
12.0 Provisions to Monitor the Data to Ensure the Safety of Subjects .............. 14 
13.0 Withdrawal of Subjects .............................................................................. 14 
14.0 Risks to Subjects....................................................................................... 15 
15.0 Potential Benefits to Subjects ................................................................... 15 
16.0 Vulnerable Populations ............................................................................. 15 
17.0 Community-Based Participatory Research ............................................... 15 
18.0 Sharing of Results with Subjects ............................................................... 15 
19.0 Setting ....................................................................................................... 15 
20.0 Resources Available ................................................................................. 15 
21.0 Prior Approvals ......................................................................................... 16 
22.0 Recruitment Methods ................................................................................ 17 
23.0 Local Number of Subjects ......................................................................... 18 
24.0 Provisions to Protect the Privacy Interests of Subjects ............................. 18 
25.0 Compensation for Research-Related Injury .............................................. 18 
26.0 Economic Burden to Subjects ................................................................... 18 
27.0 Consent Process ....................................................................................... 18 
28.0 Process to Document Consent in Writing .................................................. 19 
29.0 Drugs or Devices....................................................................................... 19 
 

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1.0 
Objectives 
Aim 1a. Develop preliminary nutrition algorithms based on the Cancer 
Nutrition Consortium (CNC) study findings1,2 and iteratively refine through 
an expert dietitian panel from the DFCI Longwood/Chestnut Hill campus 
with consultation from oncology clinicians, as needed. 
Aim 1b. Refine draft algorithms through feedback from a panel of 4-6 
Patient and Family Advisory Council (PFAC) members. 
Aim 2a. Evaluate algorithm usability and acceptability with 4-6 oncology 
clinicians and a second expert dietitian panel from the DFCI satellite 
locations using semi-structured interviews or focus groups and heuristic 
evaluation methodology.3  
Aim 2b. Evaluate algorithm usability and acceptability with 4-6 patients 
actively undergoing treatment or who have completed primary therapy 
using semi-structured interviews and heuristic evaluation methodology.3  
Aim 3 (Exploratory). Assess the usability (i.e., engagement with the web-
based nutrition algorithm), acceptability (i.e., completion of feedback 
questionnaire), and effectiveness (i.e., clinical [e.g., BMI, adverse events], 
self-reported symptom and QOL questionnaires]) of the algorithm among 
100 individuals undergoing chemotherapy treatment for breast, 
gastrointestinal (GI), lung, or gynecologic cancers, or hematologic 
malignancies. 
 
We are currently seeking approval to conduct Aim 1a and 1b only. We 
will submit amendments sequentially to conduct following aims as 
materials are developed. 
 
As of January 2025, we are opening Aim 2a and 2b. 
 
2.0 
Background 
2.1 
Individuals undergoing treatment for cancer experience an 
average of 10 co-occurring symptoms4 that often occur in clusters 
and negatively impact quality of life (QOL).5,6 Frequently, 
individuals experience a GI-based symptom cluster (e.g., nausea, 
changes in taste, distress).7 Depending on clinical status and 
treatments, individuals can also experience constipation, diarrhea, 
vomiting, mucositis, and other symptoms that can impair nutritional 
well-being.8 Notably, there is a high amount of inter-individual 
variability in these symptom experiences.4 Some of this variability 
has been explained by the identification of certain demographic 
and clinical characteristics associated with high symptom burden 
groups such as older age,9 a high body mass index (BMI),10,11 poor 
functional status,12 multiple comorbidities,12 and poor baseline 
nutritional status.2,13 During and following treatments for cancer, 

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altered nutritional status may be associated with perturbations in 
inflammatory and metabolic pathways.14,15 Older age,9 a high 
BMI,10,11 and poor nutritional status2,13 may contribute to chronic 
inflammation. Of note, the majority of individuals diagnosed with 
cancer are over the age of 65.2 In addition, individuals with cancer 
who are overweight (i.e., BMI>25 kg/m2) are at increased risk for 
worse cancer-related symptoms (e.g., pain, fatigue, depression, 
sleep disturbance)16,17 and at the obese level (i.e., BMI>30 kg/m2), 
are at increased risk for morbidity and mortality during and 
following cancer treatments.18 Being underweight (i.e., BMI<18.5 
kg/m2) increases the risk for poor prognosis and death.19 During 
cancer treatment, decreases in nutrient consumption may occur 
due to treatment-related symptoms (e.g., nausea, vomiting, 
esophagitis, dysphagia).20 These nutritional alterations, coupled 
with chronic inflammation, can lead to dysbiosis (alterations in the 
gut microbiota) which, in turn, alters immune function.21,22 Since 
microbiota aid in the degradation and processing of foods 
consumed and are integral in the systemic process of metabolism, 
GI, and cardiometabolic function,13 it is essential to mitigate 
damage and/or restore the integrity of the microbiome. Therefore, 
ensuring good nutrition is critical during and following treatments 
for cancer. 
2.2 
Scientific Background and Rationale for the Research 
Studies investigating associations between nutrition, inflammation, 
immune function, symptoms, and QOL in people with cancer are 
lacking. Information is emerging, however, related to diet, food 
preferences, and symptom experiences. The Cancer Nutrition 
Consortium (CNC) conducted a large multi-site study to 
understand nutritional challenges and preferences of individuals 
undergoing treatment for breast, GI, lung, or gynecologic cancers, 
or hematologic malignancies. In one analysis of 800 adults >55 
years old with cancer, fatigue and poor appetite were frequently 
reported.2 Similarly, in the parent study of nearly 1200 adults (>18 
years old) with cancer, variability in taste and odor sensitivities, 
food preferences, and symptom experiences were identified.1 
Notably, individuals who reported decreased appetite, increased 
sensitivity to certain tastes and smells, and avoidance of certain 
foods reported decreased energy over treatment time.1 
 
In response to the findings from this large study, the CNC enlisted 
culinary experts to develop nutritional recipes for people with 
cancer. Recipes are publicly available through the CNC website. 
Currently lacking is a precision health person-centered approach 
to providing the best nutritional support based on an individual’s 

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age, BMI, cancer diagnosis, treatments, comorbidities, symptom 
experiences (e.g., nausea, vomiting, changes in taste, 
constipation, diarrhea, mucositis),7,8 preferences, and nutritional 
needs. Of note, symptom experiences have a temporal nature 
during and following treatments.23 Addressing nutritional needs, 
therefore, need to shift with shifting symptom experiences, health 
status, preferences, and needs.  
 
One method to addressing shifting care needs is through a 
person-centered, algorithm-based, clinical decision support metric 
developed from research evidence.24,25 Guided by the Model for 
Symptom Management,26 the adaptation of clinical guidelines 
(ADAPTE) methodology,27 and the findings from the CNC’s 
comprehensive study,1 this proposed study will develop and 
evaluate a nutrition recommendation program centered on 
individual clinical characteristics, GI symptom experiences, and 
personal preferences. Initial nutrition algorithms will be developed 
and vetted through panels of expert dietitians, oncology clinicians, 
and patients with cancer who have completed treatment. In a 
subsequent study, a technology-based platform will be developed 
to house the algorithms for the person-centered nutrition program, 
termed: Nutrition Algorithm for Cancer Health Outcomes 
(NACHO). The final program will include the input of 
demographic/clinical (e.g., age, BMI, comorbidities, disease type, 
treatment regimen) characteristics that will drive the algorithms. 
Decision points will include current patient symptoms and 
preferences. Individual food and recipe recommendations will be 
generated for each patient with each interaction with the NACHO 
program. As patient symptoms, preferences, and treatment 
regimens change, the recommendations will shift accordingly. 
Following the development and testing of the prototype, we 
anticipate subsequent studies that will include evaluation of 
changes in the microbiome and the incorporation of foods and 
recipes across diverse cultures. We hypothesize that using 
NACHO will optimize patient nutritional status and improve QOL.  
 
3.0 
Inclusion and Exclusion Criteria 
 
For aims 1a, 1b, 2a, and 2b, subjects include dietitians (1a and 2a), 
oncology clinicians (2a), members of PFAC (1b), and patients with 
cancer (actively undergoing treatment or have completed 
treatment, 2b) in groups of 4-6 each. For aim 3 (exploratory), 100 
patients undergoing treatment for breast, GI, lung, or gynecologic 
cancers, or hematologic malignancies will be included.  
 

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3.1 
Inclusion criteria: 
Dietitians/Oncology clinicians 
- 
Have worked with at least 3 patients at the study site who 
had nutritional challenges  
- 
Patient and Family Advisory Council (PFAC) 
participants 
- 
Current member of adult PFAC 
- 
> 18 years old 
Patient participants 
- 
> 18 years old 
- 
Able to speak and read English  
- 
Completed primary treatment (aim 2b) or actively 
undergoing treatment (aim 2b and aim 3, exploratory) 
- 
Access to a device (e.g., computer, tablet, 
smartphone) through which they can receive and 
engage with a REDCap link  
Exclusion criteria: 
Patient participants 
- 
Provider does not recommend  
3.2 
Excluded: 
• Adults unable to consent  
• Individuals who are not yet adults (infants, children, teenagers)  
• Pregnant women  
• Prisoners  
 
4.0 
Study-Wide Number of Subjects 
4.1 
This single-site study will accrue a sample of up to 30 subjects in 
formative phases (Aims 1 and 2) and 100 subjects with breast, GI, 
lung, or gynecologic cancers, or hematologic malignancies to test 
the algorithms in Aim 3. Efforts will be made to include 20 subjects 
in each disease group in Aim 3. 
 
Aim 
Subjects (n) 
Aim 1a 
Dietitians (4-6) 
Aim 1b 
PFAC members (4-6) 
Aim 2a 
Oncology clinicians (4-6) + dietitians (4-6) 
Aim 2b 
Patients (4-6) 
Aim 3 
Patients (100) 
Overall 
All subjects (N = up to 130) 

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5.0 
Study-Wide Recruitment Methods 
5.1 
All subjects will be recruited by DFCI staff. Recruitment methods 
are outlined in section 22.0. 
 
6.0 
Multi-Site Research 
NA 
 
7.0 
Study Timelines 
7.1 
Duration of participation in this study will be up to one year from the 
time of consent.  
7.2 
It is anticipated that it will take up to three months from study 
approval to develop and refine the initial algorithms with up to 30 
panel members in formative phases (Aims 1 and 2), six months to 
enroll 100 patient subjects who will be followed for six months, and 
an additional six months for analyses and dissemination following 
participant engagement in the study. 
7.3 
This study, with a final sample of 100 patient subjects and up to 30 
panel members, is estimated to be completed by aim, as follows: 
-  1a) Develop preliminary nutrition algorithms based on the 
Cancer Nutrition Consortium (CNC) study findings1,2 and 
iteratively refine through an expert DFCI dietitian panel and 
expert clinician consultations, as needed – June 2023 
- 
1b) Refine draft algorithms through feedback from a panel of 4-6 
Patient and Family Advisory Council (PFAC) members – July 
2023 
-  2a) Evaluate algorithm usability and acceptability with a 4-6 
member DFCI oncology clinician and a second 4-6 member 
DFCI dietitian panel using semi-structured interviews or focus 
groups and heuristic evaluation methodology3 – September 
2023 
-  2b) Evaluate algorithm usability and acceptability with 4-6 
patients (on treatment or have completed treatment) using semi-
structured interviews and heuristic evaluation methodology3 – 
December 2023 
- 
3) Assess the usability (i.e., engagement with the web-based 
nutrition algorithm), acceptability (i.e., completion of feedback 
questionnaire), and effectiveness (i.e., clinical [e.g., BMI, 
adverse events], self-reported symptom and QOL 
questionnaires]) of the algorithm among 100 individuals 
undergoing treatment for breast, GI, lung, or gynecologic 
cancers, or hematologic malignancies – December 2024 

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-  4) Analyze data, disseminate findings, submit grant application 
for larger scale study including the developing of a web-based 
application (app) – March 2025 
 
8.0 
Study Endpoints 
8.1.1 Primary study endpoints: Develop a preliminary nutrition algorithm 
using the CNC study findings1 and iteratively refine through an 
expert dietitian panel with clinician consultation, as needed, as 
follows: 
• Conduct a secondary analysis of the CNC study data to 
evaluate subgroups of patients by cancer type (i.e., breast, 
GI, lung, gynecologic cancers or hematologic malignancy), 
dietary changes (e.g., increased/decreased appetite, food 
aversions), and outcomes (i.e., changes in energy level, 
changes in weight) using data collected in the CNC study.1  
• Develop, review, and refine nutrition algorithms that will 
provide suggested foods and recipes with the expert dietitian 
panel of 4-6 members plus clinician consultation over six 
months. 
• Evaluate draft algorithms with a panel of 4-6 PFAC members. 
 
8.1.2 Secondary study endpoints:  
2a) Evaluate algorithm usability and acceptability with 4-6 oncology 
clinicians and a second 4-6 member expert dietitian panel and 2b) 
a panel of 4-6 patients who have completed primary cancer 
treatments.  
• Using semi-structured interviews and heuristic evaluation 
methodology3, we will conduct individual, cognitive interviews 
and/or focus groups with subjects  as they use an interactive 
system of the algorithm through the Research Electronic Data 
Capture (REDCap)28 platform. A heuristic evaluation includes 
the assessment of an interface (e.g., nutrition algorithm) in 
following pre-specified standard rules (i.e., heuristics) and 
violations associated with its use.3 For this study, the 
heuristics related to the nutrition algorithm decision tree will 
be evaluated. This is followed by a checklist evaluation of the 
user interface (with REDCap for this study). 
 
• Following each cognitive interview and/or focus group, 
participants will complete a questionnaire to quantitatively 
assess the extent to which the algorithm is engaging, usable, 
and acceptable. Acceptability is a multi-dimensional construct 
comprising burden, affective attitudes, subjective 
experiences, opportunity costs, and intentions to use the 

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tool.29 Acceptability of NACHO will be assessed using a 
survey that includes the System Usability Scale (SUS)30 and 
the Acceptability e-Scale (AES).31 The SUS (Cronbach’s α = 
0.85) is a 10-item instrument that is widely used to assess the 
usability of products such as websites and mobile 
applications. Total SUS scores may range from 0-100, with 
higher scores representing greater usability. The AES 
(Cronbach’s α = 0.76) is a six-item scale that measures how 
easy, enjoyable, understandable, and helpful a tool is; 
whether the participant liked the tool; acceptability of time to 
complete the tool; and overall satisfaction with the program. 
Total scores range from 6-30, with higher scores representing 
greater acceptability. Together, these two tools assess the 
five dimensions of acceptability. Consistent with published 
recommendations, we will define acceptability as a SUS 
score >70 and an AES score >24.30,31 
 
8.1.3 
Tertiary study endpoint: In this exploratory aim, we will assess the 
following:  
8.1.3.1 Usability will be evaluated as the rate of engagement (i.e., 
number of times the algorithm is used) with the web-based 
nutrition algorithm over the course of six months. 
8.1.3.2 Acceptability, as described above for the panel member 
feedback, will include using a five-dimensional construct 
comprising burden, affective attitudes, subjective 
experiences, opportunity costs, and intentions to use the 
tool.32 The survey will include the User Engagement Scale 
- Short Form (UES-SF), the System Usability Scale (SUS), 
the Acceptability of Intervention Measure (AIM), and the 
Intervention Appropriateness Measure (IAM). 
8.1.3.3 Effectiveness will be evaluated by comparing baseline and 
six-month outcomes of clinical data (e.g., BMI, adverse 
events) and self-reported symptom and QOL 
questionnaires among 100 individuals undergoing 
chemotherapy treatment for breast, GI, lung, or 
gynecologic cancers, or hematologic malignancies. The 
questionnaires include: Patient Reported Outcomes Data: 
National Institutes of Health (NIH) National Cancer Institute 
(NCI) Patient-Reported Outcomes version of the Common 
Terminology Criteria for Adverse Events (PRO-
CTCAETM),33 and the Patient-Reported Outcomes 
Measurement Information System  (PROMIS)-10 Global 
Health Questionnaire v.1.234 (all described below). 
8.1.4 Safety Endpoints: None 

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9.0 
Procedures Involved 
9.1 
Study Design: This is a longitudinal, mixed-methods, pilot 
descriptive study.  
9.2 
Research Procedures: To accomplish Aims 1a and 1b, expert panel 
members will contribute to the development of the algorithms. We 
will request a waiver of written documentation of informed consent 
for this aim. Aim 1a and 1b participants will self-report basic 
demographics (Appendix C). After establishing a data transfer 
agreement, data from the CNC nutritional assessment studies1,2 will 
be used to develop the draft algorithms. In an iterative process, 
input from an expert DFCI dietitian panel will be sought as 
preliminary algorithms are developed. Oncology clinicians may be 
included as consultants, as needed. Following the development of 
draft algorithms, a panel of 4-6 PFAC members will review the 
refined algorithms. The algorithms will be hosted on the REDCap28 
platform using a secure web authentication, data logging, and 
Secure Sockets Layer (SSL) encryption process. 
To accomplish Aim 2a, oncology clinicians and dietitians will 
participate in cognitive interviews and/or focus groups in-person in 
an office or conference room at the clinic site or via a HIPAA-
compliant Zoom platform. We will request a waiver of written 
documentation of informed consent for this aim. Aim 2a participants 
will self-report basic demographics (Appendix C). Participants will 
review the algorithms using REDCap on a provided tablet device or 
personal computer along with a PDF of the full view document of 
the algorithms that visually show the decision points with branching 
logic. Interviews and focus groups will be audio recorded, de-
identified, and professionally transcribed. Based on participant 
feedback, Aim 1 expert panel members will review and revise the 
algorithms.   
To accomplish Aim 2b, patient participants will undergo cognitive 
interviews in-person in a private clinic site area or via a HIPAA-
compliant Zoom platform. Patient participants will provide written 
documentation of informed consent and will self-report 
demographics; we will collect clinical variables such as diagnosis 
from the medical record. Patient participants will review the 
algorithms using REDCap on a provided tablet or personal 
computer and provide feedback. Interviews will be audio recorded, 
de-identified, and professionally transcribed. 
 
Once the final version of the algorithm is established, we will test it 
in a group of 100 patient subjects during active treatment. Subjects 
will report baseline demographic information via REDCap. At 

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baseline and monthly for six months, subjects will be prompted by 
email through REDCap to use the nutrition algorithm. At end of 
study, subjects will answer symptom and QOL questionnaires as 
described in 8.1.3.2 and 8.1.3.3. Clinical data such as diagnosis 
and treatment type will be collected from the medical record. 
Dietitians, oncology clinicians, PFAC members, and patients 
participating in aim 2b will receive $100 gift cards for their 
contributions to algorithm development. Aim 3 patient participants 
will receive a copy of the CNC cookbook as an appreciation gift for 
participating in the study. 
Amendments will be submitted to the IRB as materials are 
developed to begin conducting successive aims of the study. 
 
Table 1. Study activities timeline 
Study 
Activities 
Months 
1-3 
Months 
4-6 
Months 
7-9 
Months 
10-12 
Months 
13-15 
Months 
16-24 
Months 
25-27 
Develop initial 
algorithms  
X, EP 
 
 
 
 
 
 
Interviews 
 
D, OC 
P 
 
 
 
 
Algorithm 
revisions 
 
X 
X 
 
 
 
 
Enroll patients 
in 6-month 
pilot study 
 
 
 
X 
X 
 
 
Monthly 
prompts to 
complete 
nutrition 
algorithms 
 
 
 
X 
X 
X 
 
Demographic 
and clinical 
data 
 
 
 
 
 
X 
 
Symptom and 
QOL 
questionnaires 
 
 
 
 
 
X 
 
Feedback 
questionnaire 
 
 
 
 
 
X 
 
Analyses, 
dissemination, 
subsequent 
grant 
preparation 
 
 
 
 
 
X 
X 
Legend: EP = expert panel, D = dietitian, OC = oncology clinician, P = patient, X= 
study team 

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Data Collection: Demographic/Clinical Data: Demographic data 
including age, sex at birth, gender identification, ethnicity/race, 
socioeconomic status, and comorbidity information will be self-
reported through the demographic questionnaire. Clinical data (e.g., 
BMI, adverse events) will be collected from the participant’s EHRs 
at baseline (visit 1) and month 5 (visit 6). Data will be obtained 
through chart abstractions. 
PROMIS-10 Global Health Questionnaire v.1.234 is an NIH 
developed, valid and reliable instrument that will be used to assess 
functional status and quality of life. This is global health version 1.2 
questionnaire consists of 10 questions consisting of Likert scale 
ranging from 1-5. The 10th pain question is a numeric scale ranging 
from 1-10. The raw sum score is computed into T-Score 
distributions, which are standardized such that a 50 represents the 
average (mean) for the US general population, and the standard 
deviation around that mean is 10 points. The scores can be 
computed to identify global physical and mental health component 
scores. Patients will complete this assessment at baseline, month 
2, and month 5 (visits 1, 3, and 6). 
Patient Reported Outcomes Data: National Institutes of Health 
(NIH) National Cancer Institute (NCI) Patient-Reported Outcomes 
version of the Common Terminology Criteria for Adverse Events 
(PRO-CTCAETM)33 is a valid and reliable instrument specific to 
oncology symptoms. The PRO-CTCAE (eSyms) Symptom Check 
Questionnaire (DFCI), will be used as outcome measures. Data on 
sleep quality (i.e., insomnia), will be obtained from protocol 03-189 
or collected monthly as part of this study. Additional related 
symptom cluster of pain, fatigue, and depression (i.e., anxiety, 
discouraged, sad) will be collected monthly as part of this study. 
 
10.0 
Data and Specimen Banking 
10.1 N/A 
 
11.0 
Data Management and Confidentiality 
11.1 Analysis plan for the exploratory aim. The rates of usability, 
acceptability and effectiveness of the algorithm will be reported 
using descriptive statistics and analyzed using a Fisher’s exact test 
and t-test to determine possible associations with the patients’ 
diagnosis. For effectiveness, the clinical-, self-reported symptom- 
and the QOL- questionnaires (sub-scales) will also be cross 
tabulated against the different diagnoses to test for possible 
associations. The demographics of the whole sample will be 

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preliminarily assessed to ascertain the balance across the different 
diagnosis groups; in case of relevant unbalances, the main features 
will be tested using the weighted versions of either the chi-squared 
or the Wilcoxon rank-sum tests (according to the outcomes). 
11.2 Power analysis: This is a descriptive exploratory study that 
will be used to determine power in a subsequent larger 
study. 
11.3 Quality control of data: Data will be monitored and quality 
checked by the research team. REDCap database’s logic 
checks will be utilized to ensure data quality and minimize 
missing data. 
11.4 Data handling: Data and the participant list will be 
(separately) electronically stored after the study is complete 
per SOP: Record Retention for Completed Research (RCL-
101). The study team is comprised of experienced 
researchers trained in human subjects’ protections. The 
study staff and all research activities will be monitored by the 
PIs. The PIs and Project Director will train all study staff in 
procedures for maintaining participant confidentiality and 
securing data. All members of the research team will be 
responsible for immediately reporting breaches of 
confidentiality or data security to the PIs, compliance office 
per institutional policy, and the IRB. Risks related to data 
privacy will be minimized by a series of standardized 
procedures to maintain strict confidentiality of all data 
collected by this study.  
Only the study team will have access to the data or specimens. All 
data will be de-identified prior to any analysis. Drs. Hammer and 
Cooley and their study team will be responsible for all data 
collection activities including tracking and transmitting of data as 
necessary. After all participant data are received/collected, they will 
be shared de-identified for analyses securely. 
 
12.0 
Provisions to Monitor the Data to Ensure the Safety of Subjects 
12.1 This study is minimal risk and, Adverse Events (AE) for this study 
are not anticipated. In the event there are AE reports, annual 
summaries will not include identifiable material. 
 
13.0 
Withdrawal of Subjects 
13.1 
This is a minimal risk study and there are no interventional drugs 
being tested. Subjects will be able to withdraw at any time with no 
impact on their current or future medical care or relationship with 
the Dana-Faber Cancer Institute. Subjects can inform the study 

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team of wanting to stop or withdraw from the study and all data 
collection activities will cease. 
 
14.0 
Risks to Subjects 
We anticipate the study to be no greater than minimal risk. Potential 
risks include feeling upset when answering questions about 
symptoms and mood. Subjects will be reminded at the start of each 
questionnaire that they can skip any question or stop at any time. 
Based on previous similar research, we expect this to be a low 
probability risk. If a subject scores 3 or higher on PHQ-4 subscales 
for depression or anxiety, they will be contacted by the study team 
and referred to their oncologist or social worker. 
 
Another risk is loss of privacy. The study team will take all usual 
precautions as stated above in section 11.4 to decrease this risk. 
 
15.0 
Potential Benefits to Subjects 
15.1 
Participants may find the recommended foods and recipes 
enjoyable and may benefit from improved nutritional status.  
 
16.0 
Vulnerable Populations 
16.1     Vulnerable populations including pregnant women and prisoners 
will not be included. 
 
17.0 
Community-Based Participatory Research 
17.1 
This study is not community-based participatory research. 
 
18.0 
Sharing of Results with Subjects 
Results will not be shared directly with participants. Findings will be 
disseminated through publications and presentations without any 
patient identifiers. Disseminated publications and presentations will 
be available to participants.  
 
19.0  Setting 
The study will take place at Dana-Farber involving dietitians and 
oncology clinicians, and patient participants from selected clinics. 
Research will be conducted virtually (REDCap, telephone/Zoom, or 
mail) and in person. 
 
19.0 
Resources Available 
19.1 
Dana-Farber Cancer Institute (DFCI) 
The study team is well equipped to complete the proposed 
research. Drs. Hammer and Cooley at DFCI will have all resources 
available through the Phyllis F. Cantor Center to conduct the study 
and provide study oversight, including research assistants, 

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coordinators, and project directors. The Cantor Center is a 1200 
square-foot office suite comprised of 7 offices and 16 workstations. 
The Cantor Center has laptop and desktop computers, telephones, 
secured filing cabinets, and office appliances (e.g., printers) for 
study use. The study will benefit from the administrative support of 
Cantor Center staff (e.g., study coordinators, clinical research 
assistants, students). The Cantor Center is located within walking 
distance from the DF/HCC clinical sites and the Department of 
Biostatistics.  
Due to the COVID-19 Pandemic, research activities have 
transitioned to a remote format. Following institutional guidelines. 
The Cantor Center is located in a non-clinical building at 375 
Longwood Avenue. Per guidelines, e-consents will be used when 
needed to minimize in-person study visits. 
Principal Investigators: 
Marilyn Hammer, PhD, DC, RN, FAAN is the Director, Phyllis 
F. Cantor Center for Research in Nursing and Patient Care 
Services 
Mary Cooley, PhD, RN, FAAN is a nurse scientist in the 
Phyllis F. Cantor Center for Research in Nursing and Patient 
Care Services.  
Co-Investigators: 
Rachel Pozzar, PhD, RN, FNP-BC is an Instructor at 
Harvard Medical School and nurse scientist in the Phyllis F. 
Cantor Center for Research in Nursing and Patient Care 
Services. 
 
Emanuele Mazzola, PhD is a biostatistician in the 
Department of Biostatistics at the Harvard T.H. Chan School 
of Public Health. 
 
Katherine McManus, MS, RD, LDN, is the Director, 
Department of Nutrition, Brigham and Women’s Hospital. 
Other study personnel: 
A Project Director from the Cantor Center will guide the 
coordination, facilitation, and data management of this study. 
CRCs from the Cantor Center will identify and enroll subjects 
and aid in data collection  
20.0 
Prior Approvals 
N/A 
 
 

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21.0 
Recruitment Methods 
 
Aim 1a Dietitians: Dietitians will be identified through the DFCI 
Nutrition Department, and a recruitment email will be sent with 
study information including elements of consent (Appendix A). 
Those interested will have the option of responding by email or 
calling a member of the study team. The first 4-6 dietitians who 
meet the study criteria and express interest will be invited to 
participate.  
 
Aim 1b PFAC Members: PFAC members will be identified through 
the DFCI PFAC staff liaison and program coordinator, and a 
recruitment email will be sent with study information including all 
elements of consent (Appendix B). Those interested will have the 
option of responding by email or calling a member of the study 
team. The first 4-6 PFAC members who meet the study criteria and 
express interest will be invited to participate. 
 
Aim 2a Dietitians/Clinicians: Dietitians will be identified through 
the DFCI Nutrition Department, and an email will be sent describing 
the study. Those interested will have the option of responding by 
email or calling a member of the study team. The first 4-6 dietitians 
who meet the study criteria and express interest will be invited to 
participate. To recruit oncology clinicians, the PI will introduce the 
study to oncology clinicians at an interdepartmental meeting. The 
first 4-6 oncology clinicians who meet the study criteria and express 
interest will be invited to participate.  
 
Aims 2b and 3 Patients: The study team will screen patients from 
the DFCI breast, GI, lung, gynecologic, and hematologic cancer 
clinic groups for eligibility. The study will be presented at faculty 
meetings. Emails will be sent to primary providers providing the 
opportunity to opt their patients out of recruitment. If a participant is 
not opted out, a recruitment letter will be sent via US mail or Patient 
Gateway to the potential participant containing study information 
and a copy of the ICF. The potential participant will have one week 
to opt out via phone, email, or text from being further contacted. 
Those who do not opt out will receive a call by a member of the 
study team to further describe the study and assess for 
participation interest. For those interested, the study team member 
will review the ICF with the potential participant (or schedule a more 
convenient time to review the study materials). 
A partial HIPAA waiver will be requested, if needed, to screen and recruit 
patient participants only (Aim 2b and 3). 
 

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22.0 
Local Number of Subjects 
22.1 
For Aim 1a, up to 6 dietitians will form a panel to develop the 
algorithms. For Aim 1b, up to 6 PFAC members will review and 
provide feedback on the algorithms. For Aim 2a, up to 6 oncology 
clinicians and up to 6 additional dietitians will be interviewed or 
participate in focus groups. For Aim 2b, up to 6 patients will be 
interviewed. For Aim 3, 100 pilot study patient subjects will be 
recruited and enrolled. Subjects will be recruited and enrolled at 
DFCI only. 
 
23.0 
Provisions to Protect the Privacy Interests of Subjects 
All study related data, inclusive of the screening and enrollment 
logs will be kept in a secure, encrypted database that requires 
authenticated login and password protection; consent forms will be 
locked in study offices at the Dana-Farber Cancer Institute in the 
Cantor Center or stored on MGB shared networks; individually 
identifiable private information will be accessible only to study staff 
who are trained in the protections of human subjects and study 
procedures and IRB approved. 
 
24.0 
Compensation for Research-Related Injury 
24.1 
This is a minimal risk study, research related injury not anticipated 
 
25.0 
Economic Burden to Subjects 
25.1 
There are no costs that participants may be responsible for due to 
participation in the study. 
 
26.0 
Consent Process 
26.1 
For Aims 1a, 1b, and 2a, we will request a waiver of written 
documentation of consent. The investigators will email dietitians, 
PFAC members, and oncology clinicians an invitation to participate, 
outlining study procedures and all required elements of consent. 
For Aims 2b and 3, we will obtain written informed consent from 
patient participants. 
26.2 
We will follow DF/HCC Policy CON-100: Informed Consent 
Process. For all participants, a consent discussion will take place 
by telephone, Zoom, or in clinic following a recruitment script which 
covers all elements of consents and includes asking the subject 
after each section if they have any questions. Study staff will be 
trained in detail by the PD on use of the recruitment script and 
ensuring that subjects are not coerced to participate. Patient 
participants will have received a blank hard copy of the consent 
form or an electronic copy through Patient Gateway or REDCap, 
while dietitian and clinician participants will have received a copy of 

PROTOCOL TITLE: Development and Testing of Nutritional Algorithms 
 
Page 19 of 22 
 
the study information sheet via e-mail. Subjects may agree to 
participate at the time of the consent review, or after additional time 
to consider and discuss participation with others. The consent 
discussion is expected to require at least 10 minutes and up to as 
long as the subject needs, including multiple discussions, to answer 
all their questions and make a decision about participating. 
Subjects will be asked to provide written documentation of consent 
by mail or REDCap.  
26.3 
The study will not be enrolling subjects who are not yet adults, 
cognitively impaired adults, or adults who are unable to consent. 
27.0 
Process to Document Consent in Writing 
27.1 
We will follow DF/HCC Policy CON-100: Informed Consent 
Process. When written documentation of informed consent is 
obtained, it will be obtained via mail (paper consent form) or 
electronically through REDCap. Participants who provide consent 
electronically will be instructed on how they can save a copy of their 
signed consent form, and those who sign with ink will receive a 
copy by secure Dropbox link or U.S. mail. 
 
28.0 
Drugs or Devices 
28.1 
The study does not involve any drug or device use. 
 
 

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