A Decentralized, Double-blinded, Randomized, 18 Month, Parallel-group, Superiority Study to Evaluate the Impact of Complement Theory's Live Coactive Exercise Coaching and Personalized Digital Application on Cancer Survivors' Quality of Life
Phase: NA
Conditions: Breast Cancer, Lung Cancer, Prostate Cancer, Colorectal Cancer, Other Cancer
Sponsor: Complement Theory Inc.

 
 
 
 
 
 
Title: A Decentralized, Double-blinded, Randomized, 18 month, Parallel-group, 
Superiority Study to evaluate the impact of Complement Theory's Live Coactive 
Exercise Coaching and Personalized Digital Application on Cancer Survivors’ Quality 
of Life 
 
 
Pro00077693 
 
 
Aug 26, 2025 
 
 
 
 
 
 
 
 
 
 
 
 
 

Section 1: PROTOCOL SUMMARY 
1.1 Protocol Synopsis 
●​ Primary and Secondary objectives and endpoints 
○​ Primary Objective - To measure the impact of Complement Theory’s 
Program on Quality of Life of cancer survivors as measured by FACT-G 
questionnaire. 
○​ Secondary Objectives: 
■​ Quantify the effect of CT’s program on employee absenteeism by 
tracking changes in the number of sick days taken by participants. 
■​ Determine the program’s impact on employee presenteeism by 
assessing changes in work motivation and employee performance 
review scores. 
○​ Exploratory Objective 
■​ To quantify the impact of Complement Theory’s Program on total 
healthcare expenditure in cancer survivors. 
■​ Assess the impact of CT’s Program on the progression and 
recurrence rates of prostate, colorectal, and lung cancers, by 
evaluating changes in tumor size and biomarker levels, including 
Blood pressure, PSA or protein, in addition to monitoring actual 
recurrence rates. 
●​ Overall Design  
○​ Several key aspects of the trial design are summarized below: 
Trial Model 
Randomized control trial with two parallel groups: 
one active comparator (control) and one test 
group. 
Test Intervention 
Live Coactive Coaching program, focusing on 
Exercise and Meditation, along with app-guided 

evidence-based information on Diet, Sleep, and 
other lifestyle practices for 48 weeks (12 months) 
Active Comparator 
(Control) 
48 weeks access to Digital application with expert 
guidelines on lifestyle modification focusing on 
exercise, meditation, as well as information on diet, 
sleep and other lifestyle practices. Does not 
include live coaching and personalization. 
Trial Intervention 
Assignment Method 
Randomization 
Population Type 
Adult survivor 
Population Diagnosis 
Active Cancer (Breast, Prostate, Colorectal, Lung 
and Other) Stage 1-4 
Population Age 
21 yrs and above 
Site Distribution 
Digital Recruitment of participants who can be 
anywhere in the US 
 
●​ Number of Arms 
○​ Two - One active comparator (control) and one test 
●​ Blinding 
○​ The study will be double-blind: Participants and the Principal Investigator 
will not be made aware of treatment assignment.  
○​ Both the groups shall be given access to the app. The contents shall be 
different for active comparator and the test group. 
●​ No of Participants 
○​ 146 (73 Maximum to be assigned randomly each to control and treatment) 
●​ Arms and Duration 

○​ Treatment Group 
■​ Participants will get access to Complement Theory’s 12 month Live 
Coactive Coaching program, focusing on Exercise and Meditation 
and supplemented with evidence-based information on Diet, Sleep, 
and other lifestyle practices, adjunct to the core treatment. 
■​ Each week, up to five sessions of 45 minutes each will be offered, 
with a recommendation for participants to engage in a minimum of 
three sessions to ensure adequate program exposure and benefits. 
■​ Each session will consist of 30 Minutes of Physical Exercise and 7 
minutes of meditation. Each session will be a combination session 
focused on Aerobic and Strength, with flexibility and balance 
exercises included as supplements. 
■​ Participants will be allocated to Low / Moderate intensity programs 
based on their specific medical profile, ensuring that the exercises 
and meditation practices are safe, effective, and aligned with their 
health status and cancer treatment plan. 
○​ Active Comparator (Control) Group 
■​ Participants in this group will receive access to a curated collection 
of publicly available guidelines for lifestyle modification. These 
resources, presented through a digital application, will focus on 
exercise, meditation, diet, and sleep, but without the live coaching or 
program personalization.  
■​ This comparison aims to evaluate the impact of personalized, 
interactive live Coactive coaching against self-guided learning using 
standard guidelines. 
○​ The overall duration for an individual participant is anticipated to be 12 
months for the active phase, with a 6 month follow-up period for long-term 
data collection.  
●​ Committees: 

○​ Throughout the study, safety oversight will be provided by the Trial 
Monitoring Committee (TMC), composed of oncologists, cancer exercise 
specialists and biostatisticians. 
○​ All participants enrolled in the study will be included in the safety analysis.  
The Trial Monitoring Committee will be responsible for reviewing relevant 
safety findings related to study outcomes. 
1.2 Trial Schema 
 
1.3 Schedule of Activities 
●​ Step 1: Enrollment and Intervention 
○​ Screening (including baseline assessment) 

○​ Randomization by recruitment to test or control groups 
○​ Informed Consent 
○​ Access to control and test programs 
○​ Regular Assessments up to 18 months 
●​ Step 2: Data Analysis 
○​ Interim Data analysis will be 3 months, 6 months, 12 months and 18 months 
data. 
●​ Step 3: Publication 
○​ Publication on protocol analysis and outcomes data is expected at 12 
months and the end of 18 months 
 
Section 2: INTRODUCTION 
2.1 Purpose of Trial  
The randomized controlled trial (RCT) aims to evaluate the efficacy of Complement 
Theory's (CT) personalized and interactive, evidence-backed lifestyle program in 
reducing healthcare costs and improving health outcomes for survivors across all major 
cancer types.  
 
Distinct from conventional interventions, CT's program offers live coactive coaching 
through a mobile app, concentrating on Exercise and Meditation, and is enriched with 
evidence-based advice on Diet, Sleep, and comprehensive lifestyle modifications. This 
trial is pivotal in assessing the program's effectiveness against an active comparator–  
expert-recommended lifestyle modification resources suitable for cancer survivors--to 
isolate the impact of coaching and personalization.  
 
The primary objective is to investigate whether CT's novel approach can more effectively 
reduce healthcare utilization, through reduction of hospitalizations, urgent care visits, and 
outpatient visits. Furthermore, the trial seeks to measure adherence to treatment, and 
significant health outcomes, including improvements in Quality of Life Scores (QoLS) to 

provide a holistic evaluation of the program's impact on patient care and well-being. As 
an exploratory effort, the trial will also measure cancer progression, recurrence in 
Prostate and Colorectal cancer survivors alone. 
 
2.2 Summary of Benefits and Risks 
Benefit Summary 
●​ Immediate Potential Benefits 
○​ Improved Physical Health: Participants may experience improvements in 
physical health through regular exercise coaching provided by a live coach 
in conjunction with the digital application. Numerous studies1,2 across 
cancer types have shown increased physical activity levels lead to 
enhanced health, improved strength and flexibility, and better overall 
physical function, yet only 15%3 patients follow recommended physical 
activity levels. 
○​ Reduced Symptom Burden: Cancer survivors often experience symptoms 
such as fatigue, pain, and nausea as a result of their disease and treatment. 
Engaging in regular exercise has been shown to alleviate these symptoms 
and improve overall well-being. By participating in the trial, individuals may 
experience a reduction in symptom severity and an improvement in their 
daily functioning. 
○​ Enhanced Emotional Well-being: Physical activity is associated with 
numerous psychological benefits, including reduced stress, anxiety, and 
depression. The personalized exercise coaching delivered by a live coach 
may help participants manage emotional distress and improve their mood 
and overall psychological well-being. 
○​ Improved Quality of Life: Engaging in regular exercise, meditation, and 
experiencing improvements in physical and emotional health can 
contribute to a better quality of life over the long term. By participating in 

the trial and adopting healthy exercise habits, individuals may enjoy a 
higher quality of life and greater satisfaction with their overall well-being. 
 
●​ Medium-Long-Range Potential Benefits 
○​ Reduced Healthcare Utilization: By incorporating exercise into their daily 
routine and experiencing improvements in health outcomes, participants 
may reduce their reliance on healthcare services such as hospitalizations, 
urgent care visits, and outpatient appointments. This could lead to cost 
savings for both the individual and the healthcare system over the long 
term. 
○​ Empowerment and Self-management: Participating in the trial and receiving 
personalized exercise coaching empowers individuals to take an active role 
in managing their health and well-being. Learning skills and strategies for 
incorporating exercise into their lifestyle can help participants feel more in 
control of their health and better equipped to cope with the challenges of 
cancer treatment and survivorship. 
○​ Improved Treatment Outcomes: The program aims to positively impact 
cancer progression, and recurrence compared to survivors receiving 
standard care. By measuring changes in levels of biomarkers, size of 
tumors and incidence of cancer recurrence, the intervention seeks to 
improve overall treatment outcomes. 
 
Risk Summary and Mitigation Strategy 
●​ Trial-specific Discussion of Intervention Risks and Mitigations 
○​ Risk of Injury or Exacerbation of Health Conditions: Even though physical 
activity is considered safe for Cancer, engaging in physical exercise, 
especially for individuals undergoing cancer treatment, carries a small risk 
of injury or exacerbation of existing health conditions for survivors with 
existing comorbidities. Participants may experience muscle strains, joint 

injuries, or fatigue, particularly if they engage in exercises beyond their 
physical capabilities. 
○​ Mitigation Strategy: To mitigate this risk, the intervention takes into account 
participants' medical history, current health status, and physical fitness 
levels through an Intake Screening Form, which assigns them to Low 
intensity or Moderate intensity groups. The live coach in conjunction with 
the digital application will provide personalized exercise plans tailored to 
each participant's needs and capabilities Additionally, participants will 
receive education and guidance on proper exercise techniques, warm-up 
and cool-down procedures, and signs of overexertion or injury. 
 
●​ Trial-specific Discussion of Procedure Risks and Mitigations 
○​ Some key risks associated with trial procedures in this trial: Engaging in the 
trial procedures, such as completing assessments, using the software app, 
may impose a burden on participants, particularly those undergoing cancer 
treatment or managing other health issues. 
○​ Mitigation Strategy: To mitigate participant burden, we will have trained 
personnel to help with data entry virtually as needed. Additionally, we will 
offer flexible scheduling to help alleviate the burden and enhance 
participant retention. 
 
Overall Benefit: Risk Conclusion 
The evaluation of our proposed trial, which integrates live coactive coaching with a 
software solution for cancer survivors, demonstrates a significant favorable balance 
between minimal risks and anticipated benefits.  The residual risks are minimized 
through tailored safety measures and are outweighed by the expected benefits of 
improved physical health, decreased symptom burden, and enhanced quality of life. 
Supporting this favorable assessment, a substantial body of research not only confirms 
the safety of exercise but also endorses the significance of physical activity and lifestyle 

changes in cancer management. This evidence base, coupled with medical endorsement 
of physical activity for enhancing survivor outcomes, bolsters confidence in the trial's 
approach. 
To ensure ongoing safety and integrity, risks and benefits will be continuously assessed, 
adjusting protocols as necessary to safeguard participant well-being. This trial aligns with 
best practices in cancer treatment and reflects a commitment to advancing survivor care 
through evidence-based lifestyle interventions. 
Section 3: TRIAL OBJECTIVES, ENDPOINTS AND ESTIMANDS 
​
Trial Objective 1:  Impact of Complement Theory’s Program on Quality of Life  
Clinical Question: How does participation in Complement Theory’s program affect Quality 
of Life Scores (as measured by FACT-G) in cancer survivors compared to those receiving 
standard care? 
●​ Endpoint(s): Measured through change in FACT-G scores which is designed to 
assess various dimensions of quality of life including pain levels and sleep quality. 
●​ Estimand(s): The mean difference in change in scores between the intervention 
and control groups at specified time points during and after the intervention 
period. 
Trial Objective 2: Effect on Employee Absenteeism 
Clinical Question: How does participation in the Complement Theory program influence 
the number of leave days taken by employed cancer survivors due to health issues? 
●​ Endpoint(s): Number of leave days (including sick leave, short-term disability, and 
long-term disability) taken by participants during the trial period. 
●​ Estimand(s): The difference in the average number of leave days between the 
intervention and control groups over the trial period. 

Trial Objective 3: Impact on Employee Presenteeism 
Clinical Question: What is the effect of Complement Theory’s program on motivation to 
work and performance review scores among employed cancer survivors? 
●​ Endpoint(s): 
●​ Motivation to work: Assessed through self-reported scales or 
questionnaires. 
●​ Performance review scores: Obtained from employer records or 
self-reported performance evaluations. 
●​ Estimand(s): The difference in mean scores of motivation and performance 
reviews between the intervention and control groups over the trial period. 
Exploratory Objective(s):  
Impact on rates of cancer progression, and recurrence 
Clinical Question: What is the effect of Complement Theory’s program on progression 
and recurrence of prostate, lung and colorectal cancers? 
●​ Endpoint(s): 
●​ Cancer progression: Measured by changes in tumor size and changes in 
levels of biomarkers. 
●​ Recurrence: Incidence of cancer recurrence. 
●​ Estimand(s): Directional trends evaluating the difference in proportions or rates of 
cancer progression and recurrence between the intervention and control groups 
during and post-trial follow-up. 
Rationale for Excluding Breast Cancer from Exploratory Objective: 
●​ Breast cancer, in particular, exhibits a longer average timeframe for recurrence 
when compared to prostate, lung and colorectal cancers. This longer latency 
could extend beyond the scope of our study's follow-up period, making it 

challenging to accurately measure the program's impact on recurrence rates 
within the study's duration. 
●​ By focusing on prostate, lung and colorectal cancers, we aim to assess the 
program's impact on cancers with more predictable progression patterns and 
well-established biomarkers, enabling a clearer evaluation of the Complement 
Theory's potential benefits in these specific cancer populations. 
 
Impact on Total Healthcare Expenditure 
Clinical Question: Does participation in Complement Theory’s 12-month Live coactive 
Coaching program, focusing on Exercise and Meditation and supplemented with 
evidence-based information on Diet, Sleep, and other lifestyle practices, adjunct to the 
core treatment, lead to a reduction in total healthcare expenditure for cancer survivors? 
●​ Endpoint(s): Total healthcare expenditure, including hospitalization costs, 
medication expenses, outpatient visits, and any other related healthcare services 
that we planned and unplanned, cancer and non-cancer, over the trial period. 
●​ Estimand(s): The difference in mean total healthcare expenditure between the 
intervention and control groups over a specified period (e.g., at 12 months and 18 
months from baseline). 
 
3.1 Summary of objectives, endpoints and estimands: 
 
 
Trial Objective 
Clinical Question 
Endpoint(s) 
Estimand(s) 

1 
Impact on 
Quality of Life 
How does participation in 
Complement Theory’s 
program affect Quality of 
Life Scores (QoLS) in 
cancer survivors compared 
to those receiving standard 
care? 
Measured through 
change in FACT-G 
score which is 
designed to assess 
various dimensions of 
quality of life, including 
physical well-being, 
pain levels, sleep 
quality. 
Mean difference in 
change in scores 
between groups 
2 
Effect on 
Employee 
Absenteeism 
How does participation in 
Complement Theory’s 
program influence 
employee absenteeism 
due to health issues? 
Number of leave days 
taken (sick leave, 
short/long-term 
disability) 
Difference in average 
number of leave days 
between groups 
3 
Impact on 
Employee 
Presenteeism 
What is the effect of 
Complement Theory’s 
program on motivation to 
work and performance 
review scores among 
employed cancer 
survivors? 
- Motivation to work 
- Performance review 
scores 
Difference in change 
of mean scores of 
motivation and 
performance between 
groups 

 
Section 4: TRIAL DESIGN 
4.1 Description of Trial Design 
●​ Description of Intervention Model 
○​ This randomized control trial features two parallel groups: an active 
comparator (control) group and a treatment group, aiming for a total of 146 
participants diagnosed with one of the following cancers - Breast, 
Colorectal, Prostate Lung and Other Cancer. 
N
/
A 
Impact on 
Cancer 
Progression, 
and 
Recurrence 
What is the effect of 
Complement Theory’s 
program on cancer 
progression, and 
recurrence on prostate 
lung and colorectal cancer? 
- Cancer progression 
(biomarkers) 
- Change in tumor size 
- Recurrence 
(incidence of cancer 
recurrence) 
Directional trends 
evaluating the 
difference in 
proportions or rates of 
cancer progression 
and recurrence 
between the 
intervention and 
control groups during 
and post-trial 
follow-up. 
N
/
A 
Impact on Total 
Healthcare 
Expenditure 
Does participation in 
Complement Theory’s 
12-month program lead to 
reduced healthcare 
expenditure? 
Total healthcare 
expenditure as defined 
as: (hospitalization, 
medication, outpatient 
visits, ER Visits) 
Difference in mean 
total healthcare 
expenditure between 
groups 

○​ The treatment group will be given live coactive coaching and personalized 
digital application program focused on Exercise and Meditation, 
supplemented with evidence-based facts on Diet, Sleep, and other lifestyle 
practices 
○​ On the other hand, the control group will be given a digital application with 
expert guidelines on lifestyle modification, available publicly but with no 
live coaching and personalization. 
○​ In essence, this is a superiority trial aimed at establishing that CT's program 
is more effective in improving outcomes.  
●​ Description of Trial Duration  
○​ The overall duration for an individual participant is anticipated to be 48 
weeks (minimum 3, up to 5 days per week, 45 mins each session) for the 
active phase, with a 6 month follow-up period for long-term data collection.  
○​ This duration allows for a comprehensive assessment of the intervention's 
immediate and sustained impacts on health outcomes and healthcare 
costs. 
●​ Method of Assignment to Trial Intervention  
○​ Participants in each group will be recruited transparently through online 
advertisements while ensuring balanced representation across cancer 
types. 
○​ Blinding: The participants will not be aware if they are in control or test 
group. 
○​ Number of Arms: Two – one control and one treatment group. 
4.2 Rationale for Trial Design 
●​ Rationale for intervention model 
○​ The chosen randomized control trial (RCT) model with an active comparator 
allows for a direct and meaningful comparison between Complement 
Theory’s live coactive guidance with a physical coach and personalized 
program and the standard guidance available to cancer survivors. This 

model is particularly suited to our objectives as it accommodates the 
evaluation of a complex intervention involving live coactive coaching and 
digital support, unlike traditional drug trials. This approach ensures that any 
observed differences in outcomes can be attributed with greater certainty 
to the unique components of the Complement Theory program, thereby 
providing a clear assessment of its added value over standard care 
practices. 
●​ Rationale for duration 
○​ The trial duration has been carefully selected to ensure sufficient time to 
observe meaningful changes in Quality of Life, Presenteeism and 
Absenteeism. A 12-month intervention period, followed by a 6 month-long 
follow-up, allows us to capture both the immediate and sustained impacts 
of lifestyle modifications on health outcomes. As an exploratory effort, the 
extended follow-up period enhances our ability to monitor long-term 
effects, particularly relevant for outcomes like cancer recurrence and 
cancer progression in three cancer types (prostate, lung and colorectal). 
The durations for these exploratory metrics in Breast cancer are much 
longer and hence not considered. 
●​ Rationale for Endpoints 
○​ The trial endpoints have been selected for their clinical relevance and their 
capacity to provide reliable and valid measurements of the intervention's 
effect. Quality of Life provides a patient-centered measure that is both 
prognostically important and assessable in the short term. Both the control 
and treatment groups are offered exercise oncology guidance, however 
our hypothesis is that CT’s live coactive coaching is expected to have 
better Quality of Life is measured measured through the FACT-G 
questionnaire. FACT-G also helps us measure the impact on Pain, Fatigue 
and Sleep Quality, providing a comprehensive assessment of well-being 
among cancer survivors.  Lastly, measures of employee absenteeism and 

presenteeism are particularly relevant to both employers and employees, 
providing insight into the program's potential to improve work-related 
outcomes in addition to health parameters. 
●​ Rationale for Comparator 
○​ The control group's engagement with a digital application with publicly 
available expert guidelines on lifestyle modification represents current 
non-pharmacological supportive care options available to cancer survivors.  
○​ This comparator was selected to underscore the added value and distinct 
benefits of Complement Theory’s personalized and interactive wellness 
approach against more generic and self-guided lifestyle resources. 
4.3 Access to Trial Intervention After End of Trial 
●​ Post-trial, participants will have the opportunity to continue accessing the 
Complement Theory’s program Free of Cost. Details on extended access will be 
communicated towards the trial's conclusion. 
4.4 Start of Trial and End of Trial 
●​ Start of Trial: Defined by the first participant's enrollment (FPI). 
●​ End of Trial: Marked by the last scheduled follow-up of the final participant, with an 
anticipated end date eighteen months post final participant enrollment to allow 
comprehensive long-term outcome analysis. 
●​ Early Termination: Criteria for early trial termination will include lack of efficacy, 
safety concerns, or regulatory guidance, detailed in Section 10.5 with 
responsibilities clearly outlined for both sponsor and investigator. 
 
Section 5: TRIAL POPULATION 
5.1 Selection of Trial Population  
●​ Participants for this trial will be identified through targeted online advertisements 
on platforms such as Facebook and Google. This approach ensures an unbiased 
recruitment process, enhancing our chances of assembling a representative 

sample of the U.S. cancer survivor population. Consequently, we do not intend to 
impose specific gender or race quotas. 
5.2 Rationale for Trial Population  
●​ We have specifically chosen cancer survivors aged 21 yrs and above who have 
received cancer treatment (ie either surgery, chemotherapy, radiation, or 
immunotherapy) within the past six months. This demographic is selected based 
on evidence suggesting they stand to significantly benefit from our intervention in 
terms of improved health outcomes, aligning with employer interests. 
5.3 Inclusion Criteria 
●​ Cancer Type : Breast, Prostate, Colorectal, Lung and Other Cancers 
○​ Other Cancers here refers all other cancer types apart from Breast, 
Prostate, Colorectal and Lung Cancer 
●​ Cancer Stage: Stage 1 to 4 
●​ Treatment Status: Has undergone any cancer-related treatment in last 12 months 
●​ Age : 21 yrs and above 
●​ Permission to access to last 1 year digital health records 
●​ Access to smartphone or a tablet 
5.4 Exclusion Criteria 
●​ Excludes individuals who have undergone surgery within the last 4 weeks or will 
undergo surgency in the next 4 weeks 
●​ Participants declared medically unfit by their physicians to do physical exercise 
●​ ECOG Score 3, 4 or 5 
5.5 Lifestyle Considerations 
●​ No lifestyle restrictions during the trial 
5.6 Screen Failures 

●​ Documentation: All screen failures will be documented, including the specific 
reason(s) for the failure. This information is crucial for trial records and may inform 
future trial design adjustments or participant recruitment strategies. 
●​ Immediate Notification: Participants who do not meet the eligibility criteria at 
screening will be promptly informed of their screen failure status. The participant 
can also get detailed explanation regarding the specific criteria not met by writing 
to trial support team (mentioned on the landing page). 
●​ Rescreening may be considered under the following conditions: 
○​ Reversible Conditions: If the screen failure is due to a reversible condition 
or temporary circumstance that rendered the participant ineligible (e.g., 
recent surgery), rescreening may be acceptable once the condition has 
resolved. 
○​ Updated Information: If new medical information becomes available that 
could change the initial screening outcome (e.g., updated diagnostic tests, 
revised cancer staging), rescreening is permissible. 
○​ All such participants would be able to write to trial support team to get 
rescreened. 
Section 6: TRIAL INTERVENTION AND CONCOMITANT THERAPY 
 
6.1 Schedule of Events 
Schedule of events for test/treatment group:  
 
Intervention or 
Assessment (Test) 
Baseline  
(Day -30 to -1) 
Week 
1/3/5/7/9/11/13/1
5/17/19/21/23/ … 
/47 
Week 
2/4/6/8/10/12/14
/16/18/20/22/24/ 
… / 48 
Month 1-6  
(Every 30 
days) 
Month 7-18  
(Every 30 
days) 
Live Coactive 
Lifestyle Coaching 
 
X 
X 
 
 

- 3-5 days per 
week, 45 mins 
each 
Async access to 
Lifestyle 
modification 
content curated by 
CT 
 
X 
X 
 
 
Informed Consent 
X 
 
 
 
 
Eligibility Criteria 
Assessment 
X 
 
 
 
 
Demographic 
Details 
X 
 
 
 
 
EHR Access 
Consent 
X 
 
 
 
 
Claims Data 
Access 
X 
 
X 
 
X 
QoLS (FACT-G 
Form)  
X 
 
X 
 
X 
Weight 
X 
 
X 
 
X 
Motivation to work 
X 
X 
 
 
X 
Employee 
Performance 
Review 
X 
X 
 
 
X 
Absenteeism 
Questions 
X 
X 
 
 
X 
Claim data 
validation with 
 
 
 
X 
X 

survivor 
Cancer 
Progression Status  
 
 
 
X 
X 
 
Schedule of events for active comparator (control) group:  
 
Intervention or 
Assessment (Test) 
Baseline 
(Day -30 to -1) 
Week 
1/3/5/7/9/11/13/
15/17/19/21/23/
… /47 
Week 
2/4/6/8/10/12/14/
16/18/20/22/24/
… /48 
Month 1-6 
(Every 30 
days) 
Month 7-18 
(Every 30 
days) 
Async access to 
publically available 
lifestyle modification 
guidance 
 
X 
X 
 
 
Informed Consent 
X 
 
 
 
 
Eligibility Criteria 
Assessment 
X 
 
 
 
 
Demographic Details 
X 
 
 
 
 
EHR Access Consent 
X 
 
X 
 
X 
Claims Data Access 
X 
 
X 
 
X 
QoLS (FACT-G Form) 
X 
 
X 
 
X 
Weight 
X 
 
X 
 
X 
Motivation to work 
X 
X 
 
 
X 
Employee 
Performance Review 
X 
X 
 
 
X 
Absenteeism 
Questions 
X 
X 
 
 
X 
Claim data validation 
with survivor 
 
 
 
X 
X 
Cancer Progression 
Status 
 
 
 
X 
X 
 
6.2 Rationale for Trial Intervention 

Previous studies have shown that exercise at recommended levels can lead to 35-45%5,6 
recurrence reduction among cancer patients, and 40-50% cancer mortality reduction5,6. 
Patients report improvements in physical function, symptom management, and quality of 
life without significant adverse effects. Meditation has shown to reduce depression and 
increase in NK cells production7. However, less than 15%3 of cancer patients practice 
clinically recommended regimen. We hypothesize that Live coactive instructions that are 
personalized will increase the adherence to exercise and related lifestyle modifications 
such as meditation & nutrition, and will enable the benefits outlined above. 
 
6.3 Dosing and Administration 
​
Details for Trial Intervention (Test Group): 
●​ Timing of Intervention: Participants can log in at their convenience, with the 
flexibility to schedule exercise coaching sessions according to their 
preferences and availability. 
●​ Intervention Structure: Over the course of 12-months or 48 weeks, each 
participant will participate in 3-5 weekly live sessions. Each session, 
spanning approximately 45 minutes, combines 30 minutes of targeted 
exercise with 7 minutes of meditation. Each session will be supervised live 
by a coactive coach for each participant. The program is strategically 
developed to progressively escalate in intensity: 
■​ Each session will consist of an optimal combination of Aerobic and 
Strength exercises. 
■​ Flexibility and Balance exercises will be included as supplemental 
exercises in the sessions. 
​
 
12 Months Program Structure 
 
Months 1 and 2 

■​ Initially participants will be given 1:1 coaching to ensure that the 
participants get immediate feedback as well as modifications as 
needed. 
■​ 10 workouts will be presented to the participants in Month 1 and 2. 
Each workout will be repeated 4 times, hence completing 40 days of 
workouts. 
■​ The first 2 weeks will be “Light”: allowing the participants to 
complete the 10 workouts in flow while building confidence without 
pushing too hard or feeling too sore. 
■​ The second 2 weeks will be “Light/Moderate”: allowing the 
participant  to repeat the same 10 workouts, feel more confident in 
their ability to finish each workout because they are not brand new, 
but also experience a slight challenge on the body with the order in 
which the workouts are laid out. 
■​ The third 2 weeks will be “Moderate”: the participants  are expected 
to begin to feel stronger and more capable at this point which allows 
them to push a little harder and enjoy the challenge without burnout. 
■​ The fourth 2 weeks will be “Moderate/Hard”: the participant  by now 
should be experiencing what it’s like for the body to master the 
foundational goals above.  
​
 
Month 3, 4, 5 and 6 
■​ Next set of 10 workouts will be introduced in months 3 and 4, and 
likewise in months 5 and 6. 
 
​
Month 6 to 12 
-​
Based on their ability and progress, participants will be slowly 
graduated from 1:1 coactive sessions to Group-coactive sessions. 
 

●​ Planned Route of Administration: The intervention will be administered 
remotely via the online platform, accessible through mobile devices. 
●​ Specific Instructions: Participants will receive login credentials and 
instructions for accessing the software upon enrollment in the trial. They 
will be guided through the process of scheduling and participating in live 
exercise sessions, including how to navigate the platform and interact with 
their exercise coach. 
●​ Delayed or Missed Intervention: Participants who miss scheduled exercise 
coaching sessions will have the opportunity to reschedule or make up 
missed sessions at a later time within the 12-month intervention period. 
●​ Coaching Modifications: The coaching strategy includes personalized 
exercise recommendations tailored to each participant's unique needs and 
physical condition.  
■​ For instance, in cases of severe fatigue post-chemotherapy, coaches 
may adapt the program to include gentle activities like simple 
stretching followed by soothing meditation to ensure participant 
comfort and safety.  
●​ Start and Stop Treatment: Participants are encouraged to engage 
consistently in the software app throughout the 12-month intervention 
period. However, they have the flexibility to start and stop treatment as 
needed, with the option to resume participation at their discretion. 
●​ Dose Reductions: As this intervention does not involve pharmaceuticals, 
there are no dose reductions; however, adjustments to the frequency, 
intensity and approach of exercises may be made in response to 
participant feedback and progress (as suggested above with examples). 
​
 
​
Details for Control Product: 
●​ Timing of Intervention: Participants can log in to the app at their 
convenience to learn about exercise, diet and meditation guidelines. 

●​ Duration: Participants will have access to the Active Comparator for the 
same 12-month period as the intervention arm. 
●​ Planned Route of Administration: The Active Comparator will be 
administered remotely via the online platform, mirroring the administration 
method of the experimental intervention. 
●​ Specific Instructions: Participants will receive login credentials and 
instructions for accessing the software upon enrollment in the trial. 
●​ Delayed or Missed Doses: Participants in the control arm are free to 
manage how they like to use the app within the 12-month intervention 
period. 
●​ Dose Modifications: N/A 
●​ Start and Stop Treatment: Participants in the control arm have the same 
flexibility to start and stop treatment as those in the intervention arm, with 
the option to resume participation at their discretion. 
●​ Dose Reductions: N/A 
 
Trial Intervention Dose Modification 
●​ For the intervention provided in this trial, the intervention involves 
personalized exercise coaching sessions tailored to each participant's 
needs and capabilities.  
●​ The intensity and frequency of exercise sessions will be adjusted 
dynamically based on individual responses (such as RPE score), progress, 
and tolerance, as guided by the exercise coach. Therefore, there are no 
predefined criteria for dose modification or dose titration. 
6.4 Treatment of Overdose 
While overdose typically refers to the administration of excessive doses of 
pharmacological agents, in the case of a software solution, it pertains to the potential for 
participants to overexert themselves during exercise sessions, leading to adverse effects 

such as muscle strains, joint injuries, fatigue, or exacerbation of underlying health 
conditions. 
 
Given the nature of the trial intervention, there are no specific antidotes or therapies for 
trial intervention overdose. However, measures will be in place to prevent and manage 
potential adverse events associated with excessive exercise. These measures include: 
●​ Individualized Exercise Prescription: The software app provides personalized 
exercise coaching tailored to each participant's fitness level, health status, and 
exercise tolerance through an intake form. Each patient is categorized into low or 
moderate based on the form. Exercise sessions will be designed to gradually 
progress in intensity and duration for each individual based on participants' 
responses and feedback. 
●​ Monitoring and Supervision: Participants will be closely monitored during exercise 
sessions by trained exercise coaches who can provide real-time feedback and 
guidance. Coaches will ensure that participants adhere to safe exercise practices 
and modify activities as needed to prevent overexertion or injury. The survivor will 
be filling a RPE (Rating of Perceived Exertion) form after each session and will be 
given feedback based on the same.  
●​ Participant Education: Participants will receive education and instruction on proper 
exercise techniques, warm-up and cool-down procedures, and signs of 
overexertion or injury. They will be encouraged to listen to their bodies and 
communicate any discomfort or concerns to their exercise coach. 
●​ Flexibility and Adaptability: The solution app offers flexibility in scheduling and 
adapting exercise sessions to accommodate participants' individual preferences, 
capabilities, and constraints. Participants have the autonomy to adjust the intensity 
or duration of exercises based on their comfort level and feedback from the 
exercise coach. 
●​ Prompt Recognition and Response: In the event of symptoms suggestive of 
overexertion or adverse effects during exercise sessions, participants will be 

instructed to stop the activity immediately and seek appropriate medical attention 
if necessary. Coaches will be trained to recognize signs of overexertion and 
intervene promptly to ensure participant safety. 
6.5 Preparation, Handling, Storage and Accountability 
●​ Preparation of Trial Intervention 
○​ For both the trial intervention and control product, there are no specific 
preparation or administration procedures beyond accessing the online 
platform and following the instructions provided therein. These procedures 
are straightforward and do not require any specialized preparation or 
handling by trial personnel.  
●​ Accountability of Trial Intervention 
○​ Distribution of Trial Intervention: 
■​ The trial intervention will be distributed to participants electronically. 
Upon enrollment in the trial, participants will receive login 
credentials and instructions for accessing the digital platform via 
email or through a secure online portal. 
■​ Distribution of the trial intervention will be managed by the study 
coordinators or research personnel responsible for participant 
enrollment and communication. They will ensure that participants 
receive the necessary information and support to access the digital 
platform and engage in exercise coaching sessions. 
●​ Expectations for Reconciliation: 
■​ Reconciliation of the trial intervention will involve tracking participant 
engagement and adherence to the software app through the online 
platform. Study coordinators or research personnel will monitor 
participant activity logs and session completion rates to ensure 
compliance with the trial protocol. 
■​ Any discrepancies or issues related to participant access or 
engagement with the digital platform will be documented and 

addressed promptly to maintain data integrity and participant 
accountability. 
6.6 Participant Recruitment, Randomization and Blinding 
●​ Participant Recruitment 
○​ Participants will be recruited through a unified online advertisement 
campaign across platforms such as Facebook and Google. Interested 
individuals will click on the advertisement, which directs them to a 
screening form where they provide preliminary information relevant to the 
study eligibility criteria. 
●​ Randomization 
○​ Screening and Eligibility Confirmation: Upon submission of the screening 
form, potential participants will undergo an initial eligibility assessment 
based on predefined inclusion and exclusion criteria. 
○​ Randomization Approach: Eligible participants will then be randomized into 
either the treatment or control group. This randomization is performed after 
the completion of the screening process and is based solely on the cancer 
type, ensuring an equal distribution of participants across different cancer 
categories within both groups. 
○​ Implementation Details: The randomization process will be conducted 
using a computer-generated random allocation sequence to ensure 
impartiality and minimize selection bias. 
●​ Blinding and Unblinding 
○​ Efforts will be made to ensure that the trial intervention and control 
products are as indistinguishable as possible to maintain the integrity of 
blinding. This includes measures such as: 
■​ Standardization of software: Both the trial intervention and control 
software products will be delivered through the same app to 
minimize visual differences that could indicate the treatment 
assignment. 

■​ Blinding of personnel: Personnel involved in the administration, 
assessment, and monitoring of participants will be blinded to the 
treatment assignment whenever possible. This includes 
investigators, outcome assessors, data analysts, and other relevant 
staff. 
6.7 Trial Intervention Compliance 
Measures will be employed to ensure and document trial intervention compliance.   
●​ Participant Engagement Metrics: The software platform will be equipped with 
tracking features to monitor participant engagement. Key metrics may include: 
○​ Frequency of logins and sessions attended. 
○​ Duration of each coaching session. 
○​ Participation in interactive features such as progress tracking and sharing 
exercise exertion feedback. 
●​ Participant Surveys or Feedback: Program feedback for the intervention will be 
collected after each session. 
●​ Attendance Records: For live Coactive coaching sessions, attendance records will 
be maintained to track participant involvement and compliance with scheduled 
sessions. 
●​ System Logs: The software will generate system logs capturing user activity, such 
as login times, session durations, and interactions within the software. These logs 
serve as objective documentation of participant engagement. 
 
Mandatory documents to complete include: 
●​ Patient Reported Outcomes: These outcomes include all primary, secondary and 
exploratory metrics as highlighted above. 
●​ Participant Engagement Logs: These logs will capture key metrics related to 
participant engagement and compliance with the software and coaching. 
●​ Attendance Records: Specifically for live coaching sessions, attendance records 
will document participant attendance and participation. 

 
Source data and records used to document trial intervention compliance will include: 
●​ Digital Platform Data: System logs and engagement metrics generated by the 
software. 
●​ Participant Surveys/Feedback: Responses collected from participant surveys or 
feedback forms. 
●​ Attendance Records: Records of participant attendance at live coaching sessions. 
6.8 Concomitant Therapy 
Complement Theory is an adjunct treatment along with undergoing cancer treatment. 
Hence, the survivor continues the standard of care as is.  
 
Section 7: DISCONTINUATION OF TRIAL INTERVENTION AND PARTICIPANT 
WITHDRAWAL FROM TRIAL 
 
7.1 Discontinuation of Trial Intervention 
Criteria for Permanent Discontinuation of Trial Intervention 
●​ Participant Withdrawal: Participants may voluntarily withdraw from the trial 
intervention at any time for any reason. This may include personal preferences, 
intolerable side effects, or changes in health status that make continued 
participation undesirable. 
●​ Adverse Events: Participants experiencing serious or intolerable adverse events 
related to the trial intervention may be discontinued from further participation in 
the intervention. Adverse events will be carefully monitored and managed. 
●​ Disease Progression: If a participant experiences disease progression or other 
significant changes in health status that render the trial intervention ineffective or 
inappropriate, discontinuation from the intervention may be warranted. This may 
include worsening of cancer symptoms, disease recurrence, or development of 
new medical conditions impacting intervention efficacy. 

●​ Non-Adherence: Participants who fail to adhere to the trial intervention protocol, 
including non-compliance with usage instructions for the Live coaching and 
software, will be discontinued from further participation in the intervention. 
●​ Ineligibility: If a participant is found to be ineligible for continued participation in 
the trial intervention due to newly discovered medical conditions or other factors, 
discontinuation from the intervention may be necessary. 
 
Participants who discontinue trial intervention may or may not be allowed to continue the 
trial, depending on the specific circumstances. In some cases, participants may continue 
to undergo follow-up assessments and data collection even if they discontinue the 
intervention. This allows for the evaluation of secondary outcomes, long-term effects, and 
safety monitoring following discontinuation of the intervention. 
 
Temporary Discontinuation or Interruption of Trial Intervention 
●​ Acute Medical Events: Temporary discontinuation may be warranted in the event 
of acute medical events such as hospitalization, surgery, or serious adverse 
reactions requiring immediate medical attention. 
●​ Non-Urgent Medical Procedures: Temporary interruption may be necessary for 
non-urgent medical procedures that temporarily interfere with the participant's 
ability to engage with the trial intervention, such as elective surgery or diagnostic 
procedures. 
●​ Serious Adverse Events: Temporary discontinuation may be indicated in the 
presence of serious adverse events related to the trial intervention, pending 
further evaluation and resolution of symptoms. 
●​ Participant Preference: Temporary discontinuation may occur at the participant's 
request due to personal reasons, travel, or other temporary circumstances that 
interfere with intervention adherence. 
 

During the period of temporary discontinuation or interruption of trial intervention, the 
following steps will be taken: 
●​ Documentation: The reason for temporary discontinuation or interruption will be 
documented in the participant's trial documentation, including the date and 
duration of interruption. 
●​ Participant Education: Participants will be informed of the temporary 
discontinuation or interruption and provided with guidance on when and how to 
resume the intervention, as well as any necessary precautions or restrictions. 
●​ Continued Trial Participation: Participants may continue in the trial during the 
period of temporary discontinuation or interruption, depending on the nature of 
the event. 
●​ Assessments: Depending on the nature and duration of the temporary 
discontinuation, certain trial assessments may continue as scheduled, while others 
may be temporarily suspended or deferred. Assessments relevant to safety 
monitoring or primary endpoints will be prioritized, while non-essential 
assessments may be postponed until the participant resumes the intervention. 
 
Rechallenge 
●​ Participants will be allowed to rejoin the trial if medically permitted. 
7.2 Participant Withdrawal from the Trial 
1.​ Voluntary Withdrawal: Participants have the right to withdraw from the trial at any 
time for any reason without facing any consequences. 
2.​ Inability to Continue: Participants may withdraw if they become unable to continue 
participating in the trial due to medical reasons, such as worsening health status, 
or other personal circumstances. 
3.​ Non-compliance: Participants may be withdrawn from the trial if they fail to adhere 
to the study protocol or follow the instructions provided by the research team. 
4.​ Safety Concerns: Participants may be withdrawn from the trial if there are safety 
concerns identified during the course of the study, such as the development of 

serious adverse events or medical conditions that may compromise their 
well-being. 
7.3 Lost to Follow-Up 
1.​ We will provide clear communication about the importance of follow-up visits with 
some incentives for participation and maintaining regular contact with participants 
through phone calls, emails or reminders. 
2.​ Offer flexibility in scheduling 
3.​ Follow up duration will be 4 weeks after a lack of response. We will re-attempt to 
contact the survivor after a brief 2 week pause after which we will no longer 
contact the survivor. 
 
Section 8: TRIAL ASSESSMENTS AND PROCEDURES 
This section outlines the comprehensive assessments and procedures deployed 
throughout the trial to ensure accurate, reliable data collection across all specified 
endpoints, emphasizing adherence to the trial's design and objectives. 
Data Collection and Assessment Methods 
●​ Claims Record: To accurately assess the financial impact of the intervention on 
healthcare expenditures, participants will be requested to provide Claims Records 
and Explanation of Benefits documentation. This comprehensive data set will 
encompass costs related to hospitalization, medication, lab visits, and other 
relevant medical expenses. 
●​ Electronic Health Records (EHR): For a detailed and objective view of medical 
histories, participants will be asked to access their Electronic Health Records 
through platforms like MyChart. This step aims to enrich the claims data with 
additional medical record insights with information like days of hospitalization, 
disease for which treatment was undertaken, whether it was an Emergency visit or 
not and so on.  
●​ Patient-Reported Outcomes: In a complementary approach to objective data 
collection, participants will also self-report on various aspects including healthcare 

expenditures, quality of life (measured by FACT-G) and cancer progression status. 
Furthermore, they will report on absenteeism (detailing the number of leave days 
taken, including short-term or long-term disability status) and presenteeism 
(evaluated through work motivation and performance review scores). These 
self-reported metrics will be securely collected through a digital platform, aiming 
to supplement and validate the analysis of claims and EHR data. 
Live Coaching Consistency 
●​ Training Program for Live Coaches: To ensure uniform delivery of the intervention 
across participants, live coaches will undergo a standardized training program. 
This program will cover the intervention's core components, ethical guidelines, 
communication skills, and use of the digital platform for interaction with 
participants. Regular refresher sessions and assessments will maintain coaching 
quality and consistency. 
Ensuring Data Integrity and Consistency 
●​ Centralized Data Collection: Utilizing a centralized digital platform for self-reported 
data and integrating EHR information will ensure data consistency and facilitate 
real-time monitoring of trial progress. 
●​ Standardized Assessments: All assessments, including all the self-reported 
metrics, will be conducted following standardized protocols. Instructions on the 
timing and conditions of assessments will be clearly communicated to participants, 
and specialized training will be provided to any personnel involved in data 
collection or analysis. 
●​ Blinding Maintenance: While blinding participants to the intervention details is not 
feasible, measures will be in place to ensure that data analysts and the Trial 
Monitoring Committee members are blinded to group assignments to minimize 
bias in outcome assessment and safety monitoring. 
8.1 Screening/Baseline Assessments and Procedures 

1.​ Informed Consent Process: 
○​ We will obtain informed consent from participants, ensuring they 
understand the nature of the trial, potential risks and benefits, and their 
rights as participants. 
2.​ Medical History and Physical Examination: 
○​ We will collect relevant  medical history information, including past medical 
conditions, current medications, surgical history from the survivor. 
3.​ Work-related Assessments: 
○​ We will conduct baseline assessment on pre-cancer work data - work 
hours, number of sick days taken; current status - if and since when they 
are on short term or long term disability from the survivor 
4.​ Disease Assessment and Staging: 
○​ We will collect survivor reported disease assessments specific to the 
cancer types under study, such as tumor staging, biomarker evaluations, or 
imaging studies to assess baseline disease status and severity. 
5.​ Stratification Variables: 
○​ See section 5.3 for Trial population variables and section 4.1 for 
Randomization variables. 
8.2 Efficacy Assessments and Procedures 
​
 
​
Improvement in Quality of Life (QoLS) as measured by FACT-G questionnaire 
(Trial Objective 1): 
●​ Endpoint: Change in FACT-G scores measuring quality of life  
●​ Assessment Procedures: Administer the above four questionnaires to 
assess participants' at baseline and specified time points during and after 
the intervention period. 
●​ Data Collection: Obtain self-reported scores from participants on Quality of 
Life. 

●​ Analysis: Calculate the mean difference in change in scores between the 
intervention and control groups at each time point to evaluate the impact of 
the intervention. 
​
Reduction in Employee Absenteeism (Trial Objective 2): 
●​ Endpoint: Number of leave days taken by employed cancer survivors due 
to health issues. 
●​ Assessment Procedures: Track the number of leave days (sick leave, 
short-term disability, long-term disability) taken by participants in both 
groups throughout the trial period. 
●​ Data Collection: Obtain leave records from participants' employers or 
self-reported information from participants. 
●​ Analysis: Compare the average number of leave days between the 
intervention and control groups to assess the impact of the intervention on 
reducing absenteeism. 
​
Improvement in Employee Presenteeism (Trial Objective 3): 
●​ Endpoints: Motivation to work (self-reported scales/questionnaires), 
performance review scores (from employer records or self-reported 
evaluations). 
●​ Assessment Procedures: Administer self-reported scales/questionnaires to 
assess participants' motivation to work and obtain performance review 
scores from employer records or self-reported evaluations. 
●​ Data Collection: Collect self-reported data on motivation to work and obtain 
performance review scores from participants and their employers. 
●​ Analysis: Compare the mean scores of motivation and performance reviews 
between the intervention and control groups to evaluate the impact of the 
intervention on enhancing presenteeism. 
8.3 Safety Assessments and Procedures 
●​ Responsibilities 

○​ The Trial Monitoring Committee will oversee safety assessments and 
procedures throughout the trial. 
●​ Safety Data Collection 
○​ Safety data will be collected through self-reported participant interviews. 
○​ Standardized forms and procedures will be used for consistent data 
collection across study sites. 
●​ Safety Reporting and Management 
○​ Procedures will be in place for the timely reporting and management of 
safety events, including serious adverse events (SAEs) and suspected 
unexpected serious adverse reactions (SUSARs). 
●​ Safety Monitoring Committee 
○​ The Trial Monitoring Committee will review safety data periodically, assess 
participant safety, and provide recommendations to the study team. 
●​ Participant Education and Counseling 
○​ Participants will receive education and counseling regarding potential 
safety risks associated with the intervention. 
○​ Open communication between participants and study staff will be 
encouraged to facilitate early detection and reporting of safety events. 
●​ Risk Mitigation Strategies 
○​ Risk mitigation strategies will be implemented to minimize potential safety 
risks associated with the intervention, such as user training and device 
monitoring. 
○​ Adherence to safety protocols will be monitored, and interventions will be 
implemented to address deviations or non-compliance. 
●​ Regulatory Compliance 
○​ Compliance with regulatory requirements governing safety reporting will be 
ensured, including adherence to Good Clinical Practice (GCP) guidelines 
and ICH regulations. 

○​ Accurate and comprehensive safety documentation will be maintained, 
including safety reports and investigator brochures. 
 
8.4 Adverse Events and Serious Adverse Events 
A serious adverse event (SAE) in this trial is defined according to the following severity 
grades: 
●​ Grade 1: Mild discomfort, not interrupting normal activities 
●​ Grade 2: Moderate discomfort, interrupts normal activities but not incapacitating 
●​ Grade 3: Severe, resulting in disability or necessitating medical consultation (SAE) 
●​ Grade 4: Requires hospitalization (SAE) 
●​ Grade 5: Results in death (SAE) 
Only events classified as Grade 3, 4, or 5 are considered SAEs within the context of this 
trial 
●​ Time Period and Frequency for Collecting SAE Information  
○​ Time period 
■​ Start: Apr 15, 2024 
■​ End: Oct 15, 2025 
○​ Frequency 
■​ SAEs will be documented as they are reported by participants. 
●​ Recording of SAEs 
○​ While prior studies suggest minimal evidence of SAEs resulting from 
exercise, diet, or meditation in cancer survivors, all SAEs encountered 
during this trial will be meticulously recorded. Participants can report SAEs 
directly via the app, or coaches may report on their behalf. Reports should 
include the severity grade, description of the event, and the participant's 
perspective on whether the SAE was related to trial interventions. 
●​ Follow up of SAEs 

○​ All participants will continue receiving standard care from their healthcare 
providers. In the event of an SAE, a dedicated physician will be assigned to 
assess the situation, provide immediate recommendations, and categorize 
the cause of the SAE based on discussions with the participant. This 
classification will also be documented. 
●​ Regulatory Reporting Requirements for SAEs 
○​ SAEs must be reported to the Institutional Review Board (IRB) within 24 
hours of the event's identification. Additionally, the Sponsor will ensure 
prompt notification of all investigators regarding any SAEs, enabling them 
to inform participants about potential risks and take any necessary 
precautions. 
●​ The grading of adverse events is aligned with the Common Toxicity Criteria for 
Adverse Events (CTCAE) standards, which detail adverse events on a scale from 1 
to 5. The complete CTCAE documentation is available on the National Cancer 
Institute's website: NCI CTCAE Information. 
 
Section 9: STATISTICAL CONSIDERATIONS 
The analysis will be conducted on all participant data at the end of 3 months, 6 months, 
12 months and 18 months (ie. end of the trial).  
9.1 Analysis Sets 
○​ The analysis will include the following datasets: 
●​ Intent-to-Treat (ITT) set: Including all randomized survivors, regardless of 
their adherence with the entry criteria. This set will be used for the primary 
analysis of Quality of Life changes and cancer progression. 
●​ Per-Protocol (PP) set: Including participants who completed the trial 
according to the protocol without significant deviations. PP set is a subset 
of ITT set, excluding survivors with major protocol deviations or those who 
do not complete the trial. This set will be used to summarize efficacy and 
support sensitivity analyses. 

 
9.2 Analyses Supporting Primary Objective(s) 
The primary analysis will focus on quantifying the impact of Complement Theory on 
changes in Quality of Life Score (QoLS), measured by the FACT-G instrument, over the 
trial period. Assessments will occur at baseline, 3, 6, 9, 12, and 18 months. 
●​ Statistical Model, Hypothesis, and Method of Analysis 
○​ Primary Estimand (Change in QoLS): 
■​ Null Hypothesis (H0): There is no difference in the mean change in 
FACT-G QoLS between participants in the Complement Theory 
program and those in the control group at specified time points. 
■​ Alternative Hypothesis (H1): Participants in the Complement Theory 
program demonstrate a statistically significant improvement in QoLS 
compared to the control group. 
○​ Baseline Data Analysis: Baseline demographics and characteristics will be 
provided and summarized in both treatment and control groups. 
Standardized mean differences (SMDs) will be calculated as the measure of 
distance between groups. SMDs of 0.2 to <0.5, 0.5 to <0.8 and ≥0.8 are 
considered small, medium, and large, respectively. Frequencies and 
percentage will be provided for the binary variables as well as the 
categorical variables (Yes/No); mean (standard deviation) and median 
(range) will be computed for continuous variables. 
○​ Method of Analysis: Mixed models for repeated measures (MMRM) will be 
utilized to analyze changes in FACT-G scores over time, accounting for 
within-subject correlations. This model allows for the inclusion of both fixed 
effects and random effects to account for individual variability. In addition, 
covariate-time interaction terms will be included to guarantee the best 
results. The strength of the effect from each covariate will be evaluated 

through the statistical test significance, i.e., P value, at 95% confidence 
interval. 
●​ Handling of Intercurrent Events of Primary Estimand(s) 
○​ For participants who discontinue the intervention or are non-adherent, we 
will employ a treatment policy strategy. This means all data collected will be 
analyzed as per the initial treatment assignment, regardless of the 
discontinuation or level of adherence, preserving the intention-to-treat 
principle. 
●​ Handling of Missing Data 
○​ Given the potential for missing QoLS data due to dropout or non-response, 
a multiple imputation (MI) approach will be adopted. The imputation model 
will incorporate variables predictive of missingness and outcomes to 
generate plausible values for missing data. 
○​ Multivariate imputation by chained equation (MICE) will be used, i.e., filling 
the missing data multiple times based on the effect from other covariates 
by constructing a multivariate regression model. MI is superior to single 
imputation, as it accounts for the uncertainty of missing values in a more 
robust way. The number of imputations will be 10, i.e., 10 datasets with 
imputed data will be created. Each imputed dataset gives a point estimate 
of the regression coefficients as well as its standard deviation, which will be 
combined across the 10 datasets to obtain the final estimate and their 95% 
CIs.  
○​ MICE is flexible and can accommodate variables of different types, as well 
as complexities such as bounded scales or survey skip patterns, making it 
well-suited for patient-reported outcomes like QoLS. 
●​ Sensitivity Analysis 
○​ To complement our intention-to-treat (ITT) analysis, a per-protocol analysis 
will be performed, including only participants who fully adhered to the 
intervention, to explore the effect of adherence on QoLS improvement. 

●​ Supplementary Analysis 
○​ Efficacy Analysis: survivors in the treatment and control group will be 
compared for the outcome variables. The comparison will be evaluated 
based on both SMD and P value. SMD greater than 0.2 will be considered 
as acceptable differences (section 3.3 indicated the definition of SMD). 
Descriptive statistics will be compared between treatment groups and 
control groups, and P values will be calculated using ANOVA tests 
comparing means of continuous variables, Brown-Mood test to compare 
the medians, and Chi-Square tests for binary and categorical variables. The 
differences will be considered as statistically significant within 95% 
confidence interval, i.e., P value less than 0.05. 
9.3 Analysis Supporting Secondary Objective(s) 
●​ Secondary Objective 1: Effect on Employee Absenteeism 
○​ Statistical Model and Hypothesis: 
■​ Model: Generalized linear models with a Poisson distribution to 
compare the number of leave days between groups. 
■​ Hypothesis: H0: No difference in the number of leave days between 
groups. H1: A significant reduction in leave days in the intervention 
group. 
○​ Handling of Intercurrent Events: 
■​ Analysis will consider any change in employment status as an 
intercurrent event, with a modified intention-to-treat analysis 
excluding participants who lose their job unrelated to health status. 
○​ Handling of Missing Data: 
■​ Worst-case scenario imputation for missing absenteeism data, 
assuming maximum observed absence for missing periods. 
○​ Sensitivity Analysis: 

■​ Repeating analyses with and without worst-case imputation to 
evaluate the impact of different missing data assumptions on the 
outcome. 
●​ Secondary Objective 2: Impact on Employee Presenteeism 
○​ Statistical Model and Hypothesis: 
■​ Model: Mixed-effects models to analyze changes in work motivation 
and performance review scores over time. 
■​ Hypothesis: H0: No difference in changes in motivation and 
performance scores between groups. H1: Significant improvement in 
these measures in the intervention group. 
○​ Handling of Intercurrent Events: 
■​ Job changes or significant alterations in work responsibilities will be 
documented and explored in sensitivity analyses to understand their 
impact on presenteeism outcomes. 
○​ Handling of Missing Data: 
■​ LOCF for interim missing data points in motivation and performance 
scores, acknowledging potential limitations in this approach. 
○​ Sensitivity Analysis: 
■​ Analysis excluding participants with significant job changes during 
the trial to assess the effect of such changes on presenteeism 
outcomes. 
9.4 Safety Analyses 
●​ We shall continuously monitor and document all serious adverse events (SAEs), 
categorizing them by severity, causality, and timing relative to the intervention. 
This includes both anticipated events related to cancer and potential unexpected 
events related to the intervention. 

●​ Comparative Analysis: Compare the incidence rates of SAEs between the 
intervention and control groups. This can help ascertain whether the intervention 
group experiences a higher rate of events, indicating potential safety concerns. 
●​ The Trial Monitoring Committee shall regularly monitor these and can decide to 
forfeit the trials when there are clear indications that safety of the survivor is in 
danger due to our intervention 
●​ Along with that we shall utilize QoL and well-being measures to indirectly assess 
safety, as significant declines could indicate adverse impacts of the intervention. 
9.5 Other Analyses 
●​ Futility Analysis: will be accessed to the inability of the clinical trial to achieve the 
primary and secondary objectives. In that case, both operational and statistical 
futility will be analyzed. Operational futility includes slow recruitment or slow 
accumulation of primary endpoints. Statistical futility includes, for the most part, 
group sequential methods and conditional power. 
9.6 Interim Analyses 
●​ Interim analyses are planned to evaluate the primary and secondary objectives' 
safety and efficacy data. These analyses may also explore data trends that could 
necessitate adjustments to the trial conduct. 
●​ Statistical Methods:  
○​ The interim analyses will employ group sequential testing methods with an 
O’Brien-Fleming spending function to rigorously control the type I error rate 
across multiple looks at the data. 
●​ Execution:  
○​ The analyses will be performed by an independent biostatistician from the 
trial investigators to maintain objectivity. 
●​ Timing and Triggers 
○​ Scheduled Interim Analyses: Interim analyses are planned at 3 months, 6 
months and 12 months of trial commencement. 

○​ Ad Hoc Requests: Additional interim analyses may be conducted at the 
request of the Trial Monitoring Committee, particularly if unexpected safety 
concerns arise. 
●​ Decision Criteria and Oversight 
○​ Decision Criteria: The criteria for early stopping or trial adaptation include a 
pre-specified boundary for efficacy (significant improvement in Quality of 
Life Scores or improvement in health outcomes) or safety concerns 
(unacceptable adverse events rate). 
○​ The Trial Monitoring Committee will oversee the interim analyses, reviewing 
the results to make recommendations on continuing, stopping, or 
modifying the trial. 
○​ Blinding Integrity: Individuals analyzing the data may have access to 
unblinded data; however, measures will be taken to ensure that the trial 
team remains blinded to maintain the integrity of the trial implementation. 
○​ Authority to Stop or Modify: The ultimate authority to stop or modify the trial 
rests with the TMC, in consultation with the principal investigator and the 
sponsor, based on the interim findings and established stopping guidelines. 
9.7 Sample Size Determination 
●​ The metric-wise sample size calculation is provided in the table below on alpha as 
0.05 and power of 80% for the one-tail test at enrollment ratio = 1. 
●​ While we are conducting the power analysis and sample size calculation based on 
several variables (outcomes) of interest, the sample size was computed separately 
for each parameter in the study and the greatest is used to obtain sample size.  
●​ The analysis (detailed below in table) showed that sample of size of 102 is 
powerful enough for the analysis to cover 100% of primary and secondary metrics.  
●​ Now since we believe that the long follow-up duration of 6 months for our trial will 
lead to around 30% drop-offs, we decided a final sample size of 146 (73 control, 73 
test). 

●​ So even if get 30% or 44 participants drop off we end up with final sample set of 
102 (51 control, 51 test) and would be able to come to statistically significant 
effects (p < 0.05) with respect to 100% of primary and secondary metrics. 
 
Metric 
Segment 
Sub Metric  
Control 
Data 
Test 
Data 
Assumed 
Variance 
Sample Size 
Primary Outcome / Concerns 
Quality of Life 
Improvement 
QoLS Score 
(FACT-G) 
70 
85 
Variance of 
20 
42 (21 Control, 
21 Test) 
Secondary Outcome / Concerns 
Presenteeism 
Attitude towards 
work 
2 
4 
Variance of 
1.5 
16 (8 Control, 8 
Test) 
Employee 
Performance 
0.6 
0.7 
Variance of 
20% 
102 (51 Control, 
51 Test) 
Absenteeism 
Working Hours 
30 
40 
Variance of 
10 
28 (14 Control, 
14 Test) 
Vacation Days 
0.5 
0.3 
Variance of 
0.15 
16 (8 Control, 8 
Test) 
Exploratory Outcomes 
Cancer Care  
Cancer 
Progression 
Status 
0.85 
0.88 
Variance of 
0.04 
46 (23 Control, 
23 Test) 

Cancer 
recurrence status 
0.3 
0.21 
Variance of 
10% 
32 (16 Control, 
16 Test) 
Medical 
Expenditure 
Total Healthcare 
Expenditure 
(Planned + 
Unplanned) 
10000 
8000 
Variance of 
4000 
102 (51 Control, 
51 Test) 
No of Urgent 
Care Visits  
3 
2.5 
Variance of 
0.5 
28 (14 Control, 
14 Test) 
No of ED Visits 
5 
3.45 
Variance of 
0.8 
10 (5 Control, 5 
Test) 
No of unplanned 
outpatient/office 
visits (other than 
ED) 
4.28 
3.5 
Variance of 
0.8 
28 (14 Control, 
14 Test) 
Unplanned 
Hospitalisations  
5 
4 
Variance of 
0.8 
18 (9 Control, 9 
Test) 
Length of 
hospital stay 
3 
2 
Variance of 
0.8 
18 (9 Control, 9 
Test) 
No of planned 
outpatient visits 
2 
1.8 
Variance of 
0.3 
58 (29 Control, 
29 Test) 
No of planned 
hospital visits 
1.25 
1 
Variance of 
0.1 
10 (5 Control, 5 
Test) 
Length of 
hospital stay 
3 
2 
Variance of 
0.8 
18 (9 Control, 9 
Test) 

Total Prescription 
Medicine 
Expenditure 
1000 
950 
Variance of 
80 
80 (40 Control, 
40 Test) 
 
9.9 Protocol Deviations 
Protocol deviation begins as soon as the survivor signs the informed consent. Deviations 
are defined as a departure from approved protocol schedule of events or procedures 
with or without IRB approval. Protocol deviations will be classified as major or minor 
dependent per the identifications below.  
Major: A major protocol deviation is one that will have a substantive effect on the safety, 
rights, or well being of subjects, data integrity, or the quality of the intervention product 
(CT technology).  
Minor: A minor protocol deviation is a deviation that does not have a substantive effect 
on the safety, rights, or well being of subjects, data integrity, or the quality of the 
intervention product (CT technology).  
Below are examples of how each protocol deviation will be coded and classified:  
 
Category 
Description 
Major/Minor 
Eligibility Criteria 
Inclusion or exclusion not met 
Major 
Informed Consent 
Performing study related material prior to 
obtaining written informed consent 
Major 
Withdrawal or 
Termination 
Any situation where the study treatment 
discontinuation criteria are met but the 
subject is not discontinued from the study 
and continues to participate 
Major 

Serious Adverse 
Event Reporting 
Failure to report serious adverse events 
(SAEs) within 24 hours of awareness 
Major 
Missed Visits 
Failure to attend all 5 sessions in a 7 day 
period of time 
Minor 
Out of Window Visits Make up sessions with live instructor are 
not rescheduled within a 2 week timeframe 
Minor 
  
Every major or minor deviation would be carefully monitored and registered in our 
database. It will be used on a regular basis, starting with FPI, by the Trial Monitoring 
Committee (TMC) to review the protocol deviations for that reporting period.  
The TMC will identify issues trending on the study. Trends that are deemed critical by the 
TMC will be evaluated for safety concerns.  
Section 10: GENERAL CONSIDERATIONS: REGULATORY, ETHICAL, AND TRIAL 
OVERSIGHT 
10.1 Regulatory and Ethical Considerations 
This trial will be conducted in accordance with the protocol and with the following:  
●​ Consensus ethical principles derived from international guidelines including the 
Declaration of Helsinki and Council for International Organisations of Medical  
Sciences (CIOMS) International Ethical Guidelines  
●​ ICH Good Clinical Practice (GCP) Guidelines 
●​ Applicable laws and regulations 
 
Investigators’ Responsibilities: 

●​ Ensuring that the trial is conducted in accordance with the protocol, International 
Conference on Harmonisation Good Clinical Practice (ICH GCP) guidelines, and 
applicable regulatory requirements. 
●​ Obtaining informed consent from all participants prior to their participation in the 
trial. 
●​ Reporting all serious adverse events (SAEs) to the sponsor promptly and 
accurately. 
●​ Ensuring the accuracy and completeness of all data collected during the trial. 
●​ Complying with regulatory requirements for the conduct of clinical trials in their 
jurisdiction. 
●​ Maintaining the confidentiality of participants' data and protecting their rights and 
well-being throughout the trial. 
 
Sponsor’s Responsibilities: 
●​ Designing the trial protocol and ensuring it is scientifically sound and ethically 
appropriate. 
●​ Obtaining regulatory approval to conduct the trial and ensuring ongoing 
compliance with regulatory requirements. 
●​ Providing the necessary investigational product and ensuring its quality and 
supply throughout the trial. 
●​ Monitoring the conduct of the trial to ensure compliance with the protocol, GCP 
guidelines, and regulatory requirements. 
●​ Collecting, analyzing, and reporting trial data to regulatory authorities and other 
relevant stakeholders. 
●​ Ensuring that all investigators are adequately trained and informed about their 
roles and responsibilities. 
●​ Ensuring that appropriate insurance coverage is in place to protect participants 
and investigators. 

●​ Addressing any safety concerns or protocol deviations promptly and 
appropriately. 
●​ Ensuring that the trial is conducted in accordance with ethical principles and that 
participants’ rights and well-being are protected. 
●​ Providing financial support for the conduct of the trial, including funding for 
investigator fees, site costs, and other expenses. 
 
10.2 Committees 
The trial will establish an Trial Monitoring Committee (TMC) to oversee the safety and 
integrity of the trial. The TMC will consist of independent experts in relevant fields such 
as oncology, biostatistics, and cancer exercise specialists. Their primary role will be to 
review safety data at regular intervals during the trial to ensure participant safety.  
 
Trial Monitoring Committee will perform safety assessments every 6 months. But they will 
meet more often if needed such as in case of increase in AEs. The Trial Monitoring 
Committee will be responsible for making a determination of continuing the study based 
upon results of the safety assessment.  
 
10.3 Informed Consent Process 
The informed consent process will include the following key elements: 
●​ Explanation of the trial: Participants will be provided with detailed information 
about the purpose, procedures, risks, and potential benefits of the trial. 
●​ Voluntary participation: Participants will be informed that their participation in the 
trial is entirely voluntary, and they have the right to withdraw at any time without 
penalty. 
●​ Understanding: The information provided will be presented in a clear and 
understandable manner, ensuring that participants comprehend the nature of the 
trial and its implications for their health. 

●​ Confidentiality: Participants will be assured that their personal information will be 
kept confidential to the extent allowed by law. 
●​ Opportunity for questions: Participants will be given the opportunity to ask 
questions and seek clarification about any aspect of the trial before providing 
consent. 
 
Rescreening: 
●​ Participants can be rescreened. Refer section 5.6 for the details. 
●​ Participants who undergo rescreening will not typically be required to complete a 
new informed consent process if their initial consent remains valid. However, this 
will be clearly stated in the protocol, and any specific circumstances requiring a 
new consent will be outlined. 
10.4 Data Protection 
●​ Confidentiality Measures: Personal data will be anonymized or pseudonymized 
whenever possible to protect participant identity. Only authorized personnel will 
have access to identifiable information, and strict confidentiality protocols will be 
followed. 
●​ Secure Data Storage: Participant data will be stored securely in electronic 
databases with restricted access. The databases will be encrypted and 
password-protected to prevent unauthorized access. 
●​ Limited Access: Only authorized personnel involved in the conduct of the trial will 
have access to participant data. Access will be granted based on predefined roles 
and responsibilities, and access logs will be maintained to track data access. 
●​ Data Transfer: When transferring data between sites or to third-party vendors, 
encryption and secure file transfer protocols will be used to minimize the risk of 
interception or unauthorized access. 
●​ Training and Awareness: All personnel handling participant data will receive 
training on data protection policies and procedures. Regular awareness 
campaigns will be conducted to reinforce the importance of data security. 

 
In the event of a data security breach, the following steps will be taken: 
●​ Immediate Response: Upon discovery of a breach, the responsible personnel will 
take immediate action to contain the breach and mitigate any potential harm. 
●​ Notification: Relevant stakeholders, including participants, regulatory authorities, 
and ethics committees, will be promptly notified of the breach in accordance with 
applicable regulations and guidelines. 
●​ Investigation: A thorough investigation will be conducted to determine the cause 
and extent of the breach. This may involve forensic analysis of systems and data 
logs. 
●​ Remediation: Measures will be implemented to address the vulnerabilities that led 
to the breach, such as software patches, system updates, or changes to 
procedures. 
●​ Documentation: A detailed report of the breach, including the cause, impact, and 
remedial actions taken, will be documented for regulatory compliance and future 
reference. 
 
10.5 Trial Termination 
Decision Rights of Sponsor or Designee to Terminate the Trial: 
●​ The sponsor or designee may also terminate the trial if there are safety concerns, 
lack of efficacy, or other unforeseen circumstances that jeopardize the integrity of 
the trial or the safety of participants. 
●​ The sponsor holds the decision-making power to suspend or terminate the trial 
based on recommendations from the Trial Monitoring Committee, IRB and PI. 
 
Section 11: GENERAL CONSIDERATIONS: RISK MANAGEMENT AND QUALITY 
ASSURANCE 
11.1 Quality Tolerance Limits 

The purpose of this section is to identify what will trigger internal quality assurance (QA) 
processes to ensure continuous improvement. The Trial Monitoring Committee will 
provide the oversight to review the following parameters in the table. The parameter 
thresholds will be evaluated on a monthly basis. When these thresholds have crossed, 
the primary QA process employed by the committee will conduct a Root Cause Analysis 
(RCA). These are the following steps: 
1.​ Collect relevant data 
2.​ Identifying the root causes 
3.​ Find corrective solution 
4.​ Update protocol 
5.​ Implement changes with appropriate change management with relevant 
stakeholders 
6.​ Monitor if the corrective solution works. 
 
Critical to 
Quality Factor 
Parameter 
Definition 
Justification for 
Parameter 
Parameter 
Threshold 
Safety reporting Percentage or 
number of 
immediately 
reportable 
events reported 
late 
Percentage or 
number of 
immediately 
reportable events 
(e.g., SAEs and other 
events as defined in 
the protocol) that 
are reported more 
than 1 day after 
awareness of the 
event 
A high number of 
late reported, 
immediately 
reportable events 
could impact 
participant safety 
due to lack of timely 
awareness of 
emerging safety 
profile 
5% 

Eligibility criteria Percentage or 
number of 
participants 
randomized 
who do not 
meet 
inclusion/exclusi
on criteria 
Percentage or 
number of 
randomized 
participants with 
Protocol Deviations 
in 
inclusion/exclusion 
criteria 
A high number of 
study participants 
not meeting the 
entrance criteria 
could have a 
significant impact on 
interpretation of the 
primary endpoint 
and overall validity 
of the trial results. 
5% 
Intervention 
handling and 
administration 
Percentage or 
number of 
participants with 
premature 
discontinuation 
Percentage or 
number of 
participants who 
discontinued 
treatment before the 
end of the treatment 
period as defined by 
protocol 
A high number of 
participants 
discontinuing 
treatment could 
have a significant 
impact on 
interpretation of the 
primary endpoint. 
5% 
Withdrawal 
criteria and trial 
participant 
retention 
Percentage or 
number of 
participants with 
withdrawal of 
informed 
consent 
Percentage or 
number of 
participants with 
withdrawal of 
informed consent 
after treatment 
allocation 
A high number of 
participants 
withdrawing 
informed consent 
may indicate 
excessive survivor 
burden and could 
significantly impact 
collection and 
interpretation of the 
5% 

primary endpoint. 
Withdrawal 
criteria and trial 
participant 
retention 
Percentage or 
number of lost 
to follow-up 
participants 
Percentage or 
number of 
participants who are 
lost to follow-up (i.e., 
have not continued 
in the trial until the 
last planned safety 
assessment and 
have not revoked 
consent nor have 
been reached by 
investigator site 
personnel through 
normal 
communication 
methods). These 
participants have 
not completed the 
trial and their status 
is unknown 
A high number of 
participants lost to 
follow-up may 
indicate excessive 
participant burden 
and could impact the 
collection and 
interpretation of 
long-term safety and 
efficacy data. 
10% 
Procedures 
supporting study 
endpoints and 
data integrity 
Percentage or 
number of study 
participants for 
whom study 
endpoint data 
was not 
collected 
Percentage or 
number of study 
participants for 
whom study 
endpoint data was 
not collected; this 
could include 
A high number of 
study participants for 
whom the failure to 
collect study 
endpoint data could 
impact analysis and 
interpretation of 
15% 

inability to perform 
study procedure at 
the protocol-defined 
time point 
study results 
Procedures 
supporting trial 
endpoints and 
data integrity 
Percentage or 
number of 
participants with 
"Major" protocol 
deviations other 
than eligibility 
Percentage or 
number of 
participants with 
protocol deviations 
during the trial 
which are not 
related to protocol 
inclusion/exclusion 
criteria (i.e., informed 
consent, trial 
intervention, 
prohibited 
concomitant 
medication, trial 
procedures, safety 
reporting, and 
discontinuation) 
A high number of 
study participants 
with important 
protocol deviations 
during the trial could 
have a significant 
impact on 
interpretation of the 
primary endpoint 
and overall validity 
of the trial results. It 
can also impact 
participant safety 
10% 
Procedures 
supporting trial 
endpoints and 
data integrity 
Percentage of 
participants 
censored in the 
statistical 
analysis 
because they 
had no bills the 
Percentage or 
number of 
participants who are 
at risk of censoring 
for hospital costs 
High number of 
participants 
censored for primary 
objective analysis 
would translate into 
smaller than 
assumed sample 
10% 

entire time 
size and may impact 
the interpretation of 
the efficacy results. 
Alternatively, final 
primary objective 
analysis would be 
delayed if required 
sample maturity is 
not reached within 
the assumed 
timelines 
Randomization 
Percentage or 
number of 
randomized 
participants 
who were 
incorrectly 
stratified 
Percentage or 
number of 
randomized 
participants who 
were incorrectly 
stratified 
High number of 
participants who 
were incorrectly 
stratified may lead to 
imbalances in 
baseline 
characteristics 
between treatment 
arms, introduce 
biases in the data, 
and significantly 
affect the outcome 
of a trial 
10% 
 
11.2 Data Quality Assurance 
1.​ Electronic Data Capture:  
○​ Since the trial is virtual with survivors located anywhere in the United 
States, and the intervention is delivered through a in-house custom 

HIPAA-compliant software product, we will have a custom form system 
directly in the same software for survivors to enter self reported data. 
2.​ All Data stored is in AWS with appropriate data redundancy rules in place. 
3.​ Data Validation: Data entered goes through testing (e.g. outliers, missing rows, 
etc) before being entered into the database. 
4.​ Electronic Health Records and Claims Records: All medical data and billing data 
will be shared by survivors using their electronic access to their data i.e. medical 
records, claims data, and prescription drug costs. 
○​ A clear PDF with instructions and screenshots will be shared for survivors 
to do this easily. 
○​ We will recommend survivors give us access for a minimum of 6 months 
and a maximum of 18 months to minimize streamline survivor workload. 
References 
1.​ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8576825/ 
2.​ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9454950/ 
3.​ https://progressreport.cancer.gov/after/physical_activity 
4.​ https://www.cancerresearchuk.org/about-cancer/what-is-cancer/why-some-cancer
s-come-back 
5.​ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7071977/ 
6.​ https://journals.lww.com/acsm-msse/fulltext/2019/06000/physical_activity_in_can
cer_prevention_and.20.aspx 
7.​ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6623989/