Harnessing Mobile Technology to Deliver Tailored, Brief Pain-CBT for Advanced Cancer Patients on Opioids for Pain
Phase: NA
Conditions: Active Cancer, Active Cancer Treatment, Advanced Cancer, Palliative Care, Chronic Pain Due to Cancer
Sponsor: Dana-Farber Cancer Institute

Study Protocol and Statistical Analysis Plan  
 
Study title: Harnessing mobile technology to deliver tailored, brief pain-CBT for 
advanced cancer patients on opioids for pain  
 
Document Approval Date: May 13, 2022 
 
Principle Investigator/ Institution(s): 
 
Desiree Azizoddin/ Dana-Farber Cancer Institute  
 

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for advanced cancer patients on opioids for pain 
 
 
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DF/HCC NON-CLINICAL PROTOCOL  
Version Date:   May 13, 2022 
 
 
PROTOCOL TITLE: 
Harnessing mobile technology to deliver tailored, brief pain-CBT for advanced cancer 
patients on opioids for pain 
 
*Sponsor-Investigator: 
 
N/A 
 
*Principal Investigators (PI): 
 
Desiree Azizoddin, PsyD 
 
Dana-Farber Cancer Institute  
 
Desiree_Azizoddin@DFCI.Harvard.edu 
 
Address- CTEP protocols only 
 
 
 
 
VERSION NUMBER: 1.2 
DATE: 
May 13, 2022

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Table of Contents 
1.0 
Objectives* .............................................................................................................. 4 
2.0 
Background* ............................................................................................................ 4 
3.0 
Inclusion and Exclusion Criteria* ............................................................................ 8 
4.0 
Study-Wide Number of Subjects* ........................................................................... 9 
5.0 
Study-Wide Recruitment Methods* ........................................................................ 9 
6.0 
Multi-Site Research* ............................................................................................. 10 
7.0 
Study Timelines* ................................................................................................... 10 
8.0 
Study Endpoints* ................................................................................................... 10 
9.0 
Procedures Involved* ............................................................................................. 11 
10.0 Data and Specimen Banking* ................................................................................ 21 
11.0 Data Management* and Confidentiality ................................................................ 22 
12.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* ........................ 25 
13.0 Withdrawal of Subjects* ........................................................................................ 26 
14.0 Risks to Subjects* .................................................................................................. 27 
15.0 Potential Benefits to Subjects* .............................................................................. 28 
16.0 Vulnerable Populations* ........................................................................................ 28 
17.0 Community-Based Participatory Research* .......................................................... 28 
18.0 Setting .................................................................................................................... 28 
19.0 Resources Available ............................................................................................... 28 
20.0 Prior Approvals ...................................................................................................... 29 
21.0 Recruitment Methods ............................................................................................. 29 
22.0 Local Number of Subjects ..................................................................................... 30 
23.0 Provisions to Protect the Privacy Interests of Subjects .......................................... 31 
24.0 Compensation for Research-Related Injury ........................................................... 32 
25.0 Economic Burden to Subjects ................................................................................ 32 
26.0 Consent Process ..................................................................................................... 32 
27.0 Process to Document Consent in Writing .............................................................. 33 
28.0 Drugs or Devices .................................................................................................... 33 
 

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1.0 
Objectives* 
1. 
As a pain psychologist and palliative care researcher, I developed 
develop a novel mHealth intervention that harmonizes psychological 
and pharmacological support for advanced cancer pain. I adapted 
core components of pain-CBT and integrated them into STAMP 
(Smartphone Technology to Alleviate Malignant Pain), an 
existing NINR-funded cancer pain mHealth intervention. STAMP 
enables patients with advanced cancer to track their pain, opioid use, 
and side effects. It delivers tailored education and self-management 
advice while facilitating clinician monitoring and patients’ proactive 
outreach. Having developed an extensive suite of multi-media cancer 
pain psycho-education covering core pain psychology principles, I 
seized a strategic opportunity to refine and integrate pain-CBT 
treatment into medically oriented self-management support in 
STAMP. Capitalizing on mHealth technology, I strove to 
destigmatize pain psychology through a potentially scalable model 
that can disseminate behavioral treatments for advanced cancer pain 
paired with their palliative care pain management plan. My aim is to: 
• Determine feasibility and acceptability of the 
STAMP+CBT app: up to 15 patients with advanced cancer 
pain will be recruited from outpatient palliative care clinics 
at a major cancer center to participate in a single-arm, 6-
week study of STAMP+CBT (4-week intervention period 
and a 2-week post intervention period). Surveys at baseline, 
4 weeks (end of intervention period), and 6 weeks (end of 
2-week post intervention period) will explore trends in pain 
specific intensity, self-efficacy, and catastrophizing, 
physical function, opioid use, and quality of life. End-of-
study interviews will identify facilitators and barriers to 
usability, acceptability, and satisfaction of the app. The 
primary outcome will be feasibility evaluating 1) app 
retention rates and 2) completion of app exercises. 
2.0 
Background* 
1. 
Describe the relevant prior experience and gaps in current 
knowledge. Between 39% to 75% of patients with cancer suffer 
from pain, with the highest burden of symptoms occurring 
among those with advanced disease.1 Poorly managed pain can be 
devastating to patients’ psychological health, physical functioning, 
social connectedness, and quality of life.2,3 Opioids are the 
cornerstone of treatment;4 however, up to 60% of patients experience 
inadequate relief.5,6 Side effects (e.g. constipation and fatigue) are 
extremely common and often prevent patients from engaging in their 

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lives.7,8 Effective non-pharmacologic treatments are greatly needed 
to mitigate the burden of advanced cancer pain.9 
Chronic pain is a multidimensional construct involving dynamic 
relationships between biological, psychological, behavioral and 
social factors.10 Although the biological basis of cancer pain is 
indisputable, psychological and behavioral factors impact many 
dimensions of the pain experience.11–13 For example: patients’ beliefs 
about pain, self-efficacy, affect, perceived stress, and sleep 
contribute substantially to pain severity and pain-related disability.11–
13 Moreover, beliefs surrounding cancer pain and opioid treatment, 
including stoicism, fears of addiction, and ambivalence undergird 
patients’ many critical pain self-management needs including 
optimal use of opioids and productive communication with care 
teams.2,14–16 New approaches are needed to address psychological 
factors that influence cancer pain and opioid use.17 
Numerous psychological treatments have been proven beneficial 
for chronic non-cancer pain, with growing evidence of benefit 
for cancer pain.18–21 The most efficacious programs address both 
emotional and evaluative aspects of pain while teaching pain coping 
skills.22–25 Cognitive behavioral therapy for pain (pain-CBT) is the 
most widely utilized psychological treatment for chronic pain, with 
meta-analyses demonstrating small to moderate improvements in 
pain severity and daily functioning.26 Pain-CBT differs from 
traditional CBT as it targets pain-specific psychological processes 
through pain psycho-education, cognitive restructuring to challenge 
maladaptive pain cognitions (e.g. pain catastrophizing), building 
emotional awareness, and by teaching coping skills to improve 
physical function and relaxation exercises to reduce muscle tension 
and stress reactivity.27–29 
While the broad goals of pain-CBT are highly relevant to 
advanced cancer pain, its mode of delivery and certain emphases 
require modification to be suitable for advanced cancer patients. 
For example, cognitive restructuring exercises in pain-CBT focus on 
challenging and modifying “catastrophic” appraisals of pain such as 
“something must seriously be wrong.”27 This is insensitive to 
advanced cancer patients’ realities – for whom worsening pain often 
truly signifies cancer progression and the terminal phase of illness.30 
Another problematic aspect of traditional pain-CBT is its focus on 
minimizing opioid use, yet this is fundamentally the reverse in 
advanced cancer where opioids are required. Practically, traditional 
pain-CBT involves months of in-person therapy, which is too taxing 
and frankly infeasible for this population. A few studies have sought 
to modify pain-CBT for general cancer populations. Although they 
use telehealth to overcome barriers to delivery, these interventions 

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continue to employ lengthy online sessions (e.g. 45-60 minutes).31–33 
Early data suggest these programs are feasible and acceptable to 
patients;31–33 however, to our knowledge, none tailor pain-CBT 
specifically for advanced cancer patients, and none integrate 
pharmacologic management.20 
Mobile health technology (mHealth) is a promising strategy to 
tailor, deliver, and ultimately disseminate psychological 
interventions for advanced cancer pain.34,35 Mobile health 
overcomes many of the practical barriers that limit patients’ access 
to traditional behavioral therapies while serving as a logical response 
to the severe shortages of trained therapists.36 Smartphone delivery 
co-localizes support at home where patients have the greatest need.37 
Developing a smartphone intervention that combines medical 
support with pain self-management support has great potential for 
scalability to advanced cancer populations.  
2. 
Development of an mHealth tool to support opioid management 
for advanced cancer pain. Under the mentorship of Drs. Enzinger 
and Tulsky, I have substantially contributed to the development of 
STAMP, a patient-facing smartphone application and web-based 
research portal designed to optimize the management of advanced 
cancer pain with opioids (IRB #18-504). The app hosts patients’ 
specific analgesics (including dose and frequency), which are 
integrated throughout the application features (e.g. symptom 
surveys, tailored feedback). Daily surveys assess pain and related 
symptoms (e.g. pain, opioid use, pain interference, constipation/ 
laxative use, stress, and sleep) using adaptive survey logic and 
alternating schedules to minimize survey burden. Patients receive 
feedback and tailored education based upon their reported symptoms 
(e.g. links to pain psycho-education), including advice to contact 
their care team for concerning symptoms. As part of this project, I 
have led the development of an extensive suite of multi-media 
cancer pain education covering medication support (e.g. using short 
and long-acting opioids, managing side effects, opioid safety); pain 
psychology (e.g. pain perception, pain and the stress response); 
health behaviors and pain (e.g. sleep hygiene); and skills training 
(e.g. activity pacing/ relaxation recordings). Content is presented in 
multiple engaging formats (e.g. written texts with paired 
illustrations, 2-D animated videos, audio-recordings, games), using 
real-world examples, everyday language (7th grade reading level), 
and metaphors to support important concepts (See Appendix C). 
In qualitative feedback with 15 patients with advanced cancer pain, 
the education was considered to be far better than previously 
received education. Feedback included: “We need to be heard…this 
is really validating,” “the visuals are amazing… I’m able to see a lot 

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of what you are putting into words,” and “the app is intending to 
move people from…sort of suffering in silence…to find that balance 
between pain and opioids.” The STAMP app is currently being 
piloted and will be completed by fall 2021. 
Qualitative patient interviews regarding pain self-management 
and attitudes toward psychological treatment. I recently 
completed in-depth, semi-structured, qualitative interviews with 26 
ambulatory advanced cancer patients using opioids to manage 
chronic pain. The majority (23/26) discussed how stigma of opioids 
impacted their pain management and willingness to use opioids. 
Most were also eager for behavioral tools to help manage pain; 
however, none had any prior exposure. Many expressed that they 
would be most likely to engage in behavioral treatment if it was 
recommended by their palliative care/oncology team and integrated 
into their overarching cancer pain plan. Smartphone delivery was 
viewed as an attractive way to learn behavioral skills (16/20), as very 
few patients felt capable of attending traditional in-person therapy. 
This preliminary data points toward the need for accessible 
psychological cancer pain support that acknowledges the 
psychological complexity of opioid-use, while supporting both 
medical and behavioral aspects of pain self-management.  
3. 
To our knowledge, this will be the first adaptation of pain-CBT 
content specifically for patients with advanced cancer pain. Existing 
adaptations of pain-CBT content32 have taught CBT-derived pain 
coping skills for mixed cancer cohorts,31 and for transplant 
patients.33 STAMP+CBT now adapts critical components of pain-
CBT content to address common concerns of advanced cancer 
patients, while ensuring a realistic level of engagement for this 
population.This strategy is conceptually appealing because many 
pain self-management strategies (e.g. optimal use of breakthrough 
opioids, engaging in safe physical activity) involve interrelated 
psychological, behavioral, and medical processes. This approach 
also destigmatizes psychological treatment for pain, as it is 
integrated with their opioid management, including support from 
their cancer care team. 
Using smartphones to deliver psychological pain treatment is 
innovative. Most evidence based, mHealth behavioral pain 
interventions have utilized tablets31,32 and/or video-conferencing to 
deliver traditional 50-minute, module-based treatments. These 
interventions do not fully employ the unique capabilities of mHealth 
to tailor psychological treatments37 and present content in engaging, 
empathic ways38,39 (e.g. through gamification, quizzes). 
STAMP+CBT will leverage mHealth tailored software to integrate 

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engaging media (e.g. audio, videos, graphics), and user-centered 
design (e.g. positive aesthetics, playful interface).    
4. 
STAMP+CBT content and resources were developed in a previous 
study (IRB 20-453). For the previous study, the team used 
qualitative feedback and results to help develop modifications to 
standard pain-CBT content too add them to the original STAMP app 
for a new pain mobile app that includes cognitive behavioral therapy 
for pain geared to cancer patients (STAMP+CBT). This section of 
the study has been completed, all content has been finalized and 
modifications to the application content for STAMP+CBT have been 
developed. This content can be reviewed and referenced in 
appendices D, F, Y, Z. 
In the study described above interviews were used because they 
produce qualitative results; therefore, the portion of the study did not 
employ statistical analyses. The study team instead reviewed the 
qualitative feedback from patients and clinicians across three 
previous cohorts A, B, and C  and found common themes. The study 
team used the common themes from participant responses to guide 
modifications of the application and its content. The goals of these 
previous cohorts was to identify and address any problems with the 
pain-CBT education and resources. For instance, participants 
requested revising technical psychological labels (e.g. 
“catastrophizing”) to improve literacy, in addition to shortening 
length of text, adding an option for daily opioid tracking, and 
increasing the presence of visuals throughout the app. Furthermore, 
most patients endorsed the content as being usable, informative, 
convenient to access, and relevant to their cancer pain experiences.  
 
3.0 
Inclusion and Exclusion Criteria* 
 
3.1  
 Participant engagement will be referenced as “Pilot Cohort” 
in this protocol. 
PILOT COHORT Inclusion Criteria: 
• Age ≥ 18 years  
• Patients diagnosed with an active cancer diagnosis, either 
undergoing active cancer treatment or receiving treatment 
for an advanced cancer or are receiving palliative care 
• Treatment managed at participating clinic (DFCI outpatient 
palliative care, gastrointestinal cancer center, and DFCI 
satellite clinic Merrimack Valley or Londonderry) 

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• Chronic pain related to cancer or treatment (> pain score of 
4) 
• Has an active prescription for at least one opioid 
medication to treat their cancer pain (i.e. not for post-
surgical pain) 
• Own a compatible smartphone (android) or is willing to use 
an android device provided by the study team 
• Completes baseline survey 
 
         Pilot Cohort Exclusion Criteria: 
• Patients in survivorship: patients who have completed their 
treatment regimens, are not actively receiving treatment for an 
advanced cancer, or have a cancer that is in remission 
• Cognitive impairment that would interfere with study 
participation, as judged by treating clinician 
• Inability to speak English: the intervention has not yet been 
translated to Spanish 
• History of opioid use disorders 
• Enrolled in hospice  
• Currently hospitalized  
• Use of transmucosal fentanyl, given safety concerns and ongoing 
risk mitigation program required to prescribe these (TIRF 
REMS). 
• Pain primarily related to a recent surgery  
3.2 
We will exclude adults who are unable to consent, individuals who 
are not yet adults (infants, children, teenagers), pregnant women, 
and prisoners.  
 
4.0 
Study-Wide Number of Subjects* 
 
N/A 
 
Please find the summary of study-wide number of subjects below: 
 
Cohort 
Maximum # of participants 
Pilot Cohort  
Up to 15 patients 
Total accrual 
Up to 15 participants 
 
 
 
5.0 
Study-Wide Recruitment Methods*  

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Recruitment methods are outlined for this Pilot Cohort in Reference 
section 21. 
 
6.0 
Multi-Site Research* 
 
N/A 
 
 
7.0 
Study Timelines* 
1. 
Describe: Patients in this Pilot Cohort will be in the research study 
for 6 weeks total including: a 4-week intervention period and 2-week 
post intervention period. Patients will use the app for a total of 4 
weeks (4-week intervention period), and will complete surveys at 
baseline, 4 weeks (end of intervention period), and at 6 weeks (end 
of 2-week post intervention period). 
• We anticipate enrolling 1-2 patients per week during the 
pilot period, and should thus complete the study within 4-5 
months.  
2. The study timeline may change due to unforeseen circumstances. 
The estimated date for the investigators to complete this study 
(complete primary analysis) is October 31, 2022. 
8.0 
Study Endpoints* 
8.1 ENDPOINT 1: The primary objective is to determine feasibility and 
acceptability of STAMP+CBT. Specifically, we will evaluate patients’ 
adherence to daily and weekly comprehensive symptom self-
assessments within the STAMP+CBT app. We will calculate patients’ 
overall adherence rate and 95% confidence interval. Defined using 
precision analysis, we will consider the intervention to be feasible if 
>70% of subjects complete >4 of the 6 pain-CBT modules and 
completes 50% of surveys by the end of 4 weeks (completion of the 4-
week intervention study period; completion of the 2-week post 
intervention period will be exploratory).40,41 The intervention will be 
considered acceptable if >80% of the acceptability items are rated 4 or 
higher/5; lower ratings will lead to app refinements. Other feasibility 
measures will assess time to accrual, participation rates, study 
retention and completion rates, and the number of patients who 
continue to review app content between weeks 5-6 (post-intervention 
period) . Power calculation: With 10 patients, we will be able to 
estimate these proportions with margins of error (half of a 95% 
confidence interval) of approximately 18% or less assuming that the 
feasibility threshold of 70% is reached. This margin of error is small 
enough so that proportion estimates relevant to study feasibility will be 

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accurate and provide informative guidance for future, larger studies. 
Using qualitative framework analysis methods, we will explore 
barriers/facilitators, suggested changes to content, acceptability of 
intervention engagement, and whether app use continues after 
completion. Although power is not sufficient in this pilot, we will 
explore associations between levels of engagement and changes in 
pain severity/interference, opioid use, catastrophizing, sleep, mood, 
and pain self-efficacy.  
8.2 COMPREHENSIVE ENDPOINT: The study team will use qualitative 
and quantitative results to determine the feasibility and acceptability of 
this pain CBT mobile health app for patients with cancer. This 
feasibility study will inform final modification to the application and 
study procedures in preparation for a future efficacy study of the 
STAMP+ CBT mobile health app. 
9 Procedures Involved* 
9.1 STUDY PROCEDURES:  
The content for the STAMP+CBT application can be reviewed and 
referenced in appendices D, F, Y, Z. Once app programming is 
completely finalized, patients in the Pilot Cohort will engage in the pilot 
study to evaluate app feasibility and acceptability.  
 
9.2 Patients in the Pilot Cohort will pilot the application for 4 weeks (or 6 weeks 
if they request to review the content further, this will allow us to test the 
correct length of app use). The onboarding and monitoring protocol is 
available in Appendix S. In addition, the RA will contact participants after 4 
weeks (end of intervention period), and 6 weeks (end of 2-week post-
intervention period). The purpose of these contacts would be to schedule the 
end of intervention interview and confirm completion of survey assessments, 
as well as the final survey assessments at 6 weeks (end of 2-week post 
intervention period).   
 
9.3 Participants will fall into only one eligibility category: 
 
Pilot Cohort = Patient pilot testing 
 
 
 

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Table 1. Brief description of pilot cohort activities  
Description 
Components of Participation 
Participants will include DFCI patients presenting 
to outpatient palliative care, GCC, or satellite 
(MV and LD) clinics with ongoing chronic cancer 
pain management issues. Participants will meet 
with the study team in person, over the phone, or 
via a compliant and secure video chat/screen-
share platform (i.e. Zoom).  
 
We will conduct the pilot cohort with up to 15 
patients. Each participant will receive a $25 gift 
card upon completion of the 4-week intervention 
period, and another $25 gift card upon completion 
of the 2-week post intervention survey. The first 5 
patients will onboard to the application and their 
involvement/feedback will focus on making final 
revisions onboarding for the application and 
study procedures. Therefore, the following 10 
patients’ data will be included for pilot study 
analysis and feasibility findings.  
• 
Use the STAMP+CBT mobile app for 4 
weeks (intervention period, 4 weeks for 
content introduction, extended 2 weeks for 
review of content if patient’s request this) 
• 
Engage with pain CBT content including a 
goal-setting module, relaxation exercises, 
and educational content  
• 
Daily and weekly reporting of pain, 
catastrophizing, mood, and sleep symptoms 
and painkiller usage and satisfaction through 
the app (Appendix U) 
• 
Complete survey assessments at baseline, 4 
weeks (end of intervention period), and 6 
weeks (end of 2-week post intervention 
period) assessing pain severity, self-efficacy 
and catastrophizing, physical function, 
opioid use, and quality of life outcomes. 
(Appendices P, Q, R) 
• 
End-of-intervention interview (4 weeks) 
assessing usability and acceptability 
(Appendix T) 
• 
Medical Record Abstraction (Appendix O) 
 
PILOT COHORT:   
 
The first few patients (up to 5) will onboard to the application and their 
involvement/feedback will focus on making final revisions to the mobile 
application and study procedures. All procedures will be the same for the 15 
patients, however, data for the initial patients (up to 5) will not be included in 
final analysis as their involvement will be focused on revising final app 
bugs/iterations and modifications to study procedures before the pilot trial 
initiation. The following patients (up to 10) will be considered as the core 
pilot study participants to evaluate feasibility and acceptability of the 
application and study procedures.  
 
Survey assessments 
 
An RA will ask the patient to complete a baseline survey assessment after 
consenting, at the end of the 4-week intervention study period, and at the end 
of the 2-week post intervention period to assess key outcomes (pain 
severity/interference,42 QOL43), potential mediators of intervention effects 
(catastrophizing44, self-efficacy45, perceived stress46, anxiety/depression47, 
sleep48), acceptability,49 and usability50. The survey can be completed 
remotely though a link to a Partners Healthcare compliant electronic survey 
system (e.g. REDCap), over the phone with the RA, over Zoom with the RA, 

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in person with pen and paper or on a tablet. The Baseline survey will assess 
socio-demographics, barriers to pain management, pain severity, opioid use, 
pain and psychological symptoms, and quality of life, with metrics shown in 
Table 5. End of 4-week intervention period survey will largely replicate the 
baseline survey; additionally, patients will rate their satisfaction with 
STAMP+CBT using the 6-item Acceptability E-scale. Surveys will be used 
to assess pain and psychological symptom trajectory, medication use, and 
quality of life. See Appendix P for the Baseline survey items, Appendix Q 
for 4-week (end of 4-week intervention period) survey items, and Appendix 
R for 2-week (post intervention period) follow-up survey items. 
Additionally, a subset of patients (up to 10) will be invited for a qualitative 
interview focused on study burden, facilitators/barriers to app use, 
satisfaction, and perceived utility in order to guide future refinements to the 
app (see Appendix T) when they complete use of the app at 4 weeks (end of 
intervention study period).  
 
Intervention 
 
After the patient completes the baseline survey, the RA will meet with the 
patient (in person or virtually), to assist in either 1) downloading the 
application onto participants’ mobile device or 2) providing/mailing the 
study phone to the participant. The RA will help to register the patient to the 
app and help set up any preferences. The RA will then conduct a 15-minute 
tutorial on the STAMP+CBT app and its intended use (Appendix S). The RA 
will also input the patient’s pain medications from Epic, reconciling this list 
with the patient, and with the nurse navigator on the patient’s care team if 
there are any discrepancies. As the nurse navigator is already a member of 
the care team, they’ll have access to all Epic records and any documentation 
for this study included in Epic. The participant will also input their desired 
goal to work towards for the duration of the trial. During the trial, there is 
also a function in the app that allows participants to notify the research team 
if a medication or goal needs to be changed and reflected in the app. Final 
iterations to the app, research portal, and study procedures will be made 
following the initial few patients (up to 5) recruited to using the application. 
Thereafter, we will begin recruiting patients (up to 10) for the pilot 
study cohort.  
 
Participants will utilize STAMP+CBT for 4-weeks (intervention study 
period). The 4 weeks will consist of all content introductions. Patients will 
also be offered the opportunity to continue their app use for the next 2 weeks 
(post-intervention period) until study completion (2 week follow up and 
survey), this will allow us to assess feasibility and acceptability of the 
appropriate length of use for the intervention. STAMP+CBT hosts and 
organizes patients’ opioid/non-opioid analgesics. It has an extensive multi-
media library of education content related to pain management (Appendix C) 

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and pain specific CBT concepts (Appendices C, D, and F). Content will be 
delivered on a schedule to ensure that patients receive all pain CBT and 
medication education available (Appendix U). STAMP+CBT prompts 
patients to take daily surveys for reporting of pain, pain catastrophizing, 
mood, opioid/pain medication use, and sleep symptoms and progress towards 
individualized goals (Appendix U). At the end of each survey, patients 
receive feedback according to their symptom severity, with links to tailored 
educational content about pain and psychological symptom management. 
(Appendix U). Patients also complete weekly surveys for reporting 
symptoms listed above as well as goal progress. If patients report any severe 
symptoms, they are instructed to contact their care team immediately, with a 
telephone number included on the application screen, see table 2, or to go the 
Emergency room/call 911 for a true medical emergency. If patients’ pain is 
poorly controlled but not severe enough to be prompted to immediately 
contact their care team (for example if their average pain is above a 4 and not 
acceptable), they are reminded to contact their care teams if their symptoms 
worsen or they are concerned about it.  
 
One protocol-mandated study staff outreach to patients will occur within a 
week of enrollment. An RA will call to assess any technical or usability 
problems with the app (e.g. how to access the app on their phone, where to 
find certain study areas, etc.). These technical discussions will be optional 
for the patient and more can be scheduled if requested. Thereafter, the RA 
will monitor the STAMP+CBT dashboard twice daily (Mon-Fri), for any 
patient reported severe symptoms (Table 2). If a patient reports one of these 
severe symptoms, the RA will contact the patient’s nurse through a secure 
EPIC message to notify the patient’s care team. Additionally, to assist in 
population management, a tiered system notifications, in the portal will 
indicate symptom severity, need for outreach and/or management changes 
(See Table 3). As an additional safety measure, the application always 
prompts the patients to contact their care team for any severe symptoms they 
report and there is no expectation for proactive clinician outreach. These 
procedures have been approved by participating clinic nurses. The 
application provides a direct link to call the Outpatient Palliative Care Clinic 
at DFCI.   
 
To minimize the burden of the intervention on clinicians, there are no 
automated clinician alerts (i.e. email or in-basket message) for severe 
symptoms, rather, patients are prompted to call their care teams or 911 
(emergency services) if they report severe symptoms (Table 2 and 3). 
Patients are reminded frequently throughout the application that the research 
portal is not monitored around the clock and therefore they should reach out 
for urgent needs. Reports (with summarized pain and psychological 
symptoms; opioid use data; side effects; patients’ goals and reported goal 
attainment) will be sent to nurse managers, palliative care providers, and 

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oncologists to enable effective communication, opioid titration, and other 
management changes when prompted by the patient. 
 
During the study patients will be asked to complete 3 survey assessments, 
one at baseline, one at the end of the 4-week intervention period, and another 
at the end of the 2-week post intervention period. Patients will also be invited 
to complete a short semi-structured interview about their experiences using 
the application (See Appendix T). See below for description of the surveys 
(Table 5). 
 
Table 2. Severe Symptoms 
Pain 
• Worst pain = 9-10 
• Worst pain = 7-10 and new pain 
Red Flag 
Symptoms 
• Severe weakness or fatigue 
• Lightheadedness or feeling like I was going to pass out 
• No gas or stool from my bottom (or ostomy) in the last 
2 days 
• Vomiting 2 or more times in the last 24 hours 
• Fever of 100.5 or greater 
• New or worsening chest pain 
• New or worsening shortness of breath 
• New or worsening back pain 
• New numbness and weakness in one or both of your 
legs 
• Severe difficulty eating or drinking 
• Hallucinations/nightmares 
Opioid Side 
Effects 
• Hallucinations 
 
 
 

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Table 3: Report on Research Dashboard Based on Patient Responses 
Relief with opioids 
No relief 
OK 
Unsure 
Good relief 
Pain Control 
Poor 
Suboptimal 
Good 
Other Severe Symptoms 
Number of severe symptoms on Table 2 
shown in red 
Opioids need updating 
Yes 
No 
Mood  
IF Patient responds to mood questions 17-
20 with a total score of >12: Low Mood 
IF Patient responds to mood questions 17-
20 with a total score of <12: High Mood 
Catastrophizing  
IF Patient responses to catastrophizing 
questions 12-16 with a total score greater 
than >10: High Stress 
IF Patient answers catastrophizing items 
12-16 with a total score <10: Low Stress 
Sleep  
If sleep item 23 on the survey score >3 : 
Poor 
If score <3: Good 
Goals need updating 
IF Patient answers “No, it needs to be 
changed” in goal-setting section of weekly 
survey: Goal needs updating  
*Note: The RA will check the portal twice daily and send an EPIC message to the 
patient’s nurse for all responses in red needing urgent evaluation 
 
Chart Abstraction 
The study team will complete a limited structured chart abstraction at 
baseline and at end-of-study to collect basic non-identifiable 
clinical/demographic information (See appendix O). Chart abstraction will 
assess clinical actions responding to STAMP+CBT data and healthcare 
utilization related to pain and symptom management (e.g. hospitalization, ER 
visits, urgent clinic visits for symptom management, psychosocial oncology 
social work, psychology, or psychiatry visits). As people with cancer have 
variable prognoses, they may pass away during a study; therefore, we want 
to be able to abstract and record if/when a patient passes away during or 
recently after their involvement. Should this situation arise, it can negatively 
influence outcomes of the study evaluation (feasibility/acceptability).  
 
 
 

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Chart Abstraction Information collected will include the following:  
• Demographics: Gender, age, ethnicity, race  
• Cancer: Patient’s date of diagnosis, diagnosis (cancer type), stage at 
diagnosis, status of active curative or palliative treatment, history 
and date of surgery related to cancer, and whether patient has seen 
palliative care (yes/no) 
• Pain: patient’s last pain rating, type of pain, location of pain, 
surgeries or operations for pain, documented calls about pain. 
• Prescribed Pain Medicines: Patient’s prescribed short-acting 
opioid, long-acting opioid, and non-opioid pain medications, and 
length of time taking opioids. 
• Prescribed Anxiolytics: Patients’ prescribed anxiolytics and 
whether this was prescribed before or during the study  
• Prescribed Antidepressants: Patients’ prescribed antidepressants 
and whether this was prescribed before or during the study 
• Medication/Opioid side effects: Constipation or related symptoms. 
• Clinic visits: Unplanned or urgent clinic visits that include pain 6 
months prior, during, and 6 months post-intervention, and social 
work, psychology, or psychiatry visits during study period 
• Mental Health Diagnoses: Whether the patient has a mental health 
diagnosis and what mental health diagnosis the patient has. 
 
 

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Table 4: Summary of developed STAMP+CBT content (See Appendix F for further 
descriptions): 
CBT for pain Modules 
Location of Content  
Type of Content 
Adaptive surveys: 
Depression, stress, anxiety, 
catastrophizing, sleep, personalized goals 
Appendix B 
Survey items 
Text or audio-visual content: 
Appendix C: 
Pain psychoeducation  
Appendix C 
Appendix D 
Written content 
Video content 
Emotional awareness 
Appendix C 
Written content 
Relaxation/ deep breathing  
Appendix C 
Written content  
Stress and pain  
Appendix C 
Written content  
Cognitive processes/restructuring for pain 
Appendix C 
Appendix D 
 
Written content 
Video content 
Behavioral Game: 
http://18.210.82.141/v31/ 
Goal setting 
Appendix C 
Written content 
Activity setting  
Appendix C 
Appendix D 
Written content  
Video content 
Opioid Education 
Appendix C 
Appendix D 
Written content 
Video content 
Non-opioid analgesics education 
Appendix C 
Written content 
 
 
Human Subjects Research Category (NHSR, exempt, expedited, full 
review):  
 
Pilot Cohort: Expedited 
Human subjects research designation for the Pilot Cohort is expedited.  
 
Informed Consent: Written consent will be obtained from all participants 
(Appendix AD). After identifying potential eligible patients, we will contact 
the treating physician via email or phone to request permission to approach 
any patient. If the physician approves the approach, we will ask them to 
introduce the study to the patient at a regularly scheduled visit and ask 
permission for the research team to contact them to further explain the study 
and offer participation. If the physician denies approach, we will not 
approach the patient to offer study participation.  
 
After a clinician has approved the study team to approach their patient, the 
patients may be approached in person during an upcoming clinic visit. Once 
approached, the RA will review the study letter and consent form with the 
patient (Appendices X and AD). The study letter will notify participants that 
engagement in the study is completely voluntary and can be stopped at any 

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time for any reason. The palliative care clinic in which patients are being 
recruited for this study have also largely remained remote with tele-health 
services. Few patients attend in-person clinic appointment for palliative care 
outpatient care. Therefore, if approaching patients at the clinic is not 
possible, eligible patients may be approached remotely via phone. If a patient 
is contacted by phone, the RA will send the study letter and consent forms 
through a secure and personalized link in the FDA and HSSH compliant 
Mass General Brigham/Partners REDCap database. The RA will attempt to 
contact a patient three times. If contact is not established, the RA will email a 
copy of the recruitment letter to introduce the study (Appendix AC). The 
letter encourages the patient to contact the research team if they are 
interested in participating in the study. If the patient then contacts the 
research team, the study letter and consent form will be reviewed with the 
patient before obtaining written consent. If the patient does not respond by 
email or if they opt of the study participation, they will no longer be 
contacted. To account for patient understanding, the study letter will also 
be included in the app for review at any time.  
 
9.4 MONITOR SUBJECTS FOR SAFETY AND MINIMIZE 
RISKS: The risks to participants in the Pilot Cohort are minimal. 
The primary risk is loss of confidentiality/privacy. To monitor the 
risk of loss of confidentiality/privacy, the study team has ensured 
that the STAMP+CBT app is HIPAA compliant and meets the 
privacy and security standards set by DF/HCC, and will continue to 
do so with modifications in this study (IT approval received from 
Mark Tomlinson). In addition, all collected study data will be 
maintained in a secure location and personal identifiers will be 
removed. As described above, end of study interviews will be audio 
and video recorded, and transcribed for analysis of participant 
feedback.  For the patients engaging in qualitative interviews, their 
video recorded data will be destroyed after manuscript publication. 
 
Risks to participants in the Pilot Cohort 
 
• Physical risks: Physical risks to subjects include if they feel 
reassured by the app’s feedback/content and choose not to contact 
their care team for severe symptoms. It is also theoretically possible 
that patients are given medication advice that is either ineffective at 
relieving pain.   
• Psychological risks: Reporting pain and psychological symptoms 
daily may be distressing for some patients. It may also be the case 
that reviewing psychological content may be distressing as 
awareness of cognitive and emotional factors relevant to pain will 
be acknowledged.  

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• Privacy risks: There is a risk of privacy violation or loss of 
confidentiality; however, this is anticipated to be minimal, and the 
study team is committed to guaranteeing adequate protection 
against risk as described in the following section.  
9.5 Data to be collected:  
9.5.1 Interview Data: Audio and video recordings of feedback will 
be collected from all interview participants regarding their 
perceived feasibility and acceptability of the mobile application 
as well as their experience with the app.  
9.5.2 E-Acceptability (Survey) Data: Participants will complete an 
acceptability survey following review of finalized content (see 
Appendices I). 
9.5.3 Chart Abstraction: Baseline demographic and clinical data will 
be collected from all patient participants via chart abstraction. 
Data will also be collected at the end of the pilot intervention. 
Data will include non-identifiable clinical/demographic 
information, including the following:  
9.5.3.1 Gender  
9.5.3.2 Age 
9.5.3.3 Ethnicity 
9.5.3.4 Race 
9.5.3.5 Cancer type  
9.5.3.6 Cancer stage 
9.5.3.7 Opioid medications 
9.5.3.8 Pain score during last visit (see Appendices O). 
9.5.3.9 Health service utilization (e.g. ED visits, 
hospitalizations, unplanned urgent clinic visits, 
changes to opioid medications, psychosocial 
oncology visits) 
9.5.4 Survey Assessment Data: Demographic, disease, 
medication, pain, mood, stress, and sleep data will be 
collected at baseline before the intervention, end of the 4-
week intervention, and at the end of the 2-week post 
intervention period (see Appendices P, Q, R). T1 and T2 of 
Table 5.  
9.5.5 Symptom Reporting: Individual pain, pain interference, 
pain medication use, stress, mood, and sleep symptoms as 
well as pain management data will be recorded for each 
participant over the course of the pilot intervention 
(Appendix U). Participants will report their symptoms and 
management daily and weekly. 
9.6 Long term follow-up: Participants in the Pilot Cohort complete a 
survey assessment assessing quality of life, pain, psychological 

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measures, healthcare utilization, and app use at the end of the 2 weeks 
post-intervention (T3 of Table 5). 
Table 5: Measures collected from patients at each of three survey timepoints 
 
10 Data and Specimen Banking* 
10.1 This study does not involve any specimen collection/banking of any 
kind. Personal health information will be collected as part of the 
study. The consent form informs the participants that data collected 
for this study may be used in the future. By consenting, participants 
agree. Participants will not be asked to provide additional informed 
consent for the use of de-identified information in future research. 
There is no scheduled date on which the audio recording and 
transcription information and data that is being used or shared for 
this research will be destroyed, because research is an ongoing 
process. However, the video recorded data will be destroyed after 
manuscript publication. Patients will not provide any data on their 
Measures collected via patient 
assessments 
Survey 
 
App 
data 
Chart  
review 
Assessment 
Measure 
T1 
T2 
T3 
 
 
Socio-demographics 
Standard 
x 
 
 
 
 
Clinical characteristics 
Standard 
 
 
 
 
x 
Baseline cellphone use 
MTUAS 
x 
 
 
 
 
Pain 
severity/interference 
BPI 
 x 
x 
x 
 
 
Opioid use/adherence 
Self-report 
x 
x 
x 
 
 
Quality of life 
FACT-G 
x  
x 
x 
 
 
Satisfaction  
Novel metric 
 
x 
 
 
 
Use of STAMP+CBT 
- 
 
x 
x 
X 
 
Usability 
SUS 
 
x 
 
 
 
Management changes  
- 
 
 
 
 
x 
Healthcare utilization 
- 
 
x 
x 
X 
x 
Self-efficacy in 
managing symptoms 
PROMIS 
x 
x 
 
 
 
Self-efficacy in 
managing medications 
PROMIS 
x 
x 
 
 
 
Pain catastrophizing 
PCS 
x 
x 
x 
 
 
Stress 
PSS 
x 
x 
x 
 
 
Patient reported 
outcomes 
PRO-
CTCAE 
x 
x 
x 
 
 
Depression and 
Anxiety 
PROMIS 
x 
x 
x 
 
 
Sleep Disturbance 
PROMIS 
x 
x 
x 
 
 

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personal symptoms’ reports; no specific patient symptom data will 
be collected.  
10.2 All data collected during this study will be stored and used for future 
research. Any personal identifiers will be removed so that 
information cannot be linked back to a patient. For the patients 
engaging in qualitative interviews, their video recorded data will be 
destroyed after manuscript publication. 
10.3 Investigators can request the data collected from this study for new 
research. Data may also be shared with outside non-profit academic 
investigators as well as with for-profit pharmaceutical investigators 
or commercial entities with whom Dana-Farber collaborates such as 
the University of Oklahoma Health Sciences Center, Stephenson 
Cancer Center. Requests must be sent to the study chair (Dr. Desiree 
Azizoddin) and must be approved by the Dana-Farber IRB prior to 
sharing.  
11 Data Management* and Confidentiality 
11.1 Because interviews produce qualitative results, statistical analyses 
will not be employed for a portion of this study. The study team will 
review qualitative feedback from patients and find common themes 
related to app feasibility and acceptability. The study team will use 
the common themes derived from qualitative thematic analysis of the 
interview that review this feasibility study to guide further iterations 
of the application and study procedures for a future larger, efficacy 
study of the STAMP+CBT app.  
11.2 Statistical analyses will be utilized in the pilot intervention portion of 
this study to ascertain feasibility and acceptability. We will measure 
time spent on the app per day and per week, completion rates for 
surveys and content review, and frequency of log-ons over the 
course of the pilot. The primary objective is to determine feasibility 
and acceptability of STAMP+CBT. Defined using precision 
analysis, we will consider the intervention to be feasible if >70% of 
subjects complete >4 of the 6 pain-CBT modules and patients will 
complete 50% of surveys by the end of 4-weeks (completion of the 
4-week intervention study period and completion of the 2-week post 
intervention period).40,41 A module will be considered complete if 
the participant engages in >70% of its content, including completing 
mHealth survey items, psycho-educational content, and app 
exercises. The intervention will be considered acceptable if >80% of 
the acceptability items are rated 4 or higher/5; lower ratings will lead 
to app refinements. Other feasibility measures will assess time to 
accrual, participation rates, and study retention and completion rates. 
Power calculation: With 10 patients, we will be able to estimate 
these proportions with margins of error (half of a 95% confidence 

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interval) of approximately 18% or less assuming that the feasibility 
threshold of 70% is reached. This margin of error is small enough so 
that proportion estimates relevant to study feasibility will be accurate 
and provide informative guidance for future, larger studies. Although 
power is not sufficient in this pilot, we will explore associations 
between levels of engagement and changes in pain 
severity/interference, opioid use, catastrophizing, sleep, mood, and 
pain self-efficacy. 
11.3 
The data the research team will access regarding app utilization 
will include; date and time of app log-ins, date of time of survey 
completion, survey responses, including clinical reporting of daily 
symptoms and medication usage, total app log-ins during intervention 
period, percent of surveys completed during intervention period, date 
time and frequency patients access external educational content. 
11.4 PHI data will be collected using REDCap and the STAMP+CBT 
app. 
11.4.1 REDCap: For this study, data and patient consent will be 
collected using the Partners instance of REDCap 
(redcap.partners.org).  In collaboration with the Harvard 
Catalyst | The Harvard Clinical and Translational Science 
Center, REDCap (Research Electronic Data Capture) is a 
free, secure, HIPAA compliant web-based application 
hosted by Partners HealthCare Research Computing, 
Enterprise Research Infrastructure & Services (ERIS). 
Vanderbilt University, with collaboration from a 
consortium of academic and non-profit institutional 
partners, develops this software application for electronic 
collection and management of research and clinical study 
data. Data collection is customized for each study or 
clinical trial by the research team with guidance from ERIS 
REDCap administrators.  REDCap is built around HIPAA 
guidelines and is 21 CFR Part 11 capable. 
11.4.2 STAMP+CBT app: The final application will be HIPAA 
compliant and compliant with DFCI security and privacy 
standards. The application is built on the Insight Platform 
where data is secure on Microsoft Azure servers (see 
Appendix AA for further details on this application and 
Appendix AB for previous IRB approval research at the 
University of Oklahoma Health Sciences Center through 
their IRB). 
Microsoft enterprise cloud services are also covered by 
FedRAMP assessments. Microsoft Azure and Microsoft 
Azure Government received a Provisional Authority to 

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Operate from the FedRAMP Joint Authorization Board; 
Microsoft Dynamics 365 U.S. Government received an 
Agency Authority to Operate from the US Department of 
Housing and Urban Development, as did Microsoft Office 
365 U.S. Government from the US Department of Health 
and Human Services.  
All data collected by the Insight Platform is encrypted 
during storage and in transit. The Insight platform has been 
approved for research at the University of Oklahoma 
Health Sciences Center through their IRB (See Appendix 
AB). Users of the OUHSC Insight Platform should confer 
with their institution’s policies regarding restrictions 
associated with data collection and transfer between the 
Insight mobile application, Microsoft Azure servers, and 
users institutional servers. Data collected and stored by 
users is intended to be de-identified. Any data classified as 
PHI will require users institution to enter into an 
appropriate Business Associate Agreement. 
Study specific procedures to maximize data security: 
 
Controlled access: The REDCap and STAMP+CBT app administrators 
will set up all user accounts so that each user only has access to their own 
relevant participant data in a prototype model only. 
 
Use of unique study ID numbers: REDCap automatically assigns unique 
study ID numbers to each new case.   
 
Extensive training: All personnel involved in this study are required to 
complete and document completion of extensive protocol training.  
Furthermore, all research personnel are required to have valid certification 
of human subjects research training 
Storage of Patient Research Data: All patient research data is 
subject to HIPAA regulations at the host institution.  
Note: Interviews will be audio and video recorded using the 
HIPAA compliant platform, Zoom. The audio and video 
recordings will be stored in a password protected Dropbox 
business account. The audio recordings will be transcribed analysis 
of feedback. It is important to keep the facial features of patients in 
the videos as this provides important sociobehavioral analysis. To 
protect the identity of subjects, we will advise patients to modify 
their name on screen and use their initials when logging into zoom, 
instead of their full name. Patients’ video recorded data will be 
destroyed after manuscript publication. 

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The STAMP+CBT app will use the Microsoft Azure cloud service 
with multilayered security for storage of research data collected 
(see appendix AA).  
11.5 The staff at Dana-Farber will be responsible for monitoring the data 
for completion, accuracy, and compliance. All personnel involved in 
this study are required to complete and document completion of 
extensive protocol training.  Furthermore, all research personnel are 
required to have valid certification of human subjects’ research 
training. 
12 Provisions to Monitor the Data to Ensure the Safety of Subjects* 
This is a social behavioral research project, not a treatment protocol.  The 
study involves minimal risk.  
As such, the only adverse event that will be monitored and reported is 
psychological distress as determined by the treating oncologist or 
palliative care provider. For any patient who exhibits severe distress as 
result of the study procedures, the study research assistant will notify the 
patients’ oncologist, palliative care provider, and/or social worker for 
appropriate response, including possible mental health referral if 
necessary. Furthermore, participants will be reminded that participation is 
voluntary and can be stopped at any time for any reason. See the DSMP 
(Appendix N) for more details. 
12.1 
Protection against physical risks: The study team has placed extensive 
protections against the aforementioned physical risks of the app. These 
protections significantly exceed the level of support and guidance that patients 
would receive with usual care. Moreover, patients’ symptom reports will be 
reviewed daily by the study staff and shared with clinical nurse navigators that 
are part of the patients’ care teams, which represents closer monitoring than 
usual care. Finally, the patient-facing app always instructs patients to contact 
their care teams and reminds them that the portal is not monitored 
continuously, or to call 911/go to an emergency room for medical 
emergencies. First, the application sets a low bar for instructing patients to 
contact their care teams for reported symptoms. This includes reporting any 
new pain, fever, new or worsening back pain, new or worsening chest pain, 
any pain rated > 8 out of a 0 to 10 scale (See table 2 for the detailed list). 
Moreover, if patients report moderate to severe pain levels that do not meet 
the previous criteria, in addition to receiving education about their pain 
management, they are also reminded that their care team wants to hear from 
them if they are concerned about their symptoms or if their symptoms are not 
improving. A link to their care team’s number is included in the application. 
This level of support is much greater than what patients have usually with 
routine care.  

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12.2 
Protection against psychological risks: if in the course of their 
participation patients raise significant emotional distress, the 
appropriate care team members i.e. nurse navigator, physician, mid-
level provider will be contacted to make appropriate social work or 
mental health referrals. Similar to that of physical risks, this app 
provides closer monitoring than what is provided for usual care for 
psychosocial needs; In addition to instructing patients to call their care 
team for advice, the RA will share patient’s elevated symptoms with a 
nurse navigator, already assigned to patients’ care teams, for follow 
up. As such, these nurse navigators, will have access to all health 
records and including any documentation for this study included in 
EPIC. 
12.3 
Protection against privacy risks: To monitor the risk of loss of 
confidentiality/privacy, the study team has ensured that the 
STAMP+CBT app is HIPPA compliant and meet the privacy and 
security standards set by DF/HCC. In addition, all collected study data 
will be maintained in a secure location and personal identifiers will be 
removed.  
12.4 
To maximize data security, both REDCap and STAMP+CBT 
employ: 
• User Privileges - To ensure that users have access only to data and 
information that they are supposed to have within the application, user 
privileges are utilized within the software. Each user has their own 
account, and their user account will only have access to information 
that they themselves have created or to which administrators have 
granted them access. 
• Password-protection & Authentication - Both systems are password 
protected and implement authentication to validate the identity of end-
users that log in to the system. 
• Logging and Audit Trail - Both systems maintain built-in audit trails 
that log all user activity and all pages viewed by every user. 
12.5 
Institutions will register eligible participants in the Clinical Trials 
Management System (CTMS) OnCore as required by DF/HCC Policy 
REGIST-101. 
13 Withdrawal of Subjects* 
13.1 Subjects who do not complete app onboarding within 3 weeks of 
study enrollment will be withdrawn from the research study without 
their consent.  
13.2 These patients will be informed of their withdrawal from the study 
by study staff. The overall DF/HCC study PI, Dr. Desiree Azizoddin, 

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will make all decisions regarding early termination of the study. The 
study team will then notify all participants accordingly.  
13.3 Patients will be notified by research staff if they will be partially 
withdrawn from the research, as reviewed in their study letter 
(Appendix X) as well.  
 
14 Risks to Subjects* 
14.1 There are risks to taking part in any research study.  The primary risk 
of this study is loss of privacy or confidentiality. The risk of loss of 
privacy or confidentiality by using the STAMP+CBT app or taking 
part in this study is minimal.  The study team has taken many steps 
to prevent any loss of privacy or confidentiality, including training of 
all clinic and research staff in best practices, rules, and regulations 
surrounding privacy and confidentiality, collecting research data 
using unique study ID numbers instead of names or other identifying 
information, and use of data collection systems that meet data 
security standards. 
14.2 Recruitment and Informed Consent: Participants will only be 
approached if approval is received by their treating clinician. If the 
physician deems them unsuitable for the study, they will not be 
approached. Participants will be approached in clinic or by phone by 
the RA in a private and confidential manner. If the patient is eligible 
and interested in participation, the study letter and consent forms 
(Appendices X and AD) will be reviewed with the participant.  
In the case of remote approach by phone, the RA will attempt to 
contact the patient 3 times. If the patient contact cannot be 
established, the RA will email a copy of the recruitment letter to the 
patient (Appendix AC). The recruitment letter encourages the patient 
to reach out to the study staff if they are interested in participating. If 
a patient reaches out to the study staff then the study letter and 
consent form will be reviewed before the patient provides written 
consent. During remote approaches by phone the study letter and 
consent forms will be sent by email through a secure and 
personalized link in the FDA and HSSH compliant Mass General 
Brigham/Partners REDCap database. While discussing the study 
letter and consent the study staff will emphasize that participation is 
voluntary and the participant may stop participating at any time. 
Consent discussions may take place over the phone or HIPAA 
compliant Zoom.  
The study letter and consent forms for consent to participate will 
adhere to strict standards regarding its content. Required sections 
include: Introduction; Why is this research study being done? What 

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other options are there? What is involved in the research study? How 
long will I be in this research study? What are the risks or 
discomforts of the research study? What are the benefits of the 
research study? Can I stop being in the research study and what are 
my rights? What are the costs? What happens if I am injured or sick 
because I took part in this research study? What about 
confidentiality? Whom do I contact if I have questions about the 
research study? 
15 Potential Benefits to Subjects* 
15.1 Using the STAMP+CBT app and taking part in this research study 
may or may not benefit participants. We hope that by reviewing the 
content in the STAMP+CBT app, patients are able to learn to better 
manage their symptoms and the increased flow of information 
between a patient and their care team improves their experiences. 
We also hope the information learned from this research study will 
provide more information about how to best help patients and their 
care team work together during and between visits to achieve better 
symptom management in cancer patients. 
16 Vulnerable Populations* 
16.1 This research does not involve vulnerable populations of prisoners, 
children, cognitively impaired adults, or pregnant women. Prisoners, 
children, cognitively impaired adults, and pregnant women are 
excluded. 
17 Community-Based Participatory Research* 
N/A 
18 Setting  
18.1 This is a pilot study that will take place at the Dana-Farber Cancer 
Institute. The research procedures will all be conducted online 
through secure, HIPAA compliant portals (i.e. Zoom, partners email, 
etc.). The research team will identify and recruit potential subjects 
through outpatient palliative care, GCC, and satellite clinics 
including MV and LD. See section 22.0.  
19 Resources Available 
19.1 The research team is well-qualified to perform their duties. Dr. 
Azizoddin has extensive experience in conducting research studies in 
cancer distress screening, pain psychology, and education. She has 
deep knowledge of the clinical and research environments and the 
patient population and culture at DFCI. 
19.2 This study team will be taking place under the Department of 
Psychosocial Oncology and Palliative Care (POPC) at Dana-Farber. 

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The POPC Department maintains its own server infrastructure and 
systems administration staff that provide data storage, data backup, 
and data security in support of large data analysis projects. The 
servers are configured as a virtual server pool with virtual server 
hosts connected to a centralized Storage Area Network (SAN) 
device. Server virtualization increases the efficiency and flexibility 
of the server pool while minimizing downtime and cost. The server 
pool currently has 20 processor cores and a data storage capacity of 
9 terabytes. This server infrastructure has a dedicated Systems 
Administrator to optimize performance, maintain security patches, 
perform backups, and execute other related tasks. Researchers in the 
Division have access to additional resources through the Research 
Computing group. Research Computing provides a variety of 
services including file server space, backup services, website 
hosting, and support of some workstation computers. 
All individuals in the study team will review the protocol and be 
updated on protocol procedures and study needs, at the beginning of 
study activation and throughout the study period.  
20 Prior Approvals 
20.1 The existing pain educational text and audio-visual content has been 
previously approved in the initial STAMP pilot study (DF/HCC IRB 
#18-504 and # 384-811).  
20.2 The additional pain CBT content was developed during study 
procedures previously approved in DF/HCC IRB #20-453. This 
content can be viewed in appendices C, D, U, Y, and Z.  
21 Recruitment Methods 
21.1 Identifying potential subjects: Potentially eligible patients will be 
identified by 1) referrals from clinic staff, and 2) by screening the 
EMR for outpatient solid tumor or hematology disease center clinic 
schedules, 3) by screening the palliative care clinic schedules. Once 
the study team identifies a potentially eligible patient, the team will 
reach out to the treating clinician for permission to approach and 
offer engagement in the study. If the provider does not approve that 
the study staff approach a patient, the study staff with NOT approach 
the patient to offer engagement in the study. Patients will provide 
written consent on the consent form after viewing study letter 
according to IRB procedures (see Appendices X and AD).   
21.2 Recruitment of potential subjects: Under a HIPAA waiver, study 
staff will look in the electronic medical record, scheduling systems, 
and inpatient lists to identify potentially eligible patients who meet 
the eligibility criteria. Study staff may also query Epic, 
administrative/ operations/billing databases, order entry databases, 

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and/or cancer registry databases to identify potentially eligible 
participants.  Study staff may also accept potential patient referrals 
from site clinicians, through palliative care, DFCI satellite clinics 
Merrimack Valley and Londonderry, and outpatient GCC clinic.  
Purposive sampling based on data from the electronic medical record 
(e.g., demographics, cancer stage, number of recent hospitalizations, 
number of prescription drugs) will be used to ensure that 
perspectives of diverse patients are included. 
21.3 Patient approaches can occur through the following mechanisms 
dependent upon COVID-19 related research regulations and clinic 
operations at the time. 
• In person approach: A research assistant (RA) will 
approach the patient in clinic to explain the study and offer 
participation. Interested participants will then review the 
study letter and consent form with a research team 
member (Appendices X and AD) and if interested provide 
written consent. The patient and RA will then set up a time 
for onboarding to the application. 
• Remote approach: The clinician can introduce the study to 
the patient during a clinic visit and the RA will follow up 
by phone to explain the study and offer participation. The 
study letter and consent form will be sent electronically 
through a secure and personalized link in REDCap 
(Appendices X and AD). The RA will attempt to contact 
the patient three times. If no contact is established, the RA 
will email the participant a copy of the recruitment letter 
(Appendix AC). The recruitment letter introduces the 
study and encourages the patient to contact the study team 
if they are interested in participating. If the patient 
contacts the RA after the recruitment letter, the RA will 
review the study letter and consent form before obtaining 
written consent.   
21.4 See study letter Appendix X, recruitment letter Appendix AC, and 
consent form Appendix AD for the Pilot Cohort.  
21.5 A $25 giftcard will be provided upon completion of the 4-week 
intervention period, and another $25 gift card will be provided when 
patients complete the 2week post intervention period survey. 
Clinicians will not receive compensation for their engagement.  
22 Local Number of Subjects 
22.1 This project will ONLY be taking place at Dana-Farber and 
participating DFCI satellite clinics. Therefore, all study participants 
will be recruited on site and through remote approach and follow-up 

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(phone and zoom). In total, approximately 15 subjects will be 
accrued at DFCI and participating DFCI satellite clinics.  
Activity  
Maximum # of participants 
Pilot Cohort 
Up to 15 
23 Provisions to Protect the Privacy Interests of Subjects 
23.1 To protect PHI, the following measures will be taken. Patients will 
be approached and interviewed in private settings. All study form 
hard copies will use only de-identified unique study ID numbers and 
be kept in the patients’ study files in locked drawers to which only 
the designated study team member has a key. All electronic data will 
be kept on secure, password protected servers as evaluated and 
managed by the Dana-Farber Department of Research Computing 
and IS.  
Departmental and institute-wide policies enforce the protection of our 
electronic information, especially with regards to HIPAA regulations and the 
integrity of patient care. These policies also safeguard again theft, abuse, 
misuse, and any form of damage. The scope of protection includes 
information which is printed from or stored on a database, mainframe, server 
desktop, laptop, PDA, CD-ROM, hard disk, flash drive, optical platter, tape, 
smart phone, network, telephone, and other computer-enabled medical 
devices. These policies regulate usage of system IDs, passwords, e-mail 
accounts, anti-virus mechanisms, encryption, mobile devices, remote access, 
remote control software, and wireless devices. IS responsibilities and 
governance including firewall protection of all Dana-Farber internal 
networks and the internet, system evaluation, risk analysis, information 
access, regular review of user accounts, systems audit, regular review of 
remote access, and physical location access. Specific to this project, no data 
will be stored on laptops at any point and secure transfer protocols will be 
used for any electronic exchange of information. All staff/users receive 
mandatory institutional trainings on Information Security and must adhere to 
policies at all times.  
Subjects will be approached for potential participation in private or 
by phone. They will also complete all study assessments in private 
and at their own comfort (remote completion). At each assessment, 
subjects will be reminded that they can skip any questions they do 
not wish to answer and are free to withdraw from the study at any 
time. 
Study research assistants will have access to subject’s medical 
records to abstract information as discussed in other sections of this 
protocol. RAs will only access information that is necessary to 
collect for the study protocol and will not be permitted to access the 
medical record for other purposes. 

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24 Compensation for Research-Related Injury 
 
N/A 
 
25 Economic Burden to Subjects 
25.1 Costs that subjects may be responsible for because of participation in 
the research: Subjects participating in this study will be asked to 
complete online surveys using an internet-enabled device.  
Participants will have to use their own hardware (e.g., smartphone, 
tablet, computer) and their own WiFi or Data Plan which may cost 
them money; subjects are responsible for these costs. Devices and/or 
data plans may also be provided by the study staff to interested 
participants who do not own an android device.  
Patient participants in the Pilot Cohort will receive a $25 gift card 
upon completion of the 4-week intervention period, and a second 
$25 gift card upon completion of the  2-week post-intervention 
survey.  
26 Consent Process 
26.1 Potentially eligible patients will be identified by 1) referrals from 
clinic staff, or 2) by screening the EMR for outpatient GCC or 
palliative care clinic schedules. Once the study team identifies a 
potentially eligible patient, the team will reach out to the treating 
clinician for permission to approach. 
Once approved to approach, the study staff may approach patients 
in-person during clinic. Once approached the RA will review the 
study letter and consent form with the patient (Appendices X and 
AD). If it is not possible for the RA to meet the patient during a 
clinic visit, the clinician may introduce the study and the RA will 
follow up by phone. During a phone call the RA will explain the 
study and offer participation before obtaining written informed 
consent. During this phone call, the RA will email a copy of the 
study letter and consent form and the participant will provide written 
consent. The RA will send the study letter and consent forms 
through a secure and personalized link in the FDA and HSSH 
compliant Mass General Brigham/Partners REDCap database. The 
RA will attempt to contact a patient three times. If contact is not 
established, the RA will email a copy of the recruitment letter to 
introduce the study (Appendix AC). The letter encourages the patient 
to contact the research team if they are interested in participating in 
the study. If the patient then contacts the research team, the study 
letter and consent form will be reviewed remotely during a phone 
call with the patient before obtaining written consent. If the RA is 

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unable to establish contact with the patient after 3 call contacts and if 
the patients does not respond to the email recruitment letter, the 
patients will no longer be contacted 
All interested participants will provide written consent after 
thorough review of the study letter and consent form. Next, they will 
complete the baseline survey to ensure enrollment in the study. 
Thereafter, the RA will coordinate with the patient to onboard with 
the pilot application. They will be notified that participation is 
completely voluntary and can be stopped at any time for any reason.  
27 Process to Document Consent in Writing 
27.1 Participants will be given a study letter and consent form to provide 
written consent. The research presents no more than minimal risk of 
harm to subject. The research procedures for this tech-based 
intervention will also primarily occur remotely given COVID-19 
barriers to in-person care (the majority of outpatient palliative care 
visits continue to occur remotely). We will email the study letter and 
consent forms through a secure and personalized link in the FDA and 
HSSH compliant Mass General Brigham/Partners REDCap database. 
Additionally, a copy of the study letter will be housed in the app 
itself in the event that patients want to review this study letter after 
onboarding and during study participation for this mobile health app.  
28 Drugs or Devices 
N/A for this study.  
 
 
 
 
 
 
 
 

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