Leveraging mHealth to Deliver Integrated Pain-CBT, Opioid Monitoring, and Self-management Support for Advanced Cancer Patients Coping With Chronic Pain (STAMP+CBT)
Phase: NA
Conditions: Cancer Pain, Opioid Use, Cognitive Behavior Therapy
Sponsor: University of Oklahoma

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RESEARCH PROTOCOL OUTLINE
Title of Project:
Leveraging mHealth to deliver integrated pain-CBT, 
opioid monitoring, and self-management support for 
advanced cancer patients coping with chronic pain
Principal Investigator:
Desiree Azizoddin, PsyD, Department of Family and 
Preventive Medicine
Abstract
The primary purpose of this project is to determine feasibility and acceptability of 
a novel mobile health application focused on integrating behavioral coping tools 
with medication management for pain for patients with advanced cancer and pain. 
The majority of patients with advanced cancer experience pain, which is 
extremely psychologically and physically distressing. Current pain management 
strategies include the use of opioid and nonopioid medications in combination 
with other analgesics. However, many patients who take opioids experience 
inadequate relief. Strong evidence suggests that psychological interventions, 
namely cognitive behavioral therapy for pain (pain-CBT), lead to significant 
improvement in pain. The STAMP+CBT app (Smartphone Technology to 
Alleviate Malignant Pain + Cognitive Behavioral Therapy) seeks to provide 
education about pain medications alongside cognitive behavioral therapy 
techniques for pain to patients with advanced cancer. The application uses multi-
media educational materials and survey algorithms assessing pain, medication 
usage, mood, stress, and sleep to improve pain management in this population. In 
this study, patients with advanced cancer at OU (n=60) will participate in a single-
arm, 6-week study of STAMP+CBT (4-week intervention period and a 2-week 
post intervention period). 
A.
Specific Aims
The purpose of this study is to pilot test 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 (R21 NR017745, PI, Enzinger; 
IRB #18-504 at Dana Farber Cancer Institute). It delivers tailored education and 
self-management advice while facilitating clinician monitoring and patients’ 
proactive outreach. We developed an extensive suite of multi-media cancer pain 
psycho-education covering core pain psychology principles. We refined and 
integrated pain-CBT treatment with medically oriented self-management support 
in STAMP (OUHSC IRB #13-725). Capitalizing on mHealth technology, this app 
strives to destigmatize pain psychology through a potentially scalable model that 
disseminates behavioral treatments for advanced cancer pain paired with their 
palliative care pain management plan. 
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Aim 1 (App Feasibility and Acceptability): Determine feasibility and 
acceptability of the STAMP+CBT app: up to 60 patients with advanced cancer 
pain will be recruited from Stephenson Cancer Center outpatient supportive 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 with up to 30 patients 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. 
Outcomes and accomplishments
ENDPOINT 1: The primary objective is to determine the feasibility and 
acceptability of the STAMP+CBT app. 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 any activity on the app at 
least 50% of days on study. The intervention will be considered acceptable if 
>80% of the sample rate the app as satisfactory and useful (4 or higher/5); lower 
ratings will lead to app and content refinements. Other feasibility measures will 
assess time to accrual participation rates, and study retention and completion 
rates. Other acceptability outcomes will be assessed through qualitative debriefing 
interviews with patients evaluating the perceived benefits, usefulness, and 
satisfaction of the app, and quantitative acceptability ratings of the app’s 
functionality, perceived utility, ease of use, and content relevance. Power 
calculation: with 35 evaluable 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 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. 
The study team will use qualitative and quantitative results to determine the 
comprehensive feasibility and acceptability of the 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. 
B.
Background and Significance
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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, 6Effective non-pharmacologic treatments are greatly needed to mitigate 
the burden of advanced cancer pain.7
The most efficacious psychological treatments for chronic non-cancer pain 
address both emotional and evaluative aspects of pain while teaching pain coping 
skills.8-11 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.12
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. A few studies have sought to modify pain-CBT for 
general cancer populations, in part by using telehealth to overcome barriers to 
delivery.13-15 Early data suggest these programs are feasible and acceptable to 
patients;13-15 however, to our knowledge, none tailor pain-CBT specifically for 
advanced cancer patients, and none integrate pharmacologic management, which 
would complement patient-centered pain-self management strategies.16 
Mobile health technology (mHealth) is a promising strategy to overcome access 
barriers and tailor, deliver, and disseminate psychological interventions for 
advanced cancer pain.17, 18 Developing a smartphone intervention that combines 
medical and pain self-management support has great potential for scalability to 
advanced cancer populations. 
To our knowledge, this will be the first adaptation of pain-CBT specifically for 
advanced cancer pain. STAMP+CBT will adapt critical components of pain-CBT 
to address common concerns of advanced cancer patients, while ensuring a 
realistic level of engagement for this population.
Traditional interventions using tablets and/or videoconferencing do not fully 
employ the unique capabilities of mHealth to tailor psychological treatments19 and 
present content in engaging, empathic ways20, 21 (e.g., through gamification, 
quizzes). STAMP+CBT will leverage mHealth tailored software to integrate 
engaging media (e.g., audio, videos, graphics), and user-centered design (e.g., 
positive aesthetics, playful interface).   
C.
Preliminary Studies/Progress Report  
Using iterative content development procedures, I led a multidisciplinary team 
that reviewed and refined pain-CBT psycho-education materials and adapted them 
for advanced cancer pain and mobile health delivery through DFCI protocols 
(IRB #20-453 and OUHSC IRB# 13-725); See Appendices A, B, J, & L. Initial 
content development occurred in Boston, MA at DFCI – patients with advanced 
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cancer (n=14, our target population, DFCI IRB #20-453), reviewed and provided 
feedback on all content leading to modifications. We then had patients with 
advanced cancer (n=14, our target population) from Oklahoma, OK at the SCC 
(OUHSC IRB # 13-725) review this modified content and provide feedback on 
the literacy, acceptability, useability, relevance, and clarity, leading to further 
iterations. Patients at both sites also reviewed survey items, survey algorithms, 
app-based feedback, and wireframes to ensure app clarity, legibility, and 
acceptability.
We developed survey schedules and programmed STAMP+CBT on the Insight ™ 
platform through the SCC mHealth Shared Resource housed within the Health 
Promotion Research Center. Daily surveys assess pain, stress, mood and related 
symptoms (e.g. pain, opioid use, pain interference, stress, mood, 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. advice on pain, mood, stress, and sleep), including advice to 
contact their care team for concerning symptoms. The app also houses links to 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.
We have completed initial user acceptability testing of the app with patients from 
our target population (n=6) at the SCC (OUHSC IRB # 13-725) testing the app at 
home for 2-4 weeks. We are also currently completing pilot testing of the app 
with patients with advanced cancer at the DFCI in Boston, MA (DFCI IRB #21-
719). Study procedures outlined in this protocol parallel those approved in DFCI 
IRB #21-719 protocol (currently enrolling). At this time, 5 patients have been 
enrolled in the study, we are recruiting 10 more patients to complete testing of the 
app at home for 4 weeks, in addition to completing survey assessments – similar 
to those outlined in this protocol. Patients who have tested the app to date (DFCI 
pilot, n=3; SCC pre-pilot, n=5) have reported finding the app easy to use (5-Point 
Likert scale for all items: DFCI=4.33; SCC=4.80), understandable (DFCI=5; 
SCC=4.8), and enjoyable (DFCI=4.33; SCC=3.80). They reported feeling that it 
took an appropriate amount of time to use the app (DFCI=4.33; SCC=4.20) and 
were satisfied with the app overall (DFCI=4.33; SCC=4.60). Patients at DFCI 
who tested the app for 4 weeks took an average of 57.14% of the surveys pushed 
by the app (median=62.50%). Patients at SCC who had tested the app for 2 weeks 
took an average of 54.76% of surveys pushed to them (median=64.29%). This 
specific study outlined in this protocol will enable pilot testing of the 
application in Oklahoma, allowing for comparison between patient samples 
between Boston and Oklahoma. 
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D.
Research Design and Methods (What, When, How, Where)
STUDY PROCEDURES: 
Patients in the Pilot Cohort will pilot the application for 4 weeks (4-week 
intervention period) and remain on study through the 2-week post-intervention 
period (6-weeks on study total). The onboarding and monitoring protocol are 
available in Appendix S. A study team member 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 (end of 4-
week intervention period), as well as the final survey assessments at 6 weeks (end 
of 2-week post intervention period).
Participants will fall into only one eligibility category:
Table 1: Brief description of pilot cohort activities
Description
Components of Participation
Participants will include OUHSC-SCC patients 
presenting to outpatient supportive care 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 60 
patients. Each participant will receive a $50 gift 
card upon completion of the 4-week intervention 
period survey, and another $25 gift card upon 
completion of the 2-week post intervention 
survey. 

Use the STAMP+CBT mobile app for 4 
weeks 

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 B)

Complete survey assessments at baseline, 4 
weeks (end of 4-week 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 assessing 
usability and acceptability (Appendix T)

Medical Record Abstraction (Appendix O)
Survey Assessments
A study team member will ask the patient to complete 3 surveys in total, a 
baseline survey assessment after consenting (to confirm their enrollment in the 
study), 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 (app acceptability, pain 
severity/interference,22 QOL23), potential mediators of intervention effects 
(catastrophizing24, self-efficacy25, perceived stress26, anxiety/depression27, 
sleep28), acceptability,29 and usability30. These surveys will be completed 
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remotely through a REDCap link.
The Baseline survey will assess socio-demographics, baseline technology use, 
current comorbidities, current pain management, pain severity, opioid use, pain 
and psychological symptoms, and quality of life, with metrics shown in Table 4. 
The 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 15) 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, a study team member 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 study team member will help to register the patient 
to the app and help set up any preferences. The study team member will then 
conduct a 20-30 minute tutorial on the STAMP+CBT app and its intended use 
(Appendix S). The study team member will also input the patient’s pain 
medications from the EMR, reconciling this list with the patient. The participant 
will also input their desired goal to work towards for the duration of the trial. 
During the trial, there is also a survey item that if selected notifies the research 
team whether a patients’ medication or goal needs to be changed and reflected in 
the app. 
Participants will utilize the STAMP+CBT app for 4-weeks (intervention study 
period). The 4 weeks will consist of all content introductions. 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 A) and 
pain specific CBT concepts (Appendices A, L, and G). Content will be delivered 
on a schedule to ensure that patients receive all pain CBT and medication 
education available (Appendix B). STAMP+CBT prompts patients to take daily 
surveys to report their pain, pain catastrophizing, mood, opioid/pain medication 
use, and sleep symptoms and progress towards individualized goals (Appendix 
B). 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 (Table 2, Appendix B). Patients also 
complete weekly surveys for reporting symptoms listed above as well as goal 
progress. 
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If patients report any severe symptoms (Table 3), 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 if they are concerned about it.
One protocol-mandated study staff outreach to patients will occur within a week 
of enrollment. A study team member 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). These technical discussions will be optional for the patient 
and more can be scheduled if requested. Thereafter, the study team member will 
monitor the STAMP+CBT dashboard twice daily (Mon-Fri) to assess app 
engagement and survey completion rates (Table 3). If a patient reports one of 
these severe symptoms, the app sends an automated email to the research team 
listing patients concerning symptoms. (See Table 3). A member of the research 
team will then forward a copy of the patients concerning symptoms to their study 
nurse for evaluation or follow-up. As an additional safety measure, the application 
always prompts the patients to contact their care team or 911 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 Supportive Care Clinic at 
OUHSC.
To minimize the burden of the intervention on clinicians, patients are prompted to 
call their care teams or 911 (emergency services) if they report severe symptoms 
(Table 3). Patients are reminded during onboarding to the app 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 from a study team member to nurse managers, supportive care providers, and 
oncologists to enable effective communication, opioid titration, and other 
management changes when alerted by a patients red flag symptom email via in-
app algorithms.
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 4).
Table 2: Algorithms used to provide feedback to patients 
Relief with opioids
No relief
OK
Unsure
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Good relief
Pain Control
Poor
Suboptimal
Good
Other Severe Symptoms
Number of severe symptoms on Table 2
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 
Table 3. Severe Symptoms that trigger an email alert to the research team
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
STUDY TIMELINES
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 and remain on study through the 2-
week post intervention period.  They will complete surveys at baseline, 4 weeks 
(end of intervention period), and at 6 weeks (end of 2-week post intervention 
period).
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We anticipate enrolling 1-2 patients per week during the pilot period, and should 
this complete the study within 6-8 months. 
The study timeline may change due to unforeseen circumstances. The estimated 
date for the investigators to complete this study (complete primary analysis) is 
July, 2024. 
E.
Chart Review
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).
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
F.
Biospecimens
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 
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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 information and data that is 
being used or shared for this research will be destroyed because research is an 
ongoing process. Patients will not provide any data on their personal symptoms 
reports; no specific patient symptom data will be collected. 
G.
Banking/Repository/Database
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. Data will be destroyed as soon as analysis is complete. 
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 the 
University of Oklahoma collaborates. Requests must be sent to the study chair 
(Desiree Azizoddin) and must be approved by the University of Oklahoma IRB as 
well as the NIH prior to sharing.
Data to be collected: 
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.
E-Acceptability (Survey) Data: Participants will complete an acceptability survey 
following review of finalized content (see Appendix F).
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: 

Gender 

Age

Ethnicity

Race

Cancer type 

Cancer stage

Opioid medications

Pain score during last visit (see Appendix O)
Health service utilization (e.g. ED visits, hospitalizations, unplanned 
urgent clinic visits, changes to opioid medications, psychosocial 
oncology visits, psychology and psychiatry visits)
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Survey Assessment Data: Demographic, disease, medication, pain, quality of life, 
mood, stress, and sleep data will be collected at baseline before the intervention, 
at 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 4.
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 
B). Participants will report their symptoms and management daily.
Long Term Follow-up: Participants in the Pilot Cohort will complete survey 
assessments assessing quality of life, pain, psychological measures, healthcare 
utilization, and app use at the end of the 2-weeks post-intervention period (T3 of 
Table 4).
Table 4: Measures collected from patients at each of the three survey timepoints
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
H.
Inclusion / Exclusion Criteria
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Pilot Cohort Inclusion Criteria: 
Age ≥ 18 years
Patient diagnosed with an active cancer diagnosis (locally advanced solid tumor 
malignancy, multiple myeloma, or other advanced hematologic malignancy), 
either undergoing active treatment or receiving treatment for an advanced cancer 
or are receiving supportive care
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) 
Completed 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)

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 (within the last 2 weeks)
We will exclude adults who are unable to consent, individuals who are not yet 
adults (infants, children, teenagers), pregnant women, and prisoners.
WITHDRAWAL OF SUBJECTS
Subjects who do not complete the baseline assessment within 4 weeks of study 
enrollment will be withdrawn from the research study without their consent and 
considered non-evaluable for the primary endpoint. Non-evaluable subjects will 
be replaced until the total evaluable subject accrual of 35 participants is met. 
These patients will be informed of their withdrawal from the study by study staff. 
The study PI, Dr. Desiree Azizoddin, will make all decisions regarding early 
termination of the study. The study team will then notify all participants 
accordingly. 
Patients will be notified by study staff if they will be partially withdrawn from the 
research, as reviewed in their consent form (Appendix AD) as well. 
I.
Gender/Minority/Pediatric Inclusion for Research
Potential participants will not be excluded based on gender or race/ethnicity, 
though note that English fluency will be required as many assessments that will be 
used in the present study are not available in other languages. We will exclude 
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adults who are unable to consent, individuals who are not yet adults (infants, 
children, teenagers), pregnant women, and prisoners. 
J.
Recruitment and Enrollment
Identifying potential subjects: Potentially eligible patients will be identified by 
1) referrals from clinic staff, and 2) by pre-screening the EMR for outpatient solid 
tumor, hematology disease center clinics, or the supportive 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 and HIPAA forms after 
reviewing the consent and HIPAA forms with a study staff member according to 
IRB procedures (see Appendices AD, X, and Y).  
Recruitment of potential subjects: Under a HIPAA waiver, study staff will look 
in the electronic medical record, scheduling systems, and inpatient lists to pre-
screen and identify potentially eligible patients who meet the eligibility criteria. 
Study staff may also accept potential patient referrals from site clinicians. 
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.
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 study team member will approach the patient in clinic to 
explain the study and offer participation. Interested participants will then review 
the study letter, consent and HIPAA forms with a research team member 
(Appendices AD, W, and X) and if interested provide signed consent. The patient 
and a study team member will then set up a time to onboard to the application. 

Remote approach: The clinician can introduce the study to the patient during a 
clinic visit and the study team member will follow up by phone to explain the 
study and offer participation. The study team member will attempt to contact the 
patient three times. The study letter, consent and HIPAA forms will be sent 
electronically through a secure and personalized link in REDCap (Appendices 
AD, W, and X). If no contact is established, the study team member 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 a study team member after 
the recruitment letter, the study team member will review the study letter and 
consent form before obtaining signed consent.
See study letter Appendix X, recruitment letter Appendix AC, consent form 
Appendix AD, and HIPAA form Appendices W and Y for the Pilot Cohort. 
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A $50 incentive will be provided upon completion of the 4-week intervention 
period survey, and another $25 incentive will be provided when patients complete 
the 2-week post intervention period survey. Clinicians will not receive 
compensation for their engagement.
K.
Risks and Benefits
 Risks and Risk Mitigation:
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 on the 
Insight platform developed at OUHSC/HPRC, 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 the NIH’s data security standards.
As such, the only adverse event that will be monitored and reported is 
psychological distress as determined by the treating clinician. For any patient who 
exhibits severe distress as result of the study procedures, the study research 
assistant will notify the patients’ clinician and social worker for appropriate 
response, including possible mental health referral if necessary. Patients’ scores 
on self-administered assessments (e.g., pain score, mood) within the app will be 
used to determine if an adverse event has occurred. In these instances, an email 
alert will be automatically sent to the study team describing the patient’s severe 
symptoms. Study staff will report the patient’s symptoms by forwarding the email 
to the patient’s care team, who will then contact the patient for further 
information. The alert will also instruct patients to contact their care team or call 
911. Patients have immediate access to study staff through a call button on the 
app’s home screen and will be advised to call research staff for any severe adverse 
events or other study-related needs, which will then be communicated with the 
clinical team when necessary and reported to the IRB. Any severe adverse event 
that is related to the physical and psychological risks described below and that 
results from participation in the study will be reported to the IRB within 2 
business days and to the NIH within 5 business days. Furthermore, participants 
will be reminded that participation is voluntary and can be stopped at any time for 
any reason. 
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 a study team member in a private and 
confidential manner. If the patient is eligible and interested in participation, the 
study letter, consent and HIPAA form (Appendices AD, W, and Y) will be 
reviewed with the participant.
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In the case of remote approach by phone, a study team member will attempt to 
contact the patient 3 times. If the patient contact cannot be established, the study 
team member 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, consent form, and HIPAA authorization form (Appendix W) will 
be reviewed before the patient provides written consent. During remote 
approaches by phone the study letter, consent and HIPAA forms will be sent by 
email through a secure and personalized link in REDCap. 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.
Protection against physical risks: The study team has placed extensive 
protections against the aforementioned physical risks of the app which have been 
approved in the initial app protocol (DF/HCC #18-504). These protections 
significantly exceed the level of support and guidance that patients would receive 
with usual care. Finally, the patient-facing app always instructs patients to contact 
their care teams and reminds them that the research portal is not monitored 
continuously. 
The STAMP+CBT 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 3 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. 
Participants may feel reassured that their symptoms are being monitored and be 
less likely to call their care team. We have sought to mitigate this possibility in 
multiple ways. First, study staff emphasize and reiterate that the study platform is 
not monitored continuously during onboarding. Staff tell participants to contact 
their care team or call 911 should any concerning symptoms arise. Second, when 
patients report potentially serious symptoms, they are specifically instructed by 
the application to notify their care team by calling or paging after hours (the clinic 
number is included in the application). See Table 3 for the list of symptoms that 
prompts phone contact.
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 
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risks, this app provides closer monitoring than what is provided for usual care for 
psychosocial needs. 
Benefits and knowledge to be gained: 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 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 patients’ pain 
management experience varies between clinic visits, as at-home app management 
will allow for increased monitoring of system and therefore increased access to 
daily symptom data. Lastly, we hope this will help patients and their care team 
work together during and between visits to achieve better symptom management 
in cancer patients.
L.
Statistical Methods  
Statistical analyses will be utilized in this pilot intervention to ascertain feasibility 
and acceptability of the STAMP+CBT app. We will measure time spent on the 
app per day and per week, completion rates for surveys and content review, and 
frequency of app interactions over the course of the pilot. Defined using precision 
analysis, we will consider the intervention to be feasible if >70% of subjects 
complete any activity on the app at least 50% of days on study. The intervention 
will be considered acceptable if >80% of the sample rate the app as satisfactory 
and useful (4 or higher/5); lower ratings will lead to app and content refinements. 
Other feasibility measures will assess time to accrual participation rates, and study 
retention and completion rates. Other acceptability outcomes will be assessed 
through qualitative debriefing interviews with patients evaluating the perceived 
benefits, usefulness, and satisfaction of the app, and quantitative acceptability 
ratings of the app’s functionality, perceived utility, ease of use, and content 
relevance. Power calculation: With 35 evaluable 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 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.
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 future larger, 
efficacy study of the STAMP+CBT app. 
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M. Data and Safety Monitoring Plan 
SCC Clinical Trials Office (CTO) study coordinators will assist in pre-screening, 
recruiting, and consenting patients. Once patients have consented, the principal 
investigator’s study team will complete app onboarding and study procedures, 
except completing documentation on clinicaltrials.gov.
For this study, we will utilize the SCC CTO for registering human subjects for 
trials via the clinical staff, including registration in Oncore; ensuring high-quality 
standards are used for data collection; ongoing management of clinical trials, 
auditing, and data and safety monitoring; and coordinating quality assurance 
efforts related to clinical research.
The following Data and Safety Monitoring Plan (DSMP) will ensure that our 
OU/SCC project will comply with Federal Regulations, Health Insurance 
Portability and Accountability Act (HIPAA) requirements, and applicable 
OU/SCC Guidelines.
The OU/SCC will: 

Ensure that the investigators and study team members are qualified and 
appropriately resourced to conduct the protocol.  

Ensure that each participating investigator and study team member receives 
adequate protocol training prior to enrolling participants and throughout trial’s 
conduct as needed. The Principal Investigator will ultimately be responsible to 
make sure that required personnel have completed their training.

Monitor progress and overall conduct of the study by Dr. Azizoddin’s team. 

Ensure all OU Institutional Review Board (IRB), OU/SCC and other applicable 
reporting requirements are met. 

Review data and maintain timely submission of data for study analysis. 

Ensure compliance with all requirements as set forth in the Code of Federal 
Regulations, applicable OU/SCC requirements, HIPAA requirements, and the 
approved protocol.

Commit to the provision that the protocol will not be rewritten or modified by 
anyone other than the OU/SCC Sponsor.

Monitor accrual and address problems meeting accrual requirements. 

Maintain documentation of Adverse Event reports and deviations/violation the 
OU/SCC study team for timely review.  

Maintain Regulatory documents which includes: IRB approvals/notifications, AE 
submissions, IRB approved consents. 
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Patient Registration: To register a participant, we will send the study letter with 
signed informed consent document/ HIPAA authorization form (if separate from 
the informed consent document) and eligibility checklist to SCC Clinical Trials 
Office. At the time of registration, SCC Clinical Trials Office requires the 
following identifiers for all subjects: initials, date of birth, gender, race and 
ethnicity. Once eligibility has been established and the participant successfully 
registered, the participant is assigned a unique protocol case number that will be 
used on all de-identified subsequent communication and documents. Participation 
may not begin without confirmation from the Coordinating Center that the 
participant has been registered.
Safety Monitoring:  
The study and all research activities will be monitored by the study team and the 
PI. The PI and project manager will work closely with SCC Clinical Trials Office 
to implement the Data and Safety Monitoring Plan that is consistent with SCC 
Clinical Trials Office. All members of the research team will be responsible for 
immediately reporting breaches to confidentiality or data security, or adverse 
reactions, to the PI, and the study tracking database will provide tools for tracking 
and reporting any of these issues. 
The PI and project manager will be responsible for timely submission of any 
necessary reports of adverse events, revisions to the protocol that indicate a 
change in risk for participants, or actions taken by the IRBs regarding the 
research. The project manager will be responsible for submission of the final 
approved protocol and any subsequent amended protocols to the OUHSC IRB. 
The CTO regulatory team will maintain a copy of the master regulatory binder in 
eREG, documenting IRB approved versions of the study protocol and consent 
forms for, correspondence with the IRB, and general human subjects and study-
specific staff training. 
The PI will monitor participant accrual monthly. A data submission and 
processing timeline will be developed for each data element. The PI and the 
project manager will monitor data submission and processing monthly. 
The PI will be responsible for assessing external factors or relevant information 
(e.g., developments in the literature) that may impact the safety or participants or 
ethics of the research study. 
It is unlikely that the intervention will cause any clinically significant AE’s, as the 
intervention is predominantly a system by which patients can self-report 
symptoms, and receive education/coaching around symptom self-management. 
All adverse events will be reported to the OUHSC IRB and study investigators in 
accordance with usual procedure. Any serious adverse event (SAE), defined as an 
adverse event that results in death, is life threatening, results in hospitalization, or 
results in another important medical event, will be reported to the IRB and to the 
study investigators within 2 working days of occurrence.  
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Although a DSMB is not required for this small pilot study of a behavioral 
intervention, any SAE’s related to study participation will be immediately 
reported to the PI and study team (Dr. Azizoddin). All SAE’s will be reviewed by 
the study staff within 2 working days of occurrence. All SAEs will also be 
reported to the NIH within 5 business days. The NIH will not be directly involved 
in the review of these SAEs, but they will be notified to maintain transparency 
during the trial. If the SAE’s are determined to be likely related to the 
intervention, the protocol and consent forms will be amended as necessary.
Data Management: PHI data will be collected using REDCap and the 
STAMP+CBT app.
REDCap: For this study, data will be collected using the REDCap platform.  
REDCap (Research Electronic Data Capture) is a free, secure, HIPAA-compliant 
web-based application. Data collection is customized for each study or clinical 
trial by the research team with guidance from REDCap administrators. REDCap 
is built around HIPAA guidelines and is 21 CFR Part 11 capable.
STAMP+CBT app: The final application will be HIPAA compliant and 
compliant with OU security and privacy standards through the Insight app 
platform developed at the OUHSC/HPRC.
Study specific procedure 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 recordings will be stored in a password protected dropbox 
business account and destroyed once the data analysis is complete. The audio 
recordings will be transcribed analysis of feedback. The entire interview will not 
be conducted in a group setting. It is important to keep the facial features of 
patients in the videos as this provides important sociobehavioral analysis. 
The staff at University of Oklahoma 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.  
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Furthermore, all research personnel are required to have valid certification of 
human subjects’ research training.
N.
Data Sharing
As noted elsewhere, data collection for this project will take place at the TSET 
Health Promotion Research Center, Stephenson Cancer Center at the University 
of Oklahoma Health Sciences Center. 
De-identified data will be shared with co-investigators at Dana-Farber Cancer 
Institute and Brigham and Women’s Hospital in Boston, MA.
O.
Confidentiality 
Protection against privacy risks: To monitor the risk of loss of 
confidentiality/privacy, the study team has ensured that the STAMP+CBT app is 
HIPAA compliant and meet the privacy and security standards set by University 
of Oklahoma Health Sciences Center. In addition, all collected study data will be 
maintained in a secure location and personal identifiers will be removed. 
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.
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IRB NUMBER: 15482
IRB APPROVAL DATE: 11/23/2023