Oncology Associated Symptoms & Individualized Strategies

Overview of study procedures - Participation in the study last for 12 weeks. Phase 1:
baseline data collection and orientation to the intervention (week 0); Phase 2: 8 weeks of
daily tracking on website and weekly eHealth visits from a nurse and two data collection
points (week 4 and week 8); Phase 3: Optional continuation of tracking on website and as
needed eHealth visits from a nurse and final data collection (week 12)

Description of the intervention: For a period of eight weeks patients will use the OASIS
web-application daily to help them get better control of their cancer symptoms. In addition,
to daily symptom and strategy tracking, participants will have eight e-visits with the
nurse-coach via the Zoom application through the UIHC eHealth and eNovation Center to
evaluate their progress with managing their symptoms, assess for barriers to implementing
strategies, and offering coaching on how to improve symptom management. Questionnaires and
blood samples will be collected at baseline (week 0) and follow-up (weeks 4, 8, and 12).

Part 1: OASIS web-application. The web-application is a secure web-site developed by The
University of Iowa ITS that contains a number of features participants can use to improve
their ability to monitor and manage their physical and emotional symptoms. The daily check-in
allows participants to keep track of their symptoms and strategies on a day-to-day basis. A
data visualization tool provides visual summary of their symptom distress and strategy use
over time. A symptom library describes the pathophysiology (in lay language) of 16 common
cancer symptoms. A strategy library contains written descriptions and videos of how to
implement 47 common symptom management strategies. The contact nurse-coach feature lists the
next scheduled coaching visit as well as provides a way to request an extra e-visit sooner if
needed. And finally, other resources will provide phone numbers and web links to resources
such as the American Cancer Society, the National Cancer Institute, and Patients Like Me. The
personal data participants enter into the OASIS web-application is considered level 3 data
and will be handled according to The University of Iowa policies and procedure (See X.4
Electronic Records). After baseline data collection, the web-application will guide
participants through the web-application to set up their tailored symptom management plan.

Step 1: On the initial login participants will complete an orientation to the intervention
that consists of a video and values exercise. The video will briefly describe how physical
and emotional symptoms develop during cancer and why symptom management is critically
important for patients with advanced cancer. They will then complete a brief values exercise
asking them to think about what is important in their lives. The purpose of the values
exercise is to help participants make the cognitive connection about how cancer symptoms may
be interfering with aspects of their lives they value most.

Step 2: Next the patient will complete a brief profile (first name, age, gender, type of
cancer, current cancer treatment) and select an image or avatar for their profile. Going
forward computer algorithms that are driven by information provided by the participant will
tailor the experience. For example, the cancer ribbon in the OASIS logo will then change to
the color associated with their cancer.

Step 3: Participants will then be instructed to select at least one symptom they want to
control better. The selected symptoms will be automatically added to the Symptom Tracker
feature of the application. The order in which the symptoms are presented on this screen will
be based on the answers provided in the profile. The most common symptoms for that cancer and
treatment will be presented first at the top of the list based on behind the scenes decision
algorithm. On this screen they can simply choose symptoms from the list or read about common
cancer symptoms in the symptom library.

Step 4: Next, participants will select at least one symptom management strategy to use for
each symptom. Participants can simply select strategies from a list or read more about them
in the strategy library. Strategies selected will be automatically added to the Strategy
Tracker. For each symptom selected, a list of common symptom management strategies known to
be effective for that symptom will be suggested.

Step 5: Once the participant has identified at least one symptom to work on and one strategy
to use, s/he can begin tracking. After completing steps 1-5, the Main Page will now show
their symptom and strategy trackers. At the end of each day, the participant is instructed to
rate the symptom distress they experienced in the previous 24 hours for the symptom(s) they
are tracking and whether they used the selected strategy or not.

Step 6: While participants are not required to read/watch all the content in the
web-application, they are encouraged to explore the symptom library and strategy library to
learn more about cancer symptoms and ways they can better manage them. Exploration will be
encouraged with factoids and teasers. Each time a participant logs in, a pop-up window with a
symptom management fact or tip will appear. This pop-up will link to the appropriate content
page if the participant is interested in learning more. For example, "TIP: Did you know that
whenever you adjust your opioid pain medicine, you should also adjust your constipation
medicines?"

Part 2: Nurse-Coach. Through weekly visit via Zoom (which is an HIPAA compliant
web-conferencing platform), the nurse-coach will provide the ongoing encouragement, support,
and accountability that has been identified as critical to behavior change in other chronic
illness self-management interventions. The focus of the communications will be to evaluate
the patient's symptoms and use of management strategies, as well as coach the patient to
identify and address barriers to effectively implementing strategies to manage their
symptoms. Prior to each e-visit the participant will be encouraged to think about how well
each management strategy is working and what barriers they are encountering with implementing
the strategy. The nurse-coach will review the symptom distress scores and use of management
strategies with the participant. The nurse-coach and participant will then discuss how well
the strategies have been working and any barriers s/he has encountered. Reviewing the tracker
data and evaluating effectiveness and barriers of the strategies is theorized to help the
participant connect the dots between how they are feeling and what they can do to improve
their symptom management. The nurse-coach may suggest other strategies to consider, assess if
there are underlying symptoms that need to be addressed in order to effectively manage
symptoms (such as pain that is causing disturbed sleep), and finally, and/or determine
additional medical management is appropriate (such as messaging the physician to change a
prescription). The nurse-coach is a key feature of the intervention in that s/he will provide
primary palliative care as well as promote a sense of therapeutic working alliance with the
patient. For the purpose of fidelity monitoring, the e-visits will be audio recorded using
the secure audio recording feature in the Zoom application. Recordings will be transcribed
verbatim. Participants will be informed that the e-visits is being recorded. The participants
will be notified before the recording begins.

Questionnaires: A member of the research team will assist the patient in completing the
questionnaires at the clinic at the time of enrollment. In week 4, 8, and 12 patient will
complete questionnaires electronically. They will receive these questionnaires via a
Qualtrics survey link through email. The questionnaires take approximately 30-90 minutes to
complete. The questionnaires include sociodemographics, usability and acceptability of the
intervention, plus instruments evaluating social support, perceived stress, optimism,
illness/symptom appraisal, symptom burden, self-management behaviors, coping, and
communication with health care provider.

Blood: The patient will be met at the phlebotomy clinic for scheduled blood draws. Blood
samples for cytokines will be obtained at the same time as other scheduled blood draws to
minimize additional needle sticks. 30 mL of blood will be collected from a central venous
access device or using standard venipuncture techniques with sodium heparin and EDTA tubes
immersed in an ice bath within 15 minutes. Study personnel will confirm that the patient has
not smoked or ingested caffeine for at least one-half hour prior to blood collection. The
blood collection takes about 15 minutes.

The entire survey data collection will take 45 to 105 minutes per visit(total for visits is
180 to 420 minutes). Daily use of the web-application for a minimum of 10 minutes is
expected, totaling 560 minutes. A total of 12 hours and 30 minutes to 16 hrs and 30 minutes
of data collection is expected for the whole study.

Medical record review: Medical records will be reviewed at each study visit via EPIC Care
Everywhere for information about cancer type and stage, cancer treatments, co-morbid
conditions, clinical blood lab values, and symptom treatment interventions.

The study population consists of 40 adults (18 years or older) that will be recruited at the
McCreery Cancer Center Clinic sites in Fairfield, IA and Ottumwa, IA. There is no control
group in this study. All participants will receive the intervention. Approximately 1 patients
per week are seen at the McCreery Cancer Center that meet eligibility criteria. The
investigators plan to approach all eligible participants. With a 50% recruitment rate and
expect to reach the sample size within 10 months.

Eligible patients will be identified by the McCreery Cancer Center clinic staff (e.g. nurses,
radiation therapists, and oncologists) weekly for the upcoming week. A research assistant
will be at the McCreery Cancer Center on day of the scheduled appointment. The clinic staff
will ask the patient if they are interested in the study. If the patient agrees, a trained
research assistant will confirm eligibility, describe participation, and obtain informed
consent. If the patient is interested in participating in the study but unwilling or unable
to complete the questionnaires or symptom and strategy tracking on the website, they can have
a caregiver assist them. The caregiver will function only as a recorder of the patient's
responses and not provide their own perceptions. If the patient is not able to verbally
interact with the caregiver to complete the questionnaires or symptom and strategy tracking,
then they will not be eligible to participate (or will be dropped from the study if already
in the intervention phase).

This intervention is based on patient's ability to perform self-care actions with the use of
web-application. Self-management activities is highly dependent on decision making ability.
As a reason, if their physical or psychological status deteriorate due to their advanced
cancer they will no longer will be able to perform self-management actions nor use the web
for self-management and will be excluded from the study. If patient's capacity to consent
changes over the course of study, their study participation will end early. The UCSD Brief
Assessment of Capacity to Consent will be used to reassess capacity as needed during the
study.

This project involves research on DNA. Analyses of associations among genetic markers for
cytokine, cancer symptoms, and coping behaviors. DNA samples will be identified and labeled
with a unique study ID number. The DNA samples and plasma for cytokine analyses will be
labeled with only the study ID and date of collection and kept in a -80º C freezer in a
locked in the College of Nursing, Office of Nursing Research. Data from the analyses will be
securely stored in RedCap.

Data management and analysis will be the primary responsibility of the PI. Questionnaires and
biological specimens will be coded to remove all direct personal identifiers. The code list
will be kept in a locked cabinet and secure location, separate from where the questionnaires
and specimens are stored. The original consent and screening forms will be stored in a locked
cabinet in the project area, separate from any data sources.

These de-identified DNA samples or data may be shared in the future with other researchers
studying cancer symptoms and cytokines. Prior to sharing any data, an approved IRB protocol
and/or material transfer agreement will be obtained.

SAS 9.3 will be used for all analyses. Initial analysis will involve calculating descriptive
statistics for all variables at all study points compared to controls. Outliers will be
investigated for accuracy. Patterns of missing data will be examined. Graphical
representation of the data will be created and examined at each point and longitudinally. The
distributions of variables will be evaluated for normality and homogeneity of variance, and
appropriate transformations will be applied as needed or statistical analyses for non-normal
data will be utilized. Correlations among variables will be examined. A significance level of
.05 will be used for statistical tests.

To evaluate the acceptability and usability of the intervention, multiple components of the
study will be examined, including resources and time spent on the intervention for each
participant, patterns and sources of missing data. In addition the investigators will review
the recruitment procedures, as well as any potential experimental confounders and logistical
challenges. Descriptive statistics will be employed for analysis of continuous variables and
qualitative analyses will be employed for open-ended questions. This information will be used
to refine the OASIS intervention and develop procedures for a pilot RCT in future

Inclusion Criteria:

- Adults (18 yrs or older) with a current diagnosis of advanced cancer of solid tumor
(stage 3 or 4) origin considered incurable by the treating oncologist,

- Experiencing with at least one distressing symptoms (rated 3 or greater on 0-10
numeric rating scale for symptom distress),

- Able to read and write in English

- Have a laptop, mobile phone and/or tablet with a video camera that can use to access
the internet

- Have high-speed internet connection in his/her home

Exclusion Criteria:

- Patients who are not able to complete the study surveys (alone or with assistance) due
impaired mental, cognitive, or physical status.