Post-op Wellness Program for Pancreatic Cancer Patients That Uses Patient Feedback and Real-time Provider Monitoring

PRIMARY OBJECTIVES:

I. To explore the feasibility and acceptability in diverse samples of cancer patients of
wireless collection and transmission of data for transfer into the open-source
cyberinfrastructure (CI) called Cyberinfrastructure for Comparative Effectiveness Research
(CYCORE).

OUTLINE: Patients are assigned to 1 of 4 arms.

ARM I (COLORECTAL CANCER PATIENTS) (CLOSED TO ACCRUAL AS OF 01/30/14): Patients use two
accelerometers, a blood pressure monitor, a heart rate monitor, a global positioning system
(GPS) device, and a smart phone that prompts patients to electronically answer questions
about exercise and health-related symptoms and feelings. The devices are used for 5
consecutive days. After a 2 week period, patients resume use of the devices for an additional
5 days.

ARM II (HEAD AND NECK CANCER PATIENTS) (CLOSED TO ACCRUAL AS OF 01/30/14): Patients use two
accelerometers, a blood pressure monitor, a weight scale, and a smart phone that prompts
patients to electronically answer questions about diet and health-related symptoms. The
devices are used for 5 consecutive days. After a 2 week period, patients resume use of the
devices for an additional 5 days.

ARM III (HEAD AND NECK CANCER PATIENTS) (CLOSED TO ACCRUAL AS OF 01/30/14): Patients use a
smart phone that prompts patients to electronically answer questions about diet,
health-related symptoms, and swallowing exercises. Patients also take video recordings of
their neck while performing swallowing exercises. The device is used for 5 consecutive days.
After a 2 week period, patients resume use of the device for an additional 5 days.

ARM IV (CANCER SURVIVORS THAT ARE CURRENT/FORMER SMOKERS) (CLOSED TO ACCRUAL AS OF 01/30/14):
Patients use a carbon monoxide (CO) monitor and a smart phone that prompts patients to
electronically answer questions about smoking. Patients also take video recordings of
themselves while exhaling into the CO monitor. The devices are used for 5 consecutive days.
After a 2 week period, patients resume use of the devices for an additional 5 days.

PANCREATIC CANCER STUDY (PCS): Patients receive post-surgical wellness program consisting of
physical activity, nutrition counseling, and daily monitoring (physical activity, weight, and
self-reported data) for up to 7 months post-op.

Inclusion Criteria:

- Diagnosis of any stage I - IV colorectal cancer or recurrent colorectal cancer (Arm 1)

- Able to speak, read, and write in English (Pre-pilot phase, Arms 1-4)

- Able to provide informed consent (Pre-pilot phase, Arms 1-4, PCS study)

- Lives in the Houston area (Harris county or a contiguous county) (Pre-pilot phase)

- Eastern Cooperative Oncology Group (ECOG) status of 0 - 2, or self-reports being up
and about more than 50% of waking hours and able to provide self-care (Arm 1)

- Diagnosis of any of the following cancers: stage 1-4b oropharyngeal, hypopharyngeal,
nasopharyngeal, salivary gland or oral cavity; stage 3-4b laryngeal; any unknown
primary head and neck cancer with cervical metastasis that will be addressed with
treatment to bilateral necks and mucosa; or other head and neck cancers medically
approved by one of our Radiation Oncology collaborating medical doctors (MDs) (Arms 2
and 3)

- History of any cancer, other than non-melanoma skin cancer (Arm 4)

- Admitted to being a current smoker or recent quitter upon admission to MD Anderson
Cancer Center (MDACC) (Arm 4)

- Has a valid home address and functioning home telephone number (Arm 4)

- Lives in the Houston or surrounding area, or resides in this same area during the time
period that coincides with this study (Arms 1-4)

- Patients who will undergo curative pancreatectomy for pancreatic adenocarcinoma,
pancreatic neuroendocrine tumors, or pancreatic cysts (malignant or benign) (PCS
study)

- Fluent in English (PCS study)

- Must have telephone access and agree to engage with research personnel using telephone
(PCS study)

Exclusion Criteria:

- Major surgery in the past 8 weeks (Arms 1 and 4)

- Self-reports hypertension that is not being monitored by a physician and is not being
managed with either medication, observation, or lifestyle change (Pre-pilot phase,
Arms 1-3)

- Overt cognitive difficulty demonstrated by not being clearly oriented to time or
person or place (Arms 1-4)

- Orthopedic, neurologic, or musculoskeletal disability that would interfere with the
functional task of standing on a weight scale (Pre-pilot phase, Arm 2)

- Not currently receiving radiation treatment for a cancer listed in the arm-specific
inclusion criteria (Arms 2 and 3)

- Zubrod performance status > 2, or self-reports either not being up and about more than
50% of waking hours or unable to provide self-care (Arms 2 and 3)

- Currently receiving treatment for a cancer other than those listed in the arm-specific
inclusion criteria (exception: the study does not exclude those receiving treatment
for non-melanoma skin cancer) (Arms 2 and 3)

- History of current oropharyngeal dysphagia unrelated to cancer diagnosis (e.g.
dysphagia due to underlying neurogenic disorder) (Arm 3 only)

- Active substance use disorder (diagnosed or strongly suspected) (Arm 4)

- Currently enrolled in protocol 2014-0712 (PCS study)

- No home access to internet (PCS study)

- No home WiFi connection (PCS study)

- During clinician's pre-surgical evaluation, presents with high risk for
non-therapeutic resection related to cancer diagnosis (PCS study)

- Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease (New
York Heart Association functional class III or IV) (PCS study)

- Recent fracture or acute musculoskeletal injury that precludes the ability to fully
bear weight on all 4 limbs in order to participate in an exercise intervention (PCS
study)

- Poorly-controlled pain with a self-reported pain score of 7/10 at the time of
enrollment (PCS study)

- Myopathic or rheumatologic disease that impacts physical function (PCS study)

- Has a pacemaker or other internal medical device, or reports being pregnant (PCS
study)