Electronic Patient Reporting of Symptoms During Cancer Treatment

This is a cluster RCT at up to 50 sites where randomization will occur in a 1:1 ratio at the
site level (not at the individual patient level). Therefore, up to 25 sites will be
randomized to the PRO-TECT intervention arm (patient-reporting of symptoms plus access to
standardized symptom management guideline), and up to 25 sites will be randomized to the
control arm (usual care delivery plus access to standardized symptom management guideline).
Specifically:

PROCEDURES AT ALL SITES (CONTROL SITES AND INTERVENTION SITES):

- Site staff (CRA and Nurse Champion required) will attend the site initiation webinar
with UNC staff, including training for the PRO-Core online data management system and
orientation to the symptom management guidelines.

- At enrollment, all participants will be given a booklet with patient-level symptom
advice and a link to the content online.

- All participants will receive compensation for participation, mailed to them as gift
cards by UNC.

- CRAs will train all participants how to complete outcomes questionnaires for the trial
using the PRO-Core online system. Participants will be given a choice to complete these
in clinic or from home online, or if necessary via paper in clinic (with the CRA
entering the data into PRO-Core). If the patient does not self-complete this
information, the CRA will contact them to collect the information and then enter it into
PRO-Core. The outcomes questionnaires will be completed at baseline; and at month 1 (+/-
2 weeks); and at months 3, 6, 9, and 12/off-study (+/- 4 weeks each), and will be
available in English, Spanish, or Mandarin Chinese. At each time point, the CRA will
contact the participant to remind them about the upcoming questionnaire and offer help.

- Chart abstraction will be conducted by CRAs at baseline and at off-study for each
participant, with data entered into the PRO-Core system. Date of death information will
additionally be abstracted at 18 and 24 months, and possibly later per the UNC study
team.

- CRAs will be asked to complete a feedback survey (entered by the CRA into the PRO-Core
online system) and may be asked to participate in a brief telephone debriefing and/or
site visit.

- Accrual will be monitored in a weekly teleconference between the UNC team and site CRAs.

ADDITIONAL PROCEDURES AT INTERVENTION SITES ONLY:

- At baseline, CRAs will also train patients to self-report symptoms and physical
functioning using the PRO-Core system weekly for up to a year, with a choice to do this
online or via an automated telephone system (patient choice), and a choice of English,
Spanish, or Mandarin Chinese.

- Whenever a concerning symptom is reported, an automated "email alert" notification will
be sent to the site CRA. The CRA will forward the email alert to the responsible
clinical nurse (or other covering clinician) and CC the site's Nurse Champion. Within 72
hours, the CRA will document what action(s), if any, were taken by the nurse in response
to the alert (entered by the CRA into a form in the PRO-Core system).

- A symptom report will be printed/generated by the site CRA whenever the patient has a
clinic visit, and will be given to the oncologist and nurse caring for the patient.

Inclusion Criteria:

1. Adults (21+) with advanced/metastatic cancer of any type (EXCEPT leukemia or indolent
[slow growing] lymphoma)

2. Receiving outpatient systemic cancer treatment for non-curative/palliative intent,
including chemotherapy, targeted therapy, or immunotherapy.

3. Enrolled at any point in their treatment trajectory, meaning during any line of
treatment, and at any point during a course or cycle of treatment.

4. Can understand English, Spanish, and/or Mandarin Chinese.

Exclusion Criteria:

1. Cognitive deficits that would preclude understanding of consent form and/or
questionnaires.

2. Current participation in a therapeutic clinical trial (because these often involve PRO
questionnaires and intensive monitoring).

3. Patients being treated with curative intent (e.g., adjuvant chemotherapy for breast,
lung, or ovarian cancer; primary curative therapy for testis cancer or lymphoma).

4. Receiving hormonal therapy only (e.g., tamoxifen or aromatase inhibitors in breast
cancer; androgen deprivation therapy in prostate cancer; or octreotide in
neuroendocrine cancers)

5. Indolent lymphomas (due to their prolonged time courses that may be minimally
symptomatic).

6. Leukemias (time courses inconsistent with other tumor types in chronic and acute
leukemias).

7. Does not understand English, Spanish, or Mandarin Chinese.