Electronic Patient Reporting of Symptoms During Cancer Treatment

Study Overview
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Brief Summary
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The current study is designed to test nationally whether patients' outcomes and utilization of services can be improved through symptom monitoring via patient-reported outcomes between visits.

Detailed Description
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This is a cluster RCT at approximately 50 sites where randomization will occur in a 1:1 ratio at the site level (not at the individual patient level). Therefore, approximately 25 sites will be randomized to the PRO-TECT intervention arm (patient-reporting of symptoms), and approximately 25 sites will be randomized to the control arm (usual care delivery). Approximately 1200 patients will be enrolled. 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.

Official Title
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PRO-TECT Patient Reported Outcomes to Enhance Cancer Treatment

Conditions
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Metastatic Cancer

Intervention / Treatment
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* Other: Patient Self-Reporting of Symptoms
* Other: Usual Care Delivery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults (21+) with metastatic cancer of any type (EXCEPT leukemia or indolent [slow growing] lymphoma) Receiving outpatient systemic cancer treatment for non-curative/palliative intent, including chemotherapy, targeted therapy, or immunotherapy. 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. Can understand English, Spanish, and/or Mandarin Chinese. Exclusion Criteria: Cognitive deficits that would preclude understanding of consent form and/or questionnaires. Current participation in a therapeutic clinical trial (because these often involve PRO questionnaires and intensive monitoring). Patients being treated with curative intent (e.g., adjuvant chemotherapy for breast, lung, or ovarian cancer; primary curative therapy for testis cancer or lymphoma). Receiving hormonal therapy only (e.g., tamoxifen or aromatase inhibitors in breast cancer; androgen deprivation therapy in prostate cancer; or octreotide in neuroendocrine cancers) Indolent lymphomas (due to their prolonged time courses that may be minimally symptomatic). Leukemias (time courses inconsistent with other tumor types in chronic and acute leukemias). Does not understand English, Spanish, or Mandarin Chinese.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient Self-Reporting of Symptoms<br>Patients report symptoms weekly via web or automated telephone system. Email alerts to nurses for severe/worsening symptoms; printouts for clinicians at visits. Evidence based symptom management pathways provided to patients and clinicians. | Other: Patient Self-Reporting of Symptoms<br>* At baseline, CRAs will train patients to self-report symptoms and physical functioning weekly for up to a year, with a choice to do so online or via an automated telephone system. Whenever a concerning symptom is reported, an automated email alert notification will be sent to the site CRA. The CRA will forward the 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.<br>|
| Active Comparator: Usual Care Delivery<br>Evidence-based symptom management pathways provided to patients and clinicians | Other: Usual Care Delivery<br>* Patients receive routine cancer care delivery with no additional systematic monitoring of symptoms<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Based on administrative datasets and practice self-report/medical records. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Functioning | Physical functioning will be measured via the QLQ-C30 | month 3 | 
| Symptom Control | Measured via the QLQ-C30 | month 3 | 
| Health-related quality of life and symptom burden time | Measured by QLQ-C30 | month 3 | 
| Patient Satisfaction/Communication | Measured via Patient Satisfaction Questionnaires | month 3 | 
| Emergency room/hospital utilization | Based on practice self-report/medical records and/or administrative datasets | 1 year |