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Electronic Patient Reporting of Symptoms During Cancer Treatment (PRO-TECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03249090
Recruitment Status : Active, not recruiting
First Posted : August 15, 2017
Last Update Posted : August 27, 2021
Sponsor:
Collaborators:
Patient-Centered Outcomes Research Institute
University of North Carolina
Mayo Clinic
American Society of Clinical Oncology
American Cancer Society, Inc.
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
Alliance Foundation Trials, LLC.

Tracking Information
First Submitted Date  ICMJE August 1, 2017
First Posted Date  ICMJE August 15, 2017
Last Update Posted Date August 27, 2021
Actual Study Start Date  ICMJE October 30, 2017
Actual Primary Completion Date March 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 23, 2021)
Overall Survival [ Time Frame: 24 months ]
Based on administrative datasets and practice self-report/medical records.
Original Primary Outcome Measures  ICMJE
 (submitted: August 10, 2017)
  • Physical Functioning [ Time Frame: 3 months ]
    Physical functioning will be measured via the QLQ-C30
  • Overall Survival [ Time Frame: Up to 24 months ]
    Overall survival will be compared between arms using a stratified log-rank test
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 23, 2021)
  • Physical Functioning [ Time Frame: month 3 ]
    Physical functioning will be measured via the QLQ-C30
  • Symptom Control [ Time Frame: month 3 ]
    Measured via the QLQ-C30
  • Health-related quality of life and symptom burden time [ Time Frame: month 3 ]
    Measured by QLQ-C30
  • Patient Satisfaction/Communication [ Time Frame: month 3 ]
    Measured via Patient Satisfaction Questionnaires
  • Emergency room/hospital utilization [ Time Frame: 1 year ]
    Based on practice self-report/medical records and/or administrative datasets
Original Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2017)
  • Emergency room/hospital utilization [ Time Frame: 3 months ]
    Emergency room/hospitalization will be compared between arms using stratified Fine-Gray competing risk regression with death as a competing event
  • Duration of cancer treatment [ Time Frame: 3 months ]
    Duration of cancer treatment will be compared between arms using stratified Fine-Gray competing risk regression with death as a competing event
  • Health-related quality of life and symptom burden [ Time Frame: 3 months ]
    Measured by QLQ-C30
  • Patient Satisfaction/Communication [ Time Frame: 3 months ]
    Measured with Patient Satisfaction Questionnaires
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Electronic Patient Reporting of Symptoms During Cancer Treatment
Official Title  ICMJE "PRO-TECT" Patient Reported Outcomes to Enhance Cancer Treatment
Brief Summary 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

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Metastatic Cancer
Intervention  ICMJE
  • Other: Patient Self-Reporting of Symptoms
    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.
  • Other: Usual Care Delivery
    Patients receive routine cancer care delivery with no additional systematic monitoring of symptoms
Study Arms  ICMJE
  • Experimental: Patient Self-Reporting of Symptoms
    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.
    Intervention: Other: Patient Self-Reporting of Symptoms
  • Active Comparator: Usual Care Delivery
    Evidence-based symptom management pathways provided to patients and clinicians
    Intervention: Other: Usual Care Delivery
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 23, 2021)
1191
Original Estimated Enrollment  ICMJE
 (submitted: August 10, 2017)
1000
Estimated Study Completion Date  ICMJE August 2023
Actual Primary Completion Date March 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Adults (21+) with 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03249090
Other Study ID Numbers  ICMJE AFT-39
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Alliance Foundation Trials, LLC.
Study Sponsor  ICMJE Alliance Foundation Trials, LLC.
Collaborators  ICMJE
  • Patient-Centered Outcomes Research Institute
  • University of North Carolina
  • Mayo Clinic
  • American Society of Clinical Oncology
  • American Cancer Society, Inc.
  • Dana-Farber Cancer Institute
Investigators  ICMJE
Study Chair: Ethan Basch, MD University of North Carolina, Chapel Hill
PRS Account Alliance Foundation Trials, LLC.
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP