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

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ClinicalTrials.gov Identifier: NCT03249090
Recruitment Status : Recruiting
First Posted : August 15, 2017
Last Update Posted : August 20, 2018
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.

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.

Condition or disease Intervention/treatment Phase
Advanced Cancer Metastatic Cancer Other: Patient Reporting of Symptoms Other: Usual Care Delivery Other: Standardized symptom management guidelines Not Applicable

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: "PRO-TECT" Patient Reported Outcomes to Enhance Cancer Treatment
Actual Study Start Date : October 30, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : September 2021

Arm Intervention/treatment
Experimental: patient reporting symptoms + symptom guidelines
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 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 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.

Other: Standardized symptom management guidelines

At baseline, the CRA will provide all participants with a symptom advice booklet, based on best available evidence, existing guidelines, and expert consensus.

Nurses involved with the clinical care of participants in this study will be provided with access to evidence-based symptom management pathways.


Active Comparator: Usual care delivery + symptom guidelines
Evidence-based symptom management pathways provided to patients and clinicians
Other: Usual Care Delivery
Patients receive routine cancer care delivery with no additional systematic monitoring of symptoms

Other: Standardized symptom management guidelines

At baseline, the CRA will provide all participants with a symptom advice booklet, based on best available evidence, existing guidelines, and expert consensus.

Nurses involved with the clinical care of participants in this study will be provided with access to evidence-based symptom management pathways.





Primary Outcome Measures :
  1. Physical Functioning [ Time Frame: 3 months ]
    Physical functioning will be measured via the QLQ-C30

  2. Overall Survival [ Time Frame: Up to 24 months ]
    Based on the number of events observed. Overall survival will be compared between arms using a stratified log-rank rest.


Secondary Outcome Measures :
  1. Emergency room/hospital utilization [ Time Frame: 12 months ]
    Emergency room/hospitalization will be compared between arms using stratified Fine-Gray competing risk regression with death a competing risk

  2. Duration of cancer treatment [ Time Frame: 12 months ]
    Duration of cancer treatment will be compared between arms using stratified Fine-Gray competing risk regression with death as a competing risk

  3. Health-related quality of life and symptom burden time [ Time Frame: 3 months ]
    Measured by QLQ-C30

  4. Patient Satisfaction/Communication [ Time Frame: 3 months ]
    Measured with Patient Satisfaction Questionnaires



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03249090


Contacts
Contact: Sydney Henson 919-445-6225 seriggsb@email.unc.edu
Contact: Amanda Bradley 617-525-9942 abradley@alliancefoundationtrials.org

  Show 32 Study Locations
Sponsors and Collaborators
Alliance Foundation Trials, LLC.
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
Study Chair: Ethan Basch, MD University of North Carolina, Chapel Hill

Publications:

Responsible Party: Alliance Foundation Trials, LLC.
ClinicalTrials.gov Identifier: NCT03249090     History of Changes
Other Study ID Numbers: AFT-39
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes