Electronic Patient Reporting of Symptoms During Cancer Treatment
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Mankato, Minnesota: 18-003847
- La Crosse, Wisconsin: 18-003847
- Eau Claire, Wisconsin: 18-003847
NCT ID: NCT03249090
Sponsor Protocol Number: AFT-39
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
Contact |
Mankato, Minn.
Mayo Clinic principal investigator Konstantinos Leventakos, M.D., Ph.D. |
Closed for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
La Crosse, Wis.
Mayo Clinic principal investigator Paula Gill, M.D. |
Closed for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
Eau Claire, Wis.
Mayo Clinic principal investigator Eyad Al-Hattab, M.D. |
Closed for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
More information
Publications
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A set of common cancer-related and treatment-related symptoms has been proposed for quality of care assessment and clinical research. Using data from a large, multicenter, prospective study, the authors assessed the effects of disease site and stage on the percentages of patients rating these proposed symptoms as moderate to severe.
Read More on PubMed
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Patients with cancer experience acute and chronic symptoms caused by their underlying disease or by the treatment. While numerous studies have examined the impact of various treatments on symptoms experienced by cancer patients, there are inconsistencies regarding the symptoms measured and reported in treatment trials. This article presents a systematic review of the research literature of the prevalence and severity of symptoms in patients undergoing cancer treatment.
Read More on PubMed
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Adverse symptom event reporting is vital as part of clinical trials and drug labeling to ensure patient safety and inform risk-benefit decision making. The purpose of this study was to assess the reliability of adverse event reporting of different clinicians for the same patient for the same visit.
Read More on PubMed
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Many patients with advanced cancer depend upon health care providers for symptom assessment. The extent of agreement between patient and provider symptom assessments and the association of agreement with demographic- and disease-related factors was examined.
Read More on PubMed
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Patient-reported measures include preferences and reports about care received, health behaviors, and outcomes of care (patient satisfaction and health-related quality of life). These measures are a core aspect of health care, but there is much to be learned about how to use them to improve clinical practice.
Read More on PubMed
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To examine the prevalence of chemotherapy-or radiotherapy-associated side effects and related treatment burden, and correlates of fatigue and missed work days among cancer patients.
Read More on PubMed
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Adverse events in chemotherapy clinical trials are assessed and reported by clinicians, yet clinician accuracy in assessing symptoms has been questioned. We compared patient reporting of eight symptoms using a validated instrument, the European Organization for the Research and Treatment of Cancer Quality-of-Life Questionnaire C30 (QLQ-C30 or QLQ) with physicians' reporting of the same symptoms in the study's adverse events log.
Read More on PubMed