A Study to Evaluate Family Member Exposure to Antineoplastic Drugs in the Home Setting
Overview
Tab Title Description
Study type
ObservationalDescribes 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
- Eau Claire, Wisconsin: 18-008786
Sponsor Protocol Number: 18-008786
About this study
The purpose of this study is to quantify active antineoplastic drug metabolites in the urine samples, oral fluids, and skin of patients receiving intravenous chemotherapy on days 1 through 7 post infusion, to quantify active antineoplastic drug metabolites in the urine samples of family member/caregiver of patient receiving chemotherapy on days 1 through 7 post infusion, and to identify the instructions received by patient/family members to avoid exposure to contaminated bodily fluids from patients’ receiving intravenous antineoplastic drugs and whether the instructions were followed.
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:
Inclusion criteria for cancer patients are:
- Age over 18 years.
- Men or women.
- On day 1 of any cycle of intravenous chemotherapy cycle containing at least one of the following drugs: 5-fluorouracil (5-FU), cyclophosphamide (CP) and platinum-compounds (cisplatin, carboplatin or oxaliplatin).
- Any cancer staging.
- Good performance status in order to avoid additional psychological stress (Eastern Cooperative Oncology Group performance status - ECOG >1, or Karnofsky Performance Status scale - KPS >80).
Inclusion criteria for family member or caregiver are:
- Age over 18 years.
- Men or women.
- Live in the same house as the patient.
- Not receiving any chemotherapy.
Exclusion Criteria:
- Patients/family members that are not able to communicate in English.
- Irrespective of racial, religious, cultural backgrounds, will be excluded from the study.
- If either the cancer patient or the family member does not consent to participate in the study, neither will participate; both should consent to be included in the study.
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 |
Eau Claire, Wis.
Mayo Clinic principal investigator Kaitlyn Bailey, Pharm.D., R.Ph., BCOP |
Closed for enrollment |
Contact information:
Dalete Mota Ph.D.
(715) 838-6937
Contact UsMota.Dalete@mayo.edu
|
More information
Publications
Publications are currently not available