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Does pre-exposure to the infusion context reduce nausea in first time chemotherapy patients? A Pilot.

A pilot randomised controlled trial of context pre-exposure for nausea in women undergoing chemotherapy with carboplatin/paclitaxel for the first time.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001464257
Enrollment
4
Registered
2018-08-31
Start date
2018-09-19
Completion date
2020-09-01
Last updated
2019-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of the proposed research is to assess whether pre-exposure can reduce chemo-therapy-induced nausea. Participants will be female patients who are scheduled to receive at least three cycles of chemotherapy at the ProMedica Hickman Cancer Center for the first time. Participants will be recruited prior to the educational session that teaches them about their upcoming chemotherapy treatment. As the independent variable, participants will be randomly assigned to one of two situations for the teaching event. In the treatment-as-usual condition, the teaching will occur, as usual, at the physician office (ProMedica Gynecology/Oncology office). The pre-exposure participants, instead, will have the teaching event at the Hickman Cancer Center seated in the infusion chair set up as if for an actual infusion. In both locations participants will be given the same standard pre-chemotherapy teaching instructions. To determine if the influence of this benign pre-exposure, we will measure self-reported nausea and related outcomes during their first three chemotherapy sessions and on diary measures completed at home following each session.

Interventions

The intervention involves pre-exposure to a simulated chemotherapy infusion in the chemotherapy infusion ward, delivered in addition to standard chemotherapy education. Standard chemotherapy education is routinely delivered to patients individually in the oncology offices. A trained research nurse begins the individual session by talking about the patient’s particular kind of chemotherapy, infusion, expected side effects, and scheduling. Then, the nurse follows a standardized list of topics t

The intervention involves pre-exposure to a simulated chemotherapy infusion in the chemotherapy infusion ward, delivered in addition to standard chemotherapy education. Standard chemotherapy education is routinely delivered to patients individually in the oncology offices. A trained research nurse begins the individual session by talking about the patient’s particular kind of chemotherapy, infusion, expected side effects, and scheduling. Then, the nurse follows a standardized list of topics that covers medications, lab draws, chemotherapy ports, nutrition, preventing illness, hair loss, lifestyle changes, and emergency contact. The education session typically lasts 30-60min and occurs within the week leading up to the first infusion. Patients in the intervention arm will be asked to attend their chemotherapy education in the chemotherapy infusion ward (not the oncology offices). They will be directed to an infusion chair to simulate the condition of an actual infusion. Participants will not have a needle inserted, but will have intravenous catheter and tubing taped on their arm in the same location as a needle would be inserted during chemotherapy. They will then receive their standard chemotherapy education during this simulated infusion and will remain in the infusion chair with the simulated infusion for a minimum of 30 min and until the chemotherapy education is complete.

Sponsors

University of Toledo
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

i) Female cancer patients ii) Have had surgical intervention for cancer iii) About to begin chemotherapy treatment with carboplatin/paclitaxel and scheduled to receive at least 3 infusion cycles iv) Receiving chemotherapy for the first time v) 18 years or older

Exclusion criteria

i) Currently enrolled in another research trial ii) Concurrently being treated with radiation

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026