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Trial registered on ANZCTR


Registration number
ACTRN12618001464257
Ethics application status
Approved
Date submitted
15/08/2018
Date registered
31/08/2018
Date last updated
4/09/2019
Date data sharing statement initially provided
4/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Does pre-exposure to the infusion context reduce nausea in first time chemotherapy patients? A Pilot.
Scientific title
A pilot randomised controlled trial of context pre-exposure for nausea in women undergoing chemotherapy with carboplatin/paclitaxel for the first time.
Secondary ID [1] 295341 0
Nil
Universal Trial Number (UTN)
U1111-1216-3634
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chemotherapy nausea 308547 0
Condition category
Condition code
Cancer 308301 308301 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 301664 0
Prevention
Comparator / control treatment
Standard chemotherapy education delivered to patients individually in the oncology offices (not in the chemotherapy infusion ward). 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.
Control group
Active

Outcomes
Primary outcome [1] 306596 0
Anticipatory nausea (single study specific item from 1 'no nausea' to 7 'extremely nauseated')
Timepoint [1] 306596 0
Baseline - prior to randomisation - and immediately prior to each infusion
Primary outcome [2] 307236 0
Average post-chemotherapy nausea (average of 4 day diary asking for nausea ratings at morning, afternoon, evening, and night on scale form 1 'no nausea' to 7 'extremely nauseated', Burish et al, 1987)
Timepoint [2] 307236 0
Baseline - prior to randomisation - and over 4 days from the beginning of each infusion
Primary outcome [3] 307237 0
Peak post-chemotherapy nausea (highest rating on the 4 day asking for nausea ratings at morning, afternoon, evening, and night on scale form 1 'no nausea' to 7 'extremely nauseated', Burish et al, 1987)
Timepoint [3] 307237 0
Baseline - prior to randomisation - and over 4 days from the beginning of each infusion
Secondary outcome [1] 348976 0
Occurrence of vomiting (measured via a single yes/no item each day in the nausea diary, Burish et al, 1987)
Timepoint [1] 348976 0
Over 4 days from the beginning of each infusion
Secondary outcome [2] 348977 0
Anti-emetic use (open question asked each daily)
Timepoint [2] 348977 0
Measured over 4 days from the beginning of each infusion
Secondary outcome [3] 348979 0
State Anxiety (STAI)
Timepoint [3] 348979 0
Measured at baseline (prior to random allocation) and then immediately prior to each infusion
Secondary outcome [4] 348980 0
Quality of Life (FACT-G Short form, 7 items) amended to 4 day recall period.
Timepoint [4] 348980 0
Measured at baseline (prior to random allocation) and over the 4 days following each infusion
Secondary outcome [5] 349057 0
Treatment Satisfaction (study specific measure) assessing satisfaction with chemotherapy treatment, initial education, and information provided to patients (all measured on 7-point scales)
Timepoint [5] 349057 0
Measured 4-7 days after the final infusion
Secondary outcome [6] 349059 0
Expectancy (measured on a single-item study specific question from 1 'no nausea' to 7 'expect to be extremely nauseated')
Timepoint [6] 349059 0
Measured at baseline (prior to random allocation) and then immediately prior to each infusion
Secondary outcome [7] 349710 0
Worry (measured on a single-item study specific question from 1 'not at all worried' to 7 'extremely worried')
Timepoint [7] 349710 0
Measured at baseline (prior to random allocation) and then immediately prior to each infusion

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
i) Currently enrolled in another research trial
ii) Concurrently being treated with radiation

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Prepared sealed opaque envelopes will contain patient allocations and the researcher assessing eligibility will only open these after a decision on eligibility and baseline characteristics have been measured.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomised in blocks of 10 with the sequence generated via https://www.randomizer.org/.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
BASELINE CHARACTERISTICS
Chi-squared tests and independent samples t-tests will be used to compare baseline characteristics across the two groups.

PRIMARY OUTCOMES
The three nausea measures (anticipatory, average post, and peak post) will be tested via a 2 x 3 mixed-model ANCOVA with group (intervention, standard) and infusion cycle (1,2,3) as the independent variables. Baseline characteristics that have a p-value of <0.1 when comparing the two groups will be included as covariates in these analyses.

SECONDARY OUTCOMES
The same approach will be used anti-emetic use, quality of life, state anxiety, and expectancy, i.e. 2 x 3 mixed-model ANCOVA. Treatment satisfaction will be assessed via a one-way way ANCOVA comparing the two groups, controlling for any differences in baseline characteristics. Vomiting will be assessed via logistic regression at each time point.

EXPLORATORY MEDIATOR ANALYSIS
Where any significant differences are found between the two groups on the primary (nausea) outcomes, we will conduct exploratory mediator analysis to determine whether expectancy, anxiety, or worry mediate the effect of the intervention on those primary outcomes. This will be implemented via Preacher and Hayes/PROCESS Model.


Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2018
Actual
19/09/2018
Date of last participant enrolment
Anticipated
1/09/2020
Actual
Date of last data collection
Anticipated
31/10/2020
Actual
Sample size
Target
30
Accrual to date
4
Final
Recruitment outside Australia
Country [1] 10615 0
United States of America
State/province [1] 10615 0
Ohio

Funding & Sponsors
Funding source category [1] 300040 0
University
Name [1] 300040 0
University of Toledo
Country [1] 300040 0
United States of America
Primary sponsor type
University
Name
University of Toledo
Address
The University of Toledo
2801 West Bancroft Street
Toledo Ohio, 43606, U.S.A.
Country
United States of America
Secondary sponsor category [1] 299594 0
Hospital
Name [1] 299594 0
ProMedica
Address [1] 299594 0
Research Administration
2142 N. Cove Blvd., HMT - Suite 880
Toledo, Ohio 43606, U.S.A.
Country [1] 299594 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300800 0
Institutional Review Board - ProMedica
Ethics committee address [1] 300800 0
Research Administration
2142 N. Cove Blvd., HMT - Suite 880
Toledo, Ohio 43606, U.S.A.
Ethics committee country [1] 300800 0
United States of America
Date submitted for ethics approval [1] 300800 0
21/06/2018
Approval date [1] 300800 0
08/08/2018
Ethics approval number [1] 300800 0
#18-049

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84854 0
Prof Andrew Geers
Address 84854 0
The University of Toledo
2801 West Bancroft Street
Toledo Ohio, 43606, U.S.A.
Country 84854 0
United States of America
Phone 84854 0
+1-419-530-8530
Fax 84854 0
Email 84854 0
[email protected]
Contact person for public queries
Name 84855 0
Andrew Geers
Address 84855 0
The University of Toledo
2801 West Bancroft Street
Toledo Ohio, 43606, U.S.A.
Country 84855 0
United States of America
Phone 84855 0
+1-419-530-8530
Fax 84855 0
Email 84855 0
[email protected]
Contact person for scientific queries
Name 84856 0
Andrew Geers
Address 84856 0
The University of Toledo
2801 West Bancroft Street
Toledo Ohio, 43606, U.S.A.
Country 84856 0
United States of America
Phone 84856 0
+1-419-530-8530
Fax 84856 0
Email 84856 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified baseline/demographic data, primary and secondary outcomes, potential mediators/moderators.
When will data be available (start and end dates)?
Data will be first made available upon publication of the study results. No end date of data availability has been determined.
Available to whom?
Other researchers
Available for what types of analyses?
Any reasonable request to access the data for any type of re-analysis will be permitted.
How or where can data be obtained?
By contacting the lead investigator.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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