Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000119594
Ethics application status
Approved
Date submitted
11/01/2024
Date registered
9/02/2024
Date last updated
9/02/2024
Date data sharing statement initially provided
9/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Time Toxicity and its Relationship with Quality of Life in Patients Undergoing Phase 1 Oncology Clinical Trials
Scientific title
Time Toxicity and its Relationship with Quality of Life in Patients Undergoing Phase 1 Oncology Clinical Trials
Secondary ID [1] 311299 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Time toxicity 332541 0
Cancer 332542 0
Condition category
Condition code
Cancer 329230 329230 0 0
Any cancer

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The Time Toxicity (TT, Days) of participation in phase 1 oncology clinical trials will be prospectively collected in patients newly enrolling in such trials for 3 months or earlier if discontinued from the trial. The TT and its impact on quality of life (QOL) of patients participating in these trials will be assessed through patient reported outcomes. TT will be measured using a ‘Participant Time Diary’ filled out by the patient and QOL will be assessed through semi-structured interviews and validated QOL questionnaires at baseline and 3 months or earlier. We estimate it may take up to 20 minutes over the course of the study to complete the 'Participant Time Diary' and up t0 40 minutes to complete the questionnaires and interviews at each time point.
Intervention code [1] 327744 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337067 0
To prospectively measure time toxicity in participants enrolled in Phase 1 oncology clinical trials
Timepoint [1] 337067 0
TT (days) will be measured for 3 months from commencement of the phase 1 clinical trial or earlier if the patient discontinues from the trial.
Primary outcome [2] 337226 0
To assess the impact of time toxicity on the quality of life in participants enrolled in a phase 1 oncology clinical trials
Timepoint [2] 337226 0
The semi-structured interviews and validated questionnaires will be conducted at baseline and 3-months from commencement of the phase 1 clinical trial or earlier if they are discontinued.
Secondary outcome [1] 430556 0
To determine the impact of phase 1 clinical trial participation on carers
Timepoint [1] 430556 0
Baseline (commencement of phase 1 clinical trial) and at 3 months or earlier if the patient discontinues from the trial
Secondary outcome [2] 430557 0
To assess the preference of oncologists in enrolling patients onto P1 trials
Timepoint [2] 430557 0
A standalone objective to be conducted during the course of this study
Secondary outcome [3] 430558 0
To assess the difference in expected vs actual TT in Phase 1 oncology clinical trials
Timepoint [3] 430558 0
Throughout a patient’s enrolment in this study - from the patient's commencement (baseline) on the phase 1 clinical trial till 3 months or earlier if they are discontinued.
Secondary outcome [4] 431124 0
Overall survival
Timepoint [4] 431124 0
From commencement of phase 1 clinical trial till up to 6 months.

Eligibility
Key inclusion criteria
1.Participants with advanced cancers recruited for Southern Oncology Clinical Research Unit Phase 1 trials from the commencement of this research study will be invited to participate.
2. Participants who are conversant in English and able to consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participants who do not progress to commencing the Phase 1 clinical trial post signing this research study’s consent form.

Study design
Purpose
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
19/02/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 315551 0
University
Name [1] 315551 0
Flinders University
Country [1] 315551 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Flinders University, Sturt Road, Bedford Park, South Australia, 5042
Country
Australia
Secondary sponsor category [1] 317639 0
None
Name [1] 317639 0
Address [1] 317639 0
Country [1] 317639 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314450 0
Flinders University Human Research Ethics Committee
Ethics committee address [1] 314450 0
Flinders University, Sturt Road, Bedford Park, South Australia, 5042
Ethics committee country [1] 314450 0
Australia
Date submitted for ethics approval [1] 314450 0
Approval date [1] 314450 0
27/10/2023
Ethics approval number [1] 314450 0

Summary
Brief summary
Management of cancer is a rapidly evolving field, and it occurs in 4 stages: phase 1 (P1) to phase 4. P1 clinical trials are designed to test drug pharmacokinetic profiles and toxicity. However, most often patients enrol in these trials for potential therapeutic benefits. P1 trials often require participants to frequently interact with the health care team for various investigations and treatment. This time they spend interacting with the health care team has the potential to reduce quality time that participants could have utilised otherwise. This is called 'Time Toxicity' and it is defined as the time a participant spends organising and obtaining treatment including in/out-patient visits, hospitalisations, emergency care for side effects, travel and wait times, and follow-up tests.

TT reported in participants undergoing cancer treatment has shown to carry a substantial burden, but its impact on the quality of life in participants undergoing P1 trials is not well explored. As such, it is often overlooked as a deciding factor in the consenting processes for the P1 trials.

We aim to measure TT and assess its impact on the quality of life of participants enrolled in P1 oncology clinical trials through patient-reported outcomes.

Who is it for?
You may be eligible for this study if you are an adult with cancer who is going to take part in a phase 1 cancer clinical trial.

Study details
All participants in this study will continue with their phase 1 clinical trial, and will be asked to complete a diary for 3 months to report their time toxicity. Participants will also be asked to complete questionnaires and take part in a one-on-one interview describing their experiences and expectations at the start of the phase 1 clinical trial and after the three months (or earlier).

It is hoped that this study will provide data that can help clinicians, patients, and families make the right treatment decisions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131626 0
Dr Shawgi Sukumaran
Address 131626 0
Flinders University, Sturt Road, Bedford Park, South Australia, 5042
Country 131626 0
Australia
Phone 131626 0
+61 8 8204 8997
Fax 131626 0
Email 131626 0
shawgi.sukumaran@flinders.edu.au
Contact person for public queries
Name 131627 0
Miss Benita Rajvi
Address 131627 0
Flinders University, Sturt Road, Bedford Park, South Australia, 5042
Country 131627 0
Australia
Phone 131627 0
+61 450 910 987
Fax 131627 0
Email 131627 0
rajv0009@flinders.edu.au
Contact person for scientific queries
Name 131628 0
Miss Benita Rajvi
Address 131628 0
Flinders University, Sturt Road, Bedford Park, South Australia, 5042
Country 131628 0
Australia
Phone 131628 0
+61 450 910 987
Fax 131628 0
Email 131628 0
rajv0009@flinders.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.