ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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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

1/12/2024

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]

none

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Time toxicity

Cancer

Condition category

Condition code

Cancer

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

To prospectively measure time toxicity in participants enrolled in Phase 1 oncology clinical trials

Timepoint [1]

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]

To assess the impact of time toxicity on the quality of life in participants enrolled in a phase 1 oncology clinical trials

Timepoint [2]

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]

To determine the impact of phase 1 clinical trial participation on carers

Timepoint [1]

Baseline (commencement of phase 1 clinical trial) and at 3 months or earlier if the patient discontinues from the trial

Secondary outcome [2]

To assess the preference of oncologists in enrolling patients onto P1 trials

Timepoint [2]

A standalone objective to be conducted during the course of this study

Secondary outcome [3]

To assess the difference in expected vs actual TT in Phase 1 oncology clinical trials

Timepoint [3]

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]

Overall survival

Timepoint [4]

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?

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

2/12/2024

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

University

Name [1]

Flinders University

Address [1]

Flinders University, Sturt Road, Bedford Park, South Australia, 5042

Country [1]

Australia

Primary sponsor type

University

Name

Flinders University

Address

Flinders University, Sturt Road, Bedford Park, South Australia, 5042

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Flinders University Human Research Ethics Committee

Ethics committee address [1]

Flinders University, Sturt Road, Bedford Park, South Australia, 5042

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

27/10/2023

Ethics approval number [1]

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

Dr Shawgi Sukumaran

Address

Flinders University, Sturt Road, Bedford Park, South Australia, 5042

Country

Australia

Phone

+61 8 8204 8997

Fax

shawgi.sukumaran@flinders.edu.au

Contact person for public queries

Name

Shawgi Sukumaran

Address

Flinders University, Sturt Road, Bedford Park, South Australia, 5042

Country

Australia

Phone

+61 8 8204 8997

Fax

shawgi.sukumaran@flinders.edu.au

Contact person for scientific queries

Name

Shawgi Sukumaran

Address

Flinders University, Sturt Road, Bedford Park, South Australia, 5042

Country

Australia

Phone

+61 8 8204 8997

Fax

shawgi.sukumaran@flinders.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.

Trial Review

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