None listed
Conditions
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.
Interventions
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 va
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.
Sponsors
Flinders University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Exclusion criteria
1. Participants who do not progress to commencing the Phase 1 clinical trial post signing this research study’s consent form.
Outcome results
None listed