Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-27 @ 10:56 PM
Study NCT ID:
NCT03959033
Status:
TERMINATED
Last Update Posted:
2022-08-31
First Post:
2018-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Reported Outcome Measures (PROMs) With Trabectedin
Sponsor:
University of Leeds
Organization:
Study Overview
Official Title:
A Pilot Study of Patient Reported Outcomes When Treated With Trabectedin for Unresectable and/or Metastatic Soft Tissue Sarcoma
Status:
TERMINATED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patient reported outcome measures (PROMs) are central to understanding the impact of cancer treatments on patients. Treatment may control cancer growth, and even sometimes modestly improve the length of life, but at the expense of disruption of lifestyle, and of toxicities. It is very important to use PROMs to evaluate the balance between these risks and benefits to understand the overall impact of the treatment.
It remains poorly described whether patients report improved outcomes during palliative chemotherapy with trabectedin, using high quality questionnaires, and how this may vary with the clinical effects and duration of the treatment and characteristics of the patient.
It remains poorly described whether patients report improved outcomes during palliative chemotherapy with trabectedin, using high quality questionnaires, and how this may vary with the clinical effects and duration of the treatment and characteristics of the patient.
Detailed Description:
Trabectedin improves progression-free survival in un-resectable advanced soft tissue sarcoma, in particular lipo- and leiomyo- sarcomas after failure of conventional chemotherapy, with a low level of reported grade 3 symptomatic toxicity for many patients. However objective responses are infrequent, with the largest proportion of patients who benefit using traditional oncological response criteria having a delay in progression with the cancer stable. Trabectedin may improve the duration of cancer control by the modulation of cancer growth as measured by the growth modulation index (GMI).
Patient reported outcome measures (PROMs) are central to understanding the impact of cancer therapies which may shrink cancers or control their growth, and even sometimes modestly improve the length of life, but at the expense of disruption of lifestyle, and of toxicities.
It is very important to use PROMs to evaluate the balance between these risks and benefits to understand the overall impact of the therapy. It remains poorly described whether patients report improved outcomes during palliative chemotherapy with trabectedin, using validated questionnaires, and how this may vary with the clinical efficacy and duration of the treatment and the demographic and clinical characteristics of the patient. Therefore the investigators intend to examine the feasibility of collecting patient reported outcome measures using validated instruments prospectively during English NHS administration of Trabectedin and with this to explore the pattern of patient reported outcomes, such as is the trajectory in PROMs distinct comparing groups by the size or symptoms from tumour masses.
The study will aim deliver Patient Reported Outcomes Measures (PROMs) data in patients with advanced tissue sarcoma. The recruitment target is a total of 30 patients over a 2 year period. Patients' quality of life (QoL) will be captured using a validated QoL questionnaire (EORTC QLQ-C30) during their treatment with Trabectedin. The questionnaire takes approximately 12 minutes and the patient will complete this unaided. Patients will be required to complete the electronic questionnaire using Q-Tool. Q-Tool is a web-based piece of software. Patients will be required to complete this questionnaire alongside receiving standard of care treatment with Trabectedin in the following pattern: On the day of administration of the 1st of treatment with Trabectedin; before the 2nd treatment of Trabectedin; before the 4th treatment of Trabectedin; prior to the 7th treatment of Trabectedin; prior to the 10th treatment of Trabectedin and then will continue in 3 weekly cycles until the end of treatment with Trabectedin. Patients will complete the questionnaire on the computer terminals available in the outpatient clinic before they see the doctor and nurses and prior to treatment on each of these days.
Patients at the end of treatment with Trabectedin will complete a short exit questionnaire. This will assess their experiences of completing the QoL questionnaire and ease of using Q-Tool. The exit questionnaire will take approximately 5 minutes to complete. This will be completed in the outpatient area and provided to the patient by the Research Nurse.
Patient reported outcome measures (PROMs) are central to understanding the impact of cancer therapies which may shrink cancers or control their growth, and even sometimes modestly improve the length of life, but at the expense of disruption of lifestyle, and of toxicities.
It is very important to use PROMs to evaluate the balance between these risks and benefits to understand the overall impact of the therapy. It remains poorly described whether patients report improved outcomes during palliative chemotherapy with trabectedin, using validated questionnaires, and how this may vary with the clinical efficacy and duration of the treatment and the demographic and clinical characteristics of the patient. Therefore the investigators intend to examine the feasibility of collecting patient reported outcome measures using validated instruments prospectively during English NHS administration of Trabectedin and with this to explore the pattern of patient reported outcomes, such as is the trajectory in PROMs distinct comparing groups by the size or symptoms from tumour masses.
The study will aim deliver Patient Reported Outcomes Measures (PROMs) data in patients with advanced tissue sarcoma. The recruitment target is a total of 30 patients over a 2 year period. Patients' quality of life (QoL) will be captured using a validated QoL questionnaire (EORTC QLQ-C30) during their treatment with Trabectedin. The questionnaire takes approximately 12 minutes and the patient will complete this unaided. Patients will be required to complete the electronic questionnaire using Q-Tool. Q-Tool is a web-based piece of software. Patients will be required to complete this questionnaire alongside receiving standard of care treatment with Trabectedin in the following pattern: On the day of administration of the 1st of treatment with Trabectedin; before the 2nd treatment of Trabectedin; before the 4th treatment of Trabectedin; prior to the 7th treatment of Trabectedin; prior to the 10th treatment of Trabectedin and then will continue in 3 weekly cycles until the end of treatment with Trabectedin. Patients will complete the questionnaire on the computer terminals available in the outpatient clinic before they see the doctor and nurses and prior to treatment on each of these days.
Patients at the end of treatment with Trabectedin will complete a short exit questionnaire. This will assess their experiences of completing the QoL questionnaire and ease of using Q-Tool. The exit questionnaire will take approximately 5 minutes to complete. This will be completed in the outpatient area and provided to the patient by the Research Nurse.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: