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.
Condition or disease |
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Sarcoma Liposarcoma Leiomyosarcoma |
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.
Study Type : | Observational |
Estimated Enrollment : | 30 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | A Pilot Study of Patient Reported Outcomes When Treated With Trabectedin for Unresectable and/or Metastatic Soft Tissue Sarcoma |
Actual Study Start Date : | November 29, 2016 |
Estimated Primary Completion Date : | August 1, 2019 |
Estimated Study Completion Date : | August 1, 2019 |
Ages Eligible for Study: | 16 Years to 130 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
This study will identify adult patients treated in Leeds with an indication for Trabectedin as either second or third line therapy for relapsed soft tissue sarcoma.
Patients suitable for treatment will be those with the following histologies Synovial Sarcoma Myxoid liposarcomas De-differentiated liposarcoma with some clinical sensitivity demonstrated to earlier lines of chemotherapy Leiomyosarcoma Other soft-tissue sarcomas with some clinical sensitivity demonstrated to earlier lines of chemotherapy
Inclusion Criteria:
Exclusion Criteria:
Contact: Hannah Wiggington | hannah.wigginton@nhs.net |
United Kingdom | |
Leeds Teaching Hospitals NHS Trust | Recruiting |
Leeds, West Yorkshire, United Kingdom, LS9 7TF | |
Contact: Samantha Noutch samantha.noutch@nhs.net |
Principal Investigator: | Daniel Stark | University of Leeds | |
Principal Investigator: | Daniel Stark | d.p.stark@leeds.ac.uk |
Tracking Information | |||||||
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First Submitted Date | January 12, 2018 | ||||||
First Posted Date | May 22, 2019 | ||||||
Last Update Posted Date | May 22, 2019 | ||||||
Actual Study Start Date | November 29, 2016 | ||||||
Estimated Primary Completion Date | August 1, 2019 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | ||||||
Change History | No Changes Posted | ||||||
Current Secondary Outcome Measures | Not Provided | ||||||
Original Secondary Outcome Measures | Not Provided | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title | Patient Reported Outcome Measures (PROMs) With Trabectedin | ||||||
Official Title | A Pilot Study of Patient Reported Outcomes When Treated With Trabectedin for Unresectable and/or Metastatic Soft Tissue Sarcoma | ||||||
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. |
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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. |
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Study Type | Observational | ||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||||
Biospecimen | Not Provided | ||||||
Sampling Method | Non-Probability Sample | ||||||
Study Population |
This study will identify adult patients treated in Leeds with an indication for Trabectedin as either second or third line therapy for relapsed soft tissue sarcoma. Patients suitable for treatment will be those with the following histologies Synovial Sarcoma Myxoid liposarcomas De-differentiated liposarcoma with some clinical sensitivity demonstrated to earlier lines of chemotherapy Leiomyosarcoma Other soft-tissue sarcomas with some clinical sensitivity demonstrated to earlier lines of chemotherapy |
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Condition |
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Intervention | Not Provided | ||||||
Study Groups/Cohorts | Not Provided | ||||||
Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status | Unknown status | ||||||
Estimated Enrollment |
30 | ||||||
Original Estimated Enrollment | Same as current | ||||||
Estimated Study Completion Date | August 1, 2019 | ||||||
Estimated Primary Completion Date | August 1, 2019 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 16 Years to 130 Years (Child, Adult, Older Adult) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries | United Kingdom | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number | NCT03959033 | ||||||
Other Study ID Numbers | 16/WM/0446 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Daniel Stark, University of Leeds | ||||||
Study Sponsor | University of Leeds | ||||||
Collaborators | Not Provided | ||||||
Investigators |
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PRS Account | University of Leeds | ||||||
Verification Date | May 2019 |