Patient Reported Outcome Measures (PROMs) With Trabectedin

August 26, 2022 updated by: Daniel Stark, University of Leeds

A Pilot Study of Patient Reported Outcomes When Treated With Trabectedin for Unresectable and/or Metastatic Soft Tissue Sarcoma

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.

Study Overview

Status

Terminated

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.

Study Type

Observational

Enrollment (Actual)

7

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS9 7TF
        • Leeds Teaching Hospitals NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 130 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

Inclusion Criteria:

  • This study will include adult patients treated in Leeds with an indication for Trabectedin as either second or third line therapy for relapsed soft tissue sarcoma.
  • Patients will have the ability to provide informed consent and they will have adequate literacy in reading English, or complete the instrument using an NHS interpreter.

Exclusion Criteria:

  • No exclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Global quality of life using the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire core 30 from baseline (week 1) through to 12 weeks (to day 1 of cycle 4 of trabectedin).
Time Frame: Through to study completion, an average of 12 weeks
As this is a pilot exploratory study the investigators will have multiple co-primary outcomes.The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) is a 30 question assessment of quality of life in the following categories: global health status, physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning, fatigue, nausea and vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties. Twenty-eight questions are assessed on a scale of 1 (Not at all) to 4 (Very much); 2 questions are assessed on a scale of 1 (very poor) to 7 (excellent). The range of scores on each scale is from 0 to 100. In the function scales, a score of 100 is best (indicating more function). In the symptom scores, a score of 100 is worst, indicating more symptoms. Scores are totalled from each item to form the scales, then normalised to 0-100.
Through to study completion, an average of 12 weeks
What is the trajectory in the subscales and symptom scales in the scale, from baseline (day 1 cycle 1) to day 1 cycle 4, day 1 cycle 7 and day 1 cycle 10 etc of Trabectedin?
Time Frame: Through to study completion, an average of 12 weeks
As this is a pilot exploratory study the investigators will have multiple co-primary outcomes.The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) is a 30 question assessment of quality of life in the following categories: global health status, physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning, fatigue, nausea and vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties. Twenty-eight questions are assessed on a scale of 1 (Not at all) to 4 (Very much); 2 questions are assessed on a scale of 1 (very poor) to 7 (excellent). The range of scores on each scale is from 0 to 100. In the function scales, a score of 100 is best (indicating more function). In the symptom scores, a score of 100 is worst, indicating more symptoms. Scores are totalled from each item to form the scales, then normalised to 0-100.
Through to study completion, an average of 12 weeks
What is the association between patient's prior treatment (second line versus third line) and the trajectory of the subscales and symptom scales in the EORTC QLQc30 ?
Time Frame: Through to study completion, an average of 12 weeks
As this is a pilot exploratory study the investigators will have multiple co-primary outcomes.The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) is a 30 question assessment of quality of life in the following categories: global health status, physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning, fatigue, nausea and vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties. Twenty-eight questions are assessed on a scale of 1 (Not at all) to 4 (Very much); 2 questions are assessed on a scale of 1 (very poor) to 7 (excellent). The range of scores on each scale is from 0 to 100. In the function scales, a score of 100 is best (indicating more function). In the symptom scores, a score of 100 is worst, indicating more symptoms. Scores are totalled from each item to form the scales, then normalised to 0-100.
Through to study completion, an average of 12 weeks
What is the association between patient age (in deciles) and the trajectory of the subscales and symptom scales in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire core 30 scale?
Time Frame: Through to study completion, an average of 12 weeks
As this is a pilot exploratory study the investigators will have multiple co-primary outcomes.The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) is a 30 question assessment of quality of life in the following categories: global health status, physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning, fatigue, nausea and vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties. Twenty-eight questions are assessed on a scale of 1 (Not at all) to 4 (Very much); 2 questions are assessed on a scale of 1 (very poor) to 7 (excellent). The range of scores on each scale is from 0 to 100. In the function scales, a score of 100 is best (indicating more function). In the symptom scores, a score of 100 is worst, indicating more symptoms. Scores are totalled from each item to form the scales, then normalised to 0-100.
Through to study completion, an average of 12 weeks
What is the relationship between the trajectory of responses in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire core 30 scale and the growth modulation index?
Time Frame: Through to study completion, an average of 12 weeks
As this is a pilot exploratory study the investigators will have multiple co-primary outcomes.The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) is a 30 question assessment of quality of life in the following categories: global health status, physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning, fatigue, nausea and vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties. Twenty-eight questions are assessed on a scale of 1 (Not at all) to 4 (Very much); 2 questions are assessed on a scale of 1 (very poor) to 7 (excellent). The range of scores on each scale is from 0 to 100. In the function scales, a score of 100 is best (indicating more function). In the symptom scores, a score of 100 is worst, indicating more symptoms. Scores are totalled from each item to form the scales, then normalised to 0-100.
Through to study completion, an average of 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Daniel Stark, University of Leeds
  • Principal Investigator: Daniel Stark, d.p.stark@leeds.ac.uk

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2016

Primary Completion (Actual)

August 28, 2019

Study Completion (Actual)

August 28, 2019

Study Registration Dates

First Submitted

January 12, 2018

First Submitted That Met QC Criteria

May 20, 2019

First Posted (Actual)

May 22, 2019

Study Record Updates

Last Update Posted (Actual)

August 31, 2022

Last Update Submitted That Met QC Criteria

August 26, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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