Patient Reported Outcome Measures (PROMs) With Trabectedin

NCT03959033 | Terminated

• 1 other identifier: 16/WM/0446
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcoma; Liposarcoma; Leiomyosarcoma

Keywords

PROMs; EORTC QLQc-30

Outcome Measures

Primary Outcomes (5)

• 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).

  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?

  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 ?

  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?

  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?

  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

Eligibility Criteria

• Age: 16 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Leeds: lead

Study Sites (1)

Leeds Teaching Hospitals NHS Trust

Leeds, West Yorkshire, LS9 7TF, United Kingdom

Location

MeSH Terms

Conditions

Sarcoma; Liposarcoma; Leiomyosarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Adipose Tissue; Neoplasms, Muscle Tissue

Study Officials

• Daniel Stark

  University of Leeds

  PRINCIPAL INVESTIGATOR

• Daniel Stark

  d.p.stark@leeds.ac.uk

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Cancer Medicine

Study Record Dates

• First Submitted: January 12, 2018
• First Posted: May 22, 2019
• Study Start: November 29, 2016
• Primary Completion: August 28, 2019
• Study Completion: August 28, 2019
• Last Updated: August 31, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)