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Abstract
Introduction Chemotherapy is the mainstay of treatment for patients with advanced soft tissue sarcomas (STS). Treatment intent is usually palliative, aiming to improve symptoms, stabilise or reduce tumour burden and extend life. Clinical trials have traditionally used radiological response, time to progression and survival as measures of treatment efficacy. Health-related quality of life (HRQoL) is at least equally important or more important than survival for many patients with advanced cancer. Systematically collecting HRQoL data during chemotherapy can provide greater insight into treatment efficacy from the patient perspective.
The primary aims of this study are to evaluate HRQoL in patients with advanced STS treated with chemotherapy over time, explore the decision-making process and patient reflection post-treatment.
Methods and analysis This is an observational, international cohort study for 132 patients aged ≥18 years with advanced STS treated at eight centres (three in the UK, five in the Netherlands). Patients will be recruited prior to starting first-line or third-line chemotherapy and invited to complete questionnaires using the Patient-Reported Outcomes Following Initial treatment and Long-term Evaluation of Survivorship registry (PROFILES); an established international registry for collection of cancer patient-reported outcomes. Online (or paper) questionnaires will be completed at baseline, each cycle of chemotherapy and 2–3 monthly during follow-up. The questionnaire package includes the Decisional Conflict Scale, Control Preferences Scale, Quality–Quantity Questionnaire, treatment expectations, European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30), EORTC financial toxicity items, Work Ability Index, Functional Assessment of Cancer Therapy-General (FACT-G) items and Decisional Regret Scale. Clinical data will be extracted from patient records and linked with questionnaire responses. The primary outcome measure is the change in global HRQoL from baseline to after cycle 4 of first-line chemotherapy (based on published data showing that patients with advanced STS complete a median number of four cycles of first-line chemotherapy).
Ethics and dissemination Heath Research Authority and Research Ethics Committee (REC 17/NI/0197). Results from the Health-related quality Of Life In patients with advanced Soft TIssue sarcomas treated with Chemotherapy (HOLISTIC) study will be published in peer-reviewed journals and disseminated at local, national and international conferences. We will also present our findings at any appropriate patient meetings and involve patients in study-related publications.
Trial registration number NCT03621332.
- sarcoma
- chemotherapy
- adult oncology
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Footnotes
Contributors EY, RLJ, IMED, WTAvDG and OH were involved in the conceptualisation and design of the study. CP provided support for statistical methodology. EY was responsible for writing the protocol and obtaining ethical approval for the study. All authors read and approved the final manuscript.
Funding This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors. EY (clinical research fellow) is funded by the Sarcoma Research Unit at the Royal Marsden Hospital and was responsible for writing the protocol, and will be involved in the data collection, analysis, interpretation and writing of the manuscript as part of a PhD project. The joint sponsors for this study are the Institute of Cancer Research and the Royal Marsden NHS Foundation Trust. The sponsor contact is Dr Barbara Pittam(barbara.pittam@icr.ac.uk). Role of sponsor: trial insurance and indemnity, scientific and statistical review of the protocol and study documents, ethical approval and protocol amendments, maintaining study master file, ensuring data and documentation are available for monitoring, inspection or audit, case report design, data analysis, preparation and dissemination of results (posters, presentations and publication) and data storage.
Competing interests RLJ is a consultant for: Adaptimmune, Blueprint, Clinigen, Eisai, Epizyme, Daichii, Deciphera, Immunedesign, Lilly, Merck, Pharmamar. WTAvDG has received research grants from Novartis and has been on advisory board from Bayer. The other authors declare that they have no competing interests.
Patient consent for publication Not required.
Ethics approval This study was approved by the Heath Research Authority and Research Ethics Committee of the UK (REC reference 17/NI/0197) and in the Netherlands at each participating centre (Radboud University Medical Centre and UMCG: 2018-4151, Erasmus Medical Centre: MEC-2018-1101, Leiden University Medical Centre: P18.179 P1a, Netherlands Cancer Institute: 2018-12-04 18.453). All participants will sign an informed consent form (electronic or paper version).
Provenance and peer review Not commissioned; externally peer reviewed.