Health-related quality Of Life In patients with advanced Soft TIssue sarcomas treated with Chemotherapy (The HOLISTIC study): protocol for an international observational cohort study

Abstract

IntroductionChemotherapy 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 analysisThis 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 disseminationHeath 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 numberNCT03621332.

Trabectedin Plus Radiotherapy for Advanced Soft-Tissue Sarcoma: Experience in Forty Patients Treated at a Sarcoma Reference Center

“…In other neoplasms, the strategy of adding chemotherapy to low-dose palliative RT with synergistic intention has been tested, with more clinical responses, although a better outcome could not always be demonstrated [ 28 , 29 , 30 ]. Symptomatic control remains an unmet need in advanced sarcoma patients, needing a better prospective assessment in clinical trials with the proper tools [ 31 ]. With the aim of better exploring the activity of the combination of trabectedin and radiotherapy, with a special focus on quality of life assessments, a new prospective multicohort clinical trial is planned in advanced sarcoma with this combination.…”

Priorities and preferences of advanced soft tissue sarcoma patients starting palliative chemotherapy: baseline results from the HOLISTIC study

“…HOLISTIC (Health-related quality Of Life In patients with advanced Soft TIssue sarcomas treated with Chemotherapy) is a prospective cohort study for patients aged !18 years, treated with chemotherapy for advanced STS in the UK and the NL (NCT03621332). 21 Ethical approval was obtained in the UK (REC 17/NI/1097) and at all participating sites in the NL. Data were collected in the PROFILES registry; an established international registry for collection of cancer patient-reported outcomes.…”

Qualitative study to characterize patient experience and relevance of patient-reported outcome measures for patients with metastatic synovial sarcoma

“…Studies have also examined the impact of treatment in patients with advanced STS [18]. For example, a literature review of qualitative research in STS noted concepts of elevated anxiety/depression and issues relating to treatment side effects to be present [10].…”

“…The PALETTE trial used EORTC QLQ-C30 to assess the impact of treatment on HRQoL in 369 patients with advanced STS (including 44 patients [11.9%] with SS) [12,19]. The ongoing HOLISTIC study is collating HRQoL data on patients with advanced or metastatic STS undergoing chemotherapy, using a battery of PRO measures including EORTC QLQ-C30; this cohort will also likely include a small proportion of patients with SS [18]. However, as mentioned previously, STS represents a heterogenous group of malignancies, and since only a small proportion of the samples above had a diagnosis of SS and data specifically in this subgroup were not detailed separately, these studies provide limited insight into patients with this particular form of sarcoma.…”