Chemotherapy and HRQoL in advanced soft tissue sarcomas
Research type
Research Study
Full title
The HOLISTIC study’: Health-related quality Of Life In patients with advanced Soft TIssue sarcomas treated with Chemotherapy
IRAS ID
228783
Contact name
WTA van der Graaf
Contact email
Sponsor organisation
Institute of Cancer Research
Duration of Study in the UK
3 years, 5 months, 30 days
Research summary
What research question is being addressed?
The aim of this study is to gain a better insight into impact of chemotherapy on health-related quality of life in patients with advanced soft tissue sarcomas. Although there have been many studies which have looked at the effects of chemotherapy on factors such as survival, there have been no studies which have specifically assessed how chemotherapy affects patients’ day-to-day lives. This additional information will enable patients to make a more well-informed decision about treatment.
What will be measured, and how will the data be collected?
Taking part involves completing regular questionnaires online, or by paper-and-pencil, about participants health-related quality of life, expectations of treatment and your thoughts at the end of chemotherapy. Patients will be asked to complete a questionnaire before starting chemotherapy, every time he/she attends the hospital for chemotherapy (usually 3-weekly) until the chemotherapy has finished(typically a maximum of 6 cycles). Patients will then complete questionnaires during follow-up (at home) every 2-3 months.
Who will be eligible?
All patients, aged 18 years or above, with advanced soft tissue sarcoma who are treated with standard chemotherapy will be considered for entry into this study. Patients with certain tumours such as GIST and Ewing sarcoma (different treatment regimes) will not be eligible to participate in this study.
Where is the study being run?
This study will be conducted at several hospitals in The United Kingdom where patients with sarcomas are routinely treated. All of the information which is collected will be analysed by the research team. The results will be presented locally, nationally and internationally as well as published in a scientific journal(s).
REC name
HSC REC B
REC reference
17/NI/0197
Date of REC Opinion
17 Oct 2017
REC opinion
Further Information Favourable Opinion