HRQoL in Advanced Soft Tissue Sarcoma Patients Treated With Chemotherapy.

NCT03621332 | Unknown DMC

• 1 other identifier: CCR4782
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

The benefits of cancer treatments, such as chemotherapy, are traditionally measured by outcomes such as progression free survival and overall survival. The degree to which treatments affect symptoms of disease, patient functioning and HRQoL are rarely measured or incorporated in the main endpoints of large-scale clinical trials. Systemic treatments for the majority of patients with advanced STS are not curative but aim to improve patients' HRQoL through reduction of symptoms, slowing or halting disease progression, and may extend life for some patients. Despite this, there is little research into the impact of chemotherapy on HRQoL for advanced STS patients. In order for patients to make an informed decision about chemotherapy and the predicted effects on all aspects of their lives, clinicians should be able to provide data on HRQoL. This will also enhance the shared decision-making process between clinicians and their patients. Given that survival benefits of treatment beyond 2nd line chemotherapy are marginal, and HRQoL data are lacking for patients treated with third line systemic treatment, simultaneous collection of HRQoL data in patients treated with 1st and 3rd line chemotherapy will enable assessment of the course of HRQoL in patients at the beginning, and further along, their treatment trajectory. After discontinuation of 1st or 3rd line chemotherapy, all patients will be followed up at 2-3 month intervals to determine trajectory of quality of life over time, irrespective of whether or not they receive subsequent line(s) of chemotherapy.

Conditions

Quality of Life

Outcome Measures

Primary Outcomes (1)

• Change in global health-related quality of life score after treatment with 1st line chemotherapy.

  Patients will complete the EORTC-QLQ-C30 questionnaire at baseline and each cycle of chemotherapy. Question 30 asks patients to rate their global health-related quality of life on a scale from 1(very poor)- 7 (excellent). After linear transformation, patients will have a score from 0-100. A higher score on global health-related quality of life question means better HRQoL. Change in global HRQoL over treatment with first-line chemotherapy will be presented using descriptive statistics such as mean and standard deviation after each cycle. Change in global HRQoL will be tested using a paired sample t test from baseline to 4 cycles with a 2 sided 5 % significance level. For patients who do not complete 4 cycles, the last score/observation (post baseline) will be carried forward for the analysis. A sensitivity analysis will also be performed excluding those patients who do not reach 4 cycles. If data is not normally distributed, then the Wilcoxon test will be used.

  After up to six cycles of chemotherapy (approximately six months)

Secondary Outcomes (2)

• Change in physical, cognitive, social, role and emotional functioning scores after treatment with first-line chemotherapy.

  After up to six cycles of chemotherapy (approximately six months)

• Health-related quality of life symptoms scores after treatment with first line chemotherapy

  After up to six cycles of chemotherapy (approximately six months)

Other Outcomes (7)

• Change in global health-related quality of life score after third-line chemotherapy

  From start of 3rd line chemotherapy to cessation of 3rd line chemotherapy. (1-12 months)

• Patient preference for collaborative decision-making

  2 years.

• Decisional conflict

  2 years

Study Arms (1)

Questionnaire adminstration

All patients who participate will complete questionnaires

Other: Questionnaire

Interventions

Questionnaire OTHER

Online/paper questionnaires

Questionnaire adminstration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged ≥18 years with advanced soft tissue sarcoma.

You may qualify if:

• Age ≥18 years
• Diagnosis of advanced (not amenable to curative surgical resection) soft tissue sarcoma (histology confirmed by sarcoma histopathologist)
• Starting 1st line palliative chemotherapy or 3rd line palliative chemotherapy according to standard treatment guidelines.
• Able to communicate in English
• Mental capacity to provide informed consent and to participate in the study (as determined by the treating physician).
• Patients must be able to complete questionnaires themselves (a prerequisite for 'patient reported outcome' data).
• Patients must be under treatment or follow-up at one of the participating centres

You may not qualify if:

• Patients with GIST, Ewing sarcoma, rhabdomyosarcoma and desmoplastic small round cell tumour.
• Patients who have already started 1st line or 3rd chemotherapy.
• Patients who are too ill to receive any further systemic treatment (death is imminent), as determined by the referring health care professional

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead
• Institute of Cancer Research, United Kingdom: collaborator

Study Sites (1)

Royal Marsden Hospital

London, SW3 6JJ, United Kingdom

RECRUITING

Related Publications (2)

• Roets E, Younger E, Jones RL, Hollander DD, Azarang L, Desar IME, Young RJ, Oosten AW, de Haan JJ, Gelderblom H, Steeghs N, Husson O, van der Graaf WTA. Health-related quality of life in patients with advanced soft tissue sarcoma receiving first-line palliative chemotherapy (HOLISTIC): longitudinal results from a prospective, observational cohort study. EClinicalMedicine. 2025 Oct 16;89:103561. doi: 10.1016/j.eclinm.2025.103561. eCollection 2025 Nov.

  PMID: 41146924 DERIVED

• Younger E, Jones RL, Desar IME, Peckitt C, van der Graaf WTA, Husson O. 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. BMJ Open. 2020 Jun 1;10(6):e035171. doi: 10.1136/bmjopen-2019-035171.

  PMID: 32487574 DERIVED

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Winette van der Graaf, PhD

  Royal Marsden NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Winette van der Graaf, PhD

CONTACT

0207-808-2457; winette.vandergraaf@icr.ac.uk

Robin Jones

CONTACT

robin.jones4@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2018
• First Posted: August 8, 2018
• Study Start: February 23, 2018
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: August 13, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)