Clinical trial NCT03621332: HRQoL in Advanced Soft Tissue Sarcoma Patients Treated With Chemotherapy.
Official title: The HOLISTIC Study: Health-related Quality Of Life in Patients With Advanced Soft Tissue Sarcomas Treated With Chemotherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Quality of Life
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Institute of Cancer Research, United Kingdom
First posted: 2018-08-08
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged ≥18 years with advanced soft tissue sarcoma.

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.

Detailed description: Eligible patients with advanced soft tissue sarcoma will be introduced to this study by their hospital consultant during their routine outpatient appointment. Before deciding if he/she would like to take part, the patient will be provided with a patient information sheet which describes the study in detail. Participation in the study is entirely voluntary and their care will not be affected if he/she chooses not to take part.

The patient information sheet explains that this study involves completing regular questionnaires online, or by paper-and-pencil, about health-related quality of life, expectations of treatment, preferences for making treatment choices and thoughts at the end of chemotherapy.

If a patient agrees to take part, he/she will be asked to sign an informed consent form indicating their willingness to participate. Each patient will be given unique login details to complete the consent form online using the PROFILES website. If he/she prefers to receive paper versions of the questionnaires and complete a paper version of the informed consent form.

After informed consent has been given, each patient will be asked to complete the first questionnaire. This will take around 15-20 minutes to complete. Further questionnaires are completed every time the patient attends hospital for treatment with chemotherapy (each cycle). These questionnaires will take around 10-15 minutes to complete. Most patients have a maximum of six cycles of chemotherapy and therefore will complete six questionnaires during treatment. At the end of chemotherapy, patients will complete one further questionnaire. During follow-up patients will be asked to complete questionnaires online (or by paper) at home every 2-3 months. The maximum time a patient will participate in the study is 2 years.

Only after a participant has given consent, the research team will collect information for their medical files such as the date of their cancer diagnosis and any previous treatments received. This information will be linked to the questionnaire data at the end of the study, in order to analyse whether it is associated with health-related quality of life.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in global health-related quality of life score after treatment with 1st line chemotherapy.
timeFrame: After up to six cycles of chemotherapy (approximately six months)
Secondary outcomes:
measure: Change in physical, cognitive, social, role and emotional functioning scores after treatment with first-line chemotherapy.
timeFrame: After up to six cycles of chemotherapy (approximately six months)
measure: Health-related quality of life symptoms scores after treatment with first line chemotherapy
timeFrame: After up to six cycles of chemotherapy (approximately six months)
Other outcomes:
measure: Change in global health-related quality of life score after third-line chemotherapy
timeFrame: From start of 3rd line chemotherapy to cessation of 3rd line chemotherapy. (1-12 months)
measure: Patient preference for collaborative decision-making
timeFrame: 2 years.
measure: Decisional conflict
timeFrame: 2 years
measure: Patients' expectations of treatment with chemotherapy
timeFrame: 2 years
measure: Decisional Regret scores
timeFrame: 2 years
measure: Work ability index scores
timeFrame: 2 years
measure: Patient preference for quantity versus quality of life.
timeFrame: 2 years
Locations:
city: London
country: United Kingdom
facility: Royal Marsden Hospital
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: Winette van der Graaf, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.