Quality of LifeNCT03621332
HRQoL in Advanced Soft Tissue Sarcoma Patients Treated With Chemotherapy.
An observational study of Quality of Life, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life
- What is being tested?
- Questionnaire
- How many people
- 132 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Feb 2018to Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged ≥18 years with advanced soft tissue sarcoma.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Robin Jones contact
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Marsden Hospital
London, SW3 6JJ
Julie Curtis, 02086613050, julie.curtis@icr.ac.uk
Winette van der Graaf, PhD
About this study
Official title: The HOLISTIC Study: Health-related Quality Of Life in Patients With Advanced Soft Tissue Sarcomas Treated With Chemotherapy
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.
Read the 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.
- Conditions
- Quality of Life
- Being tested
- Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Online/paper questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Questionnaire adminstration | All patients who participate will complete questionnaires Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Patients will complete the EORTC-QLQ-C30 questionnaire at baseline and each cycle of chemotherapy. After linear transformation, all functioning scores will produce a score from 0-100. A higher score on the functional scales means better functioning.
Measured: After up to six cycles of chemotherapy (approximately six months)
Health-related quality of life symptoms scores after treatment with first line chemotherapy
Patients will complete the EORTC-QLQ-C30 questionnaire at baseline and each cycle of chemotherapy. After linear transformation, all single items will produce a score from 0-100. A higher score on symptom scales means more complaints.
Measured: After up to six cycles of chemotherapy (approximately six months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start23 Feb 2018
- Primary completionApr 2021 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Cancer Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Winette van der Graaf, PhD, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03621332
- Sponsor's protocol ID
- CCR4782
- Status last verified
- Aug 2018
- First submitted
- 19 Jul 2018
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41146924Younger 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.
PubMed 32487574
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The HOLISTIC Study: Health-related Quality Of Life in Patients With Advanced Soft Tissue Sarcomas Treated With Chemotherapy
- ClinicalTrials.gov ID
- NCT03621332
- Acronym / sponsor ID
- CCR4782
- Conditions
- Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Institute of Cancer Research, United Kingdom
- Study start
- 23 Feb 2018 (actual)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 8 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Questionnaire adminstration | – | Other: QuestionnaireAll patients who participate will complete questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged ≥18 years with advanced soft tissue sarcoma.
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireOnline/paper questionnaires | Other | Questionnaire adminstration |
Primary outcome
Change in global health-related quality of life score after treatment with 1st line chemotherapy.
Time frame: After up to six cycles of chemotherapy (approximately six months)
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.
2 secondary outcomes
Change in physical, cognitive, social, role and emotional functioning scores after treatment with first-line chemotherapy.
Time frame: After up to six cycles of chemotherapy (approximately six months)
Health-related quality of life symptoms scores after treatment with first line chemotherapy
Time frame: After up to six cycles of chemotherapy (approximately six months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2018.
- Derived from this study: PubMed 41146924Roets 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.
- Derived from this study: PubMed 32487574Younger 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robin Jones contact
Winette van der Graaf, PhD principal investigator
Royal Marsden NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Winette van der Graaf, PhD (0207-808-2457, winette.vandergraaf@icr.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in global health-related quality of life score after treatment with 1st line chemotherapy. (time frame: After up to six cycles of chemotherapy (approximately six months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03621332, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2018.