Ovarian CancerPROM-OSPNCT05274867
Development of a Patient Reported Outcome Measure for Advanced Ovarian Cancer Patients Receiving Surgical and Chemotherapy Treatment
An observational study of Ovarian Cancer and Surgery, run by The Christie NHS Foundation Trust.
Trial summary
Development of a patient reported outcome measure (PROM) for ovarian cancer patients receiving combined surgery and radiotherapy Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Surgery, Chemotherapy
- How many people
- 137 participants
- Where
- No sites listed yet
- Study dates
- 7 Mar 2022to 7 Jun 2022
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women receiving combined surgery and chemotherapy treatment for advanced ovarian cancer
Who may be able to join
- Patients who are receiving combined surgery and chemotherapy for advanced ovarian cancer
- Aged over 18 (no upper age limit)
- Ability to understand and communicate in the English language
- Able to provide written informed consent
Who cannot join
- Patients who are not receiving combined surgery and chemotherapy for advanced ovarian cancer
- Unable to understand and communicate in the English language
- Aged under 18
- Unable to provide written informed consent
- Patients who are not able to complete informed consent or the study questionnaires
Trial locations and contacts
No sites are listed yet.
Grant Punnett contact
About this study
Development of a patient reported outcome measure (PROM) for ovarian cancer patients receiving combined surgery and radiotherapy
Read the detailed description
The study will be conducted in four stages:
Stage I - Item generation Approximately 20 interviews will be conducted with ovarian patients receiving combined surgery and chemotherapy to capture their experiences including quality of life, symptom experience, and other relevant themes that may emerge. The interviews will be audio recorded and transcribed verbatim. The qualitative data will be analysed thematically and key quotes extracted which will be used to create a draft item list. Interviews will be conducted either in person or virtually depending on national social distancing guidance at the time. Interviews will be audio recorded using a Dictaphone which encrypts files in real time.
Stage II - Cognitive interviewing Following the initial interviews, approximately 7 participants will undergo cognitive interviews to ensure that all items are clear and easily understood. Interviews will be audio recorded using a Dictaphone which encrypts files in real time.
Stage III - Item reduction and refinement of the draft PROM A draft PROM and the EORTC QLQ-C30 (a validated measure of health related quality of life for cancer patients in clinical trials) will be administered to approximately 100 ovarian cancer participants receiving combined surgery and chemotherapy. Approximately 50 patients will be asked to repeat the draft PROM approximately one week later to assess test-retest reliability. Hierarchical item reduction and Rasch analysis will be used to determine which items should be included in the final PROM.
Stage IV- Pilot testing The final PROM will be pilot tested with approximately 10 patients at The Christie site to assess its acceptability
- Medical subject headings
- Ovarian Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
European Organisation Research and Treatment of Cancer Quality of Life- Core 30 (EORTC
Generic cancer quality of life questionnaire
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start7 Mar 2022 (estimated)
- Primary completion7 Jun 2022 (estimated)
- Study completion7 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Other
- Enrolment
- 137 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Christie NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sally Taylor, PhD, Principal investigator, The Christie NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05274867
- Sponsor's protocol ID
- CFTSp208
- Acronym
- PROM-OSP
- Status last verified
- Mar 2022
- First submitted
- 2 Mar 2022
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Patient Reported Outcome Measure for Advanced Ovarian Cancer Patients Receiving Surgical and Chemotherapy Treatment
- ClinicalTrials.gov ID
- NCT05274867
- Acronym / sponsor ID
- PROM-OSP / CFTSp208
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 137 participants (estimated)
- Lead sponsor
- The Christie NHS Foundation TrustUniversity, hospital or other
- Study start
- 7 Mar 2022 (estimated)
- Primary completion
- 7 Jun 2022 (estimated)
- Study completion
- 7 Jun 2022 (estimated)
- First posted
- 11 Mar 2022 (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.
Development of a patient reported outcome measure (PROM) for ovarian cancer patients receiving combined surgery and radiotherapy
Detailed description
The study will be conducted in four stages:
Stage I - Item generation Approximately 20 interviews will be conducted with ovarian patients receiving combined surgery and chemotherapy to capture their experiences including quality of life, symptom experience, and other relevant themes that may emerge. The interviews will be audio recorded and transcribed verbatim. The qualitative data will be analysed thematically and key quotes extracted which will be used to create a draft item list. Interviews will be conducted either in person or virtually depending on national social distancing guidance at the time. Interviews will be audio recorded using a Dictaphone which encrypts files in real time.
Stage II - Cognitive interviewing Following the initial interviews, approximately 7 participants will undergo cognitive interviews to ensure that all items are clear and easily understood. Interviews will be audio recorded using a Dictaphone which encrypts files in real time.
Stage III - Item reduction and refinement of the draft PROM A draft PROM and the EORTC QLQ-C30 (a validated measure of health related quality of life for cancer patients in clinical trials) will be administered to approximately 100 ovarian cancer participants receiving combined surgery and chemotherapy. Approximately 50 patients will be asked to repeat the draft PROM approximately one week later to assess test-retest reliability. Hierarchical item reduction and Rasch analysis will be used to determine which items should be included in the final PROM.
Stage IV- Pilot testing The final PROM will be pilot tested with approximately 10 patients at The Christie site to assess its acceptability
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women receiving combined surgery and chemotherapy treatment for advanced ovarian cancer
Key inclusion criteria (4 listed)
- Patients who are receiving combined surgery and chemotherapy for advanced ovarian cancer
- Aged over 18 (no upper age limit)
- Ability to understand and communicate in the English language
- Able to provide written informed consent
Key exclusion criteria (5 listed)
- Patients who are not receiving combined surgery and chemotherapy for advanced ovarian cancer
- Unable to understand and communicate in the English language
- Aged under 18
- Unable to provide written informed consent
- Patients who are not able to complete informed consent or the study questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
European Organisation Research and Treatment of Cancer Quality of Life- Core 30 (EORTC
Time frame: 4 weeks
Generic cancer quality of life questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- 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.
Grant Punnett contact
Sally Taylor, PhD principal investigator
The Christie NHS Foundation Trust
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer and Surgery, run by The Christie NHS Foundation Trust.
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 4 inclusion and 5 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 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Sally Taylor, PhD (01618192446, sally.taylor38@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
European Organisation Research and Treatment of Cancer Quality of Life- Core 30 (EORTC (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Mar 2022.