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NCT05274867 Clinical Trial

Development of a Patient Reported Outcome Measure for Advanced Ovarian Cancer Patients Receiving Surgical and Chemotherapy Treatment

Ovarian Cancer Clinical Trial

— PROM-OSP  

Official title:
Development of a Patient Reported Outcome Measure for Advanced Ovarian Cancer Patients Receiving Surgical and Chemotherapy Treatment

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05274867
Other study ID # CFTSp208
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 7, 2022
Est. completion date June 7, 2022

Study information
Verified date March 2022
Source The Christie NHS Foundation Trust
Contact Sally Taylor, PhD
Phone 01618192446
Email sally.taylor38@nhs.net
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Development of a patient reported outcome measure (PROM) for ovarian cancer patients receiving combined surgery and radiotherapy

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 137
Est. completion date June 7, 2022
Est. primary completion date June 7, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
The Christie NHS Foundation Trust

Outcome
Type Measure Description Time frame Safety issue
Primary European Organisation Research and Treatment of Cancer Quality of Life- Core 30 (EORTC Generic cancer quality of life questionnaire 4 weeks
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