Development of a Patient Reported Outcome Measure for Advanced Ovarian Cancer Patients Receiving Surgical and Chemotherapy Treatment (PROM-OSP)

March 2, 2022 updated by: The Christie NHS Foundation Trust
Development of a patient reported outcome measure (PROM) for ovarian cancer patients receiving combined surgery and radiotherapy

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

137

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women receiving combined surgery and chemotherapy treatment for advanced ovarian cancer

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
European Organisation Research and Treatment of Cancer Quality of Life- Core 30 (EORTC
Time Frame: 4 weeks
Generic cancer quality of life questionnaire
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Christie NHS Foundation Trust

Investigators

  • Principal Investigator: Sally Taylor, PhD, The Christie NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 7, 2022

Primary Completion (Anticipated)

June 7, 2022

Study Completion (Anticipated)

June 7, 2022

Study Registration Dates

First Submitted

March 2, 2022

First Submitted That Met QC Criteria

March 2, 2022

First Posted (Actual)

March 11, 2022

Study Record Updates

Last Update Posted (Actual)

March 11, 2022

Last Update Submitted That Met QC Criteria

March 2, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFTSp208

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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