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

Sponsor
The Christie NHS Foundation Trust (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05274867
Collaborator
(none)
137
Enrollment
3
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    137 participants
    Observational Model:
    Other
    Time Perspective:
    Other
    Official Title:
    Development of a Patient Reported Outcome Measure for Advanced Ovarian Cancer Patients Receiving Surgical and Chemotherapy Treatment
    Anticipated Study Start Date :
    Mar 7, 2022
    Anticipated Primary Completion Date :
    Jun 7, 2022
    Anticipated Study Completion Date :
    Jun 7, 2022

    Outcome Measures

    Primary Outcome Measures

    1. European Organisation Research and Treatment of Cancer Quality of Life- Core 30 (EORTC [4 weeks]

      Generic cancer quality of life questionnaire

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • The Christie NHS Foundation Trust

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The Christie NHS Foundation Trust
    ClinicalTrials.gov Identifier:
    NCT05274867
    Other Study ID Numbers:
    • CFTSp208
    First Posted:
    Mar 11, 2022
    Last Update Posted:
    Mar 11, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Ovarian Neoplasms
    Carcinoma, Ovarian Epithelial

    Study Results

    No Results Posted as of Mar 11, 2022