NCT05274867

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
137

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

March 7, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 11, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2022

Completed
Last Updated

March 11, 2022

Status Verified

March 1, 2022

Enrollment Period

3 months

First QC Date

March 2, 2022

Last Update Submit

March 2, 2022

Conditions

Ovarian CancerSurgeryChemotherapyPatient Reported Outcome Measure

Outcome Measures

Primary Outcomes (1)

  • European Organisation Research and Treatment of Cancer Quality of Life- Core 30 (EORTC

    Generic cancer quality of life questionnaire

    4 weeks

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women receiving combined surgery and chemotherapy treatment for advanced ovarian cancer

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Sally Taylor, PhD

    The Christie NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sally Taylor, PhD

CONTACT

01618192446sally.taylor38@nhs.net

Grant Punnett

CONTACT

grant.punnett@nhs.net

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2022

First Posted

March 11, 2022

Study Start

March 7, 2022

Primary Completion

June 7, 2022

Study Completion

June 7, 2022

Last Updated

March 11, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share