Clinical trial NCT05274867: Development of a Patient Reported Outcome Measure for Advanced Ovarian Cancer Patients Receiving Surgical and Chemotherapy Treatment
Official title: Development of a Patient Reported Outcome Measure for Advanced Ovarian Cancer Patients Receiving Surgical and Chemotherapy Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ovarian Cancer
Surgery
Chemotherapy
Patient Reported Outcome Measure
Lead sponsor: The Christie NHS Foundation Trust
Sponsor class: OTHER
First posted: 2022-03-11
Enrollment: 137
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women receiving combined surgery and chemotherapy treatment for advanced ovarian cancer

Brief summary: 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

Eligibility criteria: 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

Primary outcomes:
measure: European Organisation Research and Treatment of Cancer Quality of Life- Core 30 (EORTC
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The Christie NHS Foundation Trust
name: Sally Taylor, PhD
role: PRINCIPAL_INVESTIGATOR
References: