Clinical Trial

The Psychological Impact of GTN on Women Who Have Completed Chemotherapy Treatment

Study acronym: PI-GTN
Recruiting
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Record status
This record was last updated February 21, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
A cross-sectional retrospective study of a sample of 20 women who completed single agent or multi agent chemotherapy: between 6 weeks and 24 months post treatment involving a semi structured telephone interview. A patient sample of 20 is proposed for the study. These are all the patients who meet the inclusion criteria below and are thus eligible for the study. These patients will be contacted via telephone by the principal investigator to inform them of the study and invite participation. A proposed sample size of 20 is sufficient to generate data to address the central questions and furthermore, this sample size is adequate because the intention is to gain insight into the experiences of patients' perceptions about their psychological experiences. Objectives: * Gaining insight into the emotional impact of GTN post treatment * Ascertaining if health professionals are providing adequate psychological support * Identifying sources of support that patients accessed post completion of treatment * Identifying potential areas of improvement in the follow up support for future patients Criteria for inclusion: * Treated with chemotherapy for a GTN diagnosis * Completed treatment between 6 weeks and 24 months * Are able to provide informed consent * Have no cognitive impairment as judged by the treating clinician Criteria for exclusion * Treatment received less than 6 weeks ago * Treatment received more than 24 months ago * Non-English speaking Outcome measures are not appropriate in this qualitative study. However outputs from this study include increasing knowledge and insight into: * patients' experiences of their psychological experiences post chemotherapy * patients' perspective of the support received after their treatment * potential areas of improvements in care
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2023-12-05; most recent amendment 2025-02-20.
Status change: Not Yet Recruiting → Recruiting 2025-02-20
Trial Details
NCT Number NCT06169644
Lead Sponsor Sheffield Teaching Hospitals NHS Foundation Trust
Conditions Gestational Trophoblastic Neoplasia
Enrollment 20 participants
Start Date 2024-05-15
Primary Completion 2025-12-31 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-02-21