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

NCT06169644 | Recruiting

• 2 other identifiers: STH22800331718
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Gestational Trophoblastic Neoplasia

Keywords

Gestational; Trophoblastic; Disease; Neoplasia; GTD; GTN

Outcome Measures

Primary Outcomes (3)

• Common themes of psychological experiences post-chemotherapy

  Thematic analysis will be used to interpret common themes of patient experiences following chemotherapy for GTN

  1 hour interviews

• Common opinions of post-treatment support

  Thematic analysis will be used to interpret common patient perspectives of the support received after their treatment

  1 hour interviews

• Themes of Suggested Improvement in Patient Care

  Thematic analysis will be used to interpret common suggestions of how patient care can be improved for those receiving chemotherapy for GTN.

  1 hour interviews

Study Arms (1)

Chemotherapy-treated GTN Patients

Patients with a diagnosis of Gestational Trophoblastic Neoplasia who completed chemotherapy treatment between 6 weeks and 24 months prior to the study. No IMP intervention to be administered, patients to be involved in a qualitative interview.

Eligibility Criteria

• Age: 16 Years - 55 Years
• Gender Eligibility Details: GTN affects the female reproductive organs, and as such only those with female biological anatomy. Therefore, only those of female biological sex would meet the eligibility criteria.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

A patient sample of 20 is proposed for the study. These are all the patients who meet the inclusion criteria and are thus eligible for the study. The patients will have a history of Gestational Trophoblastic Neoplasia, and have received chemotherapy between 6 weeks and 24 months ago, and presented to Weston Park Cancer Centre for this treatment.

You may qualify if:

• 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

You may not qualify if:

• Treatment received less than 6 weeks ago
• Treatment received more than 24 months ago
• Non-English speaking

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Weston Park Hospital

Sheffield, South Yorkshire, S10 2SJ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Gestational Trophoblastic Disease; Disease; Neoplasms

Condition Hierarchy (Ancestors)

Trophoblastic Neoplasms; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Pregnancy Complications, Neoplastic; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kamaljit Singh

  Nurse Consultant

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kamaljit Singh

CONTACT

01142265274; kamaljitsingh@nhs.net

Grace Cole

CONTACT

01142711899; grace.cole1@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: December 13, 2023
• Study Start: May 15, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)