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Completed
NCT07698795
Recovery and Quality of Life in Cervical Cancer Patients Using Vaginal Dilators After Radiotherapy
Conditions: Cervical Cancer Radiation Complications, QoL
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 67
Sponsor: Chulabhorn Cancer Center
Location: Chulabhorn Hospital, Chulabhorn Royal Academy Bangkok
Summary
The goal of this longitudinal observational study is to understand the trajectory of Quality of Life (QoL) recovery in women with cervical cancer who have received definitive radiation therapy. The main questions it aims to answer are:
Do functional domains, such as physical, role, and social functioning, show significant and sustained improvement over the 12 months following treatment? How does the burden of treatment-related symptoms, including fatigue, nausea, and cervical cancer-specific symptoms, resolve during the one-year recovery period? Researchers will analyze changes in QoL scores over time to identify which clinical factors-such as time elapsed since treatment and baseline disease stage-serve as the most significant predictors of a patient's overall well-being.
Participants will:
* Complete standardized Quality of Life assessments using the EORTC QLQ-C30 and the cervical cancer-specific QLQ-CX24 instruments.
* Provide data at six specific intervals: baseline (pre-treatment) and at 1, 3, 6, 9, and 12 months post-radiotherapy.
* Report on multiple functional scales, including physical, role, emotional, cognitive, and social status.
* Monitor and report symptom levels for various issues such as fatigue, pain, nausea, and sexual/vaginal functioning.
Eligibility Criteria
Inclusion Criteria:
* A confirmed diagnosis of cervical cancer, including various histological types such as Squamous cell carcinoma (85.07%), Adenocarcinoma (13.43%), or Small cell carcinoma.
* Completion of definitive radiation therapy, specifically the combination of External Beam Radiation Therapy (EBRT) and Intracavitary Radiation Therapy (ICRT/Brachytherapy).
* Participants identified as female.
* Patients were included across clinical stages I through IV, with Stage IIIC1 being the most common (28.79%).
* Willingness to participate in a 12-month longitudinal study involving assessments at six distinct time points: baseline (pre-treatment) and 1, 3, 6, 9, and 12 months post-radiotherapy.
Exclusion Criteria:
* Presence of lesions that make it impossible to use the vaginal dilator device.
* Chronic or severe bleeding that prevents the safe or effective use of the vaginal dilator.
* Emergency medical conditions or a clinical necessity for alternative treatments following the initial radiation therapy.
* Inability to attend follow-up visits or comply with the monitoring guidelines established in the study protocol.
Additionally, the sources define discontinuation criteria for participants who have already entered the study:
* The participant requests to withdraw from the project for any reason.
* The participant receives incomplete treatment due to the progression or specific nature of the disease.
Source: ClinicalTrials.gov (NCT07698795). StuddyBuddy aggregates publicly available trial information.