Recovery and Quality of Life in Cervical Cancer Patients Using Vaginal Dilators After Radiotherapy (NCT07698795) | Clinical Trial Compass
CompletedNot Applicable
Recovery and Quality of Life in Cervical Cancer Patients Using Vaginal Dilators After Radiotherapy
Thailand67 participantsStarted 2020-04-03
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Quality of Life (QoL) Scores
Timeframe: Data is collected at six specific intervals: Baseline (pre-treatment), and then at 1, 3, 6, 9, and 12 months post-treatment.