Impact of Vaginal Dilator Use on Vaginal Morbidity and Quality of Life Following Definitive Radiation Therapy for Cervical Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Change in Quality of Life (QoL) Scores
研究概览
简要总结
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.
详细描述
This study investigates the longitudinal recovery trajectory and clinical predictors of Quality of Life (QoL) and vaginal morbidity in patients with cervical cancer following definitive radiation therapy. While combined External Beam Radiation Therapy (EBRT) and Intracavitary Radiation Therapy (ICRT/Brachytherapy) are highly effective for cancer control, they frequently lead to long-term physical sequelae, most notably radiation-induced vaginal stenosis and contraction. These changes can significantly impair sexual function and overall patient well-being.
Study Objectives and Design The research utilized a longitudinal design to track a cohort of 67 patients (mean age 51·75 ± 13·23 years) over a 12-month period. The primary objectives were to identify the clinical factors that predict the recovery of functional QoL domains.
Patients were assessed at six distinct time points: baseline (pre-treatment) and at 1, 3, 6, 9, and 12 months post-radiotherapy. QoL was measured using standardized instruments, including the EORTC QLQ-C30 (general health and functioning) and the EORTC QLQ-CX24 (cervical cancer-specific symptoms).
Clinical Predictors of Recovery
The study identifies several key independent variables that serve as predictors for post-treatment outcomes:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Quality of Life (QoL)
This longitudinal cohort includes 67 women treated for cervical cancer. All participants received definitive External Beam Radiation Therapy (EBRT) and Brachytherapy (ICRT). The intervention focuses on the Quality of Life (QoL). Recovery was tracked at baseline and 1, 3, 6, 9, and 12 months post-treatment using EORTC QLQ-C30 and QLQ-CX24.
结局指标
主要结局
Change in Quality of Life (QoL) Scores
时间窗: Data is collected at six specific intervals: Baseline (pre-treatment), and then at 1, 3, 6, 9, and 12 months post-treatment.
This outcome assesses the longitudinal trajectory of a patient's overall health status, functional abilities, and symptom burden following radiotherapy. Assessment Tools: QoL is measured using two standardized instruments: the EORTC QLQ-C30 (30-item core questionnaire for general cancer patients) and the EORTC QLQ-CX24 (24-item module specific to cervical cancer). Scoring: All scales and single-item measures are transformed to a 0 to 100 scale. For the Global Health Status and functional scales (Physical, Role, Social, Emotional, and Cognitive), higher scores represent a higher/better level of functioning. For symptom scales (such as Fatigue, Pain, and Nausea), higher scores represent a higher level of symptom burden or distress.
次要结局
未报告次要终点
研究者
Saengrawee Thanthong
Dr
Chulabhorn Cancer Center