Cervical Cancer Radiation ComplicationsQoLNCT07698795
Recovery and Quality of Life in Cervical Cancer Patients Using Vaginal Dilators After Radiotherapy
An observational study of Cervical Cancer Radiation Complications and QoL, run by Chulabhorn Cancer Center at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer Radiation Complications, QoL
- How many people
- 67 participants
- Where
- 1 siteThailand
- Study dates
- 3 Apr 2020to 30 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of 67 women. All participants were diagnosed with cervical cancer and had completed definitive radiation therapy, specifically a combination of External Beam Radiation Therapy (EBRT) and Intracavitary Radiation Therapy (ICRT/Brachytherapy). This cohort was followed longitudinally for 12 months post-treatment.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Vaginal Dilator Use on Vaginal Morbidity and Quality of Life Following Definitive Radiation Therapy for Cervical Cancer.
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.
Read more
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.
Read the detailed description
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:
Time Post-Treatment: Time is a highly significant predictor for nearly all QoL domains. Acute symptoms (such as nausea, diarrhea, and fatigue) typically show the most dramatic improvement within the first 1 to 3 months.
Functional Stabilization: Functional domains, including physical and role functioning, show progressive improvement and typically peak and stabilize by the 6-to-12-month mark. Global QoL scores generally reach their highest stable levels (median 83·33) by 6 months post-treatment.
Baseline Clinical Factors: Factors such as clinical stage (with Stage IIIC1 being the most prevalent at 28·79%) and tumor extension to the upper vagina (present in 61·19% of the cohort) influence the starting QoL scores and the overall slope of the recovery curve.
Symptom Resolution and Functional Gains
Longitudinal analysis revealed significant improvements across multiple QoL metrics compared to baseline:
Symptom Burden: Scores for Fatigue, Nausea/Vomiting, and Diarrhea decreased significantly across all follow-up time points (P<0⋅001).
Functional Domains: Significant gains were sustained in Physical, Role, and Social functioning beginning as early as 1 to 3 months post-treatment.
Cervical Cancer-Specific Symptoms: The specific symptom burden (QLQ-CX24) dropped sharply and remained low throughout the year. Sexual function and vaginal aspect scores showed significant improvements later in the recovery process, specifically between 6 and 12 months.
In conclusion, this study demonstrates that while radiation therapy causes significant initial morbidity, the recovery of QoL follows a predictable timeline influenced primarily by time and adherence to vaginal dilator therapy. The dilator acts as a critical intervention to maintain anatomical integrity while the patient's functional roles and energy levels are restored over the first year of survivorship.
- Conditions
- Cervical Cancer Radiation Complications, QoL
- Keywords
- Cervical Cancer, Radiotherapy, Brachytherapy, Quality of Life (QoL), Vaginal Dilator
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of Life (QoL) Scores
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.
Measured: Data is collected at six specific intervals: Baseline (pre-treatment), and then at 1, 3, 6, 9, and 12 months post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start3 Apr 2020
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Cervical Cancer Radiation ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulabhorn Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saengrawee Thanthong, Chulabhorn Cancer Center
- Investigators
- Saengrawee Thanthong, PhD, Study director, Chulabhorn Royal Academy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07698795
- Sponsor's protocol ID
- 070/2562
- Acronym
- QoL
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study does not plan to share individual participant data (IPD) with other researchers. According to the study's formal ethical and data management protocol, all participant information is kept in a secure location (such as a locked cabinet) that is strictly inaccessible to any individuals outside the immediate research team. To further protect participant privacy, all data is converted into anonymized codes during the analysis phase so that no specific individual can be identified from the research results. Most significantly, the protocol mandates that all information, recordings, and various records must be destroyed immediately upon the completion of the research work. These measures are implemented to ensure the highest level of confidentiality and to comply with the privacy protections promised to participants during the informed consent process.
Publications
Xu Z, Traughber BJ, Fredman E, Albani D, Ellis RJ, Podder TK. Appropriate Methodology for EBRT and HDR Intracavitary/Interstitial Brachytherapy Dose Composite and Clinical Plan Evaluation for Patients With Cervical Cancer. Pract Radiat Oncol. 2019 Nov;9(6):e559-e571. doi: 10.1016/j.prro.2019.06.003. Epub 2019 Jun 22.
PubMed 31238167Torigoe R, Dennen C, Mayadev J, Makale MT. Current challenges in the assessment and management of radiotherapy-induced vaginal stenosis. Int J Gynecol Cancer. 2026 Jan;36(1):102801. doi: 10.1016/j.ijgc.2025.102801. Epub 2025 Nov 17.
PubMed 41317693Sheikh-Wu SF, Anglade D, Downs CA. A cancer survivorship model for holistic cancer care and research. Can Oncol Nurs J. 2023 Jan 1;33(1):4-16. doi: 10.5737/236880763314. eCollection 2023 Winter.
PubMed 36789222Morris L, Do V, Chard J, Brand AH. Radiation-induced vaginal stenosis: current perspectives. Int J Womens Health. 2017 May 2;9:273-279. doi: 10.2147/IJWH.S106796. eCollection 2017.
PubMed 28496367Mizutani T, Takei H, Kunitoh H, Wakabayashi M, Sekino Y, Tsuboi M, Ikeda N, Asamura H, Okada M, Takahama M, Ohde Y, Okami J, Shiono S, Aokage K, Watanabe SI; Lung Cancer Surgical Study Group of the Japan Clinical Oncology Group, Japan. Longitudinal assessment of functional independence of older adults after lung cancer surgery: Final results of the JCOG1710A prospective cohort study. J Geriatr Oncol. 2025 Jul;16(6):102268. doi: 10.1016/j.jgo.2025.102268. Epub 2025 May 30.
PubMed 40449074Liu M, Lv Z, Xing S, Yi H, Wang L, Wang S, Liu L, Li N. Decision conflict, psychological resilience, and financial toxicity in early-stage non-small cell lung cancer in China: A latent profile and mediation analysis. Asia Pac J Oncol Nurs. 2026 Feb 26;13:100929. doi: 10.1016/j.apjon.2026.100929. eCollection 2026 Dec.
PubMed 42039773Hussey C, Hanbridge M, Dowling M, Gupta A. Cancer survivorship: understanding the patients' journey and perspectives on post-treatment needs. BMC Sports Sci Med Rehabil. 2024 Apr 12;16(1):82. doi: 10.1186/s13102-024-00864-y.
PubMed 38605386Hou P, Hsieh C, Wei M, Hsiao S, Shueng P. Differences in Treatment Outcomes and Prognosis between Elderly and Younger Patients Receiving Definitive Radiotherapy for Cervical Cancer. Int J Environ Res Public Health. 2020 Jun 23;17(12):4510. doi: 10.3390/ijerph17124510.
PubMed 32585933Heyman Y, Rojlar H, Hawranek C, Numan Hellquist B, Rosen A. Quality of life, anxiety and cancer worry following hereditary cancer testing: a 6-month Swedish follow-up study. Qual Life Res. 2026 Feb 12;35(3):70. doi: 10.1007/s11136-026-04184-1.
PubMed 41677932Gupta IJ, Ghosh A, Yadav J, Tuteja JS, Gupta R, Srivastava K, Verma M, Gupta S, Srivastava S, Bhatt MLB. External Beam Radiotherapy Interdigitated with High Dose Rate(HDR) Intracavitary Brachytherapy versus External Beam Radiotherapy followed by Sequential HDR Intracavitary Brachytherapy for Locally Advanced Carcinoma Cervix-Randomized Control Study. Asian Pac J Cancer Prev. 2023 Oct 1;24(10):3441-3445. doi: 10.31557/APJCP.2023.24.10.3441.
PubMed 37898849Damast S, Jeffery DD, Son CH, Hasan Y, Carter J, Lindau ST, Jhingran A. Literature Review of Vaginal Stenosis and Dilator Use in Radiation Oncology. Pract Radiat Oncol. 2019 Nov;9(6):479-491. doi: 10.1016/j.prro.2019.07.001. Epub 2019 Jul 11.
PubMed 31302301Amies Oelschlager AM, Debiec K. Vaginal Dilator Therapy: A Guide for Providers for Assessing Readiness and Supporting Patients Through the Process Successfully. J Pediatr Adolesc Gynecol. 2019 Aug;32(4):354-358. doi: 10.1016/j.jpag.2019.05.002. Epub 2019 May 12.
PubMed 31091469
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Vaginal Dilator Use on Vaginal Morbidity and Quality of Life Following Definitive Radiation Therapy for Cervical Cancer.
- ClinicalTrials.gov ID
- NCT07698795
- Acronym / sponsor ID
- QoL / 070/2562
- Conditions
- Cervical Cancer Radiation Complications, QoL
- Keywords
- Cervical Cancer, Radiotherapy, Brachytherapy, Quality of Life (QoL), Vaginal Dilator
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Chulabhorn Cancer CenterUniversity, hospital or other
- Study start
- 3 Apr 2020 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
Time Post-Treatment: Time is a highly significant predictor for nearly all QoL domains. Acute symptoms (such as nausea, diarrhea, and fatigue) typically show the most dramatic improvement within the first 1 to 3 months.
Functional Stabilization: Functional domains, including physical and role functioning, show progressive improvement and typically peak and stabilize by the 6-to-12-month mark. Global QoL scores generally reach their highest stable levels (median 83·33) by 6 months post-treatment.
Baseline Clinical Factors: Factors such as clinical stage (with Stage IIIC1 being the most prevalent at 28·79%) and tumor extension to the upper vagina (present in 61·19% of the cohort) influence the starting QoL scores and the overall slope of the recovery curve.
Symptom Resolution and Functional Gains
Longitudinal analysis revealed significant improvements across multiple QoL metrics compared to baseline:
Symptom Burden: Scores for Fatigue, Nausea/Vomiting, and Diarrhea decreased significantly across all follow-up time points (P<0⋅001).
Functional Domains: Significant gains were sustained in Physical, Role, and Social functioning beginning as early as 1 to 3 months post-treatment.
Cervical Cancer-Specific Symptoms: The specific symptom burden (QLQ-CX24) dropped sharply and remained low throughout the year. Sexual function and vaginal aspect scores showed significant improvements later in the recovery process, specifically between 6 and 12 months.
In conclusion, this study demonstrates that while radiation therapy causes significant initial morbidity, the recovery of QoL follows a predictable timeline influenced primarily by time and adherence to vaginal dilator therapy. The dilator acts as a critical intervention to maintain anatomical integrity while the patient's functional roles and energy levels are restored over the first year of survivorship.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of 67 women. All participants were diagnosed with cervical cancer and had completed definitive radiation therapy, specifically a combination of External Beam Radiation Therapy (EBRT) and Intracavitary Radiation Therapy (ICRT/Brachytherapy). This cohort was followed longitudinally for 12 months post-treatment.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Quality of Life (QoL) Scores
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Background: PubMed 31238167Xu Z, Traughber BJ, Fredman E, Albani D, Ellis RJ, Podder TK. Appropriate Methodology for EBRT and HDR Intracavitary/Interstitial Brachytherapy Dose Composite and Clinical Plan Evaluation for Patients With Cervical Cancer. Pract Radiat Oncol. 2019 Nov;9(6):e559-e571. doi: 10.1016/j.prro.2019.06.003. Epub 2019 Jun 22.
- Background: PubMed 41317693Torigoe R, Dennen C, Mayadev J, Makale MT. Current challenges in the assessment and management of radiotherapy-induced vaginal stenosis. Int J Gynecol Cancer. 2026 Jan;36(1):102801. doi: 10.1016/j.ijgc.2025.102801. Epub 2025 Nov 17.
- Background: PubMed 36789222Sheikh-Wu SF, Anglade D, Downs CA. A cancer survivorship model for holistic cancer care and research. Can Oncol Nurs J. 2023 Jan 1;33(1):4-16. doi: 10.5737/236880763314. eCollection 2023 Winter.
- Background: PubMed 28496367Morris L, Do V, Chard J, Brand AH. Radiation-induced vaginal stenosis: current perspectives. Int J Womens Health. 2017 May 2;9:273-279. doi: 10.2147/IJWH.S106796. eCollection 2017.
- Background: PubMed 40449074Mizutani T, Takei H, Kunitoh H, Wakabayashi M, Sekino Y, Tsuboi M, Ikeda N, Asamura H, Okada M, Takahama M, Ohde Y, Okami J, Shiono S, Aokage K, Watanabe SI; Lung Cancer Surgical Study Group of the Japan Clinical Oncology Group, Japan. Longitudinal assessment of functional independence of older adults after lung cancer surgery: Final results of the JCOG1710A prospective cohort study. J Geriatr Oncol. 2025 Jul;16(6):102268. doi: 10.1016/j.jgo.2025.102268. Epub 2025 May 30.
- Background: PubMed 42039773Liu M, Lv Z, Xing S, Yi H, Wang L, Wang S, Liu L, Li N. Decision conflict, psychological resilience, and financial toxicity in early-stage non-small cell lung cancer in China: A latent profile and mediation analysis. Asia Pac J Oncol Nurs. 2026 Feb 26;13:100929. doi: 10.1016/j.apjon.2026.100929. eCollection 2026 Dec.
- Background: PubMed 38605386Hussey C, Hanbridge M, Dowling M, Gupta A. Cancer survivorship: understanding the patients' journey and perspectives on post-treatment needs. BMC Sports Sci Med Rehabil. 2024 Apr 12;16(1):82. doi: 10.1186/s13102-024-00864-y.
- Background: PubMed 32585933Hou P, Hsieh C, Wei M, Hsiao S, Shueng P. Differences in Treatment Outcomes and Prognosis between Elderly and Younger Patients Receiving Definitive Radiotherapy for Cervical Cancer. Int J Environ Res Public Health. 2020 Jun 23;17(12):4510. doi: 10.3390/ijerph17124510.
- Background: PubMed 41677932Heyman Y, Rojlar H, Hawranek C, Numan Hellquist B, Rosen A. Quality of life, anxiety and cancer worry following hereditary cancer testing: a 6-month Swedish follow-up study. Qual Life Res. 2026 Feb 12;35(3):70. doi: 10.1007/s11136-026-04184-1.
- Background: PubMed 37898849Gupta IJ, Ghosh A, Yadav J, Tuteja JS, Gupta R, Srivastava K, Verma M, Gupta S, Srivastava S, Bhatt MLB. External Beam Radiotherapy Interdigitated with High Dose Rate(HDR) Intracavitary Brachytherapy versus External Beam Radiotherapy followed by Sequential HDR Intracavitary Brachytherapy for Locally Advanced Carcinoma Cervix-Randomized Control Study. Asian Pac J Cancer Prev. 2023 Oct 1;24(10):3441-3445. doi: 10.31557/APJCP.2023.24.10.3441.
- Background: PubMed 31302301Damast S, Jeffery DD, Son CH, Hasan Y, Carter J, Lindau ST, Jhingran A. Literature Review of Vaginal Stenosis and Dilator Use in Radiation Oncology. Pract Radiat Oncol. 2019 Nov;9(6):479-491. doi: 10.1016/j.prro.2019.07.001. Epub 2019 Jul 11.
- Background: PubMed 31091469Amies Oelschlager AM, Debiec K. Vaginal Dilator Therapy: A Guide for Providers for Assessing Readiness and Supporting Patients Through the Process Successfully. J Pediatr Adolesc Gynecol. 2019 Aug;32(4):354-358. doi: 10.1016/j.jpag.2019.05.002. Epub 2019 May 12.
- Individual participant dataSharing planned: No. The study does not plan to share individual participant data (IPD) with other researchers. According to the study's formal ethical and data management protocol, all participant information is kept in a secure location (such as a locked cabinet) that is strictly inaccessible to any individuals outside the immediate research team. To further protect participant privacy, all data is converted into anonymized codes during the analysis phase so that no specific individual can be identified from the research results. Most significantly, the protocol mandates that all information, recordings, and various records must be destroyed immediately upon the completion of the research work. These measures are implemented to ensure the highest level of confidentiality and to comply with the privacy protections promised to participants during the informed consent process.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saengrawee Thanthong, PhD study director
Chulabhorn Royal Academy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer Radiation Complications and QoL, run by Chulabhorn Cancer Center at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of Life (QoL) Scores (time frame: Data is collected at six specific intervals: Baseline (pre-treatment), and then at 1, 3, 6, 9, and 12 months post-treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07698795, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.