EMBRACE Vaginal Morbidity Study

EMBRACE Vaginal Morbidity Study - Vaginal Morbidity Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON39692

Enrollment

Registered

2013-05-07

Start date

2013-10-10

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cancer of the cervix cervical cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Cancer of the uterine cervix suitable for curative treatment with definitive radio-(chemo)therapy including 3D image guided Brachytherapy. - Positive biopsy showing squamous-cell carcinoma, adenocarcinoma or adeno-squamous cell carcinoma of the uterine cervix. - Staging according to FIGO and TNM guidelines - FIGO stage IB1-IIIB, without vaginal extension (stage IIA and IIIA not allowed) - Para-aortic metastatic nodes below L1-L2 are allowed - Patient informed concent - Ability to read, understand and fill in questionaires on quality of life and sexuality

Exclusion criteria

Exclusion criteria: - Other primairy malignancies exept carcinoma in situ of the cervix and basal cell carcinoma of the skin. - Metastatic disease beyond para-aortic region (L1-L2) - Vaginal extension of primary tumor. - Pre-existent major vaginal morbidity. - Previous pelvic or abdominal radiotherapy - Combination of preoperative radiotherapy with surgery - Patients receiving BrachyTherapy only. - Patients receiing ExternalBeamRadioTherapy only. - Patients receiving neoadjuvant chemotherapy - Cotraindications to BrachyTherapy - Active infection or severe medical condition endagering treatment delivery

Design outcomes

Primary

Measure	Time frame
Vaginal changes, reported by patient and radiotherapist, and the complex interaction of the physical, dosimetric, biological, clinical and psychological factors to vaginal morbidity and the importance of these factors to sexual functioning and health related quality of life.	—

Secondary

Measure	Time frame
1. To comprehensively asses vaginal change related to radiotherapy (vaginal morbidity) over time as seen or measured at gynaecological examination. 2. To establish a vaginal dosimetry wich enables a radiotherapy dose effect relationship for physician assessed objective vaginal changes. 3. To investigate if physician recorded 'objective' vaginal changes are correlated with patient reported vaginal symptoms. 4. To examine if physician recorded 'objective' vaginal changes and/or patient reported vaginal symptoms are relevant for overall sexual functioning. 5. To evaluate the extent to which general psychological aspects (emotional sistress, relationship issues, body image, infirtility, fatigue and overall quality of life) influence sexual functioning. 6. To investigate the influence of clinically established interventions on both patient reported overall sexual functioning and physician reported vaginal changes.	—

Measure

Time frame

1. To comprehensively asses vaginal change related to radiotherapy (vaginal morbidity) over time as seen or measured at gynaecological examination. 2. To establish a vaginal dosimetry wich enables a radiotherapy dose effect relationship for physician assessed objective vaginal changes. 3. To investigate if physician recorded 'objective' vaginal changes are correlated with patient reported vaginal symptoms. 4. To examine if physician recorded 'objective' vaginal changes and/or patient reported vaginal symptoms are relevant for overall sexual functioning. 5. To evaluate the extent to which general psychological aspects (emotional sistress, relationship issues, body image, infirtility, fatigue and overall quality of life) influence sexual functioning. 6. To investigate the influence of clinically established interventions on both patient reported overall sexual functioning and physician reported vaginal changes.

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Countries

Netherlands

Outcome results