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The purpose of this study is to investigate the association between the Independent Activities of Daily Living (I-ADL) component of the Comprehensive Geriatric Assessment (CGA) and poor tolerance to radiation treatment in older and younger patients with non-ovarian gynecological cancers.
There are little data regarding the impact of functional age on tolerance to radiotherapy for gynecologic cancers. A comprehensive geriatric assessment (CGA) tool which measures functional status (including the Instrumental Activities of Daily Living (I-ADL)), among many other important geriatric related conditions, was developed by Hurria and colleagues. Geriatric assessment variables including functional status predicted for toxicity in older patients receiving chemotherapy and surgery for multiple cancer types., 2 We hypothesize that I-ADL can be used to predict treatment tolerance in patients of all ages receiving pelvic and/or paraaortic region radiation therapy for gynecologic malignancies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ≥65 years old | 20 patients greater than or equal to 65 years of age | ||
| <65 years old | 20 patients less than 65 years of age |
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| Measure | Description | Time Frame |
|---|---|---|
| Pre-treatment I-ADL dependency | Pre-treatment I-ADL dependency is defined as scoring less than 14 on the I-ADL scale of the CGA. | Pre-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Poor adherence to treatment | Poor adherence to treatment is defined by at least one of the following:
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported acute grade 3-5 radiation related toxicities | Patient-reported acute grade 3-5 radiation related toxicities will be based on the PRO-CTCAE questionnaire during and 4-8 weeks post radiation therapy and at 6 months. | During treatment and 4-8 weeks post-treatment |
| Provider-reported grade 3-5 acute radiation related toxicities |
Inclusion Criteria:
Exclusion Criteria:
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Patients age 18 years of age or above with a diagnosis of cervical, vaginal, vulvar, or endometrial cancer with either pelvic radiotherapy or chemoradiotherapy planned as part of standard treatment with curative intent at the Department of Radiation Oncology at UNC Chapel Hill.
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| Name | Affiliation | Role |
|---|---|---|
| Mahesh Varia, MD, ChB | Department of Radiation Oncology, University of North Carolina Chapel Hill | Principal Investigator |
| Noam VanderWalde, MD | Department of Radiation Oncology, Unverisity of North Carolina Chapel Hill | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC Department of Radiation Oncology Clinic | Chapel Hill | North Carolina | 27599 | United States |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D014625 | Vaginal Neoplasms |
| D014846 | Vulvar Neoplasms |
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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Whole blood
| During or 4-8 weeks post-treatment |
Provider-reported grade 3-5 acute radiation related toxicities will be based on the CTCAE (Common Toxicity Criteria for Adverse Effects) v4.03 during and 4-8 weeks post radiation therapy |
| During treatment and 4-8 weeks post-treatment |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D014623 | Vaginal Diseases |
| D014845 | Vulvar Diseases |