Treatment Outcome Clinical Trial
Official title:
A Cross-Sectional Feasibility Study of a Telephonic Questionnaire By Research Nurses For Follow-Up Of Locally Advanced Cervical Cancer Patients With Complete Response To Treatment.
Verified date | February 2018 |
Source | Tata Memorial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Cross-sectional Feasibility study on all consecutive patients of locally advanced cancer of the cervix or vault treated entirely at Tata Memorial Centre with curative intent radiation or chemoradiation.
Status | Not yet recruiting |
Enrollment | 300 |
Est. completion date | August 1, 2019 |
Est. primary completion date | February 28, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: 1. Cervical Cancer Stage Ib2, II and III (Squamous carcinoma or adenocarcinoma) 2. Cancer of the vault 3. Cancer of the cervix which inadvertently underwent hysterectomy (inadequate surgery) 4. Treated with curative intent with radical radio(chemo)therapy or NACT followed by radical radio(chemo)therapy and completed all curative treatment. 5. Within 2 years post completion of treatment 6. Has complete clinical response at 3 months post treatment 7. Informed consent 8. Contactable by telephone Exclusion Criteria: 1. Patients with Stage III disease treated with palliative intent with once monthly radiotherapy 2. Early stage cervical cancer patients who underwent Wertheims hysterectomy and who have completed adjuvant radiochemotherapy due to high-risk factors 3. Metastatic cervical cancers 4. Patients who are unable to comprehend the questions or dialogue over telephone by medical staff. 5. Patients who seem unreliable for follow up |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Tata Memorial Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Accuracy of nurse-led telephonic interview for disease recurrence | To estimate the accuracy of nurse-led telephonic interview in identifying patients with symptoms suggestive of disease recurrence, in terms of sensitivity and specificity values | 1 YEAR | |
Secondary | Accuracy of nurse-led telephonic interview for late toxicity of treatment | To estimate the accuracy of nurse-led telephonic interview in identifying patients with symptoms suggestive of late toxicity of treatment | 1 YEAR | |
Secondary | Acceptability of a nurse-led telephonic surveillance program using structured format (Form C). | To assess patients' acceptability of a nurse-led telephonic surveillance program (if found to be concordant with physical clinic visits) | 1 YEAR |
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