Feasibility Study Of A Telephonic Questionnaire For Follow-Up Of Locally Advanced Cervical Cancer Patients
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.
1 other identifier
observational
300
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2018
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 11, 2018
CompletedFirst Posted
Study publicly available on registry
March 26, 2018
CompletedStudy Start
First participant enrolled
May 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2019
CompletedMarch 26, 2018
February 1, 2018
10 months
January 11, 2018
March 23, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Accuracy of nurse-led telephonic interview for late toxicity of treatment
1 YEAR
Acceptability of a nurse-led telephonic surveillance program using structured format (Form C).
1 YEAR
Eligibility Criteria
All consecutive patients of locally advanced cancer of the cervix or vault treated entirely at Tata Memorial Centre with curative intent radiation or chemoradiation.
You may qualify if:
- Cervical Cancer Stage Ib2, II and III (Squamous carcinoma or adenocarcinoma)
- Cancer of the vault
- Cancer of the cervix which inadvertently underwent hysterectomy (inadequate surgery)
- Treated with curative intent with radical radio(chemo)therapy or NACT followed by radical radio(chemo)therapy and completed all curative treatment.
- Within 2 years post completion of treatment
- Has complete clinical response at 3 months post treatment
- Informed consent
- Contactable by telephone
You may not qualify if:
- Patients with Stage III disease treated with palliative intent with once monthly radiotherapy
- Early stage cervical cancer patients who underwent Wertheims hysterectomy and who have completed adjuvant radiochemotherapy due to high-risk factors
- Metastatic cervical cancers
- Patients who are unable to comprehend the questions or dialogue over telephone by medical staff.
- Patients who seem unreliable for follow up
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor Dr.
Study Record Dates
First Submitted
January 11, 2018
First Posted
March 26, 2018
Study Start
May 1, 2018
Primary Completion
February 28, 2019
Study Completion
August 1, 2019
Last Updated
March 26, 2018
Record last verified: 2018-02
Data Sharing
- IPD Sharing
- Will not share
No IPD will be shared