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Feasibility Study Of A Telephonic Questionnaire For Follow-Up Of Locally Advanced Cervical Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03477240
Recruitment Status : Unknown
Verified February 2018 by Dr Umesh Mahantshetty, Tata Memorial Hospital.
Recruitment status was:  Not yet recruiting
First Posted : March 26, 2018
Last Update Posted : March 26, 2018
Sponsor:
Information provided by (Responsible Party):
Dr Umesh Mahantshetty, Tata Memorial Hospital

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.

Condition or disease
Cervical Cancer Stage IIIB Treatment Outcome Follow up QUESTIONNAIRE

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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.
Estimated Study Start Date : May 1, 2018
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer




Primary Outcome Measures :
  1. Accuracy of nurse-led telephonic interview for disease recurrence [ Time Frame: 1 YEAR ]
    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


Secondary Outcome Measures :
  1. Accuracy of nurse-led telephonic interview for late toxicity of treatment [ Time Frame: 1 YEAR ]
    To estimate the accuracy of nurse-led telephonic interview in identifying patients with symptoms suggestive of late toxicity of treatment

  2. Acceptability of a nurse-led telephonic surveillance program using structured format (Form C). [ Time Frame: 1 YEAR ]
    To assess patients' acceptability of a nurse-led telephonic surveillance program (if found to be concordant with physical clinic visits)



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All consecutive patients of locally advanced cancer of the cervix or vault treated entirely at Tata Memorial Centre with curative intent radiation or chemoradiation.
Criteria

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

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Responsible Party: Dr Umesh Mahantshetty, Professor Dr., Tata Memorial Hospital
ClinicalTrials.gov Identifier: NCT03477240    
Other Study ID Numbers: TMH-1950
First Posted: March 26, 2018    Key Record Dates
Last Update Posted: March 26, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD will be shared

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Umesh Mahantshetty, Tata Memorial Hospital:
Cervical Cancer
TELEPHONIC QUESTIONNAIRE
Follow up
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female