Feasibility Study Of A Telephonic Questionnaire For Follow-Up Of Locally Advanced Cervical Cancer Patients
Feasibility Study Of A Telephonic Questionnaire For Follow-Up Of Locally Advanced Cervical Cancer Patients
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.
Our institution registers on an average 670 cases of cancer cervix in a year and almost 75%
 are treated with curative intent, therefore around 500 patients a year would be treated with
 curative intent. Assuming that 75% of patients registered in a year would be receiving
 treatment at our institute, 375 patients a year would be completing treatment, of whom the
 investigator expect 80-85% ,i.e 300 patients to have a complete response. The list of
 patients who have completed radio(chemotherapy) in 2015 &2016 can be obtained from the
 Radiation Oncology Department records. Patients identified for a follow up visit will be
 telephonically contacted between one and two weeks before the planned clinic visit and verbal
 telephonic consent taken prior to the nurse-led interview. This study should be able to
 accrue 300 patients in 6 months.

 Patients of locally advanced cervical cancer or vault cancer who have been treated with
 radiotherapy with or without concurrent chemotherapy and have a clinical complete response at
 3 months post treatment and are within the first 2 years post treatment completion will be
 eligible to participate in this study.

 Screening: Patients will be screened from the list of patients treated in the radiotherapy
 department over the last 2 years (2015-2016), available from the Radiation Oncology
 Information System (ROIS). All patients with a diagnosis of cervical cancer or vault cancer
 will be screened using the hospital Electronic Medical Record (EMR) to check stage of
 disease, schedule of treatment received, response at 3 months post treatment and expected
 date of next follow up.

 If patient fulfils all inclusion criteria, she will be called by the research nurse,
 approximately 1-2 weeks prior to her expected date of follow up, for a preliminary
 conversation and invited to participate in the study.

 After verbal telephonic consent is obtained, she will be interviewed by the clinical research
 nurse using the format of the prepared proforma (Form A) regarding symptoms suggestive of
 disease recurrence as well as treatment induced toxicity. At the end of the interview, the
 research nurse records her impression of whether the patient has worrisome symptoms of
 disease or not and has symptoms of treatment toxicity or not for which she should visit the
 hospital.

 When the patient reports to the OPD the next week for scheduled physical follow up, the nurse
 completes the consenting process by taking a short written informed consent. The examining
 physician then takes a complete history and in addition, performs a physical examination and
 any investigations he/she deems necessary. Following this he/she notes down final impression
 of disease status and toxicity which are taken as the gold standard (Form B). Each patient
 will be interviewed only once during their follow up schedule.

 In addition at the physical visit, information regarding the acceptability of nurse-led
 telephonic follow-up to the patient and the financial impact of physical follow- up will be
 collected using a structured format (Form C).

 Study participant drop-out/ Lost-to-follow up: Patients may withdraw their consent at any
 point during the telephonic interview or the subsequent follow up visit.

 -  A patient who does not attend the scheduled follow up visit within 1-2 weeks of the
 telephonic interview will be called a second time to remind her of the follow up
 appointment and enquire about reasons for non-attendance in the clinic, which will be
 recorded. If patient does not report to the clinic within the next 2 weeks, she will be
 considered to have dropped out from the study.

 -  Those patients in whom the interval between telephonic interview and the physician's
 assessment is more than 4 weeks, will be considered drop outs and follow up telephone
 call will go out to enquire about reasons for non-attendance in the clinic, which will
 be recorded.
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