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Frequency and Presentations of Chronic Pain Following Breast Cancer Surgery: An Observational Study in a Tertiary Care Hospital of Pakistan

Sponsor
Ali Sarfraz Siddiqui (Other)
Overall Status
Completed
CT.gov ID
NCT03961269
Collaborator
(none)
120
Enrollment
12
Actual Duration (Months)

Study Details

Study Description

Brief Summary

This study is designed to evaluate the frequency and presentations of chronic persistent pain in patients after breast cancer surgery at our tertiary care hospital. Results of this study will help us to understand the magnitude of problem in our population and making institutional guidelines for appropriate management of such patients.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    After approval from the Departmental Research Committee and Institutional Ethical Review Committee all adult female patients with known carcinoma of breast who are scheduled for elective definitive breast cancer surgery (Mastectomy) from 1st July 2016 to 30th December 2016 will be enrolled in this audit. Inclusion of patients will be done once operative procedure is finalized and consent taken in breast clinic. Those patients who did not give consent and those patients who need reoperation on same side for recurrence of cancer or any reason will be excluded from this study.

    Data will be obtained from patient's medical record, interview of patient on follow up visit at breast clinic and telephonic communication with patient. Variables have been defined and a special form has been designed for data collection. All patients will be followed for next three months and those who have persistent pain will be followed for six months after operation.

    Follow up information will be obtained from patient visiting breast clinic. For any missing data patient's medical records will be reviewed and patient will be contacted to know if they have chronic post-surgical pain or not. Audit forms will be filled by authors according to their availability. The primary investigator or author at breast clinic will keep all forms for safe record keeping which shall later be used for data analysis.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    120 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Actual Study Start Date :
    Jul 15, 2016
    Actual Primary Completion Date :
    Jul 15, 2017
    Actual Study Completion Date :
    Jul 15, 2017

    Outcome Measures

    Primary Outcome Measures

    1. To determine the frequency of persistent pain in patients after breast cancer surgery [3 to 6 months]

      After breast cancer surgery, patients were followed for next 3 months and those patients who developed persistent pain were followed for up to 6 months via pre designed questionnaire

    Secondary Outcome Measures

    1. To observe the distribution and characteristics of pain in these patients. [3 to 6 months]

      After breast cancer surgery, patients were followed to observe the distribution and characteristics of pain on pre-designed questionnaire

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 75 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • all adult female patients with known carcinoma of breast who are scheduled for elective definitive breast cancer surgery (Mastectomy)
    Exclusion Criteria:
    • Those patients who did not give consent and those patients who need reoperation on same side for recurrence of cancer or any reason will be excluded from this study.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Ali Sarfraz Siddiqui

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ali Sarfraz Siddiqui, Assistant Professor, Aga Khan University
    ClinicalTrials.gov Identifier:
    NCT03961269
    Other Study ID Numbers:
    • 4257-Ane-ERC-16
    First Posted:
    May 23, 2019
    Last Update Posted:
    May 23, 2019
    Last Verified:
    May 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ali Sarfraz Siddiqui, Assistant Professor, Aga Khan University
    Breast cancer surgery
    Persistent pain
    Additional relevant MeSH terms:
    Breast Neoplasms
    Chronic Pain

    Study Results

    No Results Posted as of May 23, 2019