Breast Cancer FemaleNCT03961269
Frequency and Presentations of Chronic Pain Following Breast Cancer Surgery: An Observational Study in a Tertiary Care Hospital of Pakistan
An observational study of Breast Cancer Female and Chronic Pain, run by Ali Sarfraz Siddiqui.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 75 years, women only
- Conditions the study is for
- Breast Cancer Female, Chronic Pain
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2016to 15 Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: all adult female patients with known carcinoma of breast who are scheduled for elective definitive breast cancer surgery (Mastectomy)
Who may be able to join
- all adult female patients with known carcinoma of breast who are scheduled for elective definitive breast cancer surgery (Mastectomy)
Who cannot join
- 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.
About this study
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.
Read the 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.
- Conditions
- Breast Cancer Female, Chronic Pain
- Keywords
- Breast cancer surgery, Persistent pain
- Medical subject headings
- Chronic Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the frequency of persistent pain in patients after breast cancer surgery
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
Measured: 3 to 6 months
Secondary outcomes (1)
To observe the distribution and characteristics of pain in these patients.
After breast cancer surgery, patients were followed to observe the distribution and characteristics of pain on pre-designed questionnaire
Measured: 3 to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start15 Jul 2016
- Primary completion15 Jul 2017
- Study completion15 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ali Sarfraz Siddiqui
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ali Sarfraz Siddiqui, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03961269
- Sponsor's protocol ID
- 4257-Ane-ERC-16
- Status last verified
- May 2019
- First submitted
- 16 May 2019
- Last updated
- 23 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency and Presentations of Chronic Pain Following Breast Cancer Surgery: An Observational Study in a Tertiary Care Hospital of Pakistan
- ClinicalTrials.gov ID
- NCT03961269
- Acronym / sponsor ID
- 4257-Ane-ERC-16
- Conditions
- Breast Cancer Female, Chronic Pain
- Keywords
- Breast cancer surgery, Persistent pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ali Sarfraz SiddiquiUniversity, hospital or other
- Study start
- 15 Jul 2016 (actual)
- Primary completion
- 15 Jul 2017 (actual)
- Study completion
- 15 Jul 2017 (actual)
- First posted
- 23 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all adult female patients with known carcinoma of breast who are scheduled for elective definitive breast cancer surgery (Mastectomy)
Key inclusion criteria (1 listed)
- all adult female patients with known carcinoma of breast who are scheduled for elective definitive breast cancer surgery (Mastectomy)
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine the frequency of persistent pain in patients after breast cancer surgery
Time frame: 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
1 secondary outcome
To observe the distribution and characteristics of pain in these patients.
Time frame: 3 to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Female and Chronic Pain, run by Ali Sarfraz Siddiqui.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the frequency of persistent pain in patients after breast cancer surgery (time frame: 3 to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2019.