NCT03546023

Brief Summary

Cancer-related pain has a major adverse impact on functional status and quality of life. Recently, a Survey conducted in 2015 in 10 Asian countries showed that among cancer patients in Asian population, 86% of patients reported that their pain affected their activities of daily living, 87% their sleep, 92% their concentration and focus, and 67% excessive reliance on others. Only 34% reported a good quality of life. Effective pain management may help the patient to focus on the positive aspects of life, decreasing the focus on pain and also promote better adherence to reasonable treatment plans. Hence the emphasis is on improving the Quality of Life and not mere pain control.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

June 5, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 6, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2019

Completed
Last Updated

September 11, 2019

Status Verified

September 1, 2019

Enrollment Period

12 months

First QC Date

March 26, 2018

Last Update Submit

September 9, 2019

Conditions

Keywords

Chronic cancer painpain clinicBrief Pain Inventory

Outcome Measures

Primary Outcomes (1)

  • Functional activity measurement using the Brief Pain Inventory (BPI)

    Any change in baseline score of functional activity from BPI during the followup visit.

    followup visit (minimum 7 days)

Interventions

BPI scores will be asked by the Doctor or the Research Nurse

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients attending the Pain Clinic over a period of 12 months aged 18 years and more.

You may qualify if:

  • All patients registered in chronic pain OPD for 12 months from the date of approval of the study by IEC, at Tata Memorial Hospital.
  • Age ≥ 18 years

You may not qualify if:

  • Incomplete BPI forms.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tata Memorial Centre

Mumbai, Maharashtra, 400010, India

Location

Tata Memorial Centre

Mumbai, Maharashtra, 400025, India

Location

Study Officials

  • Raghu Thota, MD, MNAMS

    Tata Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 26, 2018

First Posted

June 6, 2018

Study Start

June 5, 2018

Primary Completion

June 4, 2019

Study Completion

June 4, 2019

Last Updated

September 11, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations