NCT05628077

Brief Summary

We obtained the occurrence of pain sensation, pain mood, sleep, etc. during endocrine therapy in breast cancer patients through telephone follow-up, and analyzed risk factors through artificial intelligence

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

November 16, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 28, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

December 30, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2023

Completed
Last Updated

March 7, 2023

Status Verified

March 1, 2023

Enrollment Period

3 months

First QC Date

November 16, 2022

Last Update Submit

March 5, 2023

Conditions

Breast CancerAromatase InhibitorsEndocrine TherapyPainAnxietyDepressionSleep

Outcome Measures

Primary Outcomes (1)

  • Prevalence and risk factors for pain and related adverse reactions among breast cancer survivors on aromatase inhibitors

    2022-10 ---2023-03

Study Arms (2)

PAIN

Other: No intervention

NO PAIN

Other: No intervention

Interventions

No interventionOTHER

No intervention

NO PAINPAIN

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

I-III Breast cancer survivors on aromatase inhibitors

You may qualify if:

  • \- Breast cancer survivors on aromatase inhibitors

You may not qualify if:

  • Advanced breast cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People'S Hospital

Beijing, 000000, China

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsPainAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersBehavioral SymptomsBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

November 16, 2022

First Posted

November 28, 2022

Study Start

December 30, 2022

Primary Completion

March 20, 2023

Study Completion

April 20, 2023

Last Updated

March 7, 2023

Record last verified: 2023-03

Locations

CN(1)