Prevalence and Risk Factors for Sleep and Pain Among Breast Cancer Survivors on Aromatase Inhibitors

• Sponsor: Peking University People's Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05628077
• Collaborator: (none)
• Enrollment: 1,200
• Anticipated Duration (Months): 3.6

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer; Aromatase Inhibitors; Endocrine Therapy; Pain; Anxiety; Depression; Sleep	Other: No intervention

Study Design

• Study Type: Observational
• Anticipated Enrollment: 1200 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Doctor of Medical Sciences
• Anticipated Study Start Date: Dec 30, 2022
• Anticipated Primary Completion Date: Mar 20, 2023
• Anticipated Study Completion Date: Apr 20, 2023

Arms and Interventions

Arm	Intervention/Treatment
PAIN	Other: No intervention; No intervention
NO PAIN	Other: No intervention; No intervention

Outcome Measures

Primary Outcome Measures

1. Prevalence and risk factors for pain and sleep among breast cancer survivors on aromatase inhibitors [2022-10 ---2023-03]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Breast cancer survivors on aromatase inhibitors

Exclusion Criteria:

• Advanced breast cancer

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Peking University People's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yi Feng, MD, Dr, Peking University People's Hospital
• ClinicalTrials.gov Identifier: NCT05628077
• Other Study ID Numbers: yifeng
• First Posted: Nov 28, 2022
• Last Update Posted: Dec 6, 2022
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Dec 6, 2022