NCT02753985

Brief Summary

This is a qualitative study which explores the role that partners play in breast cancer survivors adherence to aromatase inhibitors and management of their side effects. Both patients and their partners will be interviewed (separately) in order to capture multiple perspectives. The target number of subjects is 64 (32 patients and 32 partners). The primary method of data collection will be face-to-face semi-structured interviews. These interviews will be audio-recorded.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

July 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2016

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 28, 2016

Completed
Last Updated

July 23, 2019

Status Verified

July 1, 2019

Enrollment Period

1.8 years

First QC Date

April 26, 2016

Last Update Submit

July 22, 2019

Conditions

Breast Cancer Survivors

Outcome Measures

Primary Outcomes (1)

  • Number of Surveys Completed

    2 years

Interventions

SurveyOTHER

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Women and partners of women with stage I-III breast cancer

You may qualify if:

  • Women and partners of women with stage I-III breast cancer who
  • have completed primary cancer treatments (surgery, chemotherapy, radiotherapy)
  • have experienced AI side effects
  • live with a romantic partner.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Jun Mao, MD

    Abramson Cancer Center at Penn Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2016

First Posted

April 28, 2016

Study Start

July 1, 2014

Primary Completion

April 22, 2016

Study Completion

April 22, 2016

Last Updated

July 23, 2019

Record last verified: 2019-07

Locations

US(1)