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ACTIVE NOT RECRUITING
NCT04651452
NA

Writing Interventions in Breast Cancer Patients Taking Aromatase Inhibitors

Sponsor: Carnegie Mellon University

View on ClinicalTrials.gov

Summary

Aromatase inhibitors are a powerful medication for reducing the risk of recurrence and increasing survival in postmenopausal breast cancer patients. However, these medications can lead to intolerable side effects, poor medication adherence, and increased stress levels. This project's broad objective is to assess whether an intervention can improve medication adherence and reduce physical symptoms and stress in breast cancer patients prescribed aromatase inhibitors. Participants will be randomly assigned to a values affirmation or reflective journaling condition. Interventions will be writing-based, one essay per month for six months. Physical symptoms and perceived stress will be assessed at baseline, post-intervention (one month after the intervention), and follow-up (six months from the post-intervention assessment and seven months after the end of the intervention). Furthermore, an electronic pill bottle will continuously assess daily compliance so that medication adherence rates during the intervention, post-intervention, and follow-up can be calculated.

Official title: A Value Affirmation Intervention for Physical Symptoms and Medication Adherence in Breast Cancer Patients Taking Aromatase Inhibitors

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2021-02-01

Completion Date

2026-04-30

Last Updated

2025-10-03

Healthy Volunteers

No

Conditions

Interventions

BEHAVIORAL

Value Affirmation

Participants will complete writing tasks regarding their personal values.

BEHAVIORAL

Reflective Journaling

Participants will complete writing tasks regarding their least important values and discuss why they may be important to others. They will also describe aspects of daily life.

Locations (1)

Carnegie Mellon University

Pittsburgh, Pennsylvania, United States