MedTrace Logo

Writing Interventions in Breast Cancer Patients Taking Aromatase Inhibitors

NCT04651452 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-05-22

No results posted yet for this study

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.

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.

Sponsors & Collaborators

Principal Investigators

  • J. David Creswell, Ph.D · Carnegie Mellon University

  • Janine Dutcher, Ph.D · Carnegie Mellon University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2026-04-30
Completion
2026-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04651452 on ClinicalTrials.gov