CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 250 enrolled
Drug / intervention
Value Affirmation +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04651452
NCT04651452N/ACompleted

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

Carnegie Mellon University·interventional·Posted Dec 3, 2020·Updated May 22, 2026

In Brief

A clinical study evaluating Value Affirmation and Reflective Journaling for Breast Cancer. Completed, enrolled 250 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedDec 3, 2020
Enrollment StartFeb 1, 2021
Primary CompletionApr 30, 2026
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 5.6 years ago

Interventions

Value Affirmationbehavioral

Participants will complete writing tasks regarding their personal values.

Reflective Journalingbehavioral

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.