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 sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04651452.
Locations matching your search criteria
United States
Pennsylvania
Pittsburgh
Carnegie Mellon UniversityStatus: Active
Contact: J. David Creswell
Phone: 412-268-9182
A sample of 250 participants will be recruited and randomly assigned to either the value
affirmation (N=125) or reflective journaling (N=125) condition. Participants will
complete baseline measures of physical symptoms, perceived stress, and other covariates.
They will also be given an electronic pill bottle that will record whether they have
daily opened and closed the bottle, signifying adherence to their prescribed medication
regime. This pill bottle will sync to an online dashboard. Participants in both
conditions will complete a brief essay online (or via paper and pencil for those who
prefer or do not have internet access) every month for six months. Value affirmation
condition essays will include prompts about important, core personal values. Reflective
journaling essays will have prompts that do not include any core personal value content
but ask participants, in part, to write about typical daily routines. Following the
conclusion of the intervention, participants will report on their levels of perceived
stress and physical symptoms. Six months following the post-intervention assessment,
participants will again report their perceived stress levels and physical symptoms. A
sample size of 250 has been selected for feasibility and because this sample size
provides at least 80% power to detect differences for all three outcomes of interest.
A sub-study will be conducted on 80 of these participants who will complete their 3rd
essay prompt in an fMRI scanner. In the scan session, participants will also complete a
stress reactivity task. The sub-study will allow examination of the neural mechanism of
value affirmation and reflective journaling to determine whether these neural mechanisms
lead to enhanced medication adherence rates and reductions in stress and physical
symptoms.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationCarnegie Mellon University
