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A Value Affirmation Intervention in Breast Cancer Patients Taking Aromatase Inhibitors

Trial Status: Active

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.

Inclusion Criteria

  • Inclusion Criteria: - Breast cancer diagnosis - Recently prescribed an aromatase inhibitor or anticipates being prescribed one in the future - Intention to take the prescribed aromatase inhibitor - Fluency in English Exclusion Criteria for fMRI component only: - Have implanted metal - Have an implanted electronic medical device - Have an IUD that contains metal - Are currently pregnant - Have a history of claustrophobia - Weigh more than 300 pounds

Pennsylvania

Pittsburgh
Carnegie Mellon University
Status: 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 substudy will be conducted on 120 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 substudy 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 Phase Phase NA

Trial Type Supportive care

Lead Organization
Carnegie Mellon University

  • Primary ID 1R01CA236860-01A1
  • Secondary IDs NCI-2021-00611
  • Clinicaltrials.gov ID NCT04651452