Writing Interventions in Breast Cancer Patients Taking Aromatase Inhibitors
NCT ID: NCT04651452
Last Updated: 2025-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
250 participants
INTERVENTIONAL
2021-02-01
2026-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Value Affirmation
Participants in the value affirmation condition will complete six writing prompts regarding their personal values over the course of six months. For example, participants will be given a list of values and will be asked to rate them in order of importance within their own lives and write about a time when their top value was particularly important. Participants will write for about ten minutes each session. The intervention tasks will be completed on a secure, online website that each individual participant will be emailed a link to. Participants can also receive paper copies via postal mail if they prefer.
Value Affirmation
Participants will complete writing tasks regarding their personal values.
Reflective Journaling
Participants in the reflective journaling condition will complete six writing prompts over the course of six months. However, the reflective journaling condition will be writing about values that are not important to them and discuss why they could be important to others. In other tasks, they will write about aspects of daily life (e.g. morning routine). Participants will write for about ten minutes each session. The intervention tasks will be completed on a secure, online website that each individual participant will be emailed a link to. Participants can also receive paper copies via postal mail if they prefer.
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.
Interventions
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Value Affirmation
Participants will complete writing tasks regarding their personal values.
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.
Eligibility Criteria
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Inclusion Criteria
* Prescribed an aromatase inhibitor within four weeks of enrollment or anticipates being prescribed one in the future
* Intention to take the prescribed aromatase inhibitor
* Fluency in English
* Own a smartphone that can support downloaded apps
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Carnegie Mellon University
OTHER
Responsible Party
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David Creswell
Dr. J. David Creswell
Principal Investigators
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J. David Creswell, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Carnegie Mellon University
Janine Dutcher, Ph.D
Role: STUDY_DIRECTOR
Carnegie Mellon University
Locations
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Carnegie Mellon University
Pittsburgh, Pennsylvania, United States
Countries
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References
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Other Identifiers
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