Clinical trial NCT04651452: Writing Interventions in Breast Cancer Patients Taking Aromatase Inhibitors
Official title: A Value Affirmation Intervention for Physical Symptoms and Medication Adherence in Breast Cancer Patients Taking Aromatase Inhibitors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Aromatase Inhibitors
Value Affirmation
Lead sponsor: Carnegie Mellon University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-12-03
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Breast cancer diagnosis
* 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 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

Primary outcomes:
measure: Change in Physical Symptoms
timeFrame: Change from baseline to 1-month post-intervention and 7 months post-intervention
measure: Change in Perceived Stress
timeFrame: Change from baseline to 1-month post-intervention and 7 months post-intervention
measure: Change in Medication Adherence
timeFrame: Change in adherence assessed daily, throughout 1-year participation in the study
measure: Change in Self-Reported Medication Adherence
timeFrame: Change from baseline to 1-month post-intervention and 7 months post-intervention
measure: Health-Related Quality of Life in Breast Cancer Patients as assessed by the Functional Assessment of Cancer Therapy - Breast Cancer
timeFrame: Change from baseline to 1-month post-intervention and 7 months post-intervention
measure: Neural Activity to the Affirmation Task
timeFrame: One session, midway through intervention
measure: Neural Activity to Stressful Task
timeFrame: One session, midway through intervention
measure: Functional Neural Activity to Positive Stimuli
timeFrame: One session, midway through intervention
measure: Functional Neural Activity to Negative Stimuli
timeFrame: One session, midway through intervention
measure: Change in Perceived Stress
timeFrame: Once a month for the 6-month duration of the intervention
measure: Change in Bodily Pain as assessed by the RAND 36-Item Health Survey 1.0
timeFrame: Change from baseline to 1-month post-intervention and 7 months post-intervention
measure: Change in Self-Reported Medication Adherence
timeFrame: Once a month for the 6-month duration of the intervention
Secondary outcomes:
measure: Change in Recovery from Stress
timeFrame: Change from baseline to 1-month post-intervention and 7 months post-intervention
measure: Change in Gratitude
timeFrame: Change from baseline to 1-month post-intervention and 7 months post-intervention
measure: Change in Well-Being as assessed by the Mental Health Continuum Short Form for Adults
timeFrame: Change from baseline to 1-month post-intervention and 7 months post-intervention
measure: Change in Depression Severity
timeFrame: Change from baseline to 1-month post-intervention and 7 months post-intervention
measure: Change in Engagement of Enjoyable Activities as assessed by the Pittsburgh Enjoyable Activities Test
timeFrame: Change from baseline to 1-month post-intervention and 7 months post-intervention
measure: Change in Physical and Mental Fatigue
timeFrame: Change from baseline to 1-month post-intervention and 7 months post-intervention
measure: Change in Sleep Measures
timeFrame: Change from baseline to 1-month post-intervention and 7 months post-intervention
measure: Change in Positive and Negative Emotional Style
timeFrame: Change from baseline to 1-month post-intervention and 7 months post-intervention
measure: Change in Self-Esteem
timeFrame: Change from baseline to 1-month post-intervention and 7 months post-intervention
measure: Changes in Perceived Social Support
timeFrame: Change from baseline to 1-month post-intervention and 7 months post-intervention
measure: Change in Spontaneous Self-Affirmation
timeFrame: Change from baseline to 1-month post-intervention and 7 months post-intervention
measure: Change in Loneliness
timeFrame: Change from baseline to 1-month post-intervention and 7 months post-intervention
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Carnegie Mellon University
state: Pennsylvania
Study officials:
affiliation: Carnegie Mellon University
name: J. David Creswell, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Carnegie Mellon University
name: Janine Dutcher, Ph.D
role: STUDY_DIRECTOR
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