Writing Interventions in Breast Cancer Patients Taking Aromatase Inhibitors

NCT04651452 | Completed DMC

• 1 other identifier: 1R01CA236860-01A1
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Aromatase Inhibitors; Value Affirmation

Outcome Measures

Primary Outcomes (10)

• Change in Physical Symptoms

  The Breast Cancer Prevention Trial Symptom Checklist is a 43 item self-report of physical symptoms specific to breast cancer treatment. Participants rate how bothered they were by each symptom in the last 4 weeks on a five-point Likert scale ranging from 0 (Not at all) to 4 (Extremely). Item 43 is an open response question that asks participants to indicate and rate any additional symptoms they may be experiencing. Component symptom scale scores (e.g. musculoskeletal pain, cognitive problems, weight problems) will be determined by calculating the average score of the items that make up each scale. The symptom scale scores will range from 0 to 4. A total score for all the items will be calculated by adding the scores across all symptoms. Thus, the total scores will range from 0 to 172, with higher scores reflecting greater symptom severity.

  Change from baseline to 1-month post-intervention and 7 months post-intervention

• Change in Perceived Stress

  The 10-item Perceived Stress Scale is a self-reported assessment of perceptions of stress over the past month. Total scores range from 0 to 40, with higher scores indicating higher levels of perceived stress.

  Change from baseline to 1-month post-intervention and 7 months post-intervention

• Change in Medication Adherence

  Participants will receive an electronic pill bottle that syncs over the internet in real-time to indicate when a participant opens and closes the bottle. This gives a daily record of whether the participant took their medication.

  Change in adherence assessed daily, throughout 1-year participation in the study

• Change in Self-Reported Medication Adherence

  The NIH PROMIS Medication Adherence Scale (PMAS) is a 12-item scale that will be used to assess self-reported adherence behaviors and understand why a participant may be non-compliant or discontinue their medication with items that, in part, focus on one's attitude and experience with the medication of interest. Certain items are modified to reference aromatase inhibitors.

  Change from baseline to 1-month post-intervention and 7 months post-intervention

• Health-Related Quality of Life in Breast Cancer Patients as assessed by the Functional Assessment of Cancer Therapy - Breast Cancer

  The Functional Assessment of Cancer Therapy - Breast Cancer is an instrument used to assess health-related quality of life in breast cancer patients through five domains comprised of 37 items. Participants respond to each item on a five-point Likert scale. The domains include physical well-being (score ranging from 0 to 28), social/family well-being (score ranging from 0 to 28), emotional well-being (score ranging from 0 to 24), functional well-being (score ranging from 0 to 28), and the breast cancer subscale (score ranging from 0 to 40). A total score for the instrument, ranging from 0 to 148, is calculated by summing the five domain subscale scores. Higher scores are reflective of a better quality of life.

  Change from baseline to 1-month post-intervention and 7 months post-intervention

• Neural Activity to the Affirmation Task

  Participants will complete an fMRI scan while engaging with a values affirmation or a reflective journaling task. We will specifically assess neural reward response during the task assigned compared to a control comparison condition.

  One session, midway through intervention

• Neural Activity to Stressful Task

  Participants will complete an fMRI scan while engaging with a stressful and socially evaluative math task designed to give participants feedback that suggests they are not performing well compared to their peers. We will specifically assess neural threat response during this task and compare those who complete the value affirmation task before the math task to those who complete the reflective journaling task prior to the math task.

  One session, midway through intervention

• Functional Neural Activity to Positive Stimuli

  Functional neural activity to a task displaying positive vs. neutral images. Analyses will focus on a within-subject analysis for each group, as well as between-subject analyses focusing on differences in neural reward activation to positive images for self-affirmation vs. reflective journaling. ROI and connectivity analyses will focus on the reward network. Correlations with changes in included questionnaires and medication adherence will also be assessed.

  One session, midway through intervention

• Functional Neural Activity to Negative Stimuli

  Functional neural activity to a task displaying negative vs. neutral images. Analyses will focus on a within-subject analysis for each group, as well as between-subject analyses focusing on differences in neural activation to negative images for self-affirmation vs. reflective journaling. ROI and connectivity analyses will focus on the threat/salience network. Correlations with changes in included questionnaires and medication adherence will also be assessed.

  One session, midway through intervention

• Change in Bodily Pain as assessed by the RAND 36-Item Health Survey 1.0

  We will utilize two questions from the RAND 36-Item Health Survey 1.0 that comprise the questionnaire's bodily pain component. The bodily pain component score is calculated by taking the average of the two pain items, which each have a range of 0 to 100. The component score also ranges from 0 to 100, where a lower score is indicative of a higher pain impact.

  Change from baseline to 1-month post-intervention and 7 months post-intervention

Secondary Outcomes (14)

• Change in Recovery from Stress

  Change from baseline to 1-month post-intervention and 7 months post-intervention

• Change in Gratitude

  Change from baseline to 1-month post-intervention and 7 months post-intervention

• Change in Well-Being as assessed by the Mental Health Continuum Short Form for Adults

  Change from baseline to 1-month post-intervention and 7 months post-intervention

• Change in Depression Severity

  Change from baseline to 1-month post-intervention and 7 months post-intervention

• Change in Engagement of Enjoyable Activities as assessed by the Pittsburgh Enjoyable Activities Test

  Change from baseline to 1-month post-intervention and 7 months post-intervention

Study Arms (2)

Value Affirmation

ACTIVE COMPARATOR

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.

Behavioral: Value Affirmation

Reflective Journaling

ACTIVE COMPARATOR

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.

Behavioral: Reflective Journaling

Interventions

Value Affirmation BEHAVIORAL

Participants will complete writing tasks regarding their personal values.

Value Affirmation

Reflective Journaling BEHAVIORAL

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.

Reflective Journaling

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Carnegie Mellon University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Carnegie Mellon University

Pittsburgh, Pennsylvania, 15213, United States

Location

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MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• J. David Creswell, Ph.D

  Carnegie Mellon University

  PRINCIPAL INVESTIGATOR

• Janine Dutcher, Ph.D

  Carnegie Mellon University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The participant and their care provider, who prescribes their aromatase inhibitor, will remain masked to which writing condition (self-affirmation or reflective journaling) the participant is randomized into. The outcomes assessor will remain masked to which condition the participants will complete. However, the experimenter will help set up the participant's online content and, therefore, will not be masked to the writing condition.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. J. David Creswell

Study Record Dates

• First Submitted: November 6, 2020
• First Posted: December 3, 2020
• Study Start: February 1, 2021
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The study team agrees to deposit outcome data into the ICPSR repository three years after the end of the grant period.
• Access Criteria: The study team agrees that we will identify where the data will be available and how to access the data in any publications and presentations that we author or co-author, as well as acknowledge the repository and funding source in any publications and presentations. We will be using the ICPSR, an NIH-funded repository with policies and procedures in place to provide data access to qualified researchers, fully consistent with NIH data sharing policies, applicable laws, and regulations.

Locations

US (1)