Writing Interventions in Breast Cancer Patients Taking Aromatase Inhibitors

Carnegie Mellon University

Status: Active, not recruiting

Conditions: Breast Cancer

Treatments: Behavioral: Reflective Journaling; Behavioral: Value Affirmation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04651452

1R01CA236860-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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250 participants in 2 patient groups

Value Affirmation

Active Comparator group

Description:

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.

Treatment:

Behavioral: Value Affirmation

Reflective Journaling

Active Comparator group

Description:

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.

Treatment:

Behavioral: Reflective Journaling