Breast CancerNCT04651452

Writing Interventions in Breast Cancer Patients Taking Aromatase Inhibitors

A study testing Value Affirmation and Reflective Journaling in people with Breast Cancer, run by Carnegie Mellon University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer
What is being tested?: Value Affirmation and Reflective Journaling
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 250 participants
Where: 1 siteUnited States
Study dates: 1 Feb 2021to 30 Apr 2026
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

Carnegie Mellon University
Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: A Value Affirmation Intervention for Physical Symptoms and Medication Adherence in Breast Cancer Patients Taking Aromatase Inhibitors

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.

Read the 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.

Conditions: Breast Cancer
Being tested: Value Affirmation, Reflective Journaling
Keywords: Breast Cancer, Aromatase Inhibitors, Value Affirmation
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Value AffirmationBehavioural
Participants will complete writing tasks regarding their personal values.
Reflective JournalingBehavioural
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.

Study groups in NCT04651452
Study group	Role	What they receive
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. Receives: 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. Receives: Behavioral: Reflective Journaling

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (14)

Change in Recovery from Stress
The Brief Resilience Scale is a six-item instrument that will be used to assess one's ability to recover from stress. A final score for the instrument, which ranges from 1 to 5, is determined by taking the average of the six items that comprise the instrument. Scores ranging from 1 to 2.99 indicate low resilience, 3 to 4.3 signify normal resilience, and scores 4.31 to 5 reflect high resilience.
Measured: Change from baseline to 1-month post-intervention and 7 months post-intervention
Change in Gratitude
The Gratitude Questionnaire-Six Item Form will be used to assess one's proneness to experience gratitude in daily life. Total scores for the instrument range from 6 to 42 where a higher score reflects a more grateful disposition.
Measured: 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
The Mental Health Continuum Short Form for adults will be used as a measure of well-being. The instrument measures each facet of well-being: emotional, psychological, and social. The emotional well-being component score ranges from 0 to 15, the psychological well-being score ranges from 0 to 30, and the social well-being score ranges from 0 to 25. A total score is determined by calculating the sum of all items. The total score ranges from 0 to 70, with a higher score signifying a higher level of well-being.
Measured: Change from baseline to 1-month post-intervention and 7 months post-intervention
Change in Depression Severity
The Patient Health Questionnaire is a nine-item instrument that will be utilized as a brief measure of depression severity. A total score ranges from 0 to 27 and is calculated by adding each of the nine items' scores. A higher total score signifies more severe depression levels.
Measured: 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
The Pittsburgh Enjoyable Activities Test is a brief, ten-item measure that will be used to assess the frequency of a participant's engagement in various activities on a scale of 0 (never) to 4 (every day). A total score ranges from 0 to 40 where a higher score reflects the increased frequency of participation in enjoyable activities.
Measured: Change from baseline to 1-month post-intervention and 7 months post-intervention
Change in Physical and Mental Fatigue
The Pittsburgh Fatigability Scale is a self-report questionnaire that assesses one's physical and mental fatigue in relation to activities with specific intensities and durations. Mental and physical fatigue component scores range from 0 to 50 and are determined by adding the scores of the items within the components. A higher score reflects a greater perceived physical/mental fatigability.
Measured: Change from baseline to 1-month post-intervention and 7 months post-intervention
Change in Sleep Measures
The Pittsburgh Sleep Quality Index will be used to obtain self-reported ratings of sleep. The instrument contains numerous sleep-related components, all with score ranges from 0 to 3. A higher "subjective sleep quality" component score signifies poor sleep quality. A higher "sleep latency" component score signifies increased sleep latency. An increased "sleep duration" component score signifies decreased sleep duration. A greater "sleep efficiency" component score reflects decreased efficiency. A higher "sleep disturbance" component score represents higher levels of sleep disturbance. A greater "use of sleep medication" component score signifies increased sleep medication use. A higher "daytime dysfunction" component score reflects increased daytime dysfunction. Finally, a global score is determined by calculating the sum of the seven component scores. The global score ranges from 0 to 21, where a higher score signifies decreased sleep quality.
Measured: Change from baseline to 1-month post-intervention and 7 months post-intervention
Change in Positive and Negative Emotional Style
The Positive and Negative Emotional Style instrument is a twelve-item measure of emotional style which asks participants how accurately six positive and six negative adjectives describe how they felt during the past day. Positive and negative emotional style component scores are determined by calculating the sum of the adjective ratings within each component. Component scores range from 0 to 24, with a high score signifying increased positive and negative mood on the respective scales.
Measured: Change from baseline to 1-month post-intervention and 7 months post-intervention
Change in Self-Esteem
The Rosenberg Self Esteem Scale is a ten-item instrument that assesses global self-esteem. A total score is determined by calculating the sum of the item scores. The range of total scores is 10 to 40. Higher total scores reflect higher self-esteem.
Measured: Change from baseline to 1-month post-intervention and 7 months post-intervention
Changes in Perceived Social Support
The Social Provisions Scale is a twenty-four-item measure of perceived social support that asks participants to think about the support they receive in current relationships. The six-component scores (attachment, social integration, reassurance of worth, reliable alliance, guidance, opportunity for nurturance) are determined by adding the scores of the items that comprise each component's scale. Component scores range from 4 to 16. A total score can be calculated by summing all of the items in the scale. The total scale score ranges from 4 to 96, with higher scores indicating increased levels of perceived support.
Measured: Change from baseline to 1-month post-intervention and 7 months post-intervention
Change in Perceived Stress
The 4-item Perceived Stress Scale is a self-reported assessment of perceptions of stress over the past month. Total scores range from 0 to 16, with higher scores indicating higher levels of perceived stress.
Measured: Change over the 6-month duration of the intervention, measured each month
Change in Spontaneous Self-Affirmation
The Spontaneous Self-Affirmation Measure is an instrument that asks participants how they think about themselves when they feel threatened or anxious to assess the tendency to utilize self-affirming cognitions. Component scores are used to determine if participants focus on personal strengths and attributes, values and principles, or important social relationships. A total score, ranging from 1 to 7, is calculated by taking the average of the three component scores. A higher total score reflects an increased tendency to utilize self-affirming cognitions when one feels threatened or anxious.
Measured: Change from baseline to 1-month post-intervention and 7 months post-intervention
Change in Loneliness
The UCLA Loneliness scale will be used to measure subjective feelings of loneliness and social isolation. A total score that ranges from 20 to 80 is calculated by summing the score of each item. A higher total score signifies increased feelings of loneliness.
Measured: Change from baseline to 1-month post-intervention and 7 months post-intervention
Change in Self-Reported Medication Adherence
The Basel Assessment of Adherence to Immunosuppressive Medication Scale (BAASIS) is used to assess self-reported medication adherence. Originally used to understand adherence to immunosuppressive medications, three items from the original scale will be modified to understand adherence to aromatase inhibitors in our study involving women diagnosed with breast cancer.
Measured: Change over 6-month duration of the intervention, measured each month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 202130 Apr 2026

First posted3 Dec 2020
Study start1 Feb 2021
Primary completion30 Apr 2026
Study completion30 Apr 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (24)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 250 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04651452
Sponsor's protocol ID: 1R01CA236860-01A1
Other IDs: 1R01CA236860-01A1
Status last verified: May 2026
First submitted: 6 Nov 2020
Last updated: 22 May 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The research team will share data associated with self-reports (e.g. demographics, stress levels) and adherence by depositing the data at the Inter-University Consortium for Political and Social Research (ICPSR), which is an NIH-funded repository. All data and documentation will be de-identified and will be consistent with applicable laws and regulations. Submitted data will confirm with relevant data and terminology standards. This data will be shared with investigators working under an institution with a Federal Wide Assurance (FWA) and could be used for secondary study purposes. The study team agrees that the names and Institutions of persons either given or denied access to the data, and the bases for such decisions, will be summarized in the annual progress report. We agree to deposit and maintain the phenotypic data and secondary analysis of data (if any) at ICPSR. The repository has data access policies and procedures consistent with NIH data sharing policies.

Publications

Ganz PA, Day R, Ware JE Jr, Redmond C, Fisher B. Base-line quality-of-life assessment in the National Surgical Adjuvant Breast and Bowel Project Breast Cancer Prevention Trial. J Natl Cancer Inst. 1995 Sep 20;87(18):1372-82. doi: 10.1093/jnci/87.18.1372.
PubMed 7658498
Stanton AL, Bernaards CA, Ganz PA. The BCPT symptom scales: a measure of physical symptoms for women diagnosed with or at risk for breast cancer. J Natl Cancer Inst. 2005 Mar 16;97(6):448-56. doi: 10.1093/jnci/dji069.
PubMed 15770009
Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417
Cella D, Land SR, Chang CH, Day R, Costantino JP, Wolmark N, Ganz PA. Symptom measurement in the Breast Cancer Prevention Trial (BCPT) (P-1): psychometric properties of a new measure of symptoms for midlife women. Breast Cancer Res Treat. 2008 Jun;109(3):515-26. doi: 10.1007/s10549-007-9682-9. Epub 2007 Sep 13.
PubMed 17851765
Brady MJ, Cella DF, Mo F, Bonomi AE, Tulsky DS, Lloyd SR, Deasy S, Cobleigh M, Shiomoto G. Reliability and validity of the Functional Assessment of Cancer Therapy-Breast quality-of-life instrument. J Clin Oncol. 1997 Mar;15(3):974-86. doi: 10.1200/JCO.1997.15.3.974.
PubMed 9060536
Smith BW, Dalen J, Wiggins K, Tooley E, Christopher P, Bernard J. The brief resilience scale: assessing the ability to bounce back. Int J Behav Med. 2008;15(3):194-200. doi: 10.1080/10705500802222972.
PubMed 18696313
Mccullough ME, Emmons RA, Tsang JA. The grateful disposition: a conceptual and empirical topography. J Pers Soc Psychol. 2002 Jan;82(1):112-27. doi: 10.1037//0022-3514.82.1.112.
PubMed 11811629
Keyes CL. The mental health continuum: from languishing to flourishing in life. J Health Soc Behav. 2002 Jun;43(2):207-22.
PubMed 12096700
Keyes CL. Mental illness and/or mental health? Investigating axioms of the complete state model of health. J Consult Clin Psychol. 2005 Jun;73(3):539-48. doi: 10.1037/0022-006X.73.3.539.
PubMed 15982151
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941
Pressman SD, Matthews KA, Cohen S, Martire LM, Scheier M, Baum A, Schulz R. Association of enjoyable leisure activities with psychological and physical well-being. Psychosom Med. 2009 Sep;71(7):725-32. doi: 10.1097/PSY.0b013e3181ad7978. Epub 2009 Jul 10.
PubMed 19592515
Glynn NW, Santanasto AJ, Simonsick EM, Boudreau RM, Beach SR, Schulz R, Newman AB. The Pittsburgh Fatigability scale for older adults: development and validation. J Am Geriatr Soc. 2015 Jan;63(1):130-5. doi: 10.1111/jgs.13191. Epub 2014 Dec 31.
PubMed 25556993
Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
PubMed 2748771
Cohen S, Alper CM, Doyle WJ, Treanor JJ, Turner RB. Positive emotional style predicts resistance to illness after experimental exposure to rhinovirus or influenza a virus. Psychosom Med. 2006 Nov-Dec;68(6):809-15. doi: 10.1097/01.psy.0000245867.92364.3c. Epub 2006 Nov 13.
PubMed 17101814
Rosenberg, M. Society and the adolescent self-image. Princeton University Press, 2015.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

All Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Value Affirmation Intervention for Physical Symptoms and Medication Adherence in Breast Cancer Patients Taking Aromatase Inhibitors
ClinicalTrials.gov ID: NCT04651452
Acronym / sponsor ID: 1R01CA236860-01A1
Conditions: Breast Cancer
Keywords: Breast Cancer, Aromatase Inhibitors, Value Affirmation
Study type: Interventional
Recruitment status: Completed
Enrolment: 250 participants (actual)
Lead sponsor: Carnegie Mellon UniversityUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 1 Feb 2021 (actual)
Primary completion: 30 Apr 2026 (actual)
Study completion: 30 Apr 2026 (actual)
First posted: 3 Dec 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Value Affirmation	Active comparator	Behavioral: Value AffirmationParticipants 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.
Reflective Journaling	Active comparator	Behavioral: Reflective JournalingParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (6 listed)

Have implanted metal
Have an implanted electronic medical device
Have an IUD that contains metal
Are currently pregnant
Have a history of claustrophobia

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Value AffirmationParticipants will complete writing tasks regarding their personal values.	Behavioural	Value Affirmation
Reflective JournalingParticipants 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.	Behavioural	Reflective Journaling

Primary outcome

Change in Physical Symptoms
Time frame: Change from baseline to 1-month post-intervention and 7 months post-intervention
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 in Perceived Stress
Time frame: Change from baseline to 1-month post-intervention and 7 months post-intervention
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 in Medication Adherence
Time frame: Change in adherence assessed daily, throughout 1-year participation in the study
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 Self-Reported Medication Adherence
Time frame: Change from baseline to 1-month post-intervention and 7 months post-intervention
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.
Health-Related Quality of Life in Breast Cancer Patients as assessed by the Functional Assessment of Cancer Therapy - Breast Cancer
Time frame: Change from baseline to 1-month post-intervention and 7 months post-intervention
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.
Neural Activity to the Affirmation Task
Time frame: One session, midway through intervention
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.
Neural Activity to Stressful Task
Time frame: One session, midway through intervention
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.
Functional Neural Activity to Positive Stimuli
Time frame: One session, midway through intervention
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.
Functional Neural Activity to Negative Stimuli
Time frame: One session, midway through intervention
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.
Change in Bodily Pain as assessed by the RAND 36-Item Health Survey 1.0
Time frame: Change from baseline to 1-month post-intervention and 7 months post-intervention
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.

14 secondary outcomes

Change in Recovery from Stress
Time frame: Change from baseline to 1-month post-intervention and 7 months post-intervention
Change in Gratitude
Time frame: 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
Time frame: Change from baseline to 1-month post-intervention and 7 months post-intervention
Change in Depression Severity
Time frame: 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
Time frame: Change from baseline to 1-month post-intervention and 7 months post-intervention
Change in Physical and Mental Fatigue
Time frame: Change from baseline to 1-month post-intervention and 7 months post-intervention
Change in Sleep Measures
Time frame: Change from baseline to 1-month post-intervention and 7 months post-intervention
Change in Positive and Negative Emotional Style
Time frame: Change from baseline to 1-month post-intervention and 7 months post-intervention
Change in Self-Esteem
Time frame: Change from baseline to 1-month post-intervention and 7 months post-intervention
Changes in Perceived Social Support
Time frame: Change from baseline to 1-month post-intervention and 7 months post-intervention
Change in Perceived Stress
Time frame: Change over the 6-month duration of the intervention, measured each month
Change in Spontaneous Self-Affirmation
Time frame: Change from baseline to 1-month post-intervention and 7 months post-intervention
Change in Loneliness
Time frame: Change from baseline to 1-month post-intervention and 7 months post-intervention
Change in Self-Reported Medication Adherence
Time frame: Change over 6-month duration of the intervention, measured each month

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
Background: PubMed 7658498Ganz PA, Day R, Ware JE Jr, Redmond C, Fisher B. Base-line quality-of-life assessment in the National Surgical Adjuvant Breast and Bowel Project Breast Cancer Prevention Trial. J Natl Cancer Inst. 1995 Sep 20;87(18):1372-82. doi: 10.1093/jnci/87.18.1372.
Background: PubMed 15770009Stanton AL, Bernaards CA, Ganz PA. The BCPT symptom scales: a measure of physical symptoms for women diagnosed with or at risk for breast cancer. J Natl Cancer Inst. 2005 Mar 16;97(6):448-56. doi: 10.1093/jnci/dji069.
Background: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
Background: PubMed 17851765Cella D, Land SR, Chang CH, Day R, Costantino JP, Wolmark N, Ganz PA. Symptom measurement in the Breast Cancer Prevention Trial (BCPT) (P-1): psychometric properties of a new measure of symptoms for midlife women. Breast Cancer Res Treat. 2008 Jun;109(3):515-26. doi: 10.1007/s10549-007-9682-9. Epub 2007 Sep 13.
Background: PubMed 9060536Brady MJ, Cella DF, Mo F, Bonomi AE, Tulsky DS, Lloyd SR, Deasy S, Cobleigh M, Shiomoto G. Reliability and validity of the Functional Assessment of Cancer Therapy-Breast quality-of-life instrument. J Clin Oncol. 1997 Mar;15(3):974-86. doi: 10.1200/JCO.1997.15.3.974.
Background: PubMed 18696313Smith BW, Dalen J, Wiggins K, Tooley E, Christopher P, Bernard J. The brief resilience scale: assessing the ability to bounce back. Int J Behav Med. 2008;15(3):194-200. doi: 10.1080/10705500802222972.
Background: PubMed 11811629Mccullough ME, Emmons RA, Tsang JA. The grateful disposition: a conceptual and empirical topography. J Pers Soc Psychol. 2002 Jan;82(1):112-27. doi: 10.1037//0022-3514.82.1.112.
Background: PubMed 12096700Keyes CL. The mental health continuum: from languishing to flourishing in life. J Health Soc Behav. 2002 Jun;43(2):207-22.
Background: PubMed 15982151Keyes CL. Mental illness and/or mental health? Investigating axioms of the complete state model of health. J Consult Clin Psychol. 2005 Jun;73(3):539-48. doi: 10.1037/0022-006X.73.3.539.
Background: PubMed 11556941Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
Background: PubMed 19592515Pressman SD, Matthews KA, Cohen S, Martire LM, Scheier M, Baum A, Schulz R. Association of enjoyable leisure activities with psychological and physical well-being. Psychosom Med. 2009 Sep;71(7):725-32. doi: 10.1097/PSY.0b013e3181ad7978. Epub 2009 Jul 10.
Background: PubMed 25556993Glynn NW, Santanasto AJ, Simonsick EM, Boudreau RM, Beach SR, Schulz R, Newman AB. The Pittsburgh Fatigability scale for older adults: development and validation. J Am Geriatr Soc. 2015 Jan;63(1):130-5. doi: 10.1111/jgs.13191. Epub 2014 Dec 31.
Individual participant dataSharing planned: Yes. The research team will share data associated with self-reports (e.g. demographics, stress levels) and adherence by depositing the data at the Inter-University Consortium for Political and Social Research (ICPSR), which is an NIH-funded repository. All data and documentation will be de-identified and will be consistent with applicable laws and regulations. Submitted data will confirm with relevant data and terminology standards. This data will be shared with investigators working under an institution with a Federal Wide Assurance (FWA) and could be used for secondary study purposes. The study team agrees that the names and Institutions of persons either given or denied access to the data, and the bases for such decisions, will be summarized in the annual progress report. We agree to deposit and maintain the phenotypic data and secondary analysis of data (if any) at ICPSR. The repository has data access policies and procedures consistent with NIH data sharing policies.

Related trials for Breast Cancer

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

J. David Creswell, Ph.D principal investigator

Carnegie Mellon University

Janine Dutcher, Ph.D study director

Carnegie Mellon University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Value Affirmation and Reflective Journaling in people with Breast Cancer, run by Carnegie Mellon University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Physical Symptoms (time frame: Change from baseline to 1-month post-intervention and 7 months post-intervention). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04651452, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.