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A Value Affirmation Intervention in Breast Cancer Patients Taking Aromatase Inhibitors

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ClinicalTrials.gov Identifier: NCT04651452
Recruitment Status : Recruiting
First Posted : December 3, 2020
Last Update Posted : April 28, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
David Creswell, Carnegie Mellon University

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Behavioral: Value Affirmation Behavioral: Reflective Journaling Not Applicable

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 substudy will be conducted on 120 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 substudy 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Supportive Care
Official Title: A Value Affirmation Intervention for Physical Symptoms and Medication Adherence in Breast Cancer Patients Taking Aromatase Inhibitors
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: 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.
Behavioral: Value Affirmation
Participants will complete writing tasks regarding their personal values.

Active Comparator: 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.
Behavioral: 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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Change in Self-Reported Medication Adherence [ Time Frame: Change from 1-month post-intervention to 7 months post-intervention ]
    The Morisky Medication Adherence Scale is a common, 8-item medication adherence scale that will be used to assess self-reported adherence behaviors and understand why a participant may be non-compliant or discontinue their medication. Total scores range from 0 to 8. A total score of less than 6 indicates low adherence, 6 to 7 reflects medium adherence, while a score of 8 signifies high adherence.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. Change in Self-Reported Medication Adherence [ Time Frame: Once a month for the 6-month duration of the intervention ]
    Morisky, Green, and Levine Medication Adherence Scale is a four-item questionnaire used to assess self-reported medication adherence. A total score is calculated by summing the scores of all the items. The total score can range from 0 to 4 where a high score reflects increased adherence.

  10. Change in Perceived Stress [ Time Frame: Once a month for the 6-month duration of the intervention ]
    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.


Secondary Outcome Measures :
  1. Change in Recovery from Stress [ Time Frame: Change from baseline to 1-month post-intervention and 7 months post-intervention ]
    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.

  2. Change in Gratitude [ Time Frame: Change from baseline to 1-month post-intervention and 7 months post-intervention ]
    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.

  3. 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 ]
    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.

  4. Change in Depression Severity [ Time Frame: Change from baseline to 1-month post-intervention and 7 months post-intervention ]
    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.

  5. 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 ]
    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.

  6. Change in Physical and Mental Fatigue [ Time Frame: Change from baseline to 1-month post-intervention and 7 months post-intervention ]
    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.

  7. Change in Sleep Measures [ Time Frame: Change from baseline to 1-month post-intervention and 7 months post-intervention ]
    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.

  8. Change in Positive and Negative Emotional Style [ Time Frame: Change from baseline to 1-month post-intervention and 7 months post-intervention ]
    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.

  9. Change in Self-Esteem [ Time Frame: Change from baseline to 1-month post-intervention and 7 months post-intervention ]
    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.

  10. Changes in Perceived Social Support [ Time Frame: Change from baseline to 1-month post-intervention and 7 months post-intervention ]
    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.

  11. Change in Spontaneous Self-Affirmation [ Time Frame: Change from baseline to 1-month post-intervention and 7 months post-intervention ]
    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.

  12. Change in Loneliness [ Time Frame: Change from baseline to 1-month post-intervention and 7 months post-intervention ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Breast cancer diagnosis
  • Recently prescribed an aromatase inhibitor or anticipates being prescribed one in the future
  • Intention to take the prescribed aromatase inhibitor
  • Fluency in English

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04651452


Contacts
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Contact: J. David Creswell, Ph.D 412-268-9182 creswell@cmu.edu

Locations
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United States, Pennsylvania
Carnegie Mellon University Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: J. David Creswell, Ph.D.    412-268-9182    creswell@cmu.edu   
Principal Investigator: J. David Creswell, Ph.D         
Sub-Investigator: Mary Amanda Dew, Ph.D         
Sub-Investigator: Janine Dutcher, Ph.D         
Sub-Investigator: Reyna Jones, B.Phil         
Sub-Investigator: Ava Liccione, B.A.         
Sub-Investigator: Gijsberta van Londen, M.D.         
Sub-Investigator: Carissa Low, Ph.D         
Sub-Investigator: John Pyles, Ph.D         
Sub-Investigator: David Sherman, Ph.D         
Sub-Investigator: Abdus Wahed, Ph.D         
Sponsors and Collaborators
Carnegie Mellon University
National Cancer Institute (NCI)
Investigators
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Principal Investigator: J. David Creswell, Ph.D Carnegie Mellon University
Study Director: Janine Dutcher, Ph.D Carnegie Mellon University
Publications:
Rosenberg, M. Society and the adolescent self-image. Princeton University Press, 2015.
Cutrona CE, Russell DW. The provisions of social relationships and adaptation to stress. Advances in Personal Relationships. 1987;1:37-67.
Harris, P. R., Griffin, D. W., Napper, L. E., Bond, R., Schüz, B., Stride, C., & Brearley, I.. Individual differences in self-affirmation: Distinguishing self-affirmation from positive self-regard. Self and Identity. 2019; 18(6): 589-630.
Stewart AL, Ware JE. Measuring Functioning and Well-Being: The Medical Outcomes Study Approach. Duke University Press; Durham, NC: 1992.
Cohen, S. and Williamson, G. Perceived Stress in a Probability Sample of the United States. Spacapan, S. and Oskamp, S. (Eds.) The Social Psychology of Health. Newbury Park, CA: Sage, 1988.

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Responsible Party: David Creswell, Dr. J. David Creswell, Carnegie Mellon University
ClinicalTrials.gov Identifier: NCT04651452    
Other Study ID Numbers: 1R01CA236860-01A1 ( U.S. NIH Grant/Contract )
1R01CA236860-01A1 ( U.S. NIH Grant/Contract )
First Posted: December 3, 2020    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by David Creswell, Carnegie Mellon University:
Breast Cancer
Aromatase Inhibitors
Value Affirmation
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases