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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
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.
interventionNames
Behavioral: Value Affirmation
type
ACTIVE_COMPARATOR
label
Reflective Journaling
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.
Eligibility
Eligibility (as posted)
Sex
Female
Minimum age
18 Years
Show eligibility criteria text
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
References
Publications (24)
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interventionNames
Behavioral: Reflective Journaling
Primary outcomes (10)
measure
Change in Physical Symptoms
timeFrame
Change from baseline to 1-month post-intervention and 7 months post-intervention
description
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.
measure
Change in Perceived Stress
timeFrame
Change from baseline to 1-month post-intervention and 7 months post-intervention
description
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.
measure
Change in Medication Adherence
timeFrame
Change in adherence assessed daily, throughout 1-year participation in the study
description
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.
measure
Change in Self-Reported Medication Adherence
timeFrame
Change from baseline to 1-month post-intervention and 7 months post-intervention
description
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.
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
description
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.
measure
Neural Activity to the Affirmation Task
timeFrame
One session, midway through intervention
description
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.
measure
Neural Activity to Stressful Task
timeFrame
One session, midway through intervention
description
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.
measure
Functional Neural Activity to Positive Stimuli
timeFrame
One session, midway through intervention
description
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.
measure
Functional Neural Activity to Negative Stimuli
timeFrame
One session, midway through intervention
description
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.
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
description
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.
Secondary outcomes (14)
measure
Change in Recovery from Stress
timeFrame
Change from baseline to 1-month post-intervention and 7 months post-intervention
description
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.
measure
Change in Gratitude
timeFrame
Change from baseline to 1-month post-intervention and 7 months post-intervention
description
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.
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
description
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.
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BACKGROUNDKroenke 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. PMID 11556941
BACKGROUNDPressman 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. PMID 19592515
BACKGROUNDGlynn 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. PMID 25556993
BACKGROUNDBuysse 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. PMID 2748771
BACKGROUNDCohen 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. PMID 17101814
BACKGROUNDRosenberg, M. Society and the adolescent self-image. Princeton University Press, 2015.
BACKGROUNDCutrona CE, Russell DW. The provisions of social relationships and adaptation to stress. Advances in Personal Relationships. 1987;1:37-67.
BACKGROUNDHarris, 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.
BACKGROUNDRussell D, Peplau LA, Ferguson ML. Developing a measure of loneliness. J Pers Assess. 1978 Jun;42(3):290-4. doi: 10.1207/s15327752jpa4203_11. PMID 660402
BACKGROUNDStewart AL, Ware JE. Measuring Functioning and Well-Being: The Medical Outcomes Study Approach. Duke University Press; Durham, NC: 1992.
BACKGROUNDHays RD, Sherbourne CD, Mazel RM. The RAND 36-Item Health Survey 1.0. Health Econ. 1993 Oct;2(3):217-27. doi: 10.1002/hec.4730020305. PMID 8275167
BACKGROUNDCohen, 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.
BACKGROUNDPeipert JD, Badawy SM, Baik SH, Oswald LB, Efficace F, Garcia SF, Mroczek DK, Wolf M, Kaiser K, Yanez B, Cella D. Development of the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) Medication Adherence Scale (PMAS). Patient Prefer Adherence. 2020 Jun 9;14:971-983. doi: 10.2147/PPA.S249079. eCollection 2020. PMID 32606615
BACKGROUNDVrijens B, De Geest S, Hughes DA, Przemyslaw K, Demonceau J, Ruppar T, Dobbels F, Fargher E, Morrison V, Lewek P, Matyjaszczyk M, Mshelia C, Clyne W, Aronson JK, Urquhart J; ABC Project Team. A new taxonomy for describing and defining adherence to medications. Br J Clin Pharmacol. 2012 May;73(5):691-705. doi: 10.1111/j.1365-2125.2012.04167.x. PMID 22486599
measure
Change in Depression Severity
timeFrame
Change from baseline to 1-month post-intervention and 7 months post-intervention
description
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.
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
description
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.
measure
Change in Physical and Mental Fatigue
timeFrame
Change from baseline to 1-month post-intervention and 7 months post-intervention
description
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.
measure
Change in Sleep Measures
timeFrame
Change from baseline to 1-month post-intervention and 7 months post-intervention
description
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.
measure
Change in Positive and Negative Emotional Style
timeFrame
Change from baseline to 1-month post-intervention and 7 months post-intervention
description
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.
measure
Change in Self-Esteem
timeFrame
Change from baseline to 1-month post-intervention and 7 months post-intervention
description
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.
measure
Changes in Perceived Social Support
timeFrame
Change from baseline to 1-month post-intervention and 7 months post-intervention
description
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.
measure
Change in Perceived Stress
timeFrame
Change over the 6-month duration of the intervention, measured each month
description
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.
measure
Change in Spontaneous Self-Affirmation
timeFrame
Change from baseline to 1-month post-intervention and 7 months post-intervention
description
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.
measure
Change in Loneliness
timeFrame
Change from baseline to 1-month post-intervention and 7 months post-intervention
description
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.
measure
Change in Self-Reported Medication Adherence
timeFrame
Change over 6-month duration of the intervention, measured each month
description
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.