Impact of Motivational Interviewing on Psychosocial and Symptom Outcomes During Breast Cancer Endocrine Therapy

doi:10.21203/rs.3.rs-4870748/v1

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Impact of Motivational Interviewing on Psychosocial and Symptom Outcomes During Breast Cancer Endocrine Therapy

https://doi.org/10.21203/rs.3.rs-4870748/v1

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PURPOSE: Adjuvant endocrine therapy (ET) is recommended to women with hormone receptor positive (HR+) breast cancer for 5-10 years to reduce recurrence risk and mortality, but adhering to ET for this full period is challenging, with adherence lower in Black women and those under 50. We sought to understand how participation in a patient-centered counseling intervention affected health-related quality of life (HRQoL), recurrence worry, and treatment related symptoms.

METHODS: We conducted a single arm pilot study over a 12-month period, consisting of five counselor-led motivational interviewing (MI) counseling sessions. Eligible participants were over 18 years old, English speaking, and had stage I-III HR+ breast cancer. Survey data collected at baseline and 12-months assessed HRQoL and cancer recurrence worry. Endocrine symptoms were assessed at the 12-month time point, reported descriptively, and age-stratified to examine if symptom burden and age were related.

RESULTS: Of the 42 women who initiated the intervention, 35 completed the baseline and 12-month surveys. Most participants were over 50 (63%), non-Black and non-Hispanic (63%; 97%). Overall patient-reported anxiety and depression decreased, though only the change in anxiety was statistically significant. Cancer worry increased slightly among participants. The most reported endocrine symptoms were hot flashes, night sweats, vaginal dryness, disinterest in sex, and joint pain, with no significant differences by age.

CONCLUSION: This study shows early promise in the efficacy of MI to improve patient-reported HRQoL and treatment-related endocrine symptoms.

Adjuvant endocrine therapy (ET) is typically recommended for women with hormone receptor positive (HR+) breast cancer [1]. Evidence suggests that taking ET as prescribed for up to 10 years can reduce the risk of recurrence and overall breast cancer-specific mortality [2, 3]. However, many patients struggle to take ET as directed due to the negative physical, psychosocial, and health-related quality-of-life (HRQoL) effects associated with therapy [4, 5]. As a result of these negative effects, ET discontinuation or non-adherence is common, and attenuates its potential benefits for women [4, 6–10]. Interventions that address patient barriers are needed to support women undergoing adjuvant ET.

Motivational Interviewing (MI) is a patient-centered, focused, and goal-directed counselling approach that aims to define a patient’s motivators and connect them to a behavior to facilitate behavior change [11]. In the context of ET, MI aims to elicit the core value and motivation behind the decision to take ET and help participants to connect all future decisions back to that core value or motivator [12]. Behavioral theory explains that MI helps participants build the skills necessary to keep them on track with ET even when barriers arise [12, 13]. MI as a component of behavioral interventions has been shown to improve outcomes across many behaviors and contexts by increasing self-efficacy [14], and has been efficacious in improving medication adherence in other diseases. This approach may help in supporting ET use, as increasing self-efficacy may reduce the burden of negative psychosocial and HRQoL effects associated with its use among breast cancer patients [12–16].

A failure to assess and adequately manage ET symptoms and high cancer recurrence worry have been associated with reduced quality of life, greater symptom interference, and ET discontinuation [16–19]. MI shows great promise in reducing the burden of negative treatment-related psychosocial and HRQoL impacts by encouraging women to talk about their experiences and providing them with external support [12, 14, 17]. Therefore, an MI intervention that improves self-efficacy and communication has the potential to improve overall well-being, in addition to adherence, in women undergoing ET.

MI has been used to address lifestyle behaviors in cancer patients and survivors, but has not been extensively tested in women taking ET [20]. Guiding Endocrine Therapy Success through Empowerment & Technology (GETSET) is an MI-based intervention designed to improve ET taking behaviors in women with HR + breast cancer. This intervention was designed as a flexible approach to help support diverse women taking MI, including Black women and younger women, as adherence is generally poorer among these groups [12]. A single-arm pilot study was conducted to preliminarily assess feasibility, acceptability and potential efficacy of the GETSET intervention. A previous paper on the GETSET pilot study described the success of MI in supporting endocrine therapy adherence [12]. In addition, the data suggested that MI benefited participants aside from increased medication adherence by reducing the psychosocial burden of survivorship. Here, we report on changes over time and from pre-intervention to post-intervention in patient-reported outcomes including HRQoL, cancer recurrence worry, and treatment-related symptoms among participants in the GETSET pilot study.

Study Overview

The GETSET study was a single-arm pilot study conducted over a 12-month period investigating the feasibility, acceptability, and efficacy of an MI intervention to increase ET adherence. Participants were recruited from one large academic medical center and four affiliated community clinics within the University of North Carolina’s Cancer Care Network. At the first study visit, participants consented to abstraction of their cancer history data and medical records and completed a baseline survey to provide sociodemographic and self-efficacy data. Participants were sent follow-up surveys electronically or by mail at six and twelve months after the baseline visit. Participants received USD 20, USD 30, and USD 50 for completion of the baseline, six-month, and twelve-month survey, respectively. Patients were given an electronic pill cap to monitor their medication adherence.

Study Population

Patients were eligible if they were over 18 years old, could read and speak English, and had stage I-III endocrine receptor-positive breast cancer. Patients were approached by the study team at either the appointment at which they received an ET prescription, or within six weeks of receiving an ET prescription. Patients could begin the intervention after the completion of all surgery, radiation therapy, and chemotherapy treatments. All participants identified as women. The study prioritized the recruitment of Black women and women under 50 due to low rates of adherence among these groups. Recruitment materials were developed using input from Black women and women younger than 50 to support recruitment of these groups.

Intervention

The GETSET (Guiding Endocrine Therapy Success through Empowerment and Teamwork) pilot was adapted from previous ET patient qualitative studies and MI-based medication adherence interventions [21–23]. The intervention consisted of five counselor-led sessions, the first of which was delivered in-person at baseline and lasted on average 60–90 minutes. The subsequent sessions were delivered via telephone at 3-, 6-, 9-, 12-, and 24-weeks post-initiation of the intervention, and lasted on average 30–60 minutes. Participants were assigned to an MI-trained counselor that conducted each session. Each session was structured to adapt to patient concerns, identify ET knowledge and motivations, and improve self-efficacy. Participants were guided through activities that encouraged them to set goals, identify support systems and ways to overcome the challenges of treatment. A workbook was provided to patients to guide them through the activities and content of MI sessions. The workbooks also had online and local resources for breast cancer survivors.

Data Collection

The baseline and twelve-month surveys collected data on participants’ HRQoL and recurrence worry. The Patient-Reported Outcomes Measurement Information System (PROMIS) scale was used to measure general HRQoL related to anxiety and depression at each time point [24–26]. The PROMIS Short Form v1.0 – Anxiety 6a (PROMIS-A) and Depression 6a (PROMIS-D) were administered to participants [25, 26]. Participants reported whether PROMIS statements applied to them on a 5-point Likert scale of “never” to “always” in the previous seven days. Participants also completed the Cancer Worry Scale (CWS) to report their feelings about cancer recurrence worry on a 4-point scale of “never”, “sometimes”, “often”, or “always”. CWS scores range from 8–32, with higher scores indicating greater cancer worry [19].

At the twelve-month time point, participants reported their endocrine-related symptoms. This instrument was measured with agreement to statements about symptoms over the past seven days on a 5-point Likert scale ranging from “not at all” to “very much”. Aggregated endocrine symptom scores ranged from 0–76, with higher scores indicating higher symptom burden.

Outcomes and Analysis

The primary outcome of this analysis was changes in responses to anxiety, depression, and cancer worry constructs from baseline to 1 year. Responses to each instrument were converted to a numerical label and aggregated. T-scores for both PROMIS measures were determined using the HealthMeasures Scoring Service and averaged. The T-score metric utilizes 50 as the mean of the relevant reference population and 10 as the standard deviation. Higher T-scores indicate more of a concept being measured. A T-score within normal limits is less than 0.5 standard deviations from the mean. CWS scores were determined for each participant and averaged across the sample. A two-way t-test was conducted to analyze the difference in means for responses to the instruments. An alpha level of 0.05 was used to determine statistical significance of mean differences.

A secondary outcome was reported burden of endocrine symptoms. Responses to this instrument were dichotomized as little to no endocrine symptom burden versus moderate to severe symptom burden. These data were stratified by participants over the age of 50 compared to under the age of 50 since age-related menopause is an important determinant of type of ET prescribed, and age is an important correlate of non-ET related menopausal symptoms that are similar to those experienced with ET. Participants who were exactly 50 were included in the over 50 age group. A Fisher’s exact test was conducted at an alpha level of 0.05 to see if age and symptom burden were related. All analysis was done in R version 4.3.1.

IRB Statement

Study activities were approved by the University of North Carolina’s Institutional Review Board (IRB #13–0736) and informed consent was obtained.

Table 1

GETSET Participant Characteristics by Age
	Total (N = 35)	< 50 years (n = 13)	≥ 50 years (n = 22)
	N (%)	N (%)	N (%)
Race
Black	13(37)	4(31)	9(41)
Non-Black	22(63)	9(69)	13(59)
Ethnicity
Non-Hispanic	34(97)	13(100)	21(95)
Marital Status
Unmarried, or not living with a partner	11(31)	2(16)	9(41)
Married, or living with a partner	24(69)	11(84)	13(59)
Any dependents in household	18(51)	10(77)	8(36)
Educational attainment
High school graduate (or GED)	3(9)	0(0)	3(14)
Technical school/some 4-year college	6(17)	2(15)	4(18)
4-year college graduate	18(51)	8(62)	10(45)
Post-graduate/professional degree	8(23)	3(23)	5(23)
Annual Household Income
Less than $49,999	8(23)	3(23)	5(23)
$50,000 to $99,999	8(23)	4(31)	4(18)
$100,000 +	14(40)	5(38)	9(41)
I prefer not to answer	5(14)	1(8)	4(18)
Insurance Type
Uninsured	2(6)	0(0)	2(9)
Private	26(74)	12(92)	14(64)
Public insurance	7(20)	1(8)	6(27)
Non-Black includes White and Other

Forty-six women consented to the GETSET study. Of these, four women withdrew or were lost to follow-up prior to initiating the intervention. Of the remaining 42 who initiated intervention, four additional women withdrew and three were lost to follow-up. A total of 35 women completed the baseline survey, 35 completed the twelve-month survey, with 32 women completing both surveys.

At baseline, 13 (37%) participants were under the age of 50, and 22 (63%) were over the age of 50. The majority of participants were non-Black (63%), and non-Hispanic (97%). The most common relationship status was married or living with a partner (69%), though this was more common in the younger age group (84% of under 50; 59% of over 50). Most women had at least a 4-year college degree (74%), with a slightly greater percentage of those under 50 (85%) having a 4-year degree or higher compared to those over 50 (68%). Less than half of participants reported an annual household income greater than 100,000 USD. Finally, most participants were privately insured (92% under 50; 64% over 50).

Table 2

PROMIS T-Scores and Cancer Worry Scale Scores from Baseline to Twelve-Month Follow-up
	Baseline	12 Months	Change	p-value
PROMIS-A	51.16	47.53	-3.63	0.04*
PROMIS-D	47.81	45.80	-2.01	0.10
CWS	11.22	11.88	0.66	0.14
CWS: Cancer Worry Scale * p-value < 0.05

At baseline, the average PROMIS-Anxiety T-score was 51.1. Over the twelve-month period, the average T-score decreased statistically significantly by 4 points to 47.5 (p-value: 0.04). The average PROMIS-Depression T-score decreased by 2 points, from 47.8 to 45.8 (p-value: 0.1). Average CWS scores increased slightly by 0.7 points, from 11.2 to 11.8 (p-value: 0.1). These values exceeded minimal clinically important difference established for all three scales [27].

Table 3

Age-Stratified PROMIS and Cancer Worry Scale Score Changes
	Under 50 N = 11		Over 50 N = 21
	Change	p-value	Change	p-value
PROMIS-A	-3.94	0.2045	-3.47	0.1195
PROMIS-D	-2.47	0.3094	-1.76	0.2259
CWS	1.09	0.2529	0.43	0.3835

Age-stratified changes in average scores for PROMIS and CWS are shown in Table 3. PROMIS-A T-scores for women under 50 decreased from 53.4 to 49.5. For women over 50, T-scores decreased from 49.9 to 46.4. PROMIS-D T-scores lowered from 49.70 to 47.23 in women under 50, and from 46.83 to 45.06 in women over 50. Women under 50 had higher CWS scores on average, which increased from 13.0 to 14.1 during the study period. CWS scores for women over 50 increased from 10.29 to 10.72. Although none of the stratified findings were statistically significant, possibly due to small sample sizes, the magnitude of PROMIS-A and PROMIS-D scale changes in sub-groups were similar to the magnitude observed in the overall cohort and exceeded established meaningful change thresholds for cancer patients [27].

Table 4

Symptom frequency among those reporting moderate to severe burden
Endocrine Symptom Statement	Total (%) N = 35	< 50 (%) N = 13	≥ 50 (%) N = 22	p-value
I have hot flashes.	19(54)	8(62)	11(50)	0.73
I have lost interest in sex.	17(49)	8(62)	9(41)	0.49
I have pain in my joints.	16(46)	7(54)	9(41)	0.73
I have vaginal dryness.	16(46)	8(62)	8(36)	0.18
I have night sweats.	15(43)	7(54)	8(36)	0.48
I have pain or discomfort with intercourse.	11(31)	6(46)	5(23)	0.28
I have gained weight.	10(29)	5(38)	5(23)	0.45
I have cold sweats.	9(26)	4(31)	5(23)	0.70
I have mood swings.	9(26)	6(46)	3(14)	0.05*
I have breast sensitivity/tenderness.	8(23)	3(23)	5(23)	1.0
I am irritable.	8(23)	5(38)	3(14)	0.21
I feel lightheaded (dizzy).	6(17)	4(31)	2(9)	0.17
I feel bloated.	5(14)	3(23)	2(9)	0.34
I have diarrhea.	4(11)	1(8)	3(14)	1.0
I get headaches.	2(6)	1(8)	1(5)	1.0
I have vaginal discharge.	2(6)	1(8)	1(5)	1.0
I have been vomiting.	1(3)	0(0)	1(5)	1.0
I have vaginal itching/irritation.	0(0)	0(0)	0(0)	-
I have vaginal bleeding or spotting.	0(0)	0(0)	0(0)	-
Mean ES Score (SD)	17.31 (11.59)	21.54 (12.76)	14.82 (10.34)	0.0980
Notes: Fisher’s exact test does not show the absence of symptom burden; ES: Endocrine Symptom. * p-value < 0.05

Many of the endocrine symptoms were similar across the two age groups. The most commonly reported symptoms were hot flashes (54%), night sweats (43%), vaginal dryness (46%), disinterest in sex (49%), and joint pain (46%). The average endocrine symptom score for the entire sample was 17.31 (11.59). Women under 50 had slightly numerically greater endocrine symptoms than women over 50, with respective scores of 21.54 and 14.82, but these differences did not reach statistical significance.

The GETSET Pilot study shows early promise in the efficacy of an MI intervention to affect patient-reported HRQoL and treatment-related endocrine symptoms. Anxiety decreased from pre- to post-intervention, and these patterns were similar in younger and older women. Non-significant trends toward decreased depression and increased cancer worry were also seen between time points. Hot flashes were the highest reported endocrine symptom; 54% of women reported hot flashes as moderately to severely burdensome. Reported symptoms and symptom burden among the GETSET sample are reflective the literature on endocrine symptoms in women taking ET [28]. While the present study was not powered to examine differences by subgroup, women under 50 had numerically higher burdens of common psychosocial and physical symptoms of breast cancer and its treatment, including anxiety, depression, cancer worry, and endocrine symptoms. According to the literature, side effect burden is high in younger women, which may reflect difference in symptom management, subjective perceptions of burden, or objectively higher burden [29, 30].

Relative to the general population, GETSET participants reported normal anxiety and depression [31]. Though the overall PROMIS-A T-score was within normal limits at each time point, there was a statistically significant decrease in score from baseline to follow-up. This suggests that the intervention may improve anxiety, even when the burden of anxiety is already low. Overall PROMIS-D scores, as well as age-stratified PROMIS scores were also within normal range, and the change was not significant. However, these may be considered minimal important changes, which reflect the minimal threshold of change that the participant perceives as meaningful [27]. Based on the literature, meaningful change can range from 2 to 6 T-score points, with cancer-specific meaningful change for PROMIS averaging between 2 and 3 points [27]. Given the presence of meaningful change for overall and age-stratified PROMIS-A responses, the data suggests that MI counseling may have helped reduce anxiety. The PROMIS-D scores for participants under 50 met the meaningful change threshold. These data are hypothesis-generating about the potential influence of MI on HRQoL, and warrant additional investigation to determine whether meaningful change would be present in a larger sample. The average CWS score increased very minimally between time points. The change for women under 50 was greater, which reflects the literature that younger breast cancer survivors have greater fear of recurrence compared to older survivors [32].

Women under 50 reported more endocrine symptoms on average. Data suggest that endocrine symptoms may be more prominent and burdensome in premenopausal women given the abrupt change in estrogen levels that accompany tamoxifen [33, 34]. These symptoms may be more unfamiliar in younger women than in postmenopausal women who have comparatively dealt with them for longer. Additionally, endocrine symptoms reported by older women may be due to menopause, given that aromatase inhibitors are more associated with musculoskeletal symptoms [34, 35]. The presence of more burdensome endocrine symptoms in younger women may provide evidence as to why ET nonadherence and discontinuation is greater in this age group [36]. This also provides rationale for routine symptom monitoring and patient reported outcomes (PROs) to be a more established part of the care delivery process. The use of PROs in addition to clinical indicators could improve overall clinical outcomes, HRQoL, and symptom management in this population [37–39]. Additionally, greater symptom burden in premenopausal women should be considered when designing ET adherence interventions, as they will be more efficacious in this population if they target their unique experiences.

Other interventions tested to improve ET adherence and relieve symptom burden in this population focus on improving patient information and education about breast cancer, benefits and side effects of ET, text messaging reminders, and lifestyle changes to relieve symptoms [40–42]. A similar telehealth intervention to GETSET used coping and cognitive skills and showed a reduction in reported symptom burden and an improvement in mood compared to a control group [43]. Other non-pharmacological interventions for endocrine symptoms have included weight management, cognitive behavioral therapy, and acupuncture to address hot flashes, night sweats, and joint symptoms [44–49]. Pharmacological interventions like lubricants and supplements have shown to be helpful in reducing vaginal dryness and sexual dysfunction [50, 51]. While these interventions are feasible and acceptable among participants, few of these studies report measurable change in HRQoL [40, 41, 50]. GETSET is the first MI-based oral medication adherence intervention piloted in this population.

GETSET was designed such that participants could choose each MI session topic. Relevant topics included recurrence fear, symptom worry, lack of adequate support, and feelings of stress. During sessions, participants identified coping strategies and self-efficacy to overcome identified strategies. The structure and topic selection of MI sessions may have targeted participant’s psychosocial burdens, leading to the decreases in PROMIS scores. It is important to note that participants generally had normal HRQoL at baseline, so observed changes were minimal. Perhaps for people with worse initial HRQoL, MI counseling could have a more profound impact on their psychosocial symptoms, though this would need to be observed with a larger sample. The minimal changes may also suggest that not all survivors need help with these psychosocial symptoms, and future investigation should consider more complex ways of analyzing HRQoL data.

This study has several limitations. The sample was limited to women in North Carolina who self-selected to participate in this intervention. As a result, the study population is not representative of all ET users, which limits the generalizability of the results to the broader population. The small sample size also limited our ability to detect differences and interpret non-significant findings. Additional work with a larger sample would improve precision of estimates.. However, this pilot study was conducted to assess feasibility and acceptability of an MI intervention and generate hypotheses for a larger trial. This study provides preliminary evidence for MI affecting HRQoL and recurrence worry, which can be better tested with the larger study to elucidate whether observed differences are truly due to chance.

In conclusion, ET is a critical adjuvant therapy in women with hormone receptor positive breast cancer. ET has a high rate of nonadherence, particularly due to the burdensome psychosocial and physical side effects associated with treatment. Motivational Interviewing has shown promise in reducing psychosocial burden, as was demonstrated with our data, which has led to the development of an ongoing national trial with a much larger sample to investigate these issues more fully (ClinicalTrials.gov ID NCT04379570) [52]. The GETSET intervention was piloted to improve ET use and better understand the effect of MI on medication adherence. This study reinforces the need for interventions that address the complex barriers to ET use to improve survival and survivorship in this population.

Funding: Research reported in this publication was supported by the National Cancer Institute of the National Institutes of Health. Austin R. Waters is supported by the National Cancer Institute’s National Research Service Award sponsored by the Lineberger Comprehensive Cancer Center at the University of North Carolina (T32 CA116339). The pilot study was funded by an American Cancer Society (ACS) Mentored Research Scholar Grant (MRSG-13-157-01-CPPB, Wheeler, “Improving Endocrine Therapy Utilization in Racially Diverse Populations”).

Conflicts of Interest: Stephanie Wheeler and Katie Reeder-Hayes receive unrelated grant funding paid to their institutions from the Pfizer Foundation (SW and KRH) and Astra Zeneca (SW).

Author Contributions: All authors have met the minimum criteria for authorship, including: conceptualization: Charlotte Ellis, Katie Reeder-Hayes, Sarah Drier, Stephanie Wheeler; methodology, Charlotte Ellis, Katie Reeder-Hayes, Sarah Drier, Austin R. Waters, Jennifer C. Spencer, Stephanie Wheeler; formal analysis, Charlotte Ellis, Austin R. Waters, Stephanie Wheeler; investigation, Katie Reeder-Hayes, Sarah Drier, Jennifer C. Spencer, Stephanie Wheeler; resources, Katie Reeder-Hayes, Stephanie Wheeler; data curation, Charlotte Ellis, Sarah Drier, Jennifer C. Spencer; writing––original draft preparation, Charlotte Ellis, Stephanie Wheeler; writing––review and editing, Charlotte Ellis, Katie Reeder-Hayes, Sarah Drier, Austin R. Waters, Jennifer C. Spencer, Stephanie Wheeler; visualization, Charlotte Ellis; supervision, Stephanie Wheeler; project administration, Sarah Drier; funding acquisition, Katie Reeder-Hayes, Stephanie Wheeler. All authors read and approved the final manuscript.

Data Availability Statement: Informed consent was obtained from all study participants. De-identified data are available from the corresponding author on request.

Acknowledgements: I would like to thank Dr. Karl Umble with the Department of Health Policy and Management at the Gillings School of Global Public Health for his advising and instruction while writing this thesis. I would also like to thank Dr. Stephanie Wheeler for her mentorship and guidance throughout this project. Finally, I am grateful to the patients who participated in this pilot study and aided in the design and implementation of materials.

Early Breast Cancer Trialists’ Collaborative Group (EBCTCG) (2005) Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet Lond Engl 365(9472):1687–1717. 10.1016/S0140-6736(05)66544-0
Goss PE, Ingle JN, Pritchard KI et al (2016) Extending Aromatase-Inhibitor Adjuvant Therapy to 10 Years. N Engl J Med 375(3):209–219. 10.1056/NEJMoa1604700
Goss PE, Ingle JN, Martino S et al (2005) Randomized trial of letrozole following tamoxifen as extended adjuvant therapy in receptor-positive breast cancer: updated findings from NCIC CTG MA.17. J Natl Cancer Inst 97(17):1262–1271. 10.1093/jnci/dji250
Aiello Bowles EJ, Boudreau DM, Chubak J et al (2012) Patient-Reported Discontinuation of Endocrine Therapy and Related Adverse Effects Among Women With Early-Stage Breast Cancer | JCO Oncology Practice. Am Soc Clin Oncol 8(6):149–157. 10.1200/JOP.2012.000543
Ciska Buijs, Elisabeth GE, de Vries, Marian JE, Mourits, Pax HB, Willemse (2008) The influence of endocrine treatments for breast cancer on health-related quality of life. Cancer Treat Rev 34(7):640–655. 10.1016/j.ctrv.2008.04.001
Demissie S, Silliman RA, Lash TL (2001) Adjuvant tamoxifen: predictors of use, side effects, and discontinuation in older women. J Clin Oncol Off J Am Soc Clin Oncol 19(2):322–328. 10.1200/JCO.2001.19.2.322
Fink AK, Gurwitz J, Rakowski W, Guadagnoli E, Silliman RA (2004) Patient beliefs and tamoxifen discontinuance in older women with estrogen receptor–positive breast cancer. J Clin Oncol Off J Am Soc Clin Oncol 22(16):3309–3315. 10.1200/JCO.2004.11.064
Lash TL, Fox MP, Westrup JL, Fink AK, Silliman RA (2006) Adherence to tamoxifen over the five-year course. Breast Cancer Res Treat 99(2):215–220. 10.1007/s10549-006-9193-0
Grunfeld EA, Hunter MS, Sikka P, Mittal S (2005) Adherence beliefs among breast cancer patients taking tamoxifen. Patient Educ Couns 59(1):97–102. 10.1016/j.pec.2004.10.005
Bright EE, Petrie KJ, Partridge AH, Stanton AL (2016) Barriers to and facilitative processes of endocrine therapy adherence among women with breast cancer. Breast Cancer Res Treat 158(2):243–251. 10.1007/s10549-016-3871-3
Rollnick S, Miller WR (1995) What is motivational interviewing? Behav Cogn Psychother 23(4):325–334. 10.1017/S135246580001643X
Wheeler SB, Spencer J, Drier SW, Fray N, Reeder-Hayes KE (2023) Motivational Interviewing Counseling to Increase Endocrine Therapy Adherence in Diverse Patients. Cancers 15(7):1973. 10.3390/cancers15071973
Fisher WA, Fisher JD, Harman J (2009) The Information-Motivation-Behavioral Skills Model: A General Social Psychological Approach to Understanding and Promoting Health Behavior. Social Psychol Found Health Illn 82–106. 10.1002/9780470753552.ch4
Rouleau CR, Garland SN, Carlson LE (2015) The impact of mindfulness-based interventions on symptom burden, positive psychological outcomes, and biomarkers in cancer patients. Cancer Manag Res 7:121–131. 10.2147/CMAR.S64165
Bandura A (1998) Health promotion from the perspective of social cognitive theory. Psychol Health 13(4):623–649. 10.1080/08870449808407422
Shelby RA, Edmond SN, Wren AA et al (2014) Self-efficacy for coping with symptoms moderates the relationship between physical symptoms and well-being in breast cancer survivors taking adjuvant endocrine therapy. Support Care Cancer 22(10):2851–2859. 10.1007/s00520-014-2269-1
Edmond SN, Shelby RA, Kimmick GG, Marcom PK, Peppercorn JM, Keefe FJ (2013) Symptom communication in breast cancer: relationships of holding back and self-efficacy for communication to symptoms and adjustment. J Psychosoc Oncol 31(6):698–711. 10.1080/07347332.2013.835023
Kahn KL, Schneider EC, Malin JL, Adams JL, Epstein AM (2007) Patient centered experiences in breast cancer: predicting long-term adherence to tamoxifen use. Med Care 45(5):431–439. 10.1097/01.mlr.0000257193.10760.7f
Custers JAE, van den Berg SW, van Laarhoven HWM, Bleiker EMA, Gielissen MFM, Prins JB (2014) The Cancer Worry Scale: Detecting Fear of Recurrence in Breast Cancer Survivors. Cancer Nurs 37(1):E44. 10.1097/NCC.0b013e3182813a17
Spencer JC, Wheeler SB (2016) A systematic review of Motivational Interviewing interventions in cancer patients and survivors. Patient Educ Couns 99(7):1099–1105. 10.1016/j.pec.2016.02.003
Golin CE, Earp J, Tien HC, Stewart P, Porter C, Howie L (2006) A 2-Arm, Randomized, Controlled Trial of a Motivational Interviewing–Based Intervention to Improve Adherence to Antiretroviral Therapy (ART) Among Patients Failing or Initiating ART. J Acquir Immune Defic Syndr 1999 42(1):42–51. 10.1097/01.qai.0000219771.97303.0a
Adamian MS, Golin CE, Shain LS, DeVellis B (2004) Brief Motivational Interviewing to Improve Adherence to Antiretroviral Therapy: Development and Qualitative Pilot Assessment of an Intervention. AIDS Patient Care STDs 18(4):229–238. 10.1089/108729104323038900
Thrasher AD, Golin CE, Earp JAL, Tien H, Porter C, Howie L (2006) Motivational interviewing to support antiretroviral therapy adherence: The role of quality counseling. Patient Educ Couns 62(1):64–71. 10.1016/j.pec.2005.06.003
PROMIS, Accessed (2023) November 14, https://www.healthmeasures.net/explore-measurement-systems/promis
Item Banks for Measuring Emotional Distress From the Patient-Reported Outcomes Measurement Information System (PROMIS®): Depression, Anxiety, and Anger - PMC. Accessed April 1 (2024) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3153635/
Validation of the depression item bank from the Patient-Reported Outcomes Measurement Information System (PROMIS®) in a three-month observational study - PMC. Accessed April 1 (2024) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4096965/
Terwee CB, Peipert JD, Chapman R et al (2021) Minimal important change (MIC): a conceptual clarification and systematic review of MIC estimates of PROMIS measures. Qual Life Res 30(10):2729–2754. 10.1007/s11136-021-02925-y
Rosenberg SM, Stanton AL, Petrie KJ, Partridge AH (2015) Symptoms and Symptom Attribution Among Women on Endocrine Therapy for Breast Cancer. Oncologist 20(6):598–604. 10.1634/theoncologist.2015-0007
Lorizio W, Wu AHB, Beattie MS et al (2012) Clinical and biomarker predictors of side effects from tamoxifen. Breast Cancer Res Treat 132(3):1107–1118. 10.1007/s10549-011-1893-4
Gibson L, Lawrence D, Dawson C, Bliss J (2009) Aromatase inhibitors for treatment of advanced breast cancer in postmenopausal women. Cochrane Database Syst Rev 2009(4):CD003370. 10.1002/14651858.CD003370.pub3
Setting standards for severity of common symptoms in oncology using the PROMIS item banks and expert judgment - PMC. Accessed March 29 (2024) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4710358/
Lebel S, Beattie S, Arès I, Bielajew C (2013) Young and worried: Age and fear of recurrence in breast cancer survivors. Health Psychol 32(6):695–705. 10.1037/a0030186
Vaz-Luis I, Francis PA, Di Meglio A, Stearns V (2021) Challenges in Adjuvant Therapy for Premenopausal Women Diagnosed With Luminal Breast Cancers. Am Soc Clin Oncol Educ Book 41e47–e61. 10.1200/EDBK_320595
Rosso R, D’Alonzo M, Bounous VE et al (2023) Adherence to Adjuvant Endocrine Therapy in Breast Cancer Patients. Curr Oncol 30(2):1461–1472. 10.3390/curroncol30020112
Garreau JR, Delamelena T, Walts D, Karamlou K, Johnson N (2006) Side effects of aromatase inhibitors versus tamoxifen: the patients’ perspective. Am J Surg 192(4):496–498. 10.1016/j.amjsurg.2006.06.018
Rosenberg SM, Zheng Y, Gelber S et al (2023) Adjuvant endocrine therapy non-initiation and non-persistence in young women with early-stage breast cancer. Breast Cancer Res Treat 197(3):547–558. 10.1007/s10549-022-06810-1
Tevis SE, James TA, Kuerer HM et al (2018) Patient-Reported Outcomes for Breast Cancer. Ann Surg Oncol 25(10):2839–2845. 10.1245/s10434-018-6616-1
van Egdom LSE, Oemrawsingh A, Verweij LM et al (2019) Implementing Patient-Reported Outcome Measures in Clinical Breast Cancer Care: A Systematic Review. Value Health 22(10):1197–1226. 10.1016/j.jval.2019.04.1927
Basch E, Deal AM, Kris MG et al (2016) Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized Controlled Trial. J Clin Oncol 34(6):557–565. 10.1200/JCO.2015.63.0830
Heiney SP, Parker PD, Felder TM, Adams SA, Omofuma OO, Hulett JM (2019) A systematic review of interventions to improve adherence to endocrine therapy. Breast Cancer Res Treat 173(3):499–510. 10.1007/s10549-018-5012-7
Ekinci E, Nathoo S, Korattyil T et al (2018) Interventions to improve endocrine therapy adherence in breast cancer survivors: what is the evidence? J Cancer Surviv 12(3):348–356. 10.1007/s11764-017-0674-4
Krok-Schoen JL, Naughton MJ, Young GS et al (2019) Increasing Adherence to Adjuvant Hormone Therapy Among Patients With Breast Cancer: A Smart Phone App-Based Pilot Study. Cancer Control J Moffitt Cancer Cent 26(1):1073274819883287. 10.1177/1073274819883287
Jacobs JM, Post K, Massad K et al (2022) A telehealth intervention for symptom management, distress, and adherence to adjuvant endocrine therapy: A randomized controlled trial. Cancer 128(19):3541–3551. 10.1002/cncr.34409
Caan BJ, Emond JA, Su HI et al (2012) Effect of postdiagnosis weight change on hot flash status among early-stage breast cancer survivors. J Clin Oncol Off J Am Soc Clin Oncol 30(13):1492–1497. 10.1200/JCO.2011.36.8597
Su HI, Sammel MD, Springer E, Freeman EW, DeMichele A, Mao JJ (2010) Weight gain is associated with increased risk of hot flashes in breast cancer survivors on aromatase inhibitors. Breast Cancer Res Treat 124(1):205–211. 10.1007/s10549-010-0802-6
Mann E, Smith MJ, Hellier J et al (2012) Cognitive behavioural treatment for women who have menopausal symptoms after breast cancer treatment (MENOS 1): a randomised controlled trial. Lancet Oncol 13(3):309–318. 10.1016/S1470-2045(11)70364-3
Mao JJ, Bowman MA, Xie SX, Bruner D, DeMichele A, Farrar JT (2015) Electroacupuncture Versus Gabapentin for Hot Flashes Among Breast Cancer Survivors: A Randomized Placebo-Controlled Trial. J Clin Oncol Off J Am Soc Clin Oncol 33(31):3615–3620. 10.1200/JCO.2015.60.9412
Liljegren A, Gunnarsson P, Landgren BM, Robéus N, Johansson H, Rotstein S (2012) Reducing vasomotor symptoms with acupuncture in breast cancer patients treated with adjuvant tamoxifen: a randomized controlled trial. Breast Cancer Res Treat 135(3):791–798. 10.1007/s10549-010-1283-3
Hershman DL, Unger JM, Greenlee H et al (2022) Comparison of Acupuncture vs Sham Acupuncture or Waiting List Control in the Treatment of Aromatase Inhibitor–Related Joint Pain: A Randomized Clinical Trial. JAMA Netw Open 5(11):e2241720. 10.1001/jamanetworkopen.2022.41720
Franzoi MA, Agostinetto E, Perachino M et al (2021) Evidence-based approaches for the management of side-effects of adjuvant endocrine therapy in patients with breast cancer. Lancet Oncol 22(7):e303–e313. 10.1016/S1470-2045(20)30666-5
Chan CWH, Tai D, Kwong S, Chow KM, Chan DNS, Law BMH (2020) The Effects of Pharmacological and Non-Pharmacological Interventions on Symptom Management and Quality of Life among Breast Cancer Survivors Undergoing Adjuvant Endocrine Therapy: A Systematic Review. Int J Environ Res Public Health 17(8):2950. 10.3390/ijerph17082950
Ivory J, Wheeler SB, Drier S et al (2023) Randomized phase III trial evaluating motivational interviewing and text interventions to optimize adherence to breast cancer endocrine therapy (Alliance A191901): the GETSET protocol. Trials 24:664. 10.1186/s13063-023-07672-8
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Impact of Motivational Interviewing on Psychosocial and Symptom Outcomes During Breast Cancer Endocrine Therapy

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Introduction

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Study Population

Intervention

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Outcomes and Analysis

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