Feasibility of Implementing Acupuncture in Medically Underserved Breast Cancer Survivors (FAB): A Protocol

Abstract

Nearly 94% of breast cancer survivors experience one or more symptoms or side effects during or after endocrine therapy. Joint pain, hot flashes, sleep disturbance, fatigue, depression, and anxiety are the most common concurrent symptoms, some of which can persist for 5 to 10 years. Acupuncture is a holistic modality that addresses multiple symptoms and side effects in a single therapy. Acupuncture has not yet been investigated for its effectiveness in treating the multiple symptoms experienced by breast cancer survivors receiving endocrine therapy. Medically underserved breast cancer survivors typically have limited access to acupuncture. The barriers limiting access to acupuncture need to be removed to enable equal access to breast cancer survivors for this evidence-based treatment. Thus, we developed a randomized controlled trial with a 5-week acupuncture intervention versus usual care for medically underserved breast cancer survivors. Mixed methods (semi-structured interviews, surveys, study notes) will be used to obtain in-depth understanding of barriers and facilitators for eventual implementation of the acupuncture intervention. This study will facilitate the widespread implementation, dissemination, and sustained utilization of acupuncture for symptom management among medically underserved breast cancer survivors receiving endocrine therapy.

Introduction

According to the National Cancer Institute (NCI), 3.8 million breast cancer survivors live in the United States.¹ For estrogen receptor-positive survivors, a minimum of 5 years of endocrine therapy is the mainstay of adjuvant therapy.^2,3 During endocrine therapy, breast cancer survivors experience mutiple concurrent symptoms associated with current and previous treatment.^4,5 Joint pain, hot flashes, fatigue, sleep disturbance, depression, and anxiety are the most common concurrent symptoms among breast cancer survivors receiving endocrine therapy, and they usually occur and cluster together.^6,7 Nearly 50% of breast cancer survivors report 3 or more long-term symptoms.⁷ These symptoms have a detrimental impact on cognitive function and can compromise quality of life (QOL) and work functioning.^8–10

Managing multiple long-term symptoms during endocrine therapy is challenging. Typical symptom management approaches provide one intervention for each individual symptom. For example, cancer survivors with multiple treatment-related symptoms are often prescribed multiple therapies, such as pain medication and psychotherapy.¹¹ This approach does not address the burden and cost of managing multiple treatments or the risks of polypharmacy.¹¹ Several studies have reported that exercise has a positive effect on fatigue, depression and cognitive function among breast cancer survivors.^12,13 Nevertheless, the absence of a single treatment to effectively treat the wide variety of symptoms encountered in breast cancer survivors, and to treat the whole person focusing on the mind-body connection, remains a significant gap in the field of oncology.

Acupuncture is one modality of Traditional Chinese Medicine (TCM). Acupuncture involves the insertion of fine, single-use, sterile needles into acupoints that access channels, for the purpose of balancing the body’s essential energy.¹⁴ Holism is a major tenet of TCM and asserts that the body itself is a unified whole.¹⁵ The viscera and tissues of the body comprise an entire coordinated system that communicate, depend on, and influence one another. This interrelationship is fostered by the connecting and communicating actions of the meridians. Because of the holistic interrelationships of the viscera, tissue, and meridians, each acupuncture point can treat multiple symptoms. Acupuncture has been used as a complementary and integrative health (CIH) treatment for cancer symptoms in more than 60% of the NCI-designated comprehensive cancer centers in the United States.¹⁶ Most acupuncture studies have mainly focused on evaluating the effect of acupuncture on a single symptom. Emerging evidence from randomized controlled trials (RCTs) has shown acupuncture’s efficacy in reducing joint pain,^17–21 hot flashes,^22–31 fatigue,^32–35, sleep disturbance,^36,37 and depression and anxiety.^26,31,32 To date, no published studies have evaluated the effect of acupuncture on multiple symptoms or symptom clusters as a primary outcome. Very few studies have used semi-standardized protocol (i.e., a standardized protocol plus additional acupuncture points based on additional individual symptoms) to treat multiple symptoms among breast cancer survivors.^38,39 Based on the results of previous acupuncture efficacy trials, we developed this semi-standardized acupuncture protocol to treat multiple symptoms among breast cancer survivors receiving endocrine therapy.

In the United States, medically underserved populations have distinct health needs and often experience poorer health outcomes.⁴⁰ Breast cancer survivors in underserved communities tend to have greater pain and greater mental health distress.^41,42 Health disparities concerning the use of CIH therapies are also well-documented. In the US, CIH users are typically women of middle age (≥ 40 years), middle or upper middle class, and with higher education and income levels.^43,44 These health disparities in CIH use were most often attributable to interpersonal racial and ethnic discrimination and socioeconomic status.^45,46 Access to care is one of 5 key social determinants of health.⁴⁷ The most limiting barriers to accessing acupuncture include, but are not limited to, the lack of insurance coverage for acupuncture, scheduling, transportation, health literacy, and limited diversity and availability of acupuncture providers.^48,49 At present, acupuncture clinics tend to be concentrated in upper-income neighborhoods, raising concerns about access for people who are living in underserved communities.⁵⁰ Although 60% of NCI-designated comprehensive cancer centers offer integrative medicine and incorporate acupuncture for cancer symptom management;¹⁶ the use of acupuncture from racial and ethnic minority groups remains limited. To date, very few trials have implemented acupuncture in medically underserved primary care or community-based settings.^51–53 The Acupuncture to Decrease Disparities in Outcomes of Pain Treatment (ADDOPT) study⁵² showed the feasibility of offering acupuncture in community health centers. Barriers included space, reliance on student acupuncturists rather than paid staff, and lack of adequate insurance reimbursement for acupuncture.⁵² Chao et al.⁵³ found that it was feasible and acceptable to implement group acupuncture among linguistically and racially diverse patients. Anderson et al.⁵¹ implemented a bundled acupuncture and yoga intervention to treat chronic pain in a community health care setting. They found that scheduling, treatment fidelity, communication, space adaptations, site-specific logistical and operational requirements, and patient-provider language barriers were barriers to implementation. To our knowledge, no studies have yet implemented acupuncture in a health care system that provides care for breast cancer survivors who are medically underserved.

The purpose of this paper is to describe the protocol of a randomized controlled trial designed to test the feasibility of implementing an acupuncture intervention for medically underserved breast cancer survivors.

2. Methods/design

2.1. Study design

This study used a sequential mixed methods approach.⁵⁴ A total of 62 breast cancer survivors will be randomized 1:1 into an acupuncture group versus a usual care group (see Figure 1). Participants in the acupuncture group will receive a 5-week, 10-session acupuncture treatment protocol. Participants in the usual care group will receive their normal health care. They are asked to refrain from acupuncture for 12 weeks after randomization. Semi-structured post-intervention interviews will be conducted with 24 stakeholders (12 breast cancer survivors, 6 health care providers, and 6 administrators and staff) to identify barriers and facilitators associated with the implementation of acupuncture. Electronic surveys will be sent to participants, health care providers, administrators, and staff to assess beliefs and altitudes about acupuncture and perceived barriers to implementation and access. All the interviews and surveys being developed based on the Consolidated Framework for Implementation Research (CFIR)⁵⁵ evidence-based framework. We chose to use the CFIR framework because its 5 domains can help us identify and understand how, why and under what conditions intervention implementation is effective. The CFIR domains include intervention characteristics, inner setting, outer setting, individual characteristics, and implementation process. Human subjects’ approval was obtained from the University of Illinois Chicago Human Research Protection Office (2022–0353). This study has been registered on ClinicalTrials.gov (NCT05615753).

Figure 1.

Study schema

2.2. Specific aims

The specific aims are:

1. To test the feasibility (recruitment, retention, completion, treatment fidelity) and acceptability ofimplementing a 5-week acupuncture intervention within health clinics to manage multiple symptoms (pain, hot flashes, fatigue, sleep disturbance, depression, and anxiety) among medically underserved breast cancer survivors receiving endocrine therapy. Hypothesis: More than 60% of patients approached will agree to participate, all acupuncturists will document their fidelity to the intervention after each session and 80% of participants will complete the acupuncture sessions, 80% of participants will complete measurements and 80% of participants will report satisfaction with the intervention and measures.

2. To use a mixed methods approach to identify barriers and facilitators associated with implementingacupuncture. Output: We will describe barriers and facilitators to acupuncture implementation using quantitative surveys and individual interviews with a range of stakeholders.

2.3. Setting

Participants are being recruited from the Mile Square Health Center (MSHC) Survivorship Clinic and the University of Illinois Hospital and Health Science (UI Health) Outpatient Care Center Oncology Clinic. The entire UI Health System, which includes MSHC, serves an underserved and diverse population. Most breast cancer survivors are receiving cancer treatment at UI health oncology clinic. After major cancer treatment, some of the survivors will also become patients at MSHC for longer survivorship care. Among newly diagnosed cancer patients at UI Health, 44% identified as African American, 18% Hispanic or Latino. Approximately 40–50% of patients have Medicaid, 40% have private insurance, and 5–10% have Medicare. MSHC is a federal qualified health center whose mission is to serve low-income families, elders, people with disabilities, immigrants, and unhoused people in an underserved urban community. MSHC’s diverse patient population is 77% African American; 10% Hispanic, 2% non-Hispanic White, and 11% other.

2.4. Eligibility screening and recruitment

The research coordinator (RC) first reviews participants’ electronic health records (EHRs) and identifies breast cancer survivors who meet the first four inclusion criteria: 1) women with histologically confirmed stage 0, I, II, or III breast cancer; 2) at least 18 years old; 3) women who have completed their primary cancer treatment (e.g., surgery, radiotherapy, chemotherapy) in the past 1 month and currently taking endocrine therapy; 4) able to read and speak English). The RC then sends an email and text messages to eligible breast cancer survivors that includes ing study information and a flyer. The RC also notifies providers when eligible breast cancer survivors plan to come to the clinic for their routine visits. The providers at the oncology clinic introduce this study to eligible breast cancer survivors using the recruitment script and also distribute study flyers. The RC then follows up with breast cancer survivors to provide more detail about the study and further assesses the eligibility of the potential participants. The RC will contact eligible participants by phone to schedule the baseline (week 0) study visit.

Eligible participants are: a) women with histologically confirmed stage 0, I, II, or III breast cancer; b) at least 18 years old; c) women who have completed their primary cancer treatment (e.g., surgery, radiotherapy, chemotherapy) in the past 1 month and currently taking endocrine therapy; d) able to read and speak English, and e) with self-reported pain, fatigue, sleep disturbance, depression, hot flashes and/or anxiety in the last month with an average severity rating greater than or equal to 3 (0–10 numeric rating scale) for at least 3 of the 6 symptoms, and experience at least 2 physical symptoms (pain, fatigue, or sleep disturbance). Participants are excluded if they a) have metastatic breast cancer (stage IV); b) have a bleeding disorder (e.g. hemophilia, Von Willebrand’s disease, thrombocytopenia); c) do not have time to attend the twice weekly acupuncture sessions in the next few months; d) have psychiatric or medical disorders which would affect study assessments, such as dementia, Alzheimer’s disease, a history of any neurological condition, traumatic brain injury, stroke, and e) are breastfeeding, pregnant or are planning on becoming pregnant during the study period.

2.4. Data collection

At baseline (week 0), informed consents are obtained in person. The RC then instructs the participants on completion of study questionnaires through REDCap;⁵⁶ and asks them to complete the demographic and patient-reported outcomes questionnaires. For the week 6 and week 12 assessment, participants will also complete the questionnaires through REDCap.

2.6. Randomization

After completing the baseline questionnaires through REDCap, participants are randomized 1:1 to the acupuncture or usual care group via REDCap’s randomization module, based on a stratified (e.g., age, race, baseline composite symptom score) and permuted block schedule (30% with block size of 4, 30% with block size of 6, and 40% with block size of 8). All outcome assessments will be completed in REDCap by the study participant, thus, providing a form of blinded outcomes assessment. To facilitate blinding, we created 2 separate and secure databases, one for outcomes assessment and one related to study group assignment. Blinded staff (e.g., the statistician) do not have access to the study group assignment database. The acupuncturists and investigators providing oversight and supervision of the intervention are unblinded to the assignment.

2.5. Acupuncture intervention

The acupuncture intervention consists of 10 acupuncture sessions: twice weekly for 5 weeks, with at least 1 day between sessions.⁵⁷ All participants receive the semi-standardized protocol: (1) a standardized acupuncture protocol with acupuncture points for treating generalized pain, hot flashes, fatigue, sleep disturbance, depression, and anxiety (Table 1a); and (2) additional points to treat up to 3 of the individual’s most painful areas (breast/chest, fingers, shoulders, lower back, knees, hips, wrists, feet/toes; Table 1b), which may change with each session. The needles are retained for 30 minutes and twirled with an even rotation to move qi and blood before and after insertion. One size of acupuncture needle (0.25 mm diameter x 40 mm length) is used.

Table 1.

Semi-standardized acupuncture point protocol with indications

INDICATIONS	POINTS
1a. Full body points for multiple symptoms during endocrine therapy (all participants, all visits)
Generalized pain	Bilateral LI4, LV3, GB34, KD3; right SJ5, left GB41
Hot flashes	LI11 bilateral, LU7 left side, KD6 right side
Fatigue	Bilateral LI4, LV3, SP6, CV4 unilateral
Sleep disturbance	Right side Buddha’s Triangle (PC6, HT7, LU9)
Depression/anxiety	Bilateral LI4, LV3, Right side Buddha’s Triangle (PC6, HT7, LU9)
1b. Additional points for specific pain locations (participants choose up to 3 of their most painful areas)
Breast/chest	LV14, GB41
Fingers	Baxie, SI3, LI3 (index), LU10 (thumb)
Shoulders	SJ14, LI15 (top & side of shoulder), Jianqian (anterior shoulder), SI10 (posterior shoulder)
Lower back	BL60, KD3 Yaotongxue
Knees	Heding, ST35, Medial Xiyan (overall knee pain), SP9 (medial knee), GB34 (lateral kne
Feet/toes	SP3 (big toe pain), LV3, GB41
Hips	GB29, GB39, GB34
Wrists	SJ4, SI5

2.6. Usual care arm

Participants randomized to the usual care group will be provided with written educational material about breast cancer symptom management and available resources; they will not receive any acupuncture treatments while participating in this study.

2.7. Measures

2.7.1. Demographic and Clinical Characteristics

Participants’ self-reported sociodemographic (age, race, education level, occupation, family income, number of household members, marital status) will be collected via a questionnaire at baseline. Clinical status (disease stage, types of treatments) will be extracted from the EHR.

2.7.2. Symptoms

PROMIS Measures.

The PROMIS-29 (v1.0) questionnaires are reliable measures of symptom experience among cancer patients with good internal consistency and convergent validity (Cronbach’s alphas: 0.86–0.96).^58,59 It is a 29-item multidimensional generic measure of health that includes different domains: physical functioning, anxiety, depression, fatigue, sleep disturbance, and pain interference, plus an additional single item for pain intensity. Each domain is assessed by 4 questions ranked on a 5-point Likert-type scale.

The Hot Flash Composite Score (HFCS) measures hot flash severity and has been used as a reliable and valid measure in acupuncture trials among women with breast cancer.²³ A hot flash is defined as an experience of rapid change in body temperature with dry skin, or sweating with wet skin with or without experience of change in body temperature. Participants are asked to record the frequency and intensity of hot flashes at baseline, week 5, and week 12, rating severity as 1–4 (mild to very severe). HFCS is calculated by multiplying the mean number of daily hot flashes during the week prior to the study by the mean daily severity.

Implementation

Feasibility of the intervention will be assessed by recruitment, retention, completion of acupuncture treatments, measurements, and treatment fidelity.

Treatment fidelity. All the study acupuncturists will complete the acupuncture protocol checklist after each acupuncture session on REDCap. Acupuncture protocol checklist, assess treatment delivery, receipt of treatment, and enactment of the treatment skills.⁶⁰ In addition, fidelity of the acupuncture intervention for each study acupuncturist is monitored by our team member every 6 months.

The Protocol Acceptability Scale is a 9-item self-report measure (scores ranging from 0 to 18) that assesses study acceptability and has been used in other studies with stable test-retest reliability.^61,62 Items are measured on a 0 (negative response) to 2 (positive response) scale. High acceptability is defined if 80% of participants report a total score greater than or equal to 14.5.

Attitudes and Beliefs about Complementary and Alternative Medicine (ABCAM)⁶³ is a measure used to assess survivors’ beliefs about and barriers to using acupuncture. The ABCAM has 10 items focused on the reason someone is unlikely to use acupuncture. For example, “Acupuncture may have side effects,” “Acupuncture needling is painful,” “I don’t have knowledge about acupuncture treatments,” “Acupuncture treatments are not covered by my insurance,” and “I don’t have transportation to acupuncture treatments.” Participants will be asked to rate each item from 1 (strongly disagree) to 5 (strongly agree). The summed score ranges from 10 to 50, with a higher score indicating more barriers to using acupuncture. ABCAM has shown validity and reliability among cancer patients in several acupuncture trials.^63,64

Self-Reported Provider Survey. This survey, adapted from the existing validated CFIR survey⁶⁵ and the barriers and facilitators identified in qualitative interviews, is used to quantify the barriers and facilitators to acupuncture implementation. Items assess the perceived degree of implementation of acupuncture in the survivorship clinic as well as the CFIR contextual domains. The first part of the survey contains questions about the respondents’ demographic and clinical setting characteristics. The second part of the survey consists of 2 open-ended questions and 69 items and measures on a 5-point Likert scale, with responses ranging from 1 (strongly disagree) to 5 (strongly agree). At the end of the survey, respondents can name additional barriers and facilitators and suggest improvements for acupuncture implementation through open-ended questions.

Qualitative Interviews. We developed a semi-structured interview guide to use for one-one-one interviews with breast cancer survivors (n = 12) who participate in acupuncture group and staff/providers (n=12). To ensure rigor, team members with qualitative experience developed the interview guide informed by the literature and CFIR domains and constructs and the experiences of team members familiar with the breast cancer survivor population. After participants give verbal and written consent, a team member conducted either face‐to‐face or zoom semi-structured interviews with survivors assigned to the acupuncture intervention and providers. The interview included a series of open‐ended questions and probes to learn about their beliefs or experience with acupuncture, the procedures, their perspectives on impact, and potential barriers and facilitators to integrating acupuncture to address treatment symptoms. The goal of these interviews is to explore experiences and identify facilitators and barriers to integrating acupuncture into health care systems serving medically underserved breast cancer survivors. Each audio-recorded interview will last approximately 30–60 minutes and will be professionally transcribed, checked for accuracy, and de-identified prior to analyses.

3. Analyses

Aim 1, Feasibility and Acceptability

We expect to identify any reported procedural problems regarding the 5-week, 10-session study protocol. To evaluate intervention feasibility and acceptability, we will calculate the proportion of eligible participants recruited, retained in the study through the week 12 follow-up, complete the acupuncture intervention sessions and measurements. These statistics will be used to determine if protocol changes are needed before conducting a larger, multi-site trial. Acceptability will be determined by the proportion of participants (greater than or equal to 80%), scoring greater than or equal to 14.5 on the Protocol Acceptability Scale. Descriptive statistics (mean ± standard deviation, frequency, percentage) will be used to describe participant demographics and symptom severities. All statistical analysis will be done in SPSS version 27.

Aim 2, Implementation

Quantitative (survey) and qualitative (interviews and study notes) data will be used to describe patient and provider experiences and identify implementation barriers and facilitators. A conventional content analysis will be used to identify patterns characterizing patient and provider participants’ experiences.⁶⁶ Consistent with our data management and analytical approach,⁶⁷ we will then identify each participant’s responses to the specific interview questions and display responses in data matrix.

Digitally audio-recorded interviews will be transcribed by a professional transcriptionist and checked for accuracy by a trained RC. A trained RC and team member will independently read and re-read each transcript to gain familiarity with the whole dataset and each interview it is entirety. Responses will then be condensed, coded, and reviewed to identify patterns reflecting survivors’ and providers’ perspectives on the use of acupuncture in the management of treatment-related symptoms. Using a series of matrices, we will categorize codes into preset patterns (e.g., CFIR constructs) and emerging patterns (inductive).

For the quantitative survey data, we will use descriptive statistics to analyze participant characteristics and barriers and facilitators to acupuncture use. Descriptive statistics on continuous data will include means, medians, standard deviations, and ranges, while categorical data will be summarized using frequency counts and percentages. Graphical summaries of the data may be presented. We then will work to provide explanatory insights about acupuncture and the potential facilitators and barriers to integrating it into treatment plans by linking patterning to narratives. We will meet regularly during data analysis for debriefing and to compare and evaluate analytic processes and differences through team consensus. As the analysis progresses, all team members will provide insights.

4. Discussion

The main purpose of this study is to examine the feasibility of implementing an acupuncture intervention into the UI Health System in order to alleviate multiple symptoms experienced by medically underserved breast cancer survivors during endocrine therapy. If successful, results from this study will provide the foundation for a larger multi-site hybrid effectiveness-implementation trial of integrating acupuncture into health care systems serving medically underserved breast cancer survivors.

Although acupuncture has been evaluated among breast cancer survivors for management of single symptoms (e.g., joint pain, sleep disturbance, fatigue, depression), no previous trial has developed a standardized acupuncture protocol for multiple treatment-related symptoms. Our innovative acupuncture protocol, based on TCM theory and previous RCTs, can treat multiple co-occurring symptoms simultaneously. All participants will receive the semi-standardized protocol (standardized points for pain, hot flashes, fatigue, sleep disturbance, depression, and anxiety) plus additional points for individuals’ particular pain locations. This approach aligns with the NCCIH’s strategic plan 2021–2025 to gain more insight into whole-person health.⁶⁸

To date, very few health care systems integrate acupuncture services into primary care and only 2 trials assessed acupuncture for treatment of chronic pain.^51,52 This will be the first study to test the feasibility and acceptability of an acupuncture intervention into a health care system’s oncology clinics for underserved breast cancer survivors receiving endocrine therapy. Currently, acupuncture delivery occurs largely in private clinics. It is important to identify the unique barriers and facilitators to accessing acupuncture experienced by medically underserved populations. Previous studies found that scheduling, treatment fidelity, communication, space adaptations, site-specific logistical and operational requirements, and patient-provider language barriers were barriers to implementation.^51,52 The qualitative and quantitative data collected from oncology providers and breast cancer survivors will help identify more in-depth barriers and facilitators. We will refine implementation strategies and develop a blueprint prototype to support a larger multi-site effectiveness trial. Results from this study will help reduce health disparities and promote equal access to care.

To promote equal access to acupuncture among breast cancer survivors who are medically underserved we removed two structural barriers by paying for transportation and ensuring flexible scheduling. We increased knowledge of acupuncture among breast cancer survivors by showing them videos about acupuncture and provided training to health care providers and staff regarding tenets of acupuncture. We will establish a stakeholder advisory board that will provide feedback if any barriers are encountered during the implementation process. These strategies aim to promote future integration if acupuncture is shown to improve outcomes and set the stage for future implementation studies.

Our long-term goal is to facilitate the widespread implementation, dissemination, and sustained utilization of acupuncture for symptom management in oncology clinics caring for underserved breast cancer survivors nationwide, and ultimately to promote broader public and private insurance coverage for acupuncture. New models of care are needed to reduce barriers and increase access to acupuncture among people who are underserved.