Nutritional and Metabolic Diseases

Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Overweight

Breast Neoplasms

Obesity

Body Weight

Breast Diseases

Skin Diseases

The mindful eating intervention was taught by a mindfulness-based stress reduction instructor certified by the Center of Mindfulness at the University of Massachusetts Medical School.

A Mindful Eating Workshop™ workbook was used for standardization and reproducibility of these sessions. The group sessions were focused on teaching applied strategies to consume food with intention and attention and aimed at improving emotional relationships with food. Intervention sessions were held once a week in the evening for 2 hours per session over 8 weeks. The intervention was delivered in a large conference room on the University of Georgia campus. Participants were required to attend seven out of eight sessions. If participants missed a session, they met with the instructor 30 minutes before the beginning of the following week's session to receive individual instruction on content of the missed session.

Mindful eating intervention

This pilot study examined changes in anthropometric measures as a result of and feasibility/ acceptability of a mindful eating intervention for overweight and obese postmenopausal breast cancer survivors.

Being overweight is associated with increased risk for chronic disease and premature death in breast cancer survivors. This pilot study examined changes in anthropometric measures as a result of and feasibility/ acceptability of a mindful eating intervention for overweight and obese postmenopausal breast cancer survivors. The one-group pre-posttest study design included eight weekly group-based mindful eating sessions on strategies to intentionally and attentively consume food. Anthropometrics, blood pressure, mindfulness, nutritional intake, and physical activity were collected at baseline and 12-weeks follow-up. Data on feasibility and acceptability were collected at study completion.

Effect of Mindful Eating on Weight Management in Breast Cancer Survivors

Effect of a Mindful Eating Intervention on Weight Management in Overweight and Obese Postmenopausal Breast Cancer Survivors

Habitual nutritional intake was measured using an electronic version of the Block Food Frequency Questionnaire, a 127-item food and beverage recall instrument referencing the consumption over the past month. Dietary intake data was describes as daily energy consumption (kcal), consumption of macronutrients (fat, protein, carbohydrate; grams/day), and intake of sweets (% of daily intake) to compare intake before intervention start with intake during the intervention.

Participants' physical activity levels (average daily steps; moderate-to-vigorous physical activity (MVPA) minutes) were tracked throughout the study period using FitBit® Flex accelerometers. Total daily steps and MVPA minutes were averaged for the first and the last week of the intervention to examine changes.

At the baseline and follow-up visits, trained study staff measured participants' weight and height using a standardized protocol. Height (measured by a stadiometer to the nearest 0.1 cm) and weight (measured by a scale to the nearest 0.1 kg) was used to calculate BMI (weight in kg divided by height in m²).

At the baseline and follow-up visits, trained study staff measured participants' systolic/diastolic blood pressure using a standardized protocol to the nearest mmHg. In order to ensure reliability, all measurements were taken 3 times and average values were used for analyses.

At the baseline and follow-up visits, trained study staff measured participants' waist and hip circumference by tape measure to the nearest 0.1 centimeter.

At the baseline and follow-up visits, trained study staff measured participants' body fat percentage using a bioelectrical impedance analyzer (BIA).

Feasibility was assessed by tracking participant accrual and retention rates.

To measure acceptability, participants were asked to complete a 5-question feedback survey to evaluate the mindful eating intervention at the follow-up study visit. Specifically, the open-ended survey questions asked participants about (1) their experience with intervention, (2) how the intervention affected diet and exercise management, (3) positive aspects about the intervention, (4) negative aspects about the intervention, and (5) suggested changes to the intervention. Qualitative data analysis techniques were used to identify themes within the data.

Changes in mindfulness resulting from the intervention were measured using the validated Mindful Attention Awareness Scale (MAAS). The MAAS questionnaire is a 15-item scale that was designed to assess mindfulness and receptive awareness throughout an individual's daily life. Scores from the MAAS range from 1 to 6, with higher scores associated with higher mindfulness. The MAAS was validated for use in cancer populations against the Profile of Mood States (POMS) scale that is widely used in clinical settings. Higher MAAS scores were significantly correlated with lower POMS scores, further confirming the construct validity of the MAAS questionnaire for assessing mindfulness in cancer populations. The questionnaire was self-administered to the participants pre and post intervention.

University of Georgia

Assistant Professor

Nervous System Diseases

Rare Diseases

Chronic Pain

Pain

Neurologic Manifestations

Chronic Graft Versus Host Disease

All Drugs and Chemicals

Aromatase Inhibitors

Patients with active points related to Aromatase Inhibitor Musculoskeletal Symptoms (AIMSS). The points for AIMSS include (1) points corresponding to body pain location and (2) three points known for alleviating stress and pain (i.e., shenmen, sympathetic, and nervous subcortex)

The same procedure of APA will be applied but the tapes/seeds will be placed on different points (points not related to AIMSS). Participants in the Sham APA Control will receive APA on the five ear points comprising mouth, stomach, duodenum, internal ear, and tonsils. These points are chosen for the Sham APA Control for two reasons: First, they are distinct from the zones of the ear (and the points therein) associated with AIMSS and correspond to body regions in which BCS (Breast Cancer Survivors) are usually pain-free; second, they are equivalent in number to those points used in the APA treatment group and no negative impacts have been observed among these points in our pilot study.

Participants in the Education Control will receive four, 15-minute weekly individual sessions in which the scheduling and duration of interaction with the study staff are identical to the APA and Sham interventions. Educational sessions are intended to reflect usual standard medical care per guidelines from the American Society of Clinical Oncology (ASCO), while also meeting the needs of trial participation, including (1) the knowledge of hormonal therapy and side effects; (2) assessment and management of physical long-term and late effects; (3) assessment and management of psychological long-term and late effects; and (4) dietary (developed by Co-I, van Londen) and physical activity in Breast Cancer Survivors (BCS) (developed by Co-I, Stearns). These materials have been used by the research team, and clinical practice. Materials will be tailored so that they can be delivered within 15 minutes for each session.

Light touch using vaccaria seeds on specific points of the ear

Light touch using vaccaria seeds on different points of the ear (compared to the APA group).

Sham APA control

Participants in the Education Control will receive four, 15-minute weekly individual sessions in which the scheduling and duration of interaction with the study staff are identical to the APA and Sham interventions. Materials will be tailored so that they can be delivered within 15 minutes for each session

Education control

Chao H Yeh, PhD

Aromatase inhibitor therapy has become a standard adjuvant endocrine therapy for postmenopausal women with hormone receptor-positive breast cancer. Up to 50% of postmenopausal breast cancer survivors exhibit significant aromatase inhibitor musculoskeletal symptoms, defined as severe joint pain and stiffness. Aromatase inhibitor musculoskeletal symptoms in turn has a negative effect on the women's physical function and quality of life, leading to discontinued aromatase inhibitor therapy and causing significant social and economic burden. Given aromatase inhibitor musculoskeletal symptoms' profound effects, the management of aromatase inhibitor musculoskeletal symptoms is an essential component in cancer care.

The investigators propose to test auricular point acupressure- -an innovative, non-invasive, nonpharmacologic, and low-cost intervention- -to manage aromatase inhibitor musculoskeletal symptoms in breast cancer survivors. Auricular point acupressure applies an acupuncture-like stimulation to ear acupoints without using a needle (i.e., seeds are taped to the acupoints) to treat illness/symptoms. Auricular point acupressure is particularly well suited for current challenges of unmet aromatase inhibitor musculoskeletal symptoms management. The investigators propose a randomized controlled trial to (1) determine the efficacy of auricular point acupressure in relieving aromatase inhibitor musculoskeletal symptoms, and (2) examine the inflammatory signaling of auricular point acupressure effects in breast cancer survivors treated with aromatase inhibitor. The investigators will also measure psychological, behavioral, personal, and social factors that may moderate or mediate the effects of auricular point acupressure. The investigators also believe inflammatory cytokines may partially explain the mechanism of action of auricular point acupressure for improved aromatase inhibitor musculoskeletal symptoms and physical function, and plan to measure these.

This study will identify a novel approach to manage aromatase inhibitor musculoskeletal symptoms in postmenopausal breast cancer survivors, with minimal side effects. If successful, the paradigm of pain management will shift from a traditional medical model to a larger integrative medicine and patient-management paradigm to avoid unnecessary evolution towards prolonged disability.

Women with a history of Breast Cancer (non-metastatic) before entering into postmenopausal age

Auricular Point Acupressure to Self-Manage Chronic Pain or Aromatase Inhibitor Musculoskeletal Symptoms in Breast Cancer Survivors: Effectiveness and Scientific Underpinnings

The Brief Pain Inventory-short form (BPI-sf) questionnaire includes assessment of pain location and multiple aspects of severity of pain, numbness, tingling, and stiffness, including worst, least, average pain, and present, as well as the interference with daily activities. The Brief Pain Inventory-short form (BPI-sf) has a total score ranging from 0 to 10 with higher scores indicating more pain.

The Western Ontario and McMaster Osteoarthritis Index (WOMAC) consists of 24 items divided into 3 subscales:

* Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing
* Stiffness (2 items): after first waking and later in the day
* Physical Function (17 items): stair use, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy household duties, light household duties.

The WOMAC score range from 0 to 96. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

QuickDASH outcome measure is used. At least 10 of the 11 items must be completed for a score to be calculated. The assigned values for all completed responses are simply summed and averaged, producing a score out of five. The value is then transformed to score out of 100. The score range will be 0 to 100. Higher score indicating greater disability.

Handgrip strength is a simple and commonly used test of a person's general strength level. There is a simple norm table which is categorized with age is used to measure the strength.

Analgesic use and Aromatase Inhibitor (AI) adherence will be included in the Ecological Momentary Assessment (EMA) diary during intervention and medications will be checked at study visits at follow-ups.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Mindful Eating on Weight Management in Breast Cancer Survivors	NCT03972540	Breast Neoplasm...	Mindful eating ...	50 Years -	University of Georgia
Auricular Point Acupressure to Self-Manage Chronic Pain or Aromatase Inhibitor Musculoskeletal Symptoms in Breast Cancer Survivors: Effectiveness and Scientific Underpinnings	NCT03697200	Aromatase Inhib... Musculoskeletal... Postmenopausal ...	APA Sham APA contro... Education contr...	18 Years -	Johns Hopkins University
Effect of Mindful Eating on Weight Management in Breast Cancer Survivors	NCT03972540	Breast Neoplasm...	Mindful eating ...	50 Years -	University of Georgia

Spots Global Cancer Trial Database for postmenopausal breast cancer survivors