Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Nutritional and Metabolic Diseases

Breast Neoplasms

Syndrome

Metabolic Syndrome

Breast Diseases

Skin Diseases

Insulin Resistance

Hyperinsulinism

Metabolic Diseases

Glucose Metabolism Disorders

Each participant will receive a gratitude journal (paperback or electronic journal based on preference) for eight weeks and will have the following journaling prompt to complete at least twice a week: "There are many things in our lives, both large and small, that we might be grateful about. Think back over the day and write down on the line below all that you are grateful for today" (maximum six reasons). The educational goal-setting component will be drawn from the American Cancer Society's Nutrition, Physical Activity, and Cancer toolkit. Participants will be able to choose the order in which they complete the goal-setting modules. Both exercises will be administered daily over eight weeks.

Each participant will receive a journal (paperback or electronic journal based on preference) Participants will receive the following general journaling prompt to complete at least twice a week: "What are some memorable events that happened to you today, big, or small (maximum six memories). Write a brief statement about it.

Gratitude journaling and goal setting for exercise readiness over eight weeks.

Gratitude Intervention

Lakeshia Cousin, PhD, APRN

This pilot study will assess the feasibility of a gratitude intervention to promote physical activity, and well-being and positively impact biomarkers of health among older African American breast cancer survivors. The intervention will also include a goal-setting component to promote exercise readiness and examine the cultural phenomena of the Superwoman schema among Black women.

In this pilot feasibility study, the overall aims are:

Aim 1. Assess the feasibility and acceptability of a gratitude journaling intervention using a pilot randomized controlled trial (RCT) design over eight weeks. We hypothesize that among the 28 participants 1) at least 80% of the participants will report the intervention to be acceptable, 2) biomarker collection will be completed in at least 80% of the surveys and the retention rate will be 80% in each group, and 3) physical activity, health markers, gratitude, well-being, and distress will improve over time.

Aim 2. Describe distributions of outcome variables and effect size for the gratitude journaling intervention on dispositional gratitude, spiritual well-being, psychological distress, exercise readiness, mental and health behaviors in African American/Black women (Superwoman Schema), and inflammatory biomarkers from baseline to post-intervention.

Two-group parallel random-assignment experimental design.

The principal investigator will inform participants of their group assignment and provide intervention details. The research assistant and biostatistician will be blind to group allocation.

Grateful Strides Toward Physical Activity and Well-Being for Black Breast Cancer Survivors

A Pilot Feasibility Study of a Gratitude Journaling Intervention to Enhance Well-being and Exercise Readiness in Older African American Female Breast Cancer Survivors

Percentage of women who meet the inclusion criteria relative to the number of women approached.

Percentage of participants completing baseline assessment measures.

Percentage of participants who completed baseline assessments and completed the post-intervention assessments.

We will assess treatment satisfaction using the mean Client Satisfaction Questionnaire(CSQ-8) scores. An overall score is calculated by summing the respondent's rating score for each scale item. Scores range from 8 to 32, with higher values indicating higher satisfaction.

The effect size of dispositional gratitude measured at week 0/baseline and post-intervention/week 8 will be measured using the Gratitude Questionnaire-6 designed to measure four facets of dispositional gratitude: (a) intensity, (b) frequency, (c) span, and (d) density. Each item is rated on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree). Higher scores mean higher dispositional gratitude.

The effect size of spiritual well-being baseline/week 0 and post-intervention/week 8 will be measured using the Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12 Item Scale designed to assess spiritual well-being over the past seven days in a population with a chronic illness. Items are rated on a Likert-type scale ranging from 0 (not at all) to 4 (very much). Higher scores indicate enhanced spiritual well-being.

The effect size of distress baseline/week 0 and post-intervention/week 8 will be measured using the Perceived Stress Scale designed to measure stress during the last month. The scale consists of 10 items rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often) during the last month. Higher scores indicate more distress during the last month.

The effect size of the Superwoman schema baseline/week 0 and post-intervention/week 8 will be measured using the Giscombe Superwoman Schema Questionnaire developed to measure components prominent in the superwoman schema construct. The Giscombe Superwoman Schema Questionnaire (G-SWS-Q) was developed to measure components prominent in the superwoman schema construct. It contains 35 statements rated from 0 (not true) to 4 (true all the time) across the 5 subscales of (1) obligation to present an image of strength, (2) obligation to suppress emotions, (3) resistance to being vulnerable, (4) intense motivation to succeed and (5) obligation to help others. Higher scores indicate higher agreement with the identity.

The effect size of exercise readiness baseline/week 0 and post-intervention/week 8 will be measured using the Stage of Motivational Readiness for Physical Activity questionnaire, a highly reliable instrument with items that classify a person as being in the pre-contemplation, contemplation, preparation, action, or maintenance stage of exercise behavior change based on the selection by the participant.

The effect size of inflammatory biomarkers baseline/week 0 and post-intervention/week 8 will be measured using a Luminex panel containing Tumor Necrosis Factor Alpha (TNF-α), Interleukin 6 (IL-6), Growth/Differentiation Factor-15 (GDF15), and Enzyme-linked immunosorbent assay (ELISA) kit containing C-Reactive Protein.

National Institute on Aging (NIA)

University of Florida

Nervous System Diseases

Autonomic Nervous System Diseases

Primary Dysautonomias

Lipid Metabolism Disorders

Menopause

Two cohorts of both healthy postmenopausal women and women free of postmenopausal breast cancer recurrence. Each of the groups will be split into two different exercise programmes. Both programmes, High Intensity Interval Training (HIIT) programme (metabolic power training) and Muscle Power Intervention (MPI) programme will consist of 8 weeks.

Two cohorts of both healthy postmenopausal women and women free of postmenopausal breast cancer recurrence.

Metabolic Power Training: A High Intensity Interval Training (HIIT) intervention, 3 times per week (30 min session) during 8 weeks with professional supervision and intensities adapted and modified during the intervention period.

HIIT program (8 weeks)

Muscle Power Intervention (MPI), 2 times per week (45 min session) during 8 weeks with professional supervision and intensities adapted and modified during the intervention period.

MPI program (8 weeks)

Cristina Blasco Lafarga, Tenured Professor

Cristina Blasco Lafarga, PhD

Jordi Monferrer-Marín, Predoctoral student

Ainoa Roldán, PhD

Jørn Wulff Helge, PhD

POWER Health is a randomized clinical trial with a two-arm parallel design whose objectives are 1) to study metabolic flexibility and autonomic function (both capacities that describe cardiovascular health) in a sample of postmenopausal oncological women vs postmenopausal untreated controls (CT); and 2) to analyze the impact of two different 8-week physical exercise supervised interventions: HIIT training vs strength training focused on muscle power, on both cardiovascular capacities in these populations.

Nowadays, breast cancer is the most common type of cancer worldwide, accounting for 30% of all cancers in Spanish women in 2023. Cancer is also the second leading cause of death in developed countries, following cardiovascular diseases, with which it shares a close relationship. Additionally, we know that the incidence of breast cancer increases with age, experiencing a rise after menopause. However, lifestyle and physical exercise are known to improve the prevention, prognosis, and survival of this disease, as well as enhance quality of life in these patients. Indeed, recent studies have highlighted the relevance of cardiovascular health in this oncological process, as well as the potential of physical exercise interventions to improve cardiovascular health following the disease.

POWER Health is a randomized clinical trial aimed at studying metabolic flexibility and autonomic health in a population of breast cancer recurrence-free women (RFC) compared to postmenopausal untreated controls (CT), along with the implementation of two supervised exercise interventions in both populations. These interventions will last for 8 weeks, one involving HIIT exercise focused on improving metabolic power (MPI), and the other one involving strength exercise focused on enhancing muscular power, with the hypothesis of better metabolic flexibility and autonomic function, and consequently, better cardiovascular health.

POWER health is a mixed method design: cross-sectional \& longitudinal study. Given the feasibility and simple application of POWER Health, this clinical trial will contribute to the prevention and improvement of the health of postmenopausal women, with an important clinical and economic impact, not only in the scientific community but also in clinical practice.

Metabolic Flexibility and Autonomic Control After Muscle Power vs Metabolic Power Training in Postmenopausal Oncological Women: the POWER Health Study

Postmenopausal Oncological Women Exercising for Recover Their Health. Associations and Changes in Metabolic Flexibility and Autonomic Control After Two Training Programs (Muscle Power vs Metabolic Power): the POWER Health Study

Fat oxidation rates calculated from VO2 and VCO2 values collected by indirect calorimetry (COSMED K5 portable metabolic analyzer, Rome, Italy) and after applying Frayn's stoichiometric formulae, during an incremental test from 0.45 W/kg with 0.15W/kg each 4-min step

Non-linear mathematical variable that allows collecting physiological information and vagal activity of the organism, analysed in 2-minute intervals by Kubios Scientific software (Kuopio, Finland), during the incremental test

Calf, waist and hip circumferences will be assessed with an anthropometric tape measure (cm)

Body composition assessment will be obtained by bioimpedance (Tanita DC-430 MA S; Tokyo, Japan; kg)

The investigators will also assess systolic and diastolic blood pressure in the left (whenever possible) arm at rest.

The investigators will also assess oxygen saturation in middle finger of the right hand at rest.

The SARC-F will be used to evaluate the risk of sarcopenia

The International Physical Activity Questionnaire (IPAQ) will be used to evaluate the current physical activity level of the participants. Minimum value = 0 min/day of physical activity // Maximum value = 1440 min/day of physical activity. Higher scores imply a more physically active pattern.

Lactate assessment will be obtained by lactate analyzer (Lactate Scout Sport SensLab GmbH, Leipzig, Germany)

The Rating Perceived Exertion (RPE) of Borg scale will be used to obtain the perceived effort. Minimum value: 1 // Maximum value: 10. Higher scores mean a worse outcome.

The Visual Analogue Scale of Pain (VAS) scale will be used to obtain the local pain assessment. Minimum value: 1 // Maximum value: 10. Higher scores mean a worse outcome.

Cadence will be monitorized by the smart roller Saris H3 (CycleOps Hammer Direct Drive Trainer, Saris, Madison, USA).

Power will be monitorized by the smart roller Saris H3 (CycleOps Hammer Direct Drive Trainer, Saris, Madison, USA).

Power will be calculated by Power Frail App (Toledo, Spain)

Metabolic rate will be registered by indirect calorimetry (COSMED K5 portable metabolic analyzer, Rome, Italy) in baseline conditions

Resting exchange ratio will be registered by indirect calorimetry (COSMED K5 portable metabolic analyzer, Rome, Italy) in baseline conditions

Fat oxidation will be registered by indirect calorimetry (COSMED K5 portable metabolic analyzer, Rome, Italy) in baseline conditions

Carbohydrate will be registered by indirect calorimetry (COSMED K5 portable metabolic analyzer, Rome, Italy) in baseline conditions

Carbohydrate oxidation rates will be calculated from VO2 and VCO2 values collected by indirect calorimetry (COSMED K5 portable metabolic analyzer, Rome, Italy) and after applying Frayn's stoichiometric formulae, during an incremental test from 0.45 W/kg with 0.15W/kg each 4-min step

Energy expenditure rate will be calculated will be collected by indirect calorimetry (COSMED K5 portable metabolic analyzer, Rome, Italy) during an incremental test

FATmax will be calculated will be collected by indirect calorimetry (COSMED K5 portable metabolic analyzer, Rome, Italy) during an incremental test

VO2peak will be calculated will be collected by indirect calorimetry (COSMED K5 portable metabolic analyzer, Rome, Italy) during an incremental test

Non-linear mathematical variable that allows collecting physiological information and parasympathetic activity of the organism, analysed in 3-minute intervals by Kubios Scientific software (Kuopio, Finland), during the incremental test

Linear mathematical variable that allows collecting physiological information and parasympathetic activity of the organism, analysed in 2-minute intervals by Kubios Scientific software (Kuopio, Finland), during the incremental test

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Grateful Strides Toward Physical Activity and Well-Being for Black Breast Cancer Survivors	NCT05473026	Cancer Survivor... African America... Women Psychology, Pos... Cardiometabolic... Exercise Feasibility Stu... Breast Neoplasm...	Gratitude Inter...	50 Years - 99 Years	University of Florida
Metabolic Flexibility and Autonomic Control After Muscle Power vs Metabolic Power Training in Postmenopausal Oncological Women: the POWER Health Study	NCT06336070	Breast Cancer F... Cardiometabolic... Metabolism Diso... Autonomic Dysfu... Cardiovascular ...	HIIT program (8... MPI program (8 ...	35 Years - 75 Years	University of Valencia
Metabolic Flexibility and Autonomic Control After Muscle Power vs Metabolic Power Training in Postmenopausal Oncological Women: the POWER Health Study	NCT06336070	Breast Cancer F... Cardiometabolic... Metabolism Diso... Autonomic Dysfu... Cardiovascular ...	HIIT program (8... MPI program (8 ...	35 Years - 75 Years	University of Valencia

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