Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05473026
Other study ID # IRB202201483
Secondary ID P30AG028740
Status Completed
Phase N/A
First received
Last updated
Start date November 8, 2022
Est. completion date July 25, 2023

Study information

Verified date July 2023
Source University of Florida
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date July 25, 2023
Est. primary completion date July 25, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 50 Years to 99 Years
Eligibility Inclusion Criteria: - Self-report as AA or Black - English speaking - History of BC (Stage I-IV); 3 months to 6 years post-adjuvant chemotherapy - Participants on hormonal therapies or HER-2 therapy are acceptable Exclusion Criteria: - Self-reported regular meditation or gratitude practices (more than once a week for at least a month) - Meeting the CDC's physical activity guidelines (at least 150 min of moderate-intensity aerobic physical activity or 75 min of vigorous-intensity physical activity, or an equivalent combination each week)

Study Design


Intervention

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

Locations

Country Name City State
United States University of Florida CTSI Clinical Research Center Gainesville Florida

Sponsors (2)

Lead Sponsor Collaborator
University of Florida National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Participants who met inclusion criteria compared to participants approached Percentage of women who meet the inclusion criteria relative to the number of women approached. 8 months
Primary Participant completion of baseline assessment measures Percentage of participants completing baseline assessment measures. Week 0
Primary Participant completion of both baseline assessments and post-intervention assessments Percentage of participants who completed baseline assessments and completed the post-intervention assessments. Week 0, Week 8
Primary Treatment satisfaction using Client Satisfaction Questionnaire (CSQ-8) 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. Week 8
Secondary Change in dispositional gratitude from baseline to post-intervention 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. Week 0, Week 8
Secondary Change in spiritual well-being from baseline to post-intervention 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. Week 0, Week 8
Secondary Change in Distress from baseline to post-intervention 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. Week 0, Week 8
Secondary Change in Superwoman schema (racial and gender identity) from baseline to post-intervention 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. Week 0, Week 8
Secondary Change in Exercise readiness from baseline to post-intervention 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. Week 0, Week 8
Secondary Change in Inflammatory biomarkers from baseline to post-intervention 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-a), Interleukin 6 (IL-6), Growth/Differentiation Factor-15 (GDF15), and Enzyme-linked immunosorbent assay (ELISA) kit containing C-Reactive Protein. Week 0, Week 8
See also
  Status Clinical Trial Phase
Recruiting NCT05156424 - A Comparison of Aerobic and Resistance Exercise to Counteract Treatment Side Effects in Men With Prostate Cancer Phase 1/Phase 2
Completed NCT05108181 - Muscle Typology and Strength Training Adaptations N/A
Recruiting NCT05052918 - The Effect of Exercise and Metformin on Carotid Intima-media Thickness in Patients With Prediabetes N/A
Completed NCT04508270 - Significance of Early Mobilization After VATS-L
Recruiting NCT04994340 - Physical Activity Observatory of Castilla-La Mancha
Completed NCT04815980 - Impact of Pilates on Running Mechanics N/A
Completed NCT05189795 - The Construction of Physical ACtivity Enhancement Scheme (PACES) in Hemodialysis Patients
Completed NCT03683758 - Effects of the FIFA11+ Warm-up Program on Speed, Agility, and Vertical Jump Performance in Adult Female Amateur Soccer Players N/A
Completed NCT05538520 - Effects of Pilates Stretching on Flexibility, Strength, Power and Muscular Endurance N/A
Completed NCT06315036 - Effects of Developmental Gymnastics on Preschoolers' Motor Skills N/A
Completed NCT03171064 - Exercise as a Supportive Measure for Patients Undergoing Checkpoint-inhibitor Treatment Phase 2
Recruiting NCT05496751 - Response Variability to Exercise N/A
Not yet recruiting NCT05029804 - Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes N/A
Completed NCT04207359 - Effects of Creatine Supplementation in Breast Cancer Survivors N/A
Completed NCT03832205 - Validation of Respiratory Rate and Heart Rate Measurements by Capaciflectors Placed in Four Locations on the Chest
Completed NCT04099654 - The Effect of Core Stabilization Exercise Program in Obese Subjects Awaiting Bariatric Surgery N/A
Completed NCT03477188 - The Effects of Somatosensory and Vestibular Rehabilitation Additional Conventional Therapy on Balance in Patients With Acute Stroke. N/A
Completed NCT03297567 - Physical Therapy Guidelines For Hospitalized Elderly N/A
Recruiting NCT05956327 - Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training N/A
Recruiting NCT06018311 - Exercising Together for Hispanic Prostate Cancer Survivor-Caregiver Dyads N/A