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

Exercise Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05473026
• Other study ID #: IRB202201483
• Secondary ID: P30AG028740
• Status: Completed
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• African Americans
• Breast Neoplasm Female
• Breast Neoplasms
• Cancer Survivors
• Cardiometabolic Syndrome
• Exercise
• Feasibility Studies
• Metabolic Syndrome
• Psychology, Positive
• Women

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