Grateful Strides Toward Physical Activity and Well-Being for Black Breast Cancer Survivors
NCT ID: NCT05473026
Last Updated: 2024-09-19
Study Results
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View full resultsBasic Information
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COMPLETED
NA
26 participants
INTERVENTIONAL
2022-11-08
2023-07-25
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Gratitude Intervention
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.
Gratitude Intervention
Gratitude journaling and goal setting for exercise readiness over eight weeks.
Attention Control
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.
No interventions assigned to this group
Interventions
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Gratitude Intervention
Gratitude journaling and goal setting for exercise readiness over eight weeks.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
50 Years
99 Years
FEMALE
Yes
Sponsors
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National Institute on Aging (NIA)
NIH
University of Florida
OTHER
Responsible Party
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Principal Investigators
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Lakeshia Cousin, PhD, APRN
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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University of Florida CTSI Clinical Research Center
Gainesville, Florida, United States
Countries
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References
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Cousin L, Braithwaite D, Anton S, Zhang Z, Lee JH, Leewenburgh C, Lyon D. A pilot study of a gratitude journaling intervention to enhance spiritual well-being and exercise self-efficacy in Black breast cancer survivors. BMC Psychiatry. 2024 Dec 18;24(1):931. doi: 10.1186/s12888-024-06362-2.
Cousin L. Cardio-oncology disparities: Interplay of psychosocial stress, inflammation, and cardiometabolic health among Black breast cancer survivors. Am Heart J Plus. 2024 Jan 30;38:100366. doi: 10.1016/j.ahjo.2024.100366. eCollection 2024 Feb.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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IRB202201483
Identifier Type: -
Identifier Source: org_study_id
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