Clinical trial NCT05473026: Grateful Strides Toward Physical Activity and Well-Being for Black Breast Cancer Survivors
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Survivors
African Americans
Women
Psychology, Positive
Cardiometabolic Syndrome
Exercise
Feasibility Studies
Breast Neoplasm Female
Keywords: African American Women
Breast Cancer Survivorship
Gratitude
Cardiometabolic Syndrome
Geriatrics
Physical Activity
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-07-25
Enrollment: 26
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-group parallel random-assignment experimental design.
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Participants Who Met Inclusion Criteria Compared to Participants Approached
timeFrame: 8 months
measure: Participant Completion of Baseline Assessment Measures
timeFrame: Week 0
measure: Participant Completion of Both Baseline Assessments and Post-intervention Assessments
timeFrame: Week 0, Week 8
measure: Treatment Satisfaction Using Client Satisfaction Questionnaire (CSQ-8)
timeFrame: Week 8
Secondary outcomes:
measure: Change in Dispositional Gratitude From Baseline to Post-intervention
timeFrame: Week 0, Week 8
measure: Change in Spiritual Well-being From Baseline to Post-intervention
timeFrame: Week 0, Week 8
measure: Change in Distress From Baseline to Post-intervention
timeFrame: Week 0, Week 8
measure: Change in Superwoman Schema (Racial and Gender Identity) From Baseline to Post-intervention
timeFrame: Week 0, Week 8
measure: Change in Exercise Readiness From Baseline to Post-intervention
timeFrame: Week 0, Week 8
measure: Change in Tumor Necrosis Factor Alpha (TNF-α), Interleukin 6 (IL-6), Growth/Differentiation Factor-15 (GDF15) From Baseline to Post-intervention
timeFrame: Week 0, Week 8
measure: Change in C-Reactive Protein From Baseline to Post-intervention
timeFrame: Week 0, Week 8
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida CTSI Clinical Research Center
state: Florida
Study officials:
affiliation: University of Florida
name: Lakeshia Cousin, PhD, APRN
role: PRINCIPAL_INVESTIGATOR
References: