N/A N=26 Randomized Single-blind Prevention

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

Cancer Survivors · African Americans · Women · Psychology, Positive · Cardiometabolic Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT05473026 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2024

Primary outcome: Primary: Participants Who Met Inclusion Criteria Compared to Participants Approached — 13; 13 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Gratitude Intervention (Behavioral)
Age: Adult, Older Adult · 50+ yrs
Sex: Female
Sponsor: University of Florida
Primary completion: Jul 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Participants Who Met Inclusion Criteria Compared to Participants Approached	13; 13	—
PRIMARY Participant Completion of Baseline Assessment Measures	13; 13	—
PRIMARY Participant Completion of Both Baseline Assessments and Post-intervention Assessments	8; 11	—
PRIMARY Treatment Satisfaction Using Client Satisfaction Questionnaire (CSQ-8)	29.8; 29.2	—
SECONDARY Change in Dispositional Gratitude From Baseline to Post-intervention	0.5; -0.3	—
SECONDARY Change in Spiritual Well-being From Baseline to Post-intervention	3.6; -1.8	—
SECONDARY Change in Distress From Baseline to Post-intervention	-2.1; -1.3	—
SECONDARY Change in Superwoman Schema (Racial and Gender Identity) From Baseline to Post-intervention	-0.4; -0.9; -0.8; 0.5; -2.1; -0.3	—
SECONDARY Change in Exercise Readiness From Baseline to Post-intervention	0.8; -0.2	—
SECONDARY Change in Tumor Necrosis Factor Alpha (TNF-α), Interleukin 6 (IL-6), Growth/Differentiation Factor-15 (GDF15) From Baseline to Post-intervention	-2.4; -0.2; 3.0; 0.0; 17.4; 15.2	—
SECONDARY Change in C-Reactive Protein From Baseline to Post-intervention	3.1; 0.6	—

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.

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05473026). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.