Grateful Strides Toward Physical Activity and Well-Being for Black Breast Cancer Survivors
- Conditions
- WomenPsychology, PositiveBreast Neoplasm FemaleCancer SurvivorsExerciseAfrican AmericansCardiometabolic SyndromeFeasibility Studies
- Interventions
- Behavioral: Gratitude Intervention
- Registration Number
- NCT05473026
- Lead Sponsor
- University of Florida
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 26
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Gratitude Intervention 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.
- Primary Outcome Measures
Name Time Method Participants Who Met Inclusion Criteria Compared to Participants Approached 8 months Percentage of women who meet the inclusion criteria relative to the number of women approached.
Participant Completion of Baseline Assessment Measures Week 0 Percentage of participants completing baseline assessment measures.
Participant Completion of Both Baseline Assessments and Post-intervention Assessments Week 0, Week 8 Percentage of participants who completed baseline assessments and completed the post-intervention assessments.
Treatment Satisfaction Using Client Satisfaction Questionnaire (CSQ-8) Week 8 We assessed 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.
- Secondary Outcome Measures
Name Time Method Change in Dispositional Gratitude From Baseline to Post-intervention Week 0, Week 8 The mean change of dispositional gratitude measured at week 0/baseline and post-intervention/week 8 was measured using the Gratitude Questionnaire-6 designed to measure four facets of dispositional gratitude: (a) intensity, (b) frequency, (c) span, and (d) density. The scale consists of six items, each rated on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). To calculate the GQ-6 score, each item's score is summed to yield a total score. The minimum possible score is 6, indicating the lowest level of gratitude, and the maximum possible score is 42, indicating the highest level of gratitude. For example, if a participant's responses to the six items are 5 (slightly agree), 6 (agree), 4 (neutral), 7 (strongly agree), 3 (slightly disagree), and 5 (slightly agree), the total score would be 30. This total score is then used to gauge the participant's level of gratitude, with higher scores reflecting greater gratitude.
Change in Spiritual Well-being From Baseline to Post-intervention Week 0, Week 8 The Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being is a self-report measure designed to assess spiritual well-being in individuals with chronic illness. It was used to report mean change from week 0/baseline and post-intervention/week 8. The scale comprises 12 items divided into two subscales: Meaning/Peace and Faith. Each item is rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). To calculate the FACIT-Sp-12 score, each item's score is summed. The Meaning/Peace subscale score is obtained by summing the scores of items 1 to 8, with a range of 0 to 32. The Faith subscale score is derived from items 9 to 12, with a range of 0 to 16. The total spiritual well-being score, which combines both subscales, ranges from 0 to 48. Higher scores on the FACIT-Sp-12 indicate greater spiritual well-being.
Change in Distress From Baseline to Post-intervention Week 0, Week 8 The mean change of distress baseline/week 0 and post-intervention/week 8 was measured using the Perceived Stress Scale designed to measure stress during the last month. The scale consists of 10 items, each rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). To calculate the PSS score, each item's score is summed, with items 4, 5, 7, and 8 being reverse-scored to account for their positive phrasing. The reversed scoring for these items means that a response of 0 becomes 4, 1 becomes 3, 2 remains 2, 3 becomes 1, and 4 becomes 0. The total score, ranging from 0 to 40, reflects the individual's perceived stress level, with higher scores indicating greater stress.
Change in Superwoman Schema (Racial and Gender Identity) From Baseline to Post-intervention Week 0, Week 8 The Giscombe Superwoman Schema Questionnaire (GSSQ) measured the mean change in Superwoman Schema between baseline and post-intervention at weeks 0 and 8. The GSSQ consists of 35 items across five dimensions: obligation to manifest strength (6 items), obligation to suppress emotions (7 items), resistance to being vulnerable (7 items), intense motivation to succeed (6 items), and obligation to help others (9 items). Items are rated on a Likert scale from 0 (not true) to 3 (true all the time). The total score ranges from 0 to 105, with subscale ranges as follows: Strength (0-18), Suppress (0-21), Resistance (0-21), Motivation (0-18), and Help (0-27). Higher scores indicate stronger endorsement of the Superwoman Schema. Total and subscale scores are summed, with higher scores representing stronger schema identification.
Change in Exercise Readiness From Baseline to Post-intervention Week 0, Week 8 The Exercise Readiness Scale measured the stages of exercise behavior change at baseline and post-intervention. The scale consists of five items assessing exercise behavior and intentions. Participants choose one statement that best describes their current level of physical activity, with options ranging from 1 (no participation in physical activity and no intention to start) to 5 (exercising regularly for more than 6 months). Scores range from 1 to 5, with higher scores indicating greater readiness for regular physical activity and higher stages of exercise behavior change.
Change in Tumor Necrosis Factor Alpha (TNF-α), Interleukin 6 (IL-6), Growth/Differentiation Factor-15 (GDF15) From Baseline to Post-intervention Week 0, Week 8 The mean change of inflammatory biomarkers baseline/week 0 and post-intervention/week 8 was measured using a Luminex panel containing Tumor Necrosis Factor Alpha (TNF-α), Interleukin 6 (IL-6), Growth/Differentiation Factor-15 (GDF15).
Change in C-Reactive Protein From Baseline to Post-intervention Week 0, Week 8 The mean change of inflammatory biomarkers baseline/week 0 and post-intervention/week 8 was measured using a Enzyme-linked immunosorbent assay (ELISA) kit containing C-Reactive Protein.
Trial Locations
- Locations (1)
University of Florida CTSI Clinical Research Center
🇺🇸Gainesville, Florida, United States