A Pilot Feasibility Study of a Gratitude Journaling Intervention to Enhance Well-being and Exercise Readiness in Older African American Female Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Participants Who Met Inclusion Criteria Compared to Participants Approached
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The principal investigator will inform participants of their group assignment and provide intervention details. The research assistant and biostatistician will be blind to group allocation.
入排标准
- 年龄范围
- 50 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Participants Who Met Inclusion Criteria Compared to Participants Approached
时间窗: 8 months
Percentage of women who meet the inclusion criteria relative to the number of women approached.
Participant Completion of Baseline Assessment Measures
时间窗: Week 0
Percentage of participants completing baseline assessment measures.
Participant Completion of Both Baseline Assessments and Post-intervention Assessments
时间窗: 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)
时间窗: 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.
次要结局
- Change in Dispositional Gratitude From Baseline to Post-intervention(Week 0, Week 8)
- Change in Spiritual Well-being From Baseline to Post-intervention(Week 0, Week 8)
- Change in Distress From Baseline to Post-intervention(Week 0, Week 8)
- Change in Superwoman Schema (Racial and Gender Identity) From Baseline to Post-intervention(Week 0, Week 8)
- Change in Exercise Readiness From Baseline to Post-intervention(Week 0, Week 8)
- 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)
- Change in C-Reactive Protein From Baseline to Post-intervention(Week 0, Week 8)