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
- 1
- 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)
研究组 & 干预措施
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.
干预措施: Gratitude Intervention (Behavioral)
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.
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)