Yoga to Improve Disparities in Cancer Survivorship
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Median score on the Intervention Appropriateness Measure (IAM)
研究概览
简要总结
This clinical trial tests the impact of a racially concordant trainer led yoga program on quality of life and symptom burden in Black and/or African American cancer survivors. Black individuals in the United States are more affected by cancer, despite modern advances. Cancer treatments can impact physical and mental health and overall quality of life and Black individuals report worse physical function and quality of life and less access to culturally appropriate support services. Yoga has been shown to have a positive impact on cancer and cancer treatment related symptoms and quality of life, however, a one size fits all approach has not been shown to be effective in diverse populations. A trainer that shares the same racial or ethnic background as the participant (racially concordant) may have a positive impact on communication, trust, and may improve accessibility and participation. Participating in a yoga program led by a racially concordant trainer may improve quality of life and symptom burden in Black and/or African American cancer survivors.
详细描述
PRIMARY OBJECTIVE:
I. Determine the feasibility and acceptability of a yoga intervention among Black individuals with cancer.
SECONDARY OBJECTIVES:
I. To estimate the effect of the intervention on health-related quality of life.
II. To estimate the effect of the intervention on symptom burden. III. To determine the safety of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age >=18 years.
- •Able to understand study procedures and to comply with them for the entire length of the study.
- •Ability of individual or legal guardian/representative to understand a written informed consent document, and the willingness to sign it.
- •Diagnosed with any malignancy and/or received any cancer directed therapy within 5 years of enrollment.
- •Be able to speak, read and write in English.
- •Self-identify as Black or African American race.
- •Reside in California.
排除标准
- •Contraindication to any study-related procedure or assessment.
- •a. Participants complete the PAR-Q at screening to ensure that they are physically well enough to enroll in the study. If they report any conditions that may be contraindications to physical activity, physician clearance will be required prior to enrollment.
- •Planned major surgery during the study period.
- •Any major injuries that limit physical activity.
- •Active or radiographic evidence of cancer requiring treatment during the study period. Adjuvant therapy is allowed (including hormonal, immuno-, or targeted therapy). Ongoing treatment such as hormone or maintenance therapies including HER2 directed, or immunotherapy are only allowed if patient has no evidence of disease on most recent imaging.
研究组 & 干预措施
Yoga Intervention
Participants receive a 4-week yoga intervention consisting of weekly 60-minute yoga sessions led by a trained facilitator. Participants may also participate remotely. At the end of the program, participants will also receive access to online yoga training videos (created by the study team) to continue self-practice.
干预措施: Yoga (Other)
结局指标
主要结局
Median score on the Intervention Appropriateness Measure (IAM)
时间窗: Up to 8 weeks
The IAM is a four-item measure of implementation that assesses participants perceived appropriateness of the intervention. Each item response falls on a scale of 1 (Completely disagree) to 5 (Completely agree). A scaled score is calculated by averaging responses. Scale values range from 1 to 5. The intervention will be determined acceptable if the overall median score is \>= 4.
Overall completion rate
时间窗: Up to 8 weeks
The completion rate is defined as the proportion of enrolled individuals who attend at least 2 yoga sessions.
Median score on the Feasibility of Intervention Measure (FIM)
时间窗: Up to 8 weeks
The FIM is a four-item measure of implementation that assesses participants perceived appropriateness of the intervention. Each item response falls on a scale of 1 (Completely disagree) to 5 (Completely agree). A scaled score is calculated by averaging responses. Scale values range from 1 to 5. The intervention will be determined acceptable if the overall median score is \>= 4.
Overall completion rate
时间窗: Up to 8 weeks
The completion rate is defined as the proportion of enrolled individuals who attend at least 2 yoga sessions.
Median score on the Feasibility of Intervention Measure (FIM)
时间窗: Up to 8 weeks
The FIM is a four-item measure of implementation that assesses participants perceived appropriateness of the intervention. Each item response falls on a scale of 1 (Completely disagree) to 5 (Completely agree). A scaled score is calculated by averaging responses. Scale values range from 1 to 5. The intervention will be determined acceptable if the overall median score is \>= 4.
Median score on the Intervention Appropriateness Measure (IAM)
时间窗: Up to 8 weeks
The IAM is a four-item measure of implementation that assesses participants perceived appropriateness of the intervention. Each item response falls on a scale of 1 (Completely disagree) to 5 (Completely agree). A scaled score is calculated by averaging responses. Scale values range from 1 to 5. The intervention will be determined acceptable if the overall median score is \>= 4.
Median score on the Acceptability of Intervention Measure (AIM)
时间窗: Up to 8 weeks
The AIM is a four-item measure of implementation that assesses participants perceived acceptability of the intervention. Each item response falls on a scale of 1 (Completely disagree) to 5 (Completely agree). A scaled score is calculated by averaging responses. Scale values range from 1 to 5. The intervention will be determined acceptable if the overall median score is \>= 4.
次要结局
- Change in scores on the Patient Reported Outcomes Measurement Information System (PROMIS®-29) (Version 2) score(Up to 8 weeks)
- Change in scores on the Patient Reported Outcomes Measurement Information System (PROMIS®-29) (Version 2) score(Up to 8 weeks)
- Percentage of participants reporting adverse events(Up to 8 weeks)
- Percentage of participants reporting adverse events(Up to 8 weeks)