Feasibility and Acceptability of an Individualized Online Home-Based Exercise Program on Psychoneurological Symptoms in Gynecologic Cancer Survivors: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Attrition Rates (Feasibility)
研究概览
简要总结
This clinical trial tests an individualized online home-based exercise program in gynecologic cancer survivors and its impact on gut microbiome (the bacteria and microorganisms that live in the digestive system) and symptoms such as pain, fatigue, sleep disturbance, depression, and cognitive impairment. These symptoms can significantly reduce the quality of life (QoL) and survival rate in this cancer population. Thus, promoting physical activity among cancer survivors may help mitigate these severe symptoms. Using online platforms such as Zoom can help participants access an individualized exercise program that meets their specific needs to engage in physical activity and decrease their symptom burden. Home-based exercise, by providing self-chosen time and location and low costs, can address some barriers to physical activity for cancer survivors. An individualized online home-based exercise program may be feasible, and may improve symptoms and quality of life in gynecologic cancer survivors.
详细描述
PRIMARY OBJECTIVES:
I. To examine the feasibility and acceptability of an individualized home-based exercise program in gynecologic cancer survivors.
II. To test the effect of the program on gut microbiome and psychoneurological symptoms in gynecologic cancer survivors.
OUTLINE:
Participants meet with a certified exercise trainer and complete a functional capacity assessment using a treadmill or 6-minute walk test. Participants then complete an individualized online home-based exercise intervention via Zoom consisting of progressive, moderate-intensity walking corresponding to the rate of perceived exertion (RPE) scale and receive social support over 30 minutes twice a week (BIW) for 12 weeks.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged ≥ 18 years old
- •Previously diagnosed with gynecologic cancer (e.g., uterine, ovarian, cervical)
- •Completed cancer treatment (chemotherapy or chemoradiation)
- •Able to read and speak English
- •Do not meet recommended exercise levels as defined by The American College of Sports Medicine
排除标准
- •History of metastatic or other primary cancer
- •Serious mental health conditions (e.g., bipolar disorder, schizophrenia, major depression)
- •Certain chronic diseases (e.g., muscular-skeletal diseases that limit mobility, autoimmune diseases, uncontrolled diabetes, hypertension, renal disease (creatinine > 2.5 mg/dL)
- •Unable to read/speak English
研究组 & 干预措施
Supportive Care (individualized online home-based exercise)
Participants meet with a certified exercise trainer and complete a functional capacity assessment using a treadmill or 6-minute walk test. Participants then complete an individualized online home-based exercise intervention via Zoom consisting of progressive, moderate-intensity walking corresponding to the RPE scale and receive social support over 30 minutes BIW for 12 weeks.
干预措施: Exercise Intervention (Other)
Supportive Care (individualized online home-based exercise)
Participants meet with a certified exercise trainer and complete a functional capacity assessment using a treadmill or 6-minute walk test. Participants then complete an individualized online home-based exercise intervention via Zoom consisting of progressive, moderate-intensity walking corresponding to the RPE scale and receive social support over 30 minutes BIW for 12 weeks.
干预措施: Functional Assessment (Other)
Supportive Care (individualized online home-based exercise)
Participants meet with a certified exercise trainer and complete a functional capacity assessment using a treadmill or 6-minute walk test. Participants then complete an individualized online home-based exercise intervention via Zoom consisting of progressive, moderate-intensity walking corresponding to the RPE scale and receive social support over 30 minutes BIW for 12 weeks.
干预措施: Medical Device Usage and Evaluation (Other)
Supportive Care (individualized online home-based exercise)
Participants meet with a certified exercise trainer and complete a functional capacity assessment using a treadmill or 6-minute walk test. Participants then complete an individualized online home-based exercise intervention via Zoom consisting of progressive, moderate-intensity walking corresponding to the RPE scale and receive social support over 30 minutes BIW for 12 weeks.
干预措施: Questionnaire Administration (Other)
Supportive Care (individualized online home-based exercise)
Participants meet with a certified exercise trainer and complete a functional capacity assessment using a treadmill or 6-minute walk test. Participants then complete an individualized online home-based exercise intervention via Zoom consisting of progressive, moderate-intensity walking corresponding to the RPE scale and receive social support over 30 minutes BIW for 12 weeks.
干预措施: Supportive Care (Other)
结局指标
主要结局
Attrition Rates (Feasibility)
时间窗: At 12 weeks
Feasibility will be assessed by calculating attrition and adherence rates, identifying reasons for refusal, and evaluating the completeness of the data. We will consider the intervention to have low attrition and high adherence if \>80% of participants remain enrolled and complete the study, respectively.
Adherence Rates (Feasibility)
时间窗: At 12 weeks
Feasibility will be assessed by calculating attrition and adherence rates, identifying reasons for refusal, and evaluating the completeness of the data. We will consider the intervention to have low attrition and high adherence if \> 80% of participants remain enrolled and complete the study, respectively.
Intervention Acceptability
时间窗: Up to 12 weeks
Will be evaluated with a survey to assess participants' perceptions of the acceptability of the study procedures. A response rate of \> 80% will be considered high acceptability. Descriptive statistics will be calculated using SPSS and R software.
Gut Microbiome
时间窗: From baseline to 12 weeks
Gut microbiota composition will be evaluated using collected stool samples. The preliminary efficacy of the intervention on gut microbiome and psychoneurological symptoms (PNS) will be compared using a paired t-test.
Psychoneurological Symptoms
时间窗: From baseline to 12 weeks
Will be assessed using the Fatigue Short Form, Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression and Anxiety Short Form, Pain Interference Short Form, PROMIS Cognitive Function Short Form, PROMIS Sleep Disturbance Short Form, the PROMIS gastrointestinal (GI) constipation and diarrhea Short Forms. The preliminary efficacy of the intervention on gut microbiome and PNS will be compared using a paired t-test.
次要结局
- Rapid Eating Assessment for Participants(Up to 12 weeks)
- Stress(Up to 12 weeks)
- Quality of Life Assessment(Up to 12 weeks)
- Rapid Eating Assessment for Participants(Up to 12 weeks)
- Stress(Up to 12 weeks)
研究者
Zahra A. Barandouzi
Principal Investigator
Emory University