Prehabilitation for Advanced Ovarian Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Adherence to each prehabilitation component based on patient reported adherence (Cohorts 2 & 3)
研究概览
简要总结
This clinical trial evaluates whether a prehabilitation program started at the time of neoadjuvant chemotherapy will affect surgical recovery in patients with stage IIIC-IV ovarian, fallopian tube, or primary peritoneal cancer. A prehabilitation program may improve the quality of life after surgery for patients with ovarian, fallopian tube, or primary peritoneal cancer.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the baseline difference in objective frailty measurements in patients with advanced ovarian cancer clinically deemed acceptable for primary surgery versus neoadjuvant chemotherapy.
II. To evaluate level of adherence and retention of patients with advanced ovarian cancer undergoing neoadjuvant chemotherapy with a prehabilitation program.
EXPLORATORY OBJECTIVE:
I. Will examine longitudinal trends and variability in function by the Short Physical Performance Battery (SPPB) over time and in response to the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Age >= 18 years old
- •Diagnosed with epithelial ovarian, fallopian tube, or primary peritoneal cancer based on imaging and physician diagnosis
- •Suspected Stage IIIC or IV disease based on clinician staging and imaging
- •Curative intent treatment with platinum-based chemotherapy
- •Planned surgical intervention at some point during treatment course
- •Ability to read English
- •No diagnosed severe cognitive impairment
- •Ability to provide consent
- •Ability to utilize technology to watch online modules for the Resilient Living Program
排除标准
- •Hemiplegia or paraplegia
- •Current pregnancy
研究组 & 干预措施
Cohort 1 (surveys, CT, blood samples)
Patients undergoing primary surgical intervention complete surveys, undergo CT, and undergo collection of blood samples at baseline.
干预措施: Computed Tomography (Procedure)
Cohort 1 (surveys, CT, blood samples)
Patients undergoing primary surgical intervention complete surveys, undergo CT, and undergo collection of blood samples at baseline.
干预措施: Biospecimen Collection (Procedure)
Cohort 1 (surveys, CT, blood samples)
Patients undergoing primary surgical intervention complete surveys, undergo CT, and undergo collection of blood samples at baseline.
干预措施: Survey Administration (Other)
Cohort 2 (exercise, supplement, Resilient Living)
Patients undergoing neoadjuvant chemotherapy complete physical activity for 30 minutes per day 3 times a week. Patients receive nutritional supplement drink up to 4.5 times daily, and complete Resilient Living program in-person or remotely over 60 minutes. Patients also undergo CT scans throughout the trial.
干预措施: Nutritional Supplement Drink (Dietary Supplement)
Cohort 2 (exercise, supplement, Resilient Living)
Patients undergoing neoadjuvant chemotherapy complete physical activity for 30 minutes per day 3 times a week. Patients receive nutritional supplement drink up to 4.5 times daily, and complete Resilient Living program in-person or remotely over 60 minutes. Patients also undergo CT scans throughout the trial.
干预措施: Physical Activity (Other)
Cohort 2 (exercise, supplement, Resilient Living)
Patients undergoing neoadjuvant chemotherapy complete physical activity for 30 minutes per day 3 times a week. Patients receive nutritional supplement drink up to 4.5 times daily, and complete Resilient Living program in-person or remotely over 60 minutes. Patients also undergo CT scans throughout the trial.
干预措施: Survey Administration (Other)
Cohort 2 (exercise, supplement, Resilient Living)
Patients undergoing neoadjuvant chemotherapy complete physical activity for 30 minutes per day 3 times a week. Patients receive nutritional supplement drink up to 4.5 times daily, and complete Resilient Living program in-person or remotely over 60 minutes. Patients also undergo CT scans throughout the trial.
干预措施: Computed Tomography (Procedure)
Cohort 2 (exercise, supplement, Resilient Living)
Patients undergoing neoadjuvant chemotherapy complete physical activity for 30 minutes per day 3 times a week. Patients receive nutritional supplement drink up to 4.5 times daily, and complete Resilient Living program in-person or remotely over 60 minutes. Patients also undergo CT scans throughout the trial.
干预措施: Health Education (Behavioral)
Cohort 3 (exercise, supplement, coaching, Resilient Living)
Patients undergoing neoadjuvant chemotherapy complete physical activity remotely for 30 minutes per day 3 times a week. Patients receive nutritional supplement drink up to 4.5 times daily. Patients also undergo health coaching remotely for 60 minutes weekly, complete Resilient Living program remotely over 60 minutes, and may wear a FitBit throughout the study.
干预措施: Nutritional Supplement Drink (Dietary Supplement)
Cohort 3 (exercise, supplement, coaching, Resilient Living)
Patients undergoing neoadjuvant chemotherapy complete physical activity remotely for 30 minutes per day 3 times a week. Patients receive nutritional supplement drink up to 4.5 times daily. Patients also undergo health coaching remotely for 60 minutes weekly, complete Resilient Living program remotely over 60 minutes, and may wear a FitBit throughout the study.
干预措施: Physical Activity (Other)
Cohort 3 (exercise, supplement, coaching, Resilient Living)
Patients undergoing neoadjuvant chemotherapy complete physical activity remotely for 30 minutes per day 3 times a week. Patients receive nutritional supplement drink up to 4.5 times daily. Patients also undergo health coaching remotely for 60 minutes weekly, complete Resilient Living program remotely over 60 minutes, and may wear a FitBit throughout the study.
干预措施: Survey Administration (Other)
Cohort 3 (exercise, supplement, coaching, Resilient Living)
Patients undergoing neoadjuvant chemotherapy complete physical activity remotely for 30 minutes per day 3 times a week. Patients receive nutritional supplement drink up to 4.5 times daily. Patients also undergo health coaching remotely for 60 minutes weekly, complete Resilient Living program remotely over 60 minutes, and may wear a FitBit throughout the study.
干预措施: Health Education (Behavioral)
Cohort 3 (exercise, supplement, coaching, Resilient Living)
Patients undergoing neoadjuvant chemotherapy complete physical activity remotely for 30 minutes per day 3 times a week. Patients receive nutritional supplement drink up to 4.5 times daily. Patients also undergo health coaching remotely for 60 minutes weekly, complete Resilient Living program remotely over 60 minutes, and may wear a FitBit throughout the study.
干预措施: Medical Device Usage and Evaluation (Other)
Cohort 3 (exercise, supplement, coaching, Resilient Living)
Patients undergoing neoadjuvant chemotherapy complete physical activity remotely for 30 minutes per day 3 times a week. Patients receive nutritional supplement drink up to 4.5 times daily. Patients also undergo health coaching remotely for 60 minutes weekly, complete Resilient Living program remotely over 60 minutes, and may wear a FitBit throughout the study.
干预措施: Behavioral Counseling (Behavioral)
结局指标
主要结局
Adherence to each prehabilitation component based on patient reported adherence (Cohorts 2 & 3)
时间窗: Weekly up to 4 months
Assessed based on patient reported adherence in Cohort 2. For cohort 3, adherence will be documented in MyDataHelps® and monitored remotely by the study team on the Care Evolution platform®. Participants will be evaluated weekly for compliance with the recommended exercise and nutrition and resilience interventions. Documentation of adherence will be through online patient messages, phone call, or during in person visits, whichever the patient prefers
次要结局
- Implementation outcome(Up to 4 months)
- Difference in Short Physical Performance Battery (SPPB) at baseline between cohorts 1 and 2(Baseline)
- Correlation of body composition on computed tomography (CT) scans to frailty assessments(Baseline, up to 4 months)
- Acceptability of remote setting in Cohort 3(30 days)
- Correlation of Short Physical Performance Battery (SPPB) to other assessments in cohorts 1 and 2(Baseline, up to 4 months)
- Correlation of assessments to compliance with interventions in cohort 2(Baseline, up to 4 months)
- Correlation of frailty assessments with clinical judgement of frailty(Baseline, up to 4 months)
- Change of Short Physical Performance Battery (SPPB) over time in cohort 2(Up to 4 months)
- Qualitative outcomes of the facilitators, barriers, perceived benefits, and burdens(Baseline, up to 4 months)