Physiatry-Led Prehabilitation During Neoadjuvant Systemic Treatment Before Breast Cancer Surgery: A Pilot Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Adherence (feasibility)
研究概览
简要总结
This clinical trial evaluates whether a prehabilitation program is feasible for breast cancer patients receiving neoadjuvant systemic treatment before surgery. Many people with breast cancer have problems during and after treatment. These issues can make daily activities harder and make it harder for a person to enjoy daily life. Some people with breast cancer already have other health problems, like joint pain or nerve problems, which can make these symptoms worse. Research shows that being stronger and more active before and during treatment may help people do better during cancer care and recover more easily. However, many patients do not get this type of support early enough. Prehabilitation is a program that helps patients get ready for cancer treatment and surgery. It may include help with medical care, exercise, food and nutrition, and mental health. The goal is to help patients stay as strong and healthy as possible before surgery. Starting prehabilitation during neoadjuvant systemic treatment before surgery may help breast cancer patients feel better, stay stronger and recover more easily during treatment.
详细描述
PRIMARY OBJECTIVES:
I. Determine feasibility based on exercise as evaluated by adherence (> 70%). II. Assess feasibility of nutrition and mind/spirit practice by measuring adherence (> 70% of enrolled patients for the preoperative study period).
SECONDARY OBJECTIVES:
I. Evaluate physical measures: six minute walk test, Duke Activity Status Index, 30-second sit to stand, Patient Reported Outcomes Measurement Information System (PROMIS) Cancer Function Brief 3 Dimensional (3D) Profile, body composition, and Quick Disabilities of Arm, Shoulder, and Hand (QuickDASH).
II. Assess exercise behavior measures: Godin Leisure-Time Physical Activity and Exercise Intent Questionnaire, self-reported exercise activity and future intent, self-efficacy for home exercise programs.
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
- 否
入选标准
- •PATIENT INCLUSION:
- •Documented informed consent of the participant and/or legally authorized representative
- •Willingness to comply with a physiatry consultation, start a tailored training program, and follow-up assessments
- •Age: >= 18 years
- •Able to read and write in English
- •A diagnosis of breast cancer planned for curative intent neoadjuvant systemic treatment (NST) with a goal of breast cancer surgery
- •Plan to start NST at City of Hope Orange County
- •HEALTHCARE TEAM INCLUSION:
- •Willingness to complete the Healthcare Team Feedback Survey
- •> 18 years old
- •Physicians, advanced practice providers, nurses, medical assistants, rehabilitation therapists, social workers, dietitians, mental health professionals, and other clinical staff who interact with study participants in the course of routine care
排除标准
- •PATIENT EXCLUSION:
- •Current or planned cancer treatment for a second cancer not of breast origin
- •Clinically significant uncontrolled illness limiting participation with the research intervention and assessments
- •Cancer with distant metastases
- •Other active malignancy
- •Pregnant or breastfeeding
- •Physician judgment (based on information gathered during consult visit) of medical instability including conditions such as unstable cardiopulmonary status, recent embolism (< 4 weeks), suspected or known dissecting aneurysm, severe hypertension (resting blood pressure > 180/110), chronic infectious disease, uncontrolled metabolic disease (e.g. diabetes with ketosis), active seizure, mental/physical impairments limiting safe exercise, or sepsis
- •Meeting or exceeding exercise guidelines over the last one month, based on the responses from the Godin Leisure-Time Physical Activity and Exercise Intent Questionnaire
- •Started second cycle before the physiatry consult
- •Inability to independently follow instructions for study assessments for any reason such as mental incapacitation or significant emotional or psychological disorder that, in the opinion of the investigators, precludes study entry. (These patients may not be able to cooperate with the prehabilitation interventions or with the data collection process.)
- •Unable to independently answer questionnaires in English or provide informed consent for any reason
- •HEALTHCARE TEAM EXCLUSION:
- •Healthcare workers who do not interact with study participants and therefore cannot provide relevant feedback
研究组 & 干预措施
Supportive care (prehabilitation)
See Detailed Description.
干预措施: Aerobic Exercise (Other)
Supportive care (prehabilitation)
See Detailed Description.
干预措施: Bioelectric Impedance Analysis (Procedure)
Supportive care (prehabilitation)
See Detailed Description.
干预措施: Consultation (Other)
Supportive care (prehabilitation)
See Detailed Description.
干预措施: Educational Intervention (Other)
Supportive care (prehabilitation)
See Detailed Description.
干预措施: Electronic Health Record Review (Other)
Supportive care (prehabilitation)
See Detailed Description.
干预措施: Nutritional Intervention (Other)
Supportive care (prehabilitation)
See Detailed Description.
干预措施: Physical Performance Testing (Other)
Supportive care (prehabilitation)
See Detailed Description.
干预措施: Psychosocial Care (Behavioral)
Supportive care (prehabilitation)
See Detailed Description.
干预措施: Questionnaire Administration (Other)
Supportive care (prehabilitation)
See Detailed Description.
干预措施: Referral (Other)
Supportive care (prehabilitation)
See Detailed Description.
干预措施: Resistance Training (Other)
Supportive care (prehabilitation)
See Detailed Description.
干预措施: Spiritual Therapy (Procedure)
Supportive care (prehabilitation)
See Detailed Description.
干预措施: Tailored Intervention (Procedure)
结局指标
主要结局
Adherence (feasibility)
时间窗: Up to day 168
Feasibility of exercise will be determined by participant adherence to the prescribed exercise for the evaluable preoperative study period with goal of adherence of \> 70% for \> 70% of the preoperative time period. Adherence is defined as a ratio of completed versus planned exercise amount (90 minutes per week of moderate intensity aerobic exercise when on neoadjuvant systemic treatment (NST), 150 minutes per week when off NST, and 2 times per week resistance exercise), averaged between the types of exercise. Feasibility of nutrition and mind/spirit practice will also be determined based on participant adherence (\> 70% of enrolled patients during the preoperative time period).
次要结局
- Six minute walk test(At baseline, day 42, day 84, day 126, at pre-operative visit, and post-operative visit (21-35 days after surgery [approximately day 168]))
- Duke Activity Status Index(At baseline, day 42, day 84, day 126, at pre-operative visit, and post-operative visit (21-35 days after surgery [approximately day 168]))
- 30-second sit to stand(At baseline, day 42, day 84, day 126, at pre-operative visit, and post-operative visit (21-35 days after surgery [approximately day 168]))
- Short physical performance battery(At baseline, day 42, day 84, day 126, at pre-operative visit, and post-operative visit (21-35 days after surgery [approximately day 168]))
- Patient Reported Outcomes Measurement Information System Cancer Function Brief 3-dimensional Profile(At baseline, day 42, day 84, day 126, at pre-operative visit, and post-operative visit (21-35 days after surgery [approximately day 168]))
- Body composition: Body composition measures, including but not limited to fat-free mass(At baseline, day 42, day 84, day 126, at pre-operative visit, and post-operative visit (21-35 days after surgery [approximately day 168]))
- Quick Disabilities of Arm, Shoulder, and Hand(At baseline, day 42, day 84, day 126, at pre-operative visit, and post-operative visit (21-35 days after surgery [approximately day 168]))
- Godin Leisure-Time Physical Activity and Exercise Intent Questionnaire:(At baseline, day 42, day 84, day 126, at pre-operative visit, and post-operative visit (21-35 days after surgery [approximately day 168]))
- Self-reported exercise-Survey(At baseline, day 42, day 84, day 126, at pre-operative visit, and post-operative visit (21-35 days after surgery [approximately day 168]))
- Intent to exercise- Survey(At baseline, day 42, day 84, day 126, at pre-operative visit, and post-operative visit (21-35 days after surgery [approximately day 168]))
- Self-Efficacy for Home Exercise Programs(At baseline, day 42, day 84, day 126, at pre-operative visit, and post-operative visit (21-35 days after surgery [approximately day 168]))
- Malnutrition Screening Tool(At baseline, day 42, day 84, day 126, at pre-operative visit, and post-operative visit (21-35 days after surgery [approximately day 168]))
- Edmonton Symptom Assessment Scale - Financial and Spiritual Distress(At baseline, day 42, day 84, day 126, at pre-operative visit, and post-operative visit (21-35 days after surgery [approximately day 168]))
- European Quality of Life 5 Dimensions(At baseline, day 42, day 84, day 126, at pre-operative visit, and post-operative visit (21-35 days after surgery [approximately day 168]))
- Body composition: Body composition measures, including fat mass(At baseline, day 42, day 84, day 126, at pre-operative visit, and post-operative visit (21-35 days after surgery [approximately day 168]))
- Body composition: Body composition measures, including phase angle(At baseline, day 42, day 84, day 126, at pre-operative visit, and post-operative visit (21-35 days after surgery [approximately day 168]))