The Impact of Functional Medicine On Wound Healing From Delayed Autologous Breast Reconstruction - A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Number of Serious Adverse Events (SAE's).
研究概览
简要总结
This study will examine if a functional medicine approach, delivered as an adjunct to standard of care, is feasible, safe, clinically beneficial and cost-effective for patients undergoing autologous breast reconstruction.
详细描述
Autologous microsurgical breast reconstruction is associated with a protracted recovery and a significant amount of opioid utilization. Many institutions have "Enhanced Recovery After Surgery (ERAS)" protocols that utilize multi-modality therapy to decrease opioid use, length of stay, hospital costs and expedite recovery. However, nutrition-based interventions used perioperatively are not currently part of ERAS protocols for surgical sub-specialties, including breast surgery despite ample literature that nutrition (with or without supplements) can improve surgical wound healing and other outcomes.
The functional medicine model of care expands upon the conventional medicine model of care by providing a unique operating system that works to reverse illness, promote health and optimize function. A foundation of functional medicine is the use of food as medicine to prevent, treat and reverse chronic disease. Dietary supplements are used as an adjunct to nutrition-based interventions. Dietitians support patients with implementing food plans, and health coaches support patients through lifestyle and behavioral changes focused on sleep, exercise and movement and stress reduction.
This study will examine the feasibility of implementing a functional medicine-based intervention focused on nutrition and lifestyle, and the ability of the intervention to improve wound healing and decrease various post-operative complications in patients undergoing autologous breast reconstruction.
All participants will be asked to attend study visits, complete questionnaires and have their blood drawn. Participants randomized to standard of care plus functional medicine will be asked to also follow a specific food plan, take specific dietary supplements, exercise and engage in stress reduction techniques for 3 months prior to and after surgery. The study duration is 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Undergoing uni- or bilateral delayed abdominally-based breast reconstruction at the Cleveland Clinic.
- •Women of childbearing potential must use adequate birth control measures (e.g., abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, implantable or injectable contraceptives or surgical sterilization) for the duration of the study.
- •Capable of providing written informed consent prior to any protocol-specified procedures.
- •Willing to adhere to the study visit schedule and other protocol requirements.
排除标准
- •BMI > 37
- •Women who are pregnant, nursing, or planning pregnancy during the trial.
- •Have a serious concomitant illness that could interfere with the subject's participation in the trial (allergy preventing supplement usage)
- •Undergoing chemotherapy during proposed nutritional intervention (3 months before or after surgery).
- •Are unable to or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access.
- •Clinical diagnosis of cognitive impairment or dementia.
- •Known sensitivity to nutritional supplements.
- •History of being seen or had intervention/care in Functional Medicine or following Functional Medicine principles.
结局指标
主要结局
Number of Serious Adverse Events (SAE's).
时间窗: Up to 26 weeks
Number of Serious Adverse Events (SAE's).
Number of in-person visits completed.
时间窗: Up to 26 weeks
Number of in-person visits completed.
Percent completion of study-specific surveys.
时间窗: Up to 26 weeks
Percent of the following surveys completed: * BreastQ (baseline, wks 12, and 26) * PROMIS Questionnaire (baseline and wks 5, 12 and 26) * Medical Symptom Questionnaire (MSQ) (baseline and wks 5, 12 and 26) * Nutrition and Lifestyle Adherence Survey (randomization and then weekly for the duration of the study) * Dietary Supplementation Adherence Survey (only those randomized to SOC plus functional medicine; wk1 and then weekly for the duration of the study) Note: the BRA and SKIN surveys are not completed by the patient, but by the provider.
Adherence to prescribed dietary supplementation.
时间窗: Up to 26 weeks
Percent of participants adhering to prescribed dietary supplementation.
Feasibility defined by percent randomized.
时间窗: Baseline
Success will be defined as enrolling and randomizing 25% or more of those screened per arm.
Adherence to recommended lifestyle interventions.
时间窗: Up to 26 weeks
Percent of participants adhering to lifestyle interventions.
Number of virtual visits completed.
时间窗: Up to 26 weeks
Number of virtual visits completed.
Adherence to recommended dietary intervention.
时间窗: Up to 26 weeks
Percent of participants adhering to recommended dietary intervention.
次要结局
- Length-of-stay upon hospital re-admission.(Up to 26 weeks)
- Change in Comprehensive Metabolic Pane (CMP).(Baseline to 26 weeks)
- Clinically-meaningful change in Patient-Reported Outcome Measurement Information System (PROMIS) Global Physical Health (GPH) scores.(Baseline to week 26)
- Net change in Patient-Reported Outcome Measurement Information System (PROMIS) Global Mental Health (GMH).(Baseline to week 26)
- Number of re-operations for wound management.(Up to 26 weeks)
- Change in Complete Blood Count with Differential (CBC).(Baseline to 26 weeks)
- Change in Vitamin D.(Baseline to 26 weeks)
- Change in mean value of the continuous variable of PROMIS GPH.(Baseline to week 26)
- Change in Nutrition and Lifestyle Adherence Survey scores.(Baseline to week 26)
- Number of days wounds necessitate dressing changes or packing post-surgery.(At 26 weeks)
- Correlate post-operative surgical site infection complications with the predicted risk from the BRA scoring system.(Up to 26 weeks)
- Correlate post-operative dehiscence complications with the predicted risk from the BRA scoring system.(Up to 26 weeks)
- Change in NMR LipoProfile.(Baseline to 26 weeks)
- Total healthcare costs.(At 26 weeks)
- Net change in Patient-Reported Outcome Measurement Information System (PROMIS) Global Physical Health (GPH) scores.(Baseline to week 5)
- Change in Breast-Q scores.(Baseline to week 26)
- Number of hospital re-admissions.(Up to 26 weeks)
- Number of antibiotic prescriptions.(Up to 26 weeks)
- Correlate all post-operative complications with the predicted risk from the BRA scoring system.(Up to 26 weeks)
- Correlate post-operative flap loss complications with the predicted risk from the BRA scoring system.(Up to 26 weeks)
- Change in Hemoglobin A1c (HbA1c).(Baseline to 26 weeks)
- Change in Medical System Questionnaire (MSQ) scores.(Baseline to week 26)
- Change in Dietary Supplement Adherence Survey scores.(Baseline to week 12)
- Average incision length.(At 17 weeks)
- Correlate post-operative seroma complications with the predicted risk from the BRA scoring system.(Up to 26 weeks)
- Correlate post-operative reoperation complications with the predicted risk from the BRA scoring system.(Up to 26 weeks)
- Change in nuclear magnetic resonance (NMR) LipoProfile.(Baseline to 12 weeks)
- Change in high-sensitivity C-Reactive Protein (hsCRP).(Baseline to 26 weeks)
- Change in OmegaCheck.(Baseline to 26 weeks)
- Change in mean value of the continuous variable of PROMIS GMH.(Baseline to week 26)
- Clinically-meaningful change in Patient-Reported Outcome Measurement Information System (PROMIS) Global Mental Health (GMH) scores.(Baseline to week 26)
- Change in Dietary Supplement Adherence Survey scores(Baseline to week 26)
- Average dehiscence length.(At 17 weeks)
- Evaluate narcotic utilization while in the hospital.(While in hospital, an average of 3 days)
- SKIN Survey composite scores.(At 17 weeks)