Prehabilitation in High-risk Oncologic Surgery
SURG-236: Prehabilitation in High-risk Oncologic Surgery: A Prospective Cohort Study
The goal of this clinical study is to learn whether a prehabilitation program can improve recovery after major abdominal surgery in adults with cancer who are receiving treatment before surgery. Prehabilitation is supportive care given before surgery to help patients prepare physically, nutritionally, and emotionally.
The main questions this study aims to answer are:
- Does prehabilitation reduce the number of participants who die or have serious complications within 30 days after surgery?
- Does prehabilitation improve physical strength and fitness, nutritional status, emotional well-being, and quality of life before surgery?
- Does prehabilitation affect the length of the hospital stay after surgery, the time it takes to start additional cancer treatment after surgery, or the ability to complete recommended additional treatment?
Participants will take part in a prehabilitation program during their treatment period before surgery. The program includes visits with physical therapy, nutrition, and health psychology. Participants will meet with each specialty at least twice before surgery. They will also complete questionnaires and tests that measure physical function, diet and weight, emotional well-being, and quality of life. After surgery, information about recovery and additional cancer treatment will be collected from medical records for up to 120 days.
Researchers will compare the outcomes of participants who receive the prehabilitation program with outcomes from similar patients who previously received care at Fox Chase Cancer Center but did not participate in this study.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Patients with cancer who receive treatment before major abdominal surgery may experience loss of strength, reduced nutritional status, fatigue, and emotional distress during the period leading up to surgery. These challenges may affect their ability to tolerate surgery and recover after the procedure. Prehabilitation is an approach intended to improve a patient's condition before surgery through coordinated supportive care.
This is a prospective cohort study evaluating a multidisciplinary prehabilitation program for adults with cancer who are undergoing neoadjuvant treatment before planned high-risk abdominal oncologic surgery. The program integrates physical therapy, nutritional support, and health psychology during the preoperative treatment period. The study will evaluate whether this approach is associated with improved postoperative outcomes and improved measures of physical function, nutritional status, and emotional well-being.
Outcomes for participants enrolled in the prospective prehabilitation cohort will be compared with outcomes from matched retrospective controls treated at Fox Chase Cancer Center before initiation of this study. Each prospective participant who proceeds to surgery and is eligible for analysis will be matched with one retrospective control based on relevant clinical and demographic characteristics, including age, sex, smoking status, American Society of Anesthesiologists (ASA) class, and cancer type. When more than one eligible matched control is available, one control will be selected at random.
The study is intended to assess whether a structured, multidisciplinary prehabilitation program can be implemented across several high-risk oncologic surgery populations and whether this approach may support improved recovery and continuity of cancer care after surgery.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Stephanie Greco, MD
- Número de telefone: 2152143719
- E-mail: stephanie.greco@fccc.edu
Estude backup de contato
- Nome: Henkel Valentine, PhD
- Número de telefone: 2678820820
- E-mail: henkel.valentine@fccc.edu
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Evidence of probable or confirmed primary or recurrent malignant neoplasm of any stage
- Planned to undergo neoadjuvant chemotherapy or chemoradiation
- Eligible surgical candidate for one of the following procedures: pancreatectomy, gastrectomy, esophagectomy, cystectomy, low anterior resection, abdominoperineal resection, or cytoreductive surgery with heated intraperitoneal chemotherapy
- Age greater than 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Ability to understand and willingness to sign a written informed consent form and Health Insurance Portability and Accountability Act (HIPAA) authorization document
Exclusion Criteria:
- Unable to complete study requirements, such as attending a minimum of two visits for each specialty referral. This will be assessed at the final preoperative visit, at which time the participant may be discontinued from the study and replaced. Participants will not be excluded due to lack of insurance coverage for health psychology visits.
- Does not proceed to surgery at an affiliated institution
- Pregnant or breastfeeding
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Multidisciplinary Prehabilitation Program
Participants will receive a multidisciplinary prehabilitation program during the preoperative period while undergoing neoadjuvant treatment before planned high-risk abdominal oncologic surgery.
The program includes supportive care provided by physical therapy, nutrition, and health psychology to prepare participants for surgery and support physical, nutritional, and emotional well-being.
|
A multidisciplinary prehabilitation program delivered during neoadjuvant therapy before planned high-risk abdominal oncologic surgery. The program includes physical therapy, nutrition, and health psychology support, with approximately monthly visits and at least two visits with each specialty before surgery. Physical therapy includes an individualized home strengthening and aerobic exercise program supported by resistance bands, a pedometer, and an exercise log. Nutrition includes individualized dietary counseling focused on maintaining weight and meeting protein needs, with oral nutritional supplementation when clinically indicated. Health psychology includes assessment, supportive care planning, and referral to additional psychosocial resources when needed. The intervention is completed before surgery; postoperative data collection is for follow-up only. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
30-Day Rate of Death or Serious Complications After Surgery
Prazo: Within 30 days after surgery
|
Percentage of participants who experience death or at least one serious postoperative complication within 30 days after the index surgery, as defined by the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP).
Outcomes in participants receiving the multidisciplinary prehabilitation program will be compared with outcomes in matched retrospective controls.
|
Within 30 days after surgery
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
30-Day Death or Serious Complications by Surgical Cohort
Prazo: 30 days after surgery
|
Incidence of 30-day death or serious complications (DSC) among participants undergoing partial or complete pancreatectomy, low anterior resection or abdominoperineal resection, esophagectomy or major gastrectomy, cystectomy, cytoreductive surgery with HIPEC, or other major oncologic procedures.
Outcomes will be compared with matched retrospective controls.
|
30 days after surgery
|
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Postoperative Surgical and Oncologic Outcomes
Prazo: From surgery through 120 days after surgery
|
Evaluation of postoperative outcomes including primary surgical admission length of stay, time to initiation of adjuvant therapy, and rate of completion of recommended adjuvant therapy compared with matched retrospective controls.
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From surgery through 120 days after surgery
|
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Change in Physical Function, Nutritional Status, and Emotional Well-Being
Prazo: Baseline through final preoperative evaluation (up to 6 months before surgery)
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Assessment of the effect of prehabilitation on physical fitness, nutritional status, and emotional well-being, including grip strength, 30-second sit-to-stand test performance, gait speed or 2-minute walk test completion, resting heart rate, skeletal muscle mass-to-height ratio, body weight, Healthy Eating Index score assessed using Vioscreen, Patient Health Questionnaire-9 (PHQ-9) score, Generalized Anxiety Disorder-7 (GAD-7) questionnaire score, and Patient-Reported Outcomes Measurement Information System 29-item Profile (PROMIS-29) score.
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Baseline through final preoperative evaluation (up to 6 months before surgery)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Stephanie Gzreco, MD, Fox Chase Cancer Center
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças urogenitais
- Doenças Genitais
- Doenças do Sistema Endócrino
- Processos Patológicos
- Neoplasias urogenitais
- Neoplasias por local
- Neoplasias
- Doenças Urogenitais Masculinas
- Doenças Urológicas
- Doenças Urogenitais Femininas
- Doenças urogenitais femininas e complicações na gravidez
- Doenças Intestinais
- Neoplasias gastrointestinais
- Neoplasias do Aparelho Digestivo
- Doenças do aparelho digestivo
- Doenças Gastrointestinais
- Doenças do Estômago
- Neoplasias Colorretais
- Neoplasias Intestinais
- Doenças Genitais Femininas
- Neoplasias das Glândulas Endócrinas
- Neoplasias de Cabeça e Pescoço
- Doenças pancreáticas
- Doenças do cólon
- Doenças Esofágicas
- Doenças ovarianas
- Doenças anexiais
- Neoplasias Genitais Femininas
- Distúrbios Gonadais
- Neoplasias Urológicas
- Doenças da Bexiga Urinária
- Condições Patológicas, Sinais e Sintomas
- Neoplasias do Estômago
- Neoplasias colônicas
- Neoplasias Esofágicas
- Neoplasias ovarianas
- Neoplasias Pancreáticas
- Neoplasias da Bexiga Urinária
- Complicações pós-operatórias
Outros números de identificação do estudo
- SURG-236
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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