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Intervention to Motivate Standing &Walking in Gastrointestinal Cancer Surgical Patients

21 de febrero de 2019 actualizado por: Niraj J. Gusani MD, Milton S. Hershey Medical Center
Observational research has linked physical activity with faster recovery, improved quality of life, and greater survival; however, little is known about the effects of physical activity in pre-operative, peri-operative, or post-operative treatment contexts and there is a need for interventions to improve patient outcomes across the cancer treatment continuum. Three propositions derived from basic research, epidemiological evidence, and clinical practice informed our intervention development efforts: (1) Patient outcomes will be enhanced by interventions that increase physical activity (i.e., standing, walking) across the cancer treatment continuum (i.e., pre-operative, peri-operative, post-operative). (2) Reducing sedentary behavior (i.e., seated or reclined activities involving minimal energy expenditure) will enhance patient outcomes both by increasing physical activity and by stimulating additional adaptive physiological responses to reduced sedentary time (responses which are independent of physical activity-induced responses). (3) Patients with gastrointestinal cancers often suffer functional limitations that limit their independence and their health behaviors are strongly influenced by the family environment so interventions that engage caregivers (e.g., spouses) will be more effective than those that target patients/survivors alone.

Descripción general del estudio

Estado

Terminado

Intervención / Tratamiento

Descripción detallada

Phase 1 Screening and Baseline Assessment in Clinic Patients will be recruited by their physician upon diagnosis and immediately after the Penn State Surgical Oncology team presents then with the surgical treatment option. The patient must be able to identify an adult caregiver. The caregiver must be someone who is willing to participate in the study for the intervention period.

Once enrolled by the research assistant, the participant will complete an intake questionnaire to capture demographic information. The participant will then be given a tablet computer, training on how to use it to complete the questionnaires at the beginning and end of each day, an activity monitor with materials for securing it, and training on how/where to affix it on the leg.

In this study, we will use educational materials delivered at the initial enrollment session and in daily "facts of the day" presented electronically to heighten awareness of (1) the risks of insufficient physical activity and excessive sedentary behavior, and (2) the expected beneficial outcomes of increased physical activity and reduced sedentary behavior. These messages should are designed to increase intentions to engage in physical activity and to limit sedentary behavior (motivational phase). Although intentions are necessary for behavior change, a recent review of experimental evidence indicates that they are not sufficient. In the volitional phase, people translate those intentions into action by developing actions plans that specify when/where/how they will act (e.g., after lunch I will go on a 30 min walk around my neighborhood) and coping plans that specify how they will overcome anticipated barriers to desired behavior (e.g., if it rains after lunch, I will go to the mall to walk for 30 min). Repeated planning of this nature is the basis for breaking existing behavioral habits and forming newer (and hopefully more adaptive) ones. We have already developed an electronic daily planning tool that can be used at the beginning of each day to form action and coping plans for the target behaviors in this intervention. In the first two months of this project, we will tailor this existing planning tool for the target population by drawing from existing and emerging research on strategies for and barriers to health behaviors among cancer patients.

The control group will not receive the educational or daily planning components of the motivational intervention. They will, however, engage in self-monitoring by virtue of wearing activity monitors and using tablet computers to provide self-report data on their physical activity and sedentary behavior.

After the patient's surgery while staying at the Penn State Hershey Medical Center, the study coordinator will provide the caregiver with behavioral goals to help the patient recover from his/her surgery, and additional information about how the caregiver can support the patient's behavior change efforts.

Phase 2: Intervention Period

For the duration of the study, participant will:

  • Complete beginning-and end -of-day questionnaires on the tablet computer. The beginning of day questionnaire will evaluate the patient's intentions and plans for daily physical activity. The end of day questionnaire will evaluate actual physical activity completed daily as well as the patient's physical, emotional, and social well-being.
  • Wear and activity monitor

For participants in the experimental group the research assistant will also:

  • Deliver the educational intervention for patients and caregivers during their first visit after they have signed the consent forms.
  • Train patients how to use the daily planning tool prior to the beginning -of- day prior to the beginning-of-day questionnaires.

The theoretical basis for our intervention draws from both social-cognitive theory (i.e., Health Action Process Approach [HAPA]) and self-determination theory. The Health Action Process Approach differentiates between motivational and volitional phases of action control. In the motivational phase, people form intentions or goals for their behavior based on factors such as risk awareness and outcome expectations. In this study, we will use educational materials delivered at the initial enrollment session and in daily "facts of the day" presented electronically to heighten awareness of (1) the risks of insufficient physical activity and excessive sedentary behavior, and (2) the expected beneficial outcomes of increased physical activity and reduced sedentary behavior. These messages should are designed to increase intentions to engage in physical activity and to limit sedentary behavior (motivational phase). Although intentions are necessary for behavior change, a recent review of experimental evidence indicates that they are not sufficient. In the volitional phase, people translate those intentions into action by developing actions plans that specify when/where/how they will act (e.g., after lunch I will go on a 30 min walk around my neighborhood) and coping plans that specify how they will overcome anticipated barriers to desired behavior (e.g., if it rains after lunch, I will go to the mall to walk for 30 min). Repeated planning of this nature is the basis for breaking existing behavioral habits and forming newer (and hopefully more adaptive) ones. We have already developed an electronic daily planning tool that can be used at the beginning of each day to form action and coping plans for the target behaviors in this intervention. In the first two months of this project, we will tailor this existing planning tool for the target population by drawing from existing and emerging research on strategies for and barriers to health behaviors among cancer patients.

Self-determination theory posits that social factors, such as family relationships, can also influence motivation. Our recent work using experience sampling methodology and accelerometry has shown that spouses' autonomy support for patient physical activity and the spouse's level of physical activity were associated with patients' greater daily moderate physical activity and steps taken Individuals whose family members or health care providers show autonomy support for increasing physical activity and decreasing sedentary behavior are more likely to make those changes for reasons that come from within themselves and are freely chosen. Because close family members influence the emotional and physical well-being of patients, their inclusion in behavioral interventions is logical and has the potential to boost the effects of those interventions. In this study, caregivers will be educated about the importance of autonomy support in behavior change and strategies for supporting their partner's autonomy around physical activity and sedentary behavior change across the stages of treatment. This education will be delivered by the nurse coordinator at the initial education session following enrollment.

Collectively, these three components of patient education, daily planning, and caregiver education were assembled to strengthen intentions for desired health behaviors (motivational phase of behavior change), to increase the likelihood that such intentions will translate into action (volitional phase of behavior change), and to provide social resources that support behavior change in both of those phases.

The control group will not receive the educational or daily planning components of the motivational intervention. They will, however, engage in self-monitoring by virtue of wearing activity monitors and using tablet computers to provide self-report data on their physical activity and sedentary behavior.

During the intervention period the study coordinator will also contact the patient via phone weekly to ask questions related to the patients safety including questions about frequency of falls mild/moderate/severe, chest pain, dizziness, musculoskeletal soreness or pain, and changes in swelling.

Phase 3: Follow-Up Telephone Call

The research assistant will call the participant 30, 60, and 90 days after surgery to assess the frequency of hospital readmission or emergency room visits since being discharged.

Phase 4: Follow- Up Questionnaire

21 days after discharge form the hospital, participants and caregivers will complete a brief questionnaire that we will mail to them with a self-addressed stamped envelope.

Tipo de estudio

Intervencionista

Inscripción (Actual)

32

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Pennsylvania
      • Hershey, Pennsylvania, Estados Unidos, 17033
        • Penn State Hershey Medical Center

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Diagnosis of gastrointestinal tract cancer (hepatobiliary) requiring surgical resection. for treatment
  • Failing to meet the aerobic component of national physical activity guidelines over past week (e.g., < 150 min moderate-intensity physical activity or < 75 min vigorous-intensity physical activity).
  • Excessive sedentary behavior over the past week (> 8 hrs/day sitting).
  • Minimum age 18 years.
  • A spouse or adult child serving as a caregiver who is also willing to participate.

Exclusion Criteria:

  • Functional limitations that preclude normal physical activity.
  • Patients who will be scheduled for surgery < 10 days after their clinic visit.
  • Medical contraindications to physical activity.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Education/Daily Planning
Physical Activity Education and Daily Planning Tool
In this study, we will use educational materials delivered at the initial enrollment session and in daily "facts of the day" presented electronically to heighten awareness of (1) the risks of insufficient physical activity and excessive sedentary behavior, and (2) the expected beneficial outcomes of increased physical activity and reduced sedentary behavior. These messages should are designed to increase intentions to engage in physical activity and to limit sedentary behavior (motivational phase)
Sin intervención: No Education/Daily Planning
No Physical Activity Education/ Daily Planning Tool

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of patients with diagnosed gastrointestinal cancer who showed daily compliance using activity monitors and tablet computers to measure physical activity.
Periodo de tiempo: up to 1 year
To demonstrate the feasibility and acceptability of using activity monitors and tablet computers to measure physical activity (standing, walking)/sedentary behavior (sitting) and deliver daily interventions in this patient population, we will evaluate daily compliance using activity monitors and tablet computers.
up to 1 year

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of patients with a diagnosis of gastrointestinal cancer that benefit from an intervention of physical activity daily planning and education.
Periodo de tiempo: up to 1 year
To evaluate the efficacy of this intervention, we will conduct a pilot study of a two-arm randomized controlled trial of the intervention against a self-monitoring control group.
up to 1 year

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Colaboradores

Investigadores

  • Investigador principal: Niraj J Gusani, M.D., M.S., Milton S. Hershey Medical Center
  • Director de estudio: David E Conroy, Ph.D, Penn State University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de octubre de 2013

Finalización primaria (Actual)

1 de julio de 2015

Finalización del estudio (Actual)

1 de diciembre de 2018

Fechas de registro del estudio

Enviado por primera vez

28 de octubre de 2013

Primero enviado que cumplió con los criterios de control de calidad

6 de noviembre de 2013

Publicado por primera vez (Estimar)

13 de noviembre de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de febrero de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

21 de febrero de 2019

Última verificación

1 de febrero de 2019

Más información

Términos relacionados con este estudio

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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