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Quality of Life Interventions During Cervical Cancer Treatment

25 de mayo de 2021 actualizado por: Susan Lutgendorf, University of Iowa
The proposed project will examine the effects of a healing touch intervention in women receiving chemotherapy and radiation for advanced cervical cancer.

Descripción general del estudio

Descripción detallada

Patients receiving chemoradiation for cervical cancer are at risk for distress, chemoradiation-related side effects, and immunosuppression. This prospective randomized clinical trial proposes to examine the effects of a complementary therapy, Healing Touch (HT), versus relaxation training (RT) and usual care (UC) for (1) supporting cellular immunity, (2) improving mood and quality of life (QOL), and (3) reducing treatment-associated toxicities and treatment delay in cervical cancer patients receiving chemoradiation.

Tipo de estudio

Intervencionista

Inscripción (Actual)

60

Fase

  • No aplica

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 a 100 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Descripción

Inclusion Criteria:

  • Women with stage I-IVa cervical cancer pursuing concurrent chemotherapy and radiation therapy.

Exclusion Criteria:

  • Greater than Stage IVa cervical cancer
  • Metastatic or recurrent cervical cancer
  • Patients receiving only chemotherapy or only radiation therapy
  • History of cancer of any site
  • History of a transplant
  • Diagnosed with any immunosupressive disorder (HIV, AIDS).

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: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Relaxation training following daily radiation
All relaxation sessions will be given individually, and will be provided by trained nurses or research assistants. Patients receiving relaxation will learn exercises to release tension through muscle relaxation, breathing, and imagery
Muscle relaxation training
Otros nombres:
  • Relajación
Subjects in all groups will give 4 blood samples during the study
Otros nombres:
  • Extracción de sangre
Experimental: Healing touch therapy following daily radiation
All Healing Touch sessions will be given individually, and will be provided by trained nurses or research assistants. Patients receiving Healing Touch will receive a series of standardized therapeutic techniques designed to promote optimal flow of energy throughout the body.
Subjects in all groups will give 4 blood samples during the study
Otros nombres:
  • Extracción de sangre
Healing Touch (HT) therapy
Otros nombres:
  • Toque sanador
Comparador activo: No intervention
The no intervention group will receive no special intervention other than standard medical care, which includes the regular medical care given by the patient's physician and health care professionals.
Subjects in all groups will give 4 blood samples during the study
Otros nombres:
  • Extracción de sangre

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in natural killer cell cytotoxicity (NKCC)
Periodo de tiempo: 6 weeks

Compare change in natural killer cell cytotoxicity of participants receiving HT during radiation and chemotherapy to participants receiving relaxation training or usual care during radiation and chemotherapy treatment collected via blood draw.

Fresh peripheral blood mononuclear cells tested for cytolytic activity against the NK-sensitive K562 cells and the NK-resistant LAK-sensitive ZKBL cells in a standard 4-h 51Chromium- release assay.

6 weeks
Number of chemoradiation-related toxicities
Periodo de tiempo: 6 weeks
Compare number of reported side effects of participants receiving HT during radiation and chemotherapy treatment to participants receiving relaxation training or usual care as measured by the Common Toxicity Criteria Manual Version 2.0
6 weeks
Number of days of treatment delay due to chemoradiation-related toxicities
Periodo de tiempo: 6 weeks
Compare number of days in treatment delay due to chemoradiation-related toxicity for participants receiving HT during radiation and chemotherapy treatment to participants receiving relaxation training or usual care
6 weeks
Change in participant reports of depression
Periodo de tiempo: 6 weeks
Compare changes in depression scores of participants receiving HT to participants receiving relaxation training or usual care during radiation and chemotherapy as measured by the Center for Epidemiologic Studies Depression Scale (CES-D) in which higher scores indicate worse depression (range 0-60)
6 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in participant reports of anxiety
Periodo de tiempo: 6 weeks
Compare changes in reported anxiety of participants receiving HT during radiation and chemotherapy to participants receiving relaxation training or usual care during radiation and chemotherapy treatment as measured by the Profile of Mood States- Anxiety Subscale (POMS-SF) (range 0-28)
6 weeks
Change in white blood cell counts
Periodo de tiempo: 6 weeks

Compare change in white blood cell counts of participants receiving HT during radiation and chemotherapy vs. patients receiving relaxation training or usual care during this time

hemotherapy to participants receiving relaxation training or usual care during radiation and chemotherapy treatment collected via blood draw.

6 weeks
Change in red blood cell counts
Periodo de tiempo: 6 weeks
Compare change in red blood cell counts of participants receiving HT during radiation and chemotherapy to participants receiving relaxation training or usual care during radiation and chemotherapy treatment collected via blood draw.
6 weeks
Change in participant reports of quality of life
Periodo de tiempo: 6 weeks
Compare change in reported quality of life of participants receiving HT during radiation and chemotherapy to participants receiving relaxation training or usual care during radiation and chemotherapy treatment as measured by the Functional assessment of Cancer therapies (FACT). Higher scores indicate better quality of life. Range= (0-136).
6 weeks
Change in participant reports of fatigue
Periodo de tiempo: 6 weeks
Compare reported fatigue of participants receiving HT during radiation and chemotherapy to participants receiving relaxation training or usual care during radiation and chemotherapy treatment as measured by the Fatigue Severity Inventory (FSI). Mean fatigue intensity (range 0-10) with higher scores indicating more fatigue, and fatigue duration in days last week experiencing fatigue (0-7 days) with greater number of days indicating greater fatigue duration.
6 weeks
Change in metabolomic measures
Periodo de tiempo: 6 weeks
Compare metabolic profile of participants receiving HT during radiation and chemotherapy treatment to participants receiving relaxation training or usual care. Samples were assayed using Ultrahigh Performance Liquid Chromatography-Tandem Mass Spectroscopy (UPLC-MS/MS). The metabolomic profiling analysis measures the quantity of specific compounds in the plasma vs. a platform of 844 known metabolites in a commercial platform powered by Metabolon, Inc. For any specific metabolite, higher levels indicates greater presence of the metabolite.
6 weeks

Colaboradores e Investigadores

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

Patrocinador

Investigadores

  • Investigador principal: Susan Lutgendorf, PhD, University of Iowa

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.

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 (Actual)

4 de junio de 2001

Finalización primaria (Actual)

15 de marzo de 2008

Finalización del estudio (Actual)

1 de julio de 2014

Fechas de registro del estudio

Enviado por primera vez

20 de mayo de 2021

Primero enviado que cumplió con los criterios de control de calidad

25 de mayo de 2021

Publicado por primera vez (Actual)

27 de mayo de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

27 de mayo de 2021

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

25 de mayo de 2021

Última verificación

1 de mayo de 2021

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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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