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Mobilized Psychoeducation and Skills Based Intervention (Pep-Pal) for Caregivers of Patients With Advanced Illness

31 de julio de 2020 actualizado por: University of Colorado, Denver

A Pilot Study of a Mobilized Psychoeducation and Skills Based Intervention (Pep-Pal) for Caregivers of Patients With Advanced Illness

The proposed project is a pilot study of the Pep-Pal (Psychoeducation and Skills Based Intervention) versus a treatment as usual control group. A total of 60 caregivers; including caregivers of patients with HSCT (Hematopoietic Stem Cell Transplantation), caregivers enrolled in Phase I clinical trials, and caregivers of patients with advanced cancer (Stage III, solid tumor) will be enrolled in this study. The investigators do not expect different outcomes from these three groups, rather these populations are selected to optimize recruitment within a short time frame. The caregivers will be randomized to either treatment as usual or Pep-Pal intervention.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

The proposed project is a pilot study of the Pep-Pal intervention versus a treatment as usual control group. A total of 60 caregivers; caregivers of patients with HSCT, caregivers of patients enrolled in phase I oncology trials, and caregivers of patients with advanced cancer (Stage IV, solid tumor) will be enrolled in this study. The investigators do not expect different outcomes from these three groups, rather these populations are selected to optimize recruitment within a short time frame. The caregivers will be randomized to either treatment as usual or Pep-Pal intervention. The proposed study population is based on prior research indicating that caregivers of patients receiving HSCT, caregivers of patients enrolled in phase I oncology trials, and caregivers of patients with advanced cancer experience significant distress. In addition, an initial study of caregivers of patients receiving allogeneic-HSCT were able to benefit from a brief, cognitive behavioral stress management treatment approach. A study examining distress in phase I oncology clinical trial patient caregivers highlighted the need for more support for this significantly distressed population. Furthermore, initial results of the qualitative development study for Pep-Pal yielded support for a mobilized platform delivery of resources for caregivers to manage distress because they acknowledged many barriers to engaging in in-person treatment to manage distress.

Tipo de estudio

Intervencionista

Inscripción (Actual)

69

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

  • Estados Unidos
    • Colorado
      • Aurora, Colorado, Estados Unidos, 80045
        • University of Colorado, Denver

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 85 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. Women and men ≥ 18 years of age of any ethnicity
  2. Must endorse a moderate level of anxiety (e.g. Score above an 8 on the Hospital and Anxiety Depression Scale (HADS))
  3. Speak and read in English
  4. Caregiver of a patient with auto HSCT who are moving forward with bone marrow transplant or have receive a bone marrow transplant
  5. Caregiver of a patient in a Phase I Clinical Trial
  6. Caregiver of a patient diagnosed with advanced cancer (stage III or stage IV)
  7. No Cognitive or psychiatric conditions prohibiting participation
  8. Must meet criteria for being a primary caregiver, defined as, the person in the patient's life who is primarily responsible for care decisions, emotionally invested in the patient's care, provides instrumental care such as transportation for a patient receiving auto-HSCT, enrolled in a phase I oncology clinical trial, or of a patient diagnosed with advanced cancer (stage IV, solid tumor).
  9. Have a computer, smartphone, or tablet with internet access

Exclusion Criteria:

  1. Caregivers below the age of 18
  2. Score below an 8 on the Hospital and Anxiety Depression Scale (HADS)
  3. Cannot speak and read in English
  4. Patient does not receive a bone marrow transplant
  5. Patient is not enrolled in a Phase I clinical trial
  6. Patient is not diagnosed with Stage III or Stage IV cancer
  7. Cognitive conditions prohibiting participation

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: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Pep-Pal + Treatment as Usual
If the caregiver is assigned to the Pep-Pal intervention condition, the RA will provide access to the mobilized website (passcode) through an email. Caregivers will be instructed to watch each session at least once. It will be recommended that caregivers watch one to two new sessions per week so that they can have enough time to practice the skills between sessions. In addition, they will be told that they can go back and watch the sessions for review as many times as they like. Full participation will be defined as watching at least 7/9 sessions (75% of program) based on previous criteria for similar intervention completion in a prior trial with advanced cancer patients.
Otro: Tratamiento como de costumbre
Conductual: Pep-Pal
Pep-Pal is designed to complement the utilization of other resources, provide support when no other resources can be obtained, or provide support in the interim until greater resources can be obtained. In this way, Pep-Pal is a resource for our most hard to reach caregivers.
Comparador activo: Treatment as Usual
Treatment as usual provides voluntary (at the caregiver's discretion) support services for the caregivers which is rarely used by the caregivers.
Otro: Tratamiento como de costumbre

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Evaluation of Exit Interviews
Periodo de tiempo: 12 weeks
Qualitative feedback will be gathered from the first 15 Pep-Pal completer's for individual interviews (5 from Phase I group, 5 from Hematopoietic stem cell transplantation (HSCT) group, 5 from medical oncology) upon completion of the follow-up assessments at 12 weeks about usage, acceptability of content, and impressions of using Pep-Pal.
12 weeks
Pep-Pal Self-Report sessions at 12 Weeks
Periodo de tiempo: 12 weeks
The Investigators will assess feasibility by examining recruitment, retention, as well as reasons for refusal, frequency of sessions watched and length of time spent watching each session. Self report usage of peppal: Usage of Pep-Pal will be quantitatively assessed by asking each participant in the intervention group about their usage including frequency; how many times they watched each session and length of viewing for each session (partial or complete). They will be asked to rate level of usage based on a Likert-scale ranging from not at all to very often for each session (0-10). They will be asked to rank order the list of sessions from most helpful to least helpful.
12 weeks
Evaluation of Self-Report Caregiver reported outcomes at Baseline
Periodo de tiempo: Week 1
Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A)
Week 1
Evaluation of Self-report caregiver reported outcomes at 12 weeks
Periodo de tiempo: Week 12
Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A)
Week 12

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Evaluation of Self-report caregiver reported outcomes at baseline
Periodo de tiempo: Week 1
Center for Epidemiologic Studies Depression Scale (CESD)
Week 1
Evaluation of Self-report caregiver reported outcomes at baseline
Periodo de tiempo: Week 1
Perceived Stress Scale (PSS)
Week 1
Evaluation of Self-report caregiver reported outcomes at baseline
Periodo de tiempo: Week 1
Female Sexual Function Index (FSFI)
Week 1
Evaluation of Self-report caregiver reported outcomes at baseline
Periodo de tiempo: Week 1
Male Sexual Health Questionnaire(MSHQ)
Week 1
Evaluation of Self-report caregiver reported outcomes at baseline
Periodo de tiempo: Week 1
Measure of Current Status (MOCS-A)
Week 1
Evaluation of Self-report caregiver reported outcomes at 12 weeks
Periodo de tiempo: Week 12
Center for Epidemiologic Studies Depression Scale (CESD)
Week 12
Evaluation of Self-report caregiver reported outcomes at 12 weeks
Periodo de tiempo: Week 12
Perceived Stress Scale (PSS)
Week 12
Evaluation of Self-report caregiver reported outcomes at 12 weeks
Periodo de tiempo: Week 12
Female Sexual Function Index (FSFI)
Week 12
Evaluation of Self-report caregiver reported outcomes at 12 weeks
Periodo de tiempo: Week 12
Male Sexual Health Questionnaire(MSHQ)
Week 12
Evaluation of Self-report caregiver reported outcomes at 12 weeks
Periodo de tiempo: Week 12
Measure of Current Status (MOCS-A)
Week 12

Colaboradores e Investigadores

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

Patrocinador

University of Colorado, Denver

Colaboradores

Icahn School of Medicine at Mount Sinai

Investigadores

  • Investigador principal: Nicole R Amoyal-Pensak, PhD, University of Colorado, Denver

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 (Actual)

1 de diciembre de 2016

Finalización primaria (Actual)

17 de noviembre de 2017

Finalización del estudio (Actual)

13 de julio de 2018

Fechas de registro del estudio

Enviado por primera vez

28 de septiembre de 2016

Primero enviado que cumplió con los criterios de control de calidad

21 de diciembre de 2016

Publicado por primera vez (Estimar)

26 de diciembre de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de agosto de 2020

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

31 de julio de 2020

Última verificación

1 de julio de 2020

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 16-0990

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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