Leveraging Digital Health Solutions to Collect Patient-Reported Outcomes in Rectal Cancer
2 de septiembre de 2026 actualizado por: University of California, San Francisco
Rectal cancer care is increasingly complex and may include systemic therapy, radiation therapy, surgery, or nonoperative watch-and-wait surveillance.
These treatments can have both short- and long-term effects on bowel, urinary, sexual, and stoma-related function.
Prior studies have often assessed quality of life and treatment decision experiences at a single time point or after one type of treatment, resulting in limited information about how patients' experiences change throughout their course of care.
This study will evaluate health-related quality of life and experiences with treatment decisions among patients with non-metastatic rectal cancer using validated patient-reported outcome measures over the course of treatment.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
PRIMARY OBJECTIVES:
- Evaluate feasibility and adherence of participant-reported outcomes through UCSF MyChart.
- Evaluate changes in health-related quality of life over the course of rectal cancer treatment.
SECONDARY OBJECTIVES:
- Evaluate longitudinal changes in decisional regret over the course of rectal cancer treatment.
- Evaluate the association between health-related quality of life and decisional regret over the course of rectal cancer treatment.
- Evaluate differences in health-related quality of life and decisional regret trajectories by treatment stage and modality.
- Evaluate patterns of survey completion and adherence to the MyChart survey workflow.
OUTLINE: This is a prospective observational study of adults with non-metastatic rectal cancer receiving care at University of California, San Francisco (UCSF). Participants will complete patient-reported outcome measures through UCSF MyChart during the course of their treatment and will be follow up to 24 month post treatment.
Tipo de estudio
De observación
Inscripción (Estimado)
150
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.
Estudio Contacto
- Nombre: Laleh Foroutani, MD
- Número de teléfono: (415) 299-9424
- Correo electrónico: laleh.foroutani@ucsf.edu
Ubicaciones de estudio
-
-
California
-
San Francisco, California, Estados Unidos, 94143
- University of California, San Francisco
-
Contacto:
- Laleh Foroutani, MD
- Número de teléfono: 415-299-9424
- Correo electrónico: laleh.foroutani@ucsf.edu
-
Investigador principal:
- Mark Zhao, MD
-
-
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
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
Adults with non-metastatic rectal cancer receiving treatment at University of California, San Francisco (UCSF).
Descripción
Inclusion Criteria:
- Adults age 18 years or older meet all of the following.
- Documented rectal cancer diagnosis (for example, ICD-10-CM C20) without metastatic disease at the initial study eligibility assessment.
- Established follow-up with UCSF colorectal surgery, medical oncology, or radiation oncology, generally defined as at least two encounters more than 1 month apart.
- Active UCSF MyChart access by enrollment and ability to personally complete the electronic consent and surveys, independently or with reasonable technical or accessibility assistance that does not answer questions on the participant's behalf. Individuals identified through PRP direct mail who do not yet use MyChart may activate MyChart before enrollment.
- Able to read and complete the currently validated English-language study materials.
- Able to provide informed consent and HIPAA authorization.
Exclusion Criteria:
- Metastatic disease at the initial eligibility assessment.
- Unable or unwilling to activate and personally use UCSF MyChart before enrollment, even with reasonable technical or accessibility assistance.
- Unable to complete the English-language consent and validated instruments. This initial pilot is limited to English because validated translations and translated automated workflows are not yet available.
- No UCSF clinical encounter for more than 6 months or otherwise lost to follow-up.- Unable or unwilling to provide informed consent and HIPAA authorization.
- Prisoner at enrollment. If a participant becomes incarcerated or loses decision-making capacity after enrollment, active survey collection will stop.
Participants who develop metastatic progression after enrollment are not treated as screen failures; they will receive one final general ABCRC module and then exit the automated survey sequence.
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
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Participants with rectal cancer
Participants with non-metastatic rectal cancer and who are receiving treatment at UCSF.
|
Patient-reported outcome measures: Assessment of Burden in Colorectal Cancer (ABCRC) & Decisional Regret Scale (DRS)
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Proportion of scheduled MyChart survey events completed
Periodo de tiempo: Up top 12 months
|
The proportion of scheduled MyChart survey events completed by participants will be summarized, with a target completion rate of at least 75%.
|
Up top 12 months
|
|
Change in mean ABCRC total and module-specific scores over time.
Periodo de tiempo: Up to 12 months
|
Changes in Assessment of Burden in Colorectal Cancer (ABCRC) total and module-specific scores will be evaluated from enrollment and in relation to key treatment events.
Statistical models that account for multiple measurements from the same participant will be used to evaluate changes in scores over time.
|
Up to 12 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in mean DRS score and proportion of participants with clinically significant decisional regret
Periodo de tiempo: Up to 12 months
|
Longitudinal changes in Decisional Regret Scale (DRS) scores will be evaluated over the course of treatment using statistical models that account for multiple measurements from the same participant.
The proportion of participants with clinically significant decisional regret, defined as a DRS score greater than 50, will also be summarized.
|
Up to 12 months
|
|
Association between ABCRC and DRS scores over the course of treatment
Periodo de tiempo: Up to 12 months
|
The relationship between Assessment of Burden in Colorectal Cancer (ABCRC) scores and Decisional Regret Scale (DRS) scores will be evaluated using repeated measurements collected from each participant.
The analysis will examine whether participants with different levels of quality of life also report different levels of decisional regret, and whether changes in quality of life are related to changes in decisional regret within the same participant over time.
Statistical methods that account for repeated measurements will be used.
|
Up to 12 months
|
|
Change in mean ABCRC and DRS scores over time by treatment characteristics
Periodo de tiempo: Up to 12 months
|
Changes in ABCRC and DRS scores will be evaluated and compared among participants receiving different treatments, including surgery, watch-and-wait surveillance, treatment sequence, and surgical procedure.
Statistical models that account for multiple measurements from the same participant will be used to evaluate differences in score changes over time.
|
Up to 12 months
|
|
Patterns of survey nonresponse, missingness, and workflow adherence
Periodo de tiempo: Up to 12 months
|
Patterns of survey completion, nonresponse, missing data, and adherence to scheduled MyChart survey events will be described over the course of treatment.
Missing information will be summarized and evaluated to understand how missing surveys or responses may vary over time and by participant or treatment characteristics.
|
Up to 12 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Mark Zhao, MD, University of California, San Francisco
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 (Estimado)
31 de octubre de 2026
Finalización primaria (Estimado)
30 de noviembre de 2027
Finalización del estudio (Estimado)
30 de noviembre de 2027
Fechas de registro del estudio
Enviado por primera vez
2 de septiembre de 2026
Primero enviado que cumplió con los criterios de control de calidad
2 de septiembre de 2026
Publicado por primera vez (Actual)
9 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
9 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
2 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 264516
- NCI-2026-06213 (Identificador de registro: NCI Clinical Trials Reporting System (CTRP))
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. .