Apoyo A Trabajadores de Salud Comunitarios en Cáncer y Tumores - Registro de Ensayos Clínicos - ICH GCP

3/11/23, 11:03 Apoyo a trabajadores de salud comunitarios en cáncer y tumores - Registro de ensayos clínicos - ICH GCP
PCI BPC > Registro de ensayos clínicos de EE. UU. > Ensayo clínico NCT04843332
Trabajadores de salud comunitarios

y medicina de precisión
26 de enero de 2023 actualizado por: Manali Indravadan Patel, Universidad de
Stanford
Reducción de las disparidades en el cáncer a través de una

asociación innovadora entre la comunidad y el mundo
académico para mejorar el acceso y la prestación de
medicamentos de precisión en el condado de Monterey
El propósito de este ensayo controlado aleatorio es evaluar si

un trabajador de salud comunitario (TSC) capacitado que se
relaciona con pacientes recién diagnosticados después de un
diagnóstico de cáncer puede mejorar eficazmente el
conocimiento y la recepción de servicios de atención del
cáncer con medicina de precisión basados en evidencia entre
personas de bajos ingresos y pacientes minoritarios.
Descripción general del estudio
ESTADO ?
Activo, no reclutando
CONDICIONES ?
Cáncer
Tumor
INTERVENCIÓN/TRATAMIENTO ?
Comportamiento: Apoyo de los trabajadores de salud

comunitarios
SUSCRIBIR
https://ichgcp.net/clinical-trials-registry/NCT04843332 1/33
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DESCRIPCIÓN DETALLADA
El objetivo de este estudio es reducir las disparidades en el

cáncer mejorando el conocimiento y la prestación de medicina
de precisión basada en evidencia para la atención del cáncer.
Planeamos asignar al azar a pacientes recién diagnosticados
y a aquellos que actualmente reciben atención oncológica a
un brazo de control (solo atención habitual contra el cáncer)
versus un brazo de intervención (superpuesto a la atención
habitual contra el cáncer únicamente) donde los pacientes
son asignados a un trabajador de salud comunitario que los
ayudará. pacientes para garantizar las siguientes
conversaciones con su equipo de atención: 1) atención
precisa del cáncer 2) diagnóstico del cáncer y plan de
tratamiento 2) cumplimiento de los tratamientos y 3) objetivos
de la atención y carga de síntomas. Se reclutará un total de 55
participantes por grupo de estudio (110 en total) en el
condado de Monterey de Pacific Cancer Care.
SUSCRIBIR
TIPO DE ESTUDIO ?
intervencionista
INSCRIPCIÓN (ANTICIPADA) ?
110
FASE ?
No aplica
Contactos y ubicaciones
Esta sección proporciona los detalles de contacto de quienes
realizan el estudio e información sobre dónde se lleva a cabo
este estudio.
Ubicaciones de estudio
Estados Unidos
California
Stanford, California, Estados Unidos, 94305
Universidad Stanford
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Criterios de participación
SUSCRIBIR
Los investigadores buscan personas que se ajusten a una

determinada descripción, denominada criterios 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 en adelante (Adulto, Adulto Mayor)
ACEPTA VOLUNTARIOS SALUDABLES
No
GÉNEROS ELEGIBLES PARA ESTUDIAR
Todo
DESCRIPCIÓN
Criterios de inclusión:
Pacientes recién diagnosticados con diagnóstico de

cáncer.
Pacientes con cualquier recaída o enfermedad
progresiva (cualquier diagnóstico de cáncer) identificada
mediante imágenes o biopsia y confirmada por un
médico.
Los pacientes deben tener 18 años o más.
Los pacientes deben tener la capacidad de dar su
consentimiento verbal en inglés o español.
Los pacientes deben ser minorías raciales/étnicas O
tener bajos ingresos O tener seguro público (Medi-Cal u
otro) O tener un seguro médico proporcionado por una
empresa agrícola O no tener seguro
Criterio de exclusión:
Pacientes menores de 18 años.

Incapacidad para dar consentimiento al estudio debido a
falta de capacidad documentada por el médico
remitente.
SUSCRIBIR
Patients without a newly diagnosed malignancy or

patients without relapse of disease.
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Study Plan
This section provides details of the study plan, including how
the study is designed and what the study is measuring.
How is the study designed?
DESIGN DETAILS
Primary Purpose: Health Services Research

Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Triple
ARMS AND INTERVENTIONS
Participant Group / Arm ? Intervention / ?

Treatment
No Intervention: Usual Oncology Care

This arm is the control group. They will
receive usual oncology care from their
regular oncologist and care team with
no change in their care plan or
treatment as a result of the intervention.
Outcomes will be assessed at each of
SUSCRIBIR
Participant Group / Arm ? Intervention / ?

Treatment
the following times: baseline, 3-months,

6-months, and 12-months.
Experimental: Community Health Behavioral:

Worker Intervention Community Health
This arm is the treatment group. Worker Support
Patients randomized into the For those in the
intervention will be assigned a experimental
community health worker who will group, a
contact the patient to begin the community health
intervention. They will receive usual worker will provide
oncology care from their regular health education
oncologist and care team but will also and support as
receive supplemental support and described in the
health education from a community Community Health
health worker. The lay health worker will Worker
assist patients in ensuring that patients Intervention arm.
discuss the following with their cancer
care teams: 1) precision medicine 2)
cancer diagnosis and treatment plan 3)
adherence to treatments and 3) goals of
care and 4) symptom burden. Outcomes
will be assessed at each of the
following times: baseline, 3-months, 6-
months, and 12-months.
What is the study measuring?
PRIMARY OUTCOME MEASURES ?
Outcome Measure Description Time

Measure Frame
Change in Using 7 multiple choice items Time of

knowledge adapted from an 8-item survey tool, Enrollm
of precision Knowledge and Purpose of ent to
medicine for Molecular Profiling, by Davies et. al., 3-
cancer care month
2020, we will assess knowledge of
from time of s post-
precision medicine (molecular
enrollment enrollm
profiling and tumor testing) for
to 3 months ent
post- cancer care. All questions are
SUSCRIBIR enrollment multiple choice. For example one

Measure Frame
Marco de question asks 'tumor testing is

tiempo: helpful for making decisions about
desde el future cancer risks,' with answer
momento de choices: always, frequently,
la
sometimes, rarely, never, or I don't
inscripción
know. Answers will be scored as
hasta los 3
number or percent correct.
meses
posteriores a Adapted from the following paper:
la Davies, G., Butow, P., Napier, C. E.,
inscripción
Bartley, N., Juraskova, I., Meiser, B.,
... & Best, M. C. (2020). Advanced
Cancer Patient Knowledge of and
Attitudes towards Tumor Molecular
Profiling. Translational Oncology,
13(9), 100799.
Knowledge Using 7 multiple items 6-

choice
of precision adapted from an 8-item survey tool, month
medicine for Knowledge and Purpose of s post-
cancer care Molecular Profiling, by Davies et. al., enrollm
Plazo: 6 ent
meses
después de
la
inscripción cancer care. All questions are
multiple choice. For example one
question asks 'tumor testing is
helpful for making decisions about
future cancer risks,' with answer
choices: always, frequently,
Adapted from the following paper:

Davies, G., Butow, P., Napier, C. E.,
SUSCRIBIR Attitudes towards Tumor Molecular

Measure Frame

13(9), 100799.
Knowledge Using 7 multiple items 12-

choice
of precision adapted from an 8-item survey tool, month
medicine for Knowledge and Purpose of s post-
cancer care Molecular Profiling, by Davies et. al., enrollm
Plazo: 12 ent
meses
después de
la
inscripción cancer care. All questions are
multiple choice. For example one
question asks 'tumor testing is
helpful for making decisions about
future cancer risks,' with answer
choices: always, frequently,
Adapted from the following paper:

Davies, G., Butow, P., Napier, C. E.,
Attitudes towards Tumor Molecular
13(9), 100799.
SECONDARY OUTCOME MEASURES ?

Measure Frame
Patient Each patient will receive a validated 3-

activation patient activation survey using the month
using the "Patient Activation Measure" at s
"Patient enrollment and 3 months after study post-
Activation enrollment. This is a validated measure enroll
Measure" from Insignia Health. Responses are: ment
SUSCRIBIR survey disagree strongly, disagree, agree, agree

Measure Frame
Plazo: 3 strongly with higher activation

meses correlated with responses of agree and
después agree strongly. Each item is rated on 4-
de la point scale (1 strongly disagree to 4
inscripció strongly agree, with additional "not
n applicable" option). Higher scores
indicate greater patient activation. For
the PAM-10, minimum score is 0 (if all
not-applicable) and maximum is 40.
Raw scores are converted into
activation levels per the scoring
guidelines by Insignia Health for: level 1
Disengaged and Overwhelmed, level 2
Becoming Aware but Still Struggling,
level 3 Taking Action and Gaining
Control, level 4 Maintaining "Behaviors
and Pushing Further. Scores for each
group will be averaged at 3 months after
study enrollment.

survey disagree strongly, disagree, agree, agree
SUSCRIBIR

Measure Frame

group will be averaged at 6 months after
study enrollment.

survey disagree strongly, disagree, agree, agree
group will be averaged at 12 months
after study enrollment.
Patient Each patient will receive the validated 9- 3-

Satisfacti item Shared Decision Making month
on With Questionnaire (SDM-Q-9) at 3 months s
Shared after study enrollment. Responses are post-
Decision "completely disagree, strongly disagree, enroll
Making somewhat disagree, somewhat agree, ment
using the strongly agree, or completely agree,"
"Shared with 1=completely disagree and 6=
Decision completely agree. Higher scores
Making indicate greater levels of satisfaction.
SUSCRIBIR Questionn Minimum score is 9, maximum is 54.

Measure Frame
aire" Responses for each group will be

Survey assessed at 3 months after study
Plazo: 3 enrollment. The measure is adapted
meses from: Holmes-Rovner, M., Kroll, J.,
después Schmitt, N., Rovner, D. R., Breer, M. L.,
de la Rothert, M. L., ... & Talarczyk, G. (1996).
inscripció Patient satisfaction with health care
n decisions: the satisfaction with decision
scale. Medical Decision Making, 16(1),
58-64.

Making indicate greater levels of satisfaction.
Questionn Minimum score is 9, maximum is 54.
58-64.

SUSCRIBIR Making indicate greater levels of satisfaction.

Measure Frame
Questionn Minimum score is 9, maximum is 54.

58-64.
Palliative Medical record review for quantity of 3

Care use of any palliative care, any hospice, month
Utilization any chemotherapy, any radiotherapy, or s
(Chart any surgery. post-
Review) enroll
Plazo: 3 ment
meses
después
de la
inscripció
n

Review) enroll
Plazo: 6 ment
meses
después
de la
inscripció
n

Review) enroll
Plazo: 12 ment
meses
SUSCRIBIR

Measure Frame
después
de la
inscripció
n
Patient Each patient will the validated Time

Quality of "Functional Assessment of Cancer of
Life Using Therapy - General Survey (FACT-G), " enroll
the which is a 27-item survey with response ment
"Function options including: not at all, a little bit, to 3-
al somewhat, quite a bit, or very much. month
Assessme Five items also allow for a response of s
nt of 'prefer not to answer.' Scoring for the post-
Cancer FACT-G will be done in accordance with enroll
Therapy - the FACT-G Scoring Guidelines (Version ment
General 4), available here:
Survey" https://www.facit.org/measures-
Marco de scoring-downloads/fact-g-scoring-
tiempo: downloads . In summary, scoring is for
desde el four subscales included within the
momento survey, including (1) Physical Well-
de la Being (score range: 0-28), (2) Social
inscripció Family Well-Being (score range: 0-28),
n hasta (3) Emotional Well-Being (score range:
los 3 0-24), and (4) Functional Well-Being
meses (score range: 0-28). A total score is
posteriore created from the sum of the subscale
s a la scores and has a minimum of zero and
inscripció maximum of 108, where a higher score
n indicates greater quality of life. We will
measure the change in quality of life at
baseline to 3 months.
Patient Each patient will the validated 6

Quality of "Functional Assessment of Cancer month
Life Using Therapy - General Survey (FACT-G), " s
the which is a 27-item survey with response post-
"Function options including: not at all, a little bit, enroll
al somewhat, quite a bit, or very much. ment
Assessme Five items also allow for a response of
nt of 'prefer not to answer.' Scoring for the
Cancer FACT-G will be done in accordance with
SUSCRIBIR Therapy - the FACT-G Scoring Guidelines (Version

Measure Frame

Plazo: 6 scoring-downloads/fact-g-scoring-
meses downloads . In summary, scoring is for
después four subscales included within the
de la survey, including (1) Physical Well-
inscripció Being (score range: 0-28), (2) Social
n Family Well-Being (score range: 0-28),
(3) Emotional Well-Being (score range:
0-24), and (4) Functional Well-Being
(score range: 0-28). A total score is
created from the sum of the subscale
scores and has a minimum of zero and
maximum of 108, where a higher score
indicates greater quality of life. We will
Patient Each patient will the validated 12

Quality of "Functional Assessment of Cancer month
Life Using Therapy - General Survey (FACT-G), " s
the which is a 27-item survey with response post-
"Function options including: not at all, a little bit, enroll
al somewhat, quite a bit, or very much. ment
Assessme Five items also allow for a response of
nt of 'prefer not to answer.' Scoring for the
Cancer FACT-G will be done in accordance with
Therapy - the FACT-G Scoring Guidelines (Version
Plazo: 12 scoring-downloads/fact-g-scoring-
meses downloads . In summary, scoring is for
después four subscales included within the
de la survey, including (1) Physical Well-
inscripció Being (score range: 0-28), (2) Social
n Family Well-Being (score range: 0-28),
(3) Emotional Well-Being (score range:
0-24), and (4) Functional Well-Being
(score range: 0-28). A total score is
created from the sum of the subscale
scores and has a minimum of zero and
maximum of 108, where a higher score
SUSCRIBIR

Measure Frame
indicates greater quality of life. We will

Prognosis Patients will answer 4 multiple choice 6

& items to assess understanding of their month
Treatment prognosis and their treatment s
Preference preferences. These items are not part of post-
Plazo: 6 enroll
a named tool. They are adapted from
meses ment
the prognosis and treatment preference
después
items developed by Weeks et al. (1998).
de la
inscripció
n 1. Is your cancer curable? Response
options (ROs): Yes, No, I don't
know
2. How long do most patients with
your disease live on average? ROs:
Less than 6 months, 6 months - 2
years, More than 2 years, I don't
know
3. The goal of my cancer treatment is
to: (select all that apply) ROs: Cure
my disease, help me feel better,
extend my life, I don't know
4. Would you prefer a course of
treatment that focuses on
extending life as much as
possible, even if it means having
more pain and discomfort, or
would you want a plan of care that
focuses on relieving pain and
discomfort, even if that means not
living as long? ROs: Extend life as
much as possible, relieve pain or
discomfort as much as possible, I
don't know

Preference preferences. These items are not part of post-
SUSCRIBIR

Measure Frame
Plazo: 12 a named tool. They are adapted from enroll

meses the prognosis and treatment preference ment
después items developed by Weeks et al. (1998).
de la
inscripció 1. Is your cancer curable? Response
n options (ROs): Yes, No, I don't
know
know
don't know

Preference preferences. These items are not part ofpost-
Plazo: 3 enroll
a named tool. They are adapted from
meses ment
the prognosis and treatment preference
después
items developed by Weeks et al. (1998).
de la
inscripció
n 1. Is your cancer curable? Response
options (ROs): Yes, No, I don't
know
SUSCRIBIR

Measure Frame

know
don't know
Receipt of We will look at the percent of patients 12

Molecular with receipt of molecular tumor profile month
Profile and genomic testing (evidence-based s
and treatment) post-
Genomic enroll
Testing ment
Plazo: 12
meses
después
de la
inscripció
n
Emergenc Emergency Department Use for each 3

y patient will be abstracted by electronic month
Departme medical record chart review for each s
nt Visit patient at 3 months after enrollment. post-
(Chart enroll
Review) ment
Plazo: 3
meses
SUSCRIBIR después

Measure Frame
de la
inscripció
n

(Chart enroll
Review) ment
Plazo: 6
meses
después
de la
inscripció
n

(Chart enroll
Review) ment
Plazo: 12
meses
después
de la
inscripció
n
Hospitaliz Hospitalization use for each patient will 3

ation Visit be abstracted by electronic medical month
(Chart record chart review for each patient at 3 s
Review) months after enrollment. post-
Plazo: 3 enroll
meses ment
después
de la
inscripció
n

SUSCRIBIR s

Measure Frame
(Chart record chart review for each patient at 6 post-

Review) months after enrollment. enroll
Plazo: 6 ment
meses
después
de la
inscripció
n

(Chart record chart review for each patient at s
Review) 12 months after enrollment. post-
Plazo: 12 enroll
meses ment
después
de la
inscripció
n
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Collaborators and Investigators

This is where you will find people and organizations involved
with this study.
SPONSOR ?
SUSCRIBIR Stanford University
COLLABORATORS ?
California Initiative to Advance Precision Medicine

Pacific Cancer Care
The Latino Cancer Institute
Cancer Patients Alliance
Publications and helpful links

The person responsible for entering information about the
study voluntarily provides these publications. These may be
about anything related to the study.
GENERAL PUBLICATIONS
Holmes-Rovner M, Kroll J, Schmitt N, Rovner DR, Breer ML,
Rothert ML, Padonu G, Talarczyk G. Patient satisfaction with
health care decisions: the satisfaction with decision scale.
Med Decis Making. 1996 Jan-Mar;16(1):58-64. doi:
10.1177/0272989X9601600114.
Weeks JC, Cook EF, O'Day SJ, Peterson LM, Wenger N, Reding
D, Harrell FE, Kussin P, Dawson NV, Connors AF Jr, Lynn J,
Phillips RS. Relationship between cancer patients' predictions
of prognosis and their treatment preferences. JAMA. 1998 Jun
3;279(21):1709-14. doi: 10.1001/jama.279.21.1709. Erratum
In: JAMA 2000 Jan 12;283(2):203.
Davies G, Butow P, Napier CE, Bartley N, Juraskova I, Meiser B,
Ballinger ML, Thomas DM, Schlub TE, Best MC; members of
the PiGeOn Project. Advanced Cancer Patient Knowledge of
and Attitudes towards Tumor Molecular Profiling. Transl
Oncol. 2020 Sep;13(9):100799. doi:
10.1016/j.tranon.2020.100799. Epub 2020 May 22.
Rodriguez GM, Wood EH, Xiao L, Duron Y, O'Brien D, Koontz Z,
Rosas LG, Patel MI. Community health workers and precision
medicine: A randomized controlled trial. Contemp Clin Trials.
2022 Oct;121:106906. doi: 10.1016/j.cct.2022.106906. Epub
2022 Sep 6.
HELPFUL LINKS
Scoring Guide for FACT-G
Study record dates

These dates track the progress of study record and summary
SUSCRIBIR results submissions to ClinicalTrials.gov. Study records and
reported results are reviewed by the National Library of

Medicine (NLM) to make sure they meet specific quality
control standards before being posted on the public website.
Study Major Dates
STUDY START (ACTUAL) ?
May 3, 2021
PRIMARY COMPLETION (ANTICIPATED) ?
October 31, 2023
STUDY COMPLETION (ANTICIPATED) ?
October 31, 2024
Study Registration Dates
FIRST SUBMITTED ?
April 8, 2021
FIRST SUBMITTED THAT MET QC CRITERIA ?
April 8, 2021
FIRST POSTED (ACTUAL) ?
April 13, 2021
Study Record Updates
LAST UPDATE POSTED (ACTUAL) ?
January 27, 2023
LAST UPDATE SUBMITTED THAT MET QC CRITERIA ?
January 26, 2023
SUSCRIBIR
LAST VERIFIED ?
January 1, 2023
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More Information
Terms related to this study
KEYWORDS
palliative care
quality of care
Precision medicine
patient satisfaction
community health worker
cancer diagnosis
End-of-life
cancer treatment
Cancer care
lay health worker
tumor testing
OTHER STUDY ID NUMBERS ?
59885
OPR18113 (Other Grant/Funding Number: California Initiative
to Advance Precision Medicine)
SUSCRIBIR
Plan for Individual participant data (IPD)
PLAN TO SHARE INDIVIDUAL PARTICIPANT DATA (IPD)?
No
IPD PLAN DESCRIPTION
Study data will not be shared with researchers outside of this

project.
Drug and device information, study documents
STUDIES A U.S. FDA-REGULATED DRUG PRODUCT
No
STUDIES A U.S. FDA-REGULATED DEVICE PRODUCT
No
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This information was retrieved directly from the website

clinicaltrials.gov without any changes. If you have any requests to
change, remove or update your study details, please contact
register@clinicaltrials.gov. As soon as a change is implemented on
clinicaltrials.gov, this will be updated automatically on our website as
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Apoyo A Trabajadores de Salud Comunitarios en Cáncer y Tumores - Registro de Ensayos Clínicos - ICH GCP

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Apoyo A Trabajadores de Salud Comunitarios en Cáncer y Tumores - Registro de Ensayos Clínicos - ICH GCP

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3/11/23, 11:03 Apoyo a trabajadores de salud comunitarios en cáncer y tumores - Registro de ensayos clínicos - ICH GCP

Trabajadores de salud comunitarios

Reducción de las disparidades en el cáncer a través de una

El propósito de este ensayo controlado aleatorio es evaluar si

Descripción general del estudio

Comportamiento: Apoyo de los trabajadores de salud

El objetivo de este estudio es reducir las disparidades en el

Los investigadores buscan personas que se ajusten a una

EDADES ELEGIBLES PARA ESTUDIAR

18 años en adelante (Adulto, Adulto Mayor)

ACEPTA VOLUNTARIOS SALUDABLES

GÉNEROS ELEGIBLES PARA ESTUDIAR

Pacientes recién diagnosticados con diagnóstico de

Pacientes menores de 18 años.

Patients without a newly diagnosed malignancy or

How is the study designed?

Primary Purpose: Health Services Research

ARMS AND INTERVENTIONS

Participant Group / Arm ? Intervention / ?

No Intervention: Usual Oncology Care

Participant Group / Arm ? Intervention / ?

the following times: baseline, 3-months,

Experimental: Community Health Behavioral:

What is the study measuring?

PRIMARY OUTCOME MEASURES ?

Outcome Measure Description Time

Change in Using 7 multiple choice items Time of

Outcome Measure Description Time

Marco de question asks 'tumor testing is

Knowledge Using 7 multiple items 6-

Adapted from the following paper:

Outcome Measure Description Time

Profiling. Translational Oncology,

Knowledge Using 7 multiple items 12-

Adapted from the following paper:

SECONDARY OUTCOME MEASURES ?

Outcome Measure Description Time

Patient Each patient will receive a validated 3-

Outcome Measure Description Time

Plazo: 3 strongly with higher activation

Patient Each patient will receive a validated 6-

Outcome Measure Description Time

Control, level 4 Maintaining "Behaviors

Patient Each patient will receive a validated 12-

Patient Each patient will receive the validated 9- 3-

Outcome Measure Description Time

aire" Responses for each group will be

Patient Each patient will receive the validated 9- 6-

Patient Each patient will receive the validated 9- 12-

Outcome Measure Description Time

Questionn Minimum score is 9, maximum is 54.

Palliative Medical record review for quantity of 3

Palliative Medical record review for quantity of 6

Palliative Medical record review for quantity of 12

Outcome Measure Description Time

Patient Each patient will the validated Time

Patient Each patient will the validated 6

Outcome Measure Description Time

General 4), available here:

Patient Each patient will the validated 12

Outcome Measure Description Time

indicates greater quality of life. We will

Prognosis Patients will answer 4 multiple choice 6