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EL CENTRO: Engaging Latinos in the Center of Cancer Treatment Options

EL CENTRO: Engaging Latinos in the Center of Cancer Treatment Options - RCT of Usual Chemotherapy Educational Tools Versus Investigational Chemotherapy Educational Tools

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03602885
Enrollment
10
Registered
2018-07-27
Start date
2018-09-01
Completion date
2020-11-27
Last updated
2022-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Colorectal Cancer, Metastatic Pancreatic Cancer, Unresectable Pancreatic Cancer

Keywords

Gastrointestinal Cancer, cancer, palliative, chemotherapy, metastatic, colorectal, pancreatic, communication, informed consent, video, education, oncology, patient-centered, outcomes research

Brief summary

The objective of this study is to improve the chemotherapy decision making process for Latinos with advanced gastrointestinal cancers. In this study Latinos who are considering 1st line chemotherapy for newly diagnosed advanced colorectal or pancreatic cancer will be randomized to usual care or to usual care supplemented by a Spanish/English language multimedia chemotherapy educational intervention. Primary informal caregivers will also be invited to participate. This research study is evaluating if a new set of educational materials will improve the treatment decision-making process for Latinos with advanced gastrointestinal cancers. This research study will involve about 154 patients and 154 caregivers.

Detailed description

There is growing evidence of racial/ethnic disparities in the quality of communication between oncologists and Latinos with cancer. These communication disparities are evidenced by gaps in Latino's understanding of their condition and treatment options, and by worse satisfaction with provider communication. Limited English proficiency and health literacy are very common among Latinos, yet few interventions have been developed to help Latino cancer patients better understand their condition and treatment options. In this study the investigators have partnered with Latino patients, providers, and researchers to develop a Spanish/English language intervention aimed at better informing Latinos with advanced gastrointestinal cancers about the risks and benefits of their chemotherapy options. Specifically, the intervention consists of a dual language, regimen-specific suite of videos and booklets explaining the most common chemotherapy options used to treat advanced colorectal cancer and advanced pancreatic cancer. The videos feature Latino patients describing their experiences on treatment, as well as clinicians describing factual information about treatment risks, benefits, and alternatives. In this study, self-identifying Hispanic/Latino patients with metastatic colorectal cancer, locally advanced and metastatic pancreatic cancer considering treatment with first line chemotherapy will be randomized to the usual care, or to usual care supplemented by access to the relevant chemotherapy educational materials. Caregivers will also be enrolled on the study. Participants will be surveyed at baseline, 2-weeks post-treatment initiation, 2-3 months post-treatment initiation, and 4-6 months post-treatment initiation regarding their understanding of chemotherapy risks and benefits, decisional conflict, and other metrics of informed decision-making.

Interventions

BEHAVIORALUsual chemotherapy education (CE)

Standard chemo education will given per hospital guideline

BEHAVIORALChemotherapy education intervention (CEI)

Video, booklet, and website educational materials

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Dana-Farber Cancer Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patient Inclusion Criteria: * Self-identify as Hispanic/Latino * Has been diagnosed with metastatic colorectal cancer (mCRC) OR locally advanced pancreatic cancer (LAPC) OR metastatic pancreatic cancer (mPC) AND is making a decision regarding treatment with 1st line palliative chemotherapy * Treating oncologist has recommended consideration of one or more of the regimens for which we have developed chemotherapy educational (CEI) toolkits * For mCRC: FOLFOX, FOLFOX + bevacizumab, FOLFIRI, FOLFIRI + bevacizumab * For LAPC or mPC: FOLFIRINOX, Gemcitabine, or Gemcitabine + nab-paclitaxel * Patients who are also considering treatment on a clinical trial of one of these regimens +/- an investigational agent would still be eligible, so long as the treating MD believes to the content of the CEI to be relevant to the trial regimen. * Planning to receive treatment at the enrolling site * Age ≥ 21 * English or Spanish proficient Caregiver Inclusion Criteria: * Caregivers of eligible patient participants * Age ≥ 21 * English or Spanish proficient

Exclusion criteria

* For mCRC patients: Patients with oligometastatic disease who have a definitive plan for curative surgical resection are not eligible. * Significant delirium/dementia as judged by the treating oncologist

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Accurate Understanding of Chemotherapy Benefits at 8-12 Weeks8-12 weeksParticipants were asked how likely they thought chemotherapy was to cure their cancer (response options: very likely, somewhat likely, a little likely, not at all likely, don't know). Not at all likely is considered accurate, all other responses are considered inaccurate.

Secondary

MeasureTime frameDescription
Understanding of Chemotherapy Risks2 weeksParticipants will be asked to rate the likelihood that they would experience specific side effects as a result of the chemotherapy under consideration (fatigue, nausea/vomiting, neuropathy, myalgias/arthralgias, hair loss, diarrhea). Patients' responses will be correlated to the known side effect profile of their chemotherapy regimen. Participants who are accurate on all questions will be considered to have accurate knowledge.
Communication Satisfaction as Measured by 5 Items From the CAHPS Cancer Care Survey2 weeksCommunication satisfaction: will be assessed by five communication satisfaction items from the cancer specific version of the Consumer Assessment for Health Providers and Systems (CAHPS): How often did your doctors...listen carefully to you, explain things in a way you could understand, give you as much information as you wanted about your cancer treatments, encourage you to ask all the questions you had, and treat you with courtesy and respect? Options: always, usually, sometimes, or never. Patient responses will be summed, with possible score of 0-100 (with higher scores indicating better communication). Patients will complete this assessment at the post-decision and 3-month survey, but our primary analysis for this outcome will consider the post-decision assessment because it is most proximate to chemotherapy decision-making and exposure to the intervention.
Satisfaction With Chemotherapy Educational Materials Assessed on a 5-point Likert Scale.2 weeksAt the post-decision assessment, patients in the intervention arm will be asked to rate their satisfaction with the investigational chemotherapy educational materials with the following item: Please think about the booklet, video, and website together. How would you rate them as a whole? with response options on a 5-point likert scale where higher scores indicate greater satisfaction. (range: 1-5, 5 is best) Patients could alternatively choose don't know, or I did not review them. Patients in the control arm will be asked to rate chemotherapy educational materials they were given with the same response options.
Discussions About End-of-life Care Preferences With Healthcare Proxy and Care Team3 monthsAt 8-12 weeks and 6 months, patients will indicate whether they have designated a healthcare proxy, or discussed end-of-life wishes with their physicians or proxy.
Achievement of Preferred Role in Treatment Decision Making Process, as Measured by Degner's Control Preferences Scale2 weeksWhether patients achieved their preferred role in decision-making will be assessed by the two-item Degner's Control Preferences Scale (CPS) which assesses and compares patients' preferred role (baseline) and achieved role (post-decision) decision-making. At baseline patients are asked so select among 5 options their preferred decision-making role - with two options representing an active role, two representing a passive role, and one representing shared decision-making. At post-decision, patients indicate what role they played in their treatment decision, with 5 similarly worded options representing active, passive, or shared decision-making. Patients whose preferred decision-making role (passive, shared, or active) matches their achieved role (passive, shared, or active) will be considered to have achieved their preferred role in their treatment decision.
Decisional Regret3 monthsPatient decisional regret will be assessed with Brehaut's 5-item Decisional Regret Scale. In this scale patients respond to a series of 5 questions about their recent treatment decision, with response options ranging from 1 (strongly agree) to 5 (strongly agree) on a 5-point likert scale. Two items are reverse-code, averaged, and converted to a 0-100 scale by subtracting 1 and multiplying by 25. A score of 100 indicates maximal regret.
Decisional Conflict as Measured by the 4-item SURE2 weeksDecisional conflict will be assessed by the SURE test of Legare et al, which includes 4 items assessing whether patients feel (yes/no) 1) sure of their decision, 2) understand benefits and risks of each option, 3) are clear about which risks and benefits matter most to them, and 4) if they have enough support for the decision. Scores range from 0-4, with lower scores indicating more decisional conflict. Scores of 3 or less are considered positive for the presence of decisional conflict.

Countries

United States

Participant flow

Recruitment details

At the time of study closure, 5 participants were enrolled to usual care, 5 to the intervention arm.

Participants by arm

ArmCount
Chemotherapy Education Intervention Arm
Patients randomized to the chemotherapy education intervention (CEI) arm will be given regimen specific written and video chemotherapy educational materials developed by the study team. The treating oncologist will identify which chemotherapy regimen(s) are being considered, in order to select the appropriate chemotherapy educational tool(s) to give the patient. The patient may be given more than one CEI tool if they are considering more than one regimen. Patients randomized to the intervention arm may receive the intervention in addition to OR in place of the standard institutionally approved chemotherapy information sheets (both are acceptable); this is at the discretion of the treating site or the treating physician. Chemotherapy education intervention (CEI): Video, booklet, and website educational materials
5
Usual Chemotherapy Education Arm
Patients randomized to the usual chemotherapy education (CE) arm will undergo the standard institutional practice of chemotherapy education. The oncologist may also choose to give the patient the institutionally approved chemotherapy information sheets according to site-specific policies and clinical practice. Usual chemotherapy education (CE): Standard chemo education will given per hospital guideline
5
Total10

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up30

Baseline characteristics

CharacteristicChemotherapy Education Intervention ArmUsual Chemotherapy Education ArmTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
5 Participants5 Participants10 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
5 Participants4 Participants9 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants1 Participants1 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Sex: Female, Male
Female
2 Participants3 Participants5 Participants
Sex: Female, Male
Male
3 Participants2 Participants5 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
1 / 53 / 5
other
Total, other adverse events
0 / 50 / 5
serious
Total, serious adverse events
0 / 50 / 5

Outcome results

Primary

Number of Participants With Accurate Understanding of Chemotherapy Benefits at 8-12 Weeks

Participants were asked how likely they thought chemotherapy was to cure their cancer (response options: very likely, somewhat likely, a little likely, not at all likely, don't know). Not at all likely is considered accurate, all other responses are considered inaccurate.

Time frame: 8-12 weeks

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Chemotherapy Education Intervention ArmNumber of Participants With Accurate Understanding of Chemotherapy Benefits at 8-12 Weeks0 Participants
Usual Chemotherapy Education ArmNumber of Participants With Accurate Understanding of Chemotherapy Benefits at 8-12 Weeks0 Participants
Secondary

Achievement of Preferred Role in Treatment Decision Making Process, as Measured by Degner's Control Preferences Scale

Whether patients achieved their preferred role in decision-making will be assessed by the two-item Degner's Control Preferences Scale (CPS) which assesses and compares patients' preferred role (baseline) and achieved role (post-decision) decision-making. At baseline patients are asked so select among 5 options their preferred decision-making role - with two options representing an active role, two representing a passive role, and one representing shared decision-making. At post-decision, patients indicate what role they played in their treatment decision, with 5 similarly worded options representing active, passive, or shared decision-making. Patients whose preferred decision-making role (passive, shared, or active) matches their achieved role (passive, shared, or active) will be considered to have achieved their preferred role in their treatment decision.

Time frame: 2 weeks

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Chemotherapy Education Intervention ArmAchievement of Preferred Role in Treatment Decision Making Process, as Measured by Degner's Control Preferences Scale2 Participants
Usual Chemotherapy Education ArmAchievement of Preferred Role in Treatment Decision Making Process, as Measured by Degner's Control Preferences Scale3 Participants
Secondary

Communication Satisfaction as Measured by 5 Items From the CAHPS Cancer Care Survey

Communication satisfaction: will be assessed by five communication satisfaction items from the cancer specific version of the Consumer Assessment for Health Providers and Systems (CAHPS): How often did your doctors...listen carefully to you, explain things in a way you could understand, give you as much information as you wanted about your cancer treatments, encourage you to ask all the questions you had, and treat you with courtesy and respect? Options: always, usually, sometimes, or never. Patient responses will be summed, with possible score of 0-100 (with higher scores indicating better communication). Patients will complete this assessment at the post-decision and 3-month survey, but our primary analysis for this outcome will consider the post-decision assessment because it is most proximate to chemotherapy decision-making and exposure to the intervention.

Time frame: 2 weeks

Population: Results are reported among the 5 patients in the usual care arm and 3 patients in the intervention arm that responded to this item on the 2-week survey

ArmMeasureValue (MEAN)Dispersion
Chemotherapy Education Intervention ArmCommunication Satisfaction as Measured by 5 Items From the CAHPS Cancer Care Survey90 score on a scaleStandard Deviation 17.3
Usual Chemotherapy Education ArmCommunication Satisfaction as Measured by 5 Items From the CAHPS Cancer Care Survey99 score on a scaleStandard Deviation 2.24
Secondary

Decisional Conflict as Measured by the 4-item SURE

Decisional conflict will be assessed by the SURE test of Legare et al, which includes 4 items assessing whether patients feel (yes/no) 1) sure of their decision, 2) understand benefits and risks of each option, 3) are clear about which risks and benefits matter most to them, and 4) if they have enough support for the decision. Scores range from 0-4, with lower scores indicating more decisional conflict. Scores of 3 or less are considered positive for the presence of decisional conflict.

Time frame: 2 weeks

ArmMeasureValue (MEAN)Dispersion
Chemotherapy Education Intervention ArmDecisional Conflict as Measured by the 4-item SURE3.67 score on a scaleStandard Deviation 0.58
Usual Chemotherapy Education ArmDecisional Conflict as Measured by the 4-item SURE3.8 score on a scaleStandard Deviation 0.45
Secondary

Decisional Regret

Patient decisional regret will be assessed with Brehaut's 5-item Decisional Regret Scale. In this scale patients respond to a series of 5 questions about their recent treatment decision, with response options ranging from 1 (strongly agree) to 5 (strongly agree) on a 5-point likert scale. Two items are reverse-code, averaged, and converted to a 0-100 scale by subtracting 1 and multiplying by 25. A score of 100 indicates maximal regret.

Time frame: 3 months

ArmMeasureValue (MEAN)Dispersion
Chemotherapy Education Intervention ArmDecisional Regret15 score on a scaleStandard Deviation 7
Usual Chemotherapy Education ArmDecisional Regret7 score on a scaleStandard Deviation 11
Secondary

Discussions About End-of-life Care Preferences With Healthcare Proxy and Care Team

At 8-12 weeks and 6 months, patients will indicate whether they have designated a healthcare proxy, or discussed end-of-life wishes with their physicians or proxy.

Time frame: 3 months

Population: of the 2 patients in the intervention arm who completed the 3-month survey, neither had appointed a healthcare proxy; therefore, this question was skipped

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Chemotherapy Education Intervention ArmDiscussions About End-of-life Care Preferences With Healthcare Proxy and Care Team0 Participants
Usual Chemotherapy Education ArmDiscussions About End-of-life Care Preferences With Healthcare Proxy and Care Team5 Participants
Secondary

Satisfaction With Chemotherapy Educational Materials Assessed on a 5-point Likert Scale.

At the post-decision assessment, patients in the intervention arm will be asked to rate their satisfaction with the investigational chemotherapy educational materials with the following item: Please think about the booklet, video, and website together. How would you rate them as a whole? with response options on a 5-point likert scale where higher scores indicate greater satisfaction. (range: 1-5, 5 is best) Patients could alternatively choose don't know, or I did not review them. Patients in the control arm will be asked to rate chemotherapy educational materials they were given with the same response options.

Time frame: 2 weeks

Population: Analysis population includes participants who responded to this item on the 2-week survey. Of note, only 1 out of the 5 usual care participants responded to this question (presumably because they did not recall receiving any educational materials). 3 out of the 3 2-week survey respondents on the intervention arm responded to this item. The 3 reported satisfaction scores in the intervention arm were identical, hence a standard deviation of 0

ArmMeasureValue (MEAN)Dispersion
Chemotherapy Education Intervention ArmSatisfaction With Chemotherapy Educational Materials Assessed on a 5-point Likert Scale.4 score on a scaleStandard Deviation 0
Usual Chemotherapy Education ArmSatisfaction With Chemotherapy Educational Materials Assessed on a 5-point Likert Scale.3 score on a scaleStandard Deviation 0
Secondary

Understanding of Chemotherapy Risks

Participants will be asked to rate the likelihood that they would experience specific side effects as a result of the chemotherapy under consideration (fatigue, nausea/vomiting, neuropathy, myalgias/arthralgias, hair loss, diarrhea). Patients' responses will be correlated to the known side effect profile of their chemotherapy regimen. Participants who are accurate on all questions will be considered to have accurate knowledge.

Time frame: 2 weeks

Population: participants who completed the 2-week survey

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Chemotherapy Education Intervention ArmUnderstanding of Chemotherapy Risks0 Participants
Usual Chemotherapy Education ArmUnderstanding of Chemotherapy Risks3 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026