Trial Outcomes & Findings for EL CENTRO: Engaging Latinos in the Center of Cancer Treatment Options (NCT NCT03602885)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

8-12 weeks

Results posted on

2022-01-11

Participant Flow

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

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	5	5
Overall Study COMPLETED	2	5
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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
Overall Study Lost to Follow-up	3	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chemotherapy Education Intervention Arm n=5 Participants 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	Usual Chemotherapy Education Arm n=5 Participants 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	Total n=10 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Chemotherapy Education Intervention Arm n=2 Participants 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	Usual Chemotherapy Education Arm n=5 Participants 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
Number of Participants With Accurate Understanding of Chemotherapy Benefits at 8-12 Weeks	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 2 weeks

Population: participants who completed the 2-week survey

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.

Outcome measures

Outcome measures
Measure	Chemotherapy Education Intervention Arm n=3 Participants 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	Usual Chemotherapy Education Arm n=5 Participants 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
Understanding of Chemotherapy Risks	0 Participants	3 Participants

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	Chemotherapy Education Intervention Arm n=3 Participants 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	Usual Chemotherapy Education Arm n=5 Participants 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
Communication Satisfaction as Measured by 5 Items From the CAHPS Cancer Care Survey	90 score on a scale Standard Deviation 17.3	99 score on a scale Standard Deviation 2.24

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	Chemotherapy Education Intervention Arm n=3 Participants 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	Usual Chemotherapy Education Arm n=1 Participants 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
Satisfaction With Chemotherapy Educational Materials Assessed on a 5-point Likert Scale.	4 score on a scale Standard Deviation 0	3 score on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: 2 weeks

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.

Outcome measures

Outcome measures
Measure	Chemotherapy Education Intervention Arm n=3 Participants 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	Usual Chemotherapy Education Arm n=5 Participants 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
Decisional Conflict as Measured by the 4-item SURE	3.67 score on a scale Standard Deviation .58	3.8 score on a scale Standard Deviation .45

SECONDARY outcome

Timeframe: 2 weeks

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.

Outcome measures

Outcome measures
Measure	Chemotherapy Education Intervention Arm n=3 Participants 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	Usual Chemotherapy Education Arm n=5 Participants 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
Achievement of Preferred Role in Treatment Decision Making Process, as Measured by Degner's Control Preferences Scale	2 Participants	3 Participants

SECONDARY outcome

Timeframe: 3 months

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.

Outcome measures

Outcome measures
Measure	Chemotherapy Education Intervention Arm n=2 Participants 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	Usual Chemotherapy Education Arm n=5 Participants 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
Decisional Regret	15 score on a scale Standard Deviation 7	7 score on a scale Standard Deviation 11

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	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	Usual Chemotherapy Education Arm n=5 Participants 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
Discussions About End-of-life Care Preferences With Healthcare Proxy and Care Team	0 Participants	5 Participants

Adverse Events

Chemotherapy Education Intervention Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Usual Chemotherapy Education Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Andrea Enzinger, MD

DFCI

Phone: 617-582-7335

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place