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The goals of this clinical trial are to evaluate DECIDES, a web-based decision support application that provides education about cancer and cancer treatment and provides support to encourage adolescent and young adult (AYA) patients, their caregivers, and oncology health care providers to make informed decisions about cancer treatment together.
The main questions this study aims to answer are:
AYA and caregiver participants will complete a questionnaire and be randomly assigned to participate in one of three groups: (1) Usual Care, (2) DECIDES, or (3) DECIDES+. Participants in 'Usual Care' will continue to have access to their oncology health care team for questions related to cancer and cancer treatment, as per usual standard of care. Participants in both 'DECIDES' and 'DECIDES+' groups will receive access to DECIDES, and those in 'DECIDES+' will receive additional live, coach-assisted support. After 8 weeks, AYA and caregivers will complete a follow-up questionnaire and those in the 'DECIDES' and 'DECIDES+' groups will complete a semi-structured qualitative interview. Oncology clinicians of participating AYA will be invited to participate in a semi-structured qualitative interview. Researchers will compare groups to see if AYA and caregivers that receive access to DECIDES (with an informational handout vs. coach-assisted support) report more positive decision-making processes compared to those that receive standard of care.
DECIDES is a developmentally appropriate, engaging, and interactive web-based decision support application that has been designed to address health literacy and includes:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | Subjects will not receive the intervention and will only receive standard of care (i.e., subjects will access their health care team for decision support, per usual). | |
| DECIDES with Informational Handout (DECIDES) | Experimental | Subjects will receive access to the decision support intervention (DECIDES) along with an informational handout that includes goals of the decision support intervention and instructions for accessing the web-based application independently. |
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| DECIDES with Coach-Assisted Support (DECIDES+) | Experimental | Subjects will receive access to the decision support intervention (DECIDES) along with live coach-assisted support for accessing and navigating the web-based application. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decision Aid for Education and Support about Cancer Treatment (DECIDES Intervention) | Behavioral | DECIDES is a developmentally appropriate, engaging, and interactive web-based decision support intervention for AYA diagnosed with cancer (and their caregivers) that includes components written for low health literacy. Components include:
|
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of Decision Aid | This is a 12-item study-team developed measure used to obtain acceptability ratings from AYA and caregivers (that completed participation in DECIDES or DECIDES+). This measure is based on The Ottawa Hospital's measure of acceptability regarding comprehension of components of a decision aid, its length, pace, amount of information, balance in presentation of information about options, and overall suitability for decision-making. Items are rated on a 5-point Likert scale (1=strongly disagree to 5=strongly agree). The average across 12 items is calculated to produce a total score that ranges from 1-5. Higher scores reflect greater acceptability. Two items related to the DECIDES Coach are not answered by participants in DECIDES who did not have access to a coach. | 8 weeks post-randomization |
| Usability of Decision Aid | This is a 10-item scale collected from AYA and caregivers (that completed participation in DECIDES or DECIDES + coach) and oncology health care providers to measure perceptions of DECIDES usability. Items are rated on a 5-point Likert scale (1=strongly disagree to 5=strongly agree) and summed to produce a total score that ranges from 0 to 100. Scores are normalized to produce a percentile ranking. A score >80.3 reflects letter grade "A" (adjective rating "excellent"); 68-80.3 reflects letter grade "B" (adjective rating "good"), 68 reflects letter grade "C" (adjective rating "OK"); 51-67 reflects letter grade "D" (adjective rating "poor"); and <51 reflects letter grade "F" (adjective rating "awful"). | 8 weeks post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived Involvement in Shared Treatment Decision-Making Process | The SDM-Q-9 is a valid and reliable 9-item patient-reported questionnaire collected from AYA to measure their perceived involvement in the process of shared treatment decision-making with their oncology clinician. The physician version of the SDM-Q-9 (SDM-Q-Doc) was adapted for use with caregivers in this study to measure AYA involvement in shared decision-making with their oncology clinician, from the caregiver's perspective. Total scores range from 0 to 100. Higher scores reflect greater degree to which AYA were involved in a shared treatment decision-making process. |
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Adolescent and Young Adults (AYA)
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
Caregivers
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
Oncology Clinicians
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
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| Name | Affiliation | Role |
|---|---|---|
| Lamia Barakat, PhD | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40584145 | Derived | Barakat LP, Hammer SN, Wen Y, Anil A, Schwartz LA, Reilly A, Bagatell R, Schapira MM, Li Y, Deatrick JA. Evaluation of a Decision Support Intervention for Adolescents and Young Adults Newly Diagnosed with Cancer: A Pilot Randomized Trial. MDM Policy Pract. 2025 Jun 26;10(1):23814683251344624. doi: 10.1177/23814683251344624. eCollection 2025 Jan-Jun. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Subjects will not receive the intervention and will only receive standard of care (i.e., subjects will access their health care team for decision support, per usual). |
| FG001 | DECIDES With Informational Handout (DECIDES) | Subjects will receive access to the decision support intervention (DECIDES) along with an informational handout that includes goals of the decision support intervention and instructions for accessing the web-based application independently. |
| FG002 | DECIDES With Coach-Assisted Support (DECIDES+) | Subjects will receive access to the decision support intervention (DECIDES) along with live coach-assisted support for accessing and navigating the web-based application. |
| FG003 | Oncology Clinicians | Oncology Clinicians of participating AYA are not randomized to an intervention arm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
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| Allocation to Group |
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| Post-Intervention Assessment |
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| Post-Intervention Qualitative Interview |
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Subjects will not receive the intervention and will only receive standard of care (i.e., subjects will access their health care team for decision support, per usual). |
| BG001 | DECIDES With Informational Handout (DECIDES) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report). |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Acceptability of Decision Aid | This is a 12-item study-team developed measure used to obtain acceptability ratings from AYA and caregivers (that completed participation in DECIDES or DECIDES+). This measure is based on The Ottawa Hospital's measure of acceptability regarding comprehension of components of a decision aid, its length, pace, amount of information, balance in presentation of information about options, and overall suitability for decision-making. Items are rated on a 5-point Likert scale (1=strongly disagree to 5=strongly agree). The average across 12 items is calculated to produce a total score that ranges from 1-5. Higher scores reflect greater acceptability. Two items related to the DECIDES Coach are not answered by participants in DECIDES who did not have access to a coach. | NOTE. Measure was NOT administered to Usual Care group (per protocol). 13 participants were excluded from analyses including:
| Posted | Mean | Full Range | Average Score on a Scale | 8 weeks post-randomization |
Through study completion, an average of 6 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | Subjects will not receive the intervention and will only receive standard of care (i.e., subjects will access their health care team for decision support, per usual). |
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Oncology Clinicians were not randomized to an intervention arm and did not participate in the intervention. Oncology Clinicians were enrolled to review DECIDES (live) during a semi-structured qualitative interview held via videoconference. Oncology Clinicians completed a measure of usability (Systems Usability Scale) during the interview. No other data were collected from Oncology Clinicians, including demographic data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shannon Hammer | Children's Hospital of Philadelphia | 2678878580 | bresslers@chop.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 14, 2022 | Apr 5, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D003661 | Decision Support Techniques |
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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Family Units (AYA and caregiver participants) are randomized to one of three arms:
Oncology Clinicians of participating AYA are not randomized to an intervention arm; they are enrolled to complete a singular Qualitative Interview to provide feedback for future implementation.
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|
| 8 weeks post-randomization |
| Perceptions of Physician Engagement in Decision-Making Process | This is a 5-item scale that measures AYA and caregiver perceptions of the extent to which clinicians engaged in five key elements of the decision-making process (e.g., discuss the available options with you in a way you could understand?, encourage you to ask questions or express any concerns you had about the available options?, involve you as much as you wanted in the decision making process?). The overall physician style score ranges from 0-100. Higher scores reflect more optimal communication with physician. | 8 weeks post-randomization |
| Knowledge of Cancer Clinical Trials | This is a 25-item true/false questionnaire used to assess participant understanding of clinical trials and informed consent processes. Items are scored based on % correct, with higher scores reflecting more knowledge. | 8-weeks post randomization |
| Attitudes Toward Cancer Clinical Trials | This is a 35-item measure of AYA and caregiver attitudes toward clinical trials. Continuous scores were calculated from PRPQ items reflecting 'Perceived Benefits' (with a higher score suggesting positive attitudes) and from PRPQ items reflecting 'Perceived Barriers' (with a higher score suggesting negative attitudes). A 'Decision Balance' score was computed by converting the 'Perceived Benefits' and 'Perceived Barriers' scores to Z-scores, and then subtracting the 'Perceived Barriers Z-scores' from the 'Perceived Benefits Z-scores'. A 'Decision Balance' Z-score of 0 represents the population mean; a positive valence (3) reflects more positive attitudes to clinical trials and negative valence (-3) reflects more negative attitudes. | 8 weeks post-randomization |
| Uncertainty in Cancer Treatment Decision-Making Process | This is a valid and reliable 16-item scale collected from AYA and caregivers to measure uncertainty in making cancer treatment decisions, including factors that contribute to uncertainty about cancer treatment options and perceptions of effective decision-making. Total scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict). | 8 weeks post-randomization |
| Regret About Cancer Treatment Decision-Making Process | This is a valid and reliable 5-item scale collected from AYA and caregivers to measure distress or remorse about a cancer treatment decision. Total scores range from 0 (no regret) to 100 (high regret). | 8 weeks post-randomization |
| Satisfaction With Cancer Treatment Decision-Making Process | This is a valid and reliable 6-item scale collected from AYA and caregivers to measure satisfaction with the cancer treatment decision that was made. Total scores range from 6 to 30, with higher scores reflecting higher satisfaction. | 8 weeks post-randomization |
| Self-confidence in Cancer Treatment Decision-Making Abilities | This is a valid and reliable 11-item scale collected from AYA and caregivers to measure self-confidence in decision-making abilities. Total scores range from 0 (not confident) to 100 (extremely confident). | 8 weeks post-randomization |
| Started (AYA) | Count of AYA allocated to group. |
|
| Started (Caregivers) | Count of Caregivers allocated to group. |
|
| Completed (AYA) | Count of AYA that completed participation in group. |
|
| Completed (Caregivers) | Count of Caregivers that completed participation in group. |
|
| COMPLETED | Total count that completed participation in group |
|
| NOT COMPLETED |
|
|
| Started (AYA) | Count of post-intervention assessments administered to AYA |
|
| Started (Caregiver) | Count of post-intervention assessments administered to caregivers |
|
| Completed (AYA) | Count of post-intervention assessments completed by AYA |
|
| Completed (Caregiver) | Count of post-intervention assessments completed by caregivers |
|
| COMPLETED | Total count of post-intervention assessments completed |
|
| NOT COMPLETED |
|
|
| Started (AYA) | Count of AYA contacted to participate in qualitative interview |
|
| Started (Caregiver) | Count of Caregivers contacted to participate in qualitative interview |
|
| Completed (AYA) | Count of AYA that completed qualitative interview |
|
| Completed (Caregiver) | Count of Caregivers that completed qualitative interview |
|
| COMPLETED | Total count of participants that completed qualitative interview |
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| NOT COMPLETED |
|
|
Subjects will receive access to the decision support intervention (DECIDES) along with an informational handout that includes goals of the decision support intervention and instructions for accessing the web-based application independently.
| BG002 | DECIDES With Coach-Assisted Support (DECIDES+) | Subjects will receive access to the decision support intervention (DECIDES) along with live coach-assisted support for accessing and navigating the web-based application. |
| BG003 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report). | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report). | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report). | Count of Participants | Participants |
|
| Race (NIH/OMB) | Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report). | Count of Participants | Participants |
|
|
|
|
| Primary | Usability of Decision Aid | This is a 10-item scale collected from AYA and caregivers (that completed participation in DECIDES or DECIDES + coach) and oncology health care providers to measure perceptions of DECIDES usability. Items are rated on a 5-point Likert scale (1=strongly disagree to 5=strongly agree) and summed to produce a total score that ranges from 0 to 100. Scores are normalized to produce a percentile ranking. A score >80.3 reflects letter grade "A" (adjective rating "excellent"); 68-80.3 reflects letter grade "B" (adjective rating "good"), 68 reflects letter grade "C" (adjective rating "OK"); 51-67 reflects letter grade "D" (adjective rating "poor"); and <51 reflects letter grade "F" (adjective rating "awful"). | NOTE. Measure was NOT administered to Usual Care group (per protocol). Measure was administered to Oncology Clinicians during Interview. 14 participants were excluded from analyses including:
| Posted | Mean | Standard Deviation | Score on a scale | 8 weeks post-randomization |
|
|
|
| Secondary | Perceived Involvement in Shared Treatment Decision-Making Process | The SDM-Q-9 is a valid and reliable 9-item patient-reported questionnaire collected from AYA to measure their perceived involvement in the process of shared treatment decision-making with their oncology clinician. The physician version of the SDM-Q-9 (SDM-Q-Doc) was adapted for use with caregivers in this study to measure AYA involvement in shared decision-making with their oncology clinician, from the caregiver's perspective. Total scores range from 0 to 100. Higher scores reflect greater degree to which AYA were involved in a shared treatment decision-making process. | 12 participants were excluded from analyses including:
| Posted | Mean | Standard Deviation | score on a scale | 8 weeks post-randomization |
|
|
|
| Secondary | Perceptions of Physician Engagement in Decision-Making Process | This is a 5-item scale that measures AYA and caregiver perceptions of the extent to which clinicians engaged in five key elements of the decision-making process (e.g., discuss the available options with you in a way you could understand?, encourage you to ask questions or express any concerns you had about the available options?, involve you as much as you wanted in the decision making process?). The overall physician style score ranges from 0-100. Higher scores reflect more optimal communication with physician. | 12 participants were excluded from analyses including:
| Posted | Mean | Standard Deviation | Score on a scale | 8 weeks post-randomization |
|
|
|
| Secondary | Knowledge of Cancer Clinical Trials | This is a 25-item true/false questionnaire used to assess participant understanding of clinical trials and informed consent processes. Items are scored based on % correct, with higher scores reflecting more knowledge. | 12 participants were excluded from analyses including:
| Posted | Mean | Standard Deviation | Percent Correct | 8-weeks post randomization |
|
|
|
| Secondary | Attitudes Toward Cancer Clinical Trials | This is a 35-item measure of AYA and caregiver attitudes toward clinical trials. Continuous scores were calculated from PRPQ items reflecting 'Perceived Benefits' (with a higher score suggesting positive attitudes) and from PRPQ items reflecting 'Perceived Barriers' (with a higher score suggesting negative attitudes). A 'Decision Balance' score was computed by converting the 'Perceived Benefits' and 'Perceived Barriers' scores to Z-scores, and then subtracting the 'Perceived Barriers Z-scores' from the 'Perceived Benefits Z-scores'. A 'Decision Balance' Z-score of 0 represents the population mean; a positive valence (3) reflects more positive attitudes to clinical trials and negative valence (-3) reflects more negative attitudes. | 12 participants were excluded from analyses including:
| Posted | Mean | Standard Deviation | Z-Score | 8 weeks post-randomization |
|
|
|
| Secondary | Uncertainty in Cancer Treatment Decision-Making Process | This is a valid and reliable 16-item scale collected from AYA and caregivers to measure uncertainty in making cancer treatment decisions, including factors that contribute to uncertainty about cancer treatment options and perceptions of effective decision-making. Total scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict). | 12 participants were excluded from analyses including:
| Posted | Mean | Standard Deviation | Score on a scale | 8 weeks post-randomization |
|
|
|
| Secondary | Regret About Cancer Treatment Decision-Making Process | This is a valid and reliable 5-item scale collected from AYA and caregivers to measure distress or remorse about a cancer treatment decision. Total scores range from 0 (no regret) to 100 (high regret). | 12 participants were excluded from analyses including:
| Posted | Mean | Standard Deviation | Score on a scale | 8 weeks post-randomization |
|
|
|
| Secondary | Satisfaction With Cancer Treatment Decision-Making Process | This is a valid and reliable 6-item scale collected from AYA and caregivers to measure satisfaction with the cancer treatment decision that was made. Total scores range from 6 to 30, with higher scores reflecting higher satisfaction. | 12 participants were excluded from analyses including:
| Posted | Mean | Standard Deviation | Score on a scale | 8 weeks post-randomization |
|
|
|
| Secondary | Self-confidence in Cancer Treatment Decision-Making Abilities | This is a valid and reliable 11-item scale collected from AYA and caregivers to measure self-confidence in decision-making abilities. Total scores range from 0 (not confident) to 100 (extremely confident). | 12 participants were excluded from analyses including:
| Posted | Mean | Standard Deviation | Score on a scale | 8 weeks post-randomization |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | DECIDES With Informational Handout (DECIDES) | Subjects will receive access to the decision support intervention (DECIDES) along with an informational handout that includes goals of the decision support intervention and instructions for accessing the web-based application independently. | 0 | 35 | 0 | 35 | 0 | 35 |
| EG002 | DECIDES With Coach-Assisted Support (DECIDES+) | Subjects will receive access to the decision support intervention (DECIDES) along with live coach-assisted support for accessing and navigating the web-based application. | 0 | 41 | 0 | 41 | 0 | 41 |
| EG003 | Oncology Clinicians | Oncology Clinicians of participating AYA are not randomized to an intervention arm. | 0 | 13 | 0 | 13 | 0 | 13 |
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| Between 18 and 65 years |
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| >=65 years |
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| Title | Measurements |
|---|---|
| <=18 years |
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| Between 18 and 65 years |
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| >=65 years |
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| Title | Measurements |
|---|---|
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| Male |
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| Title | Measurements |
|---|---|
| Female |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Title | Measurements |
|---|---|
| Hispanic or Latino |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Title | Measurements |
|---|---|
| American Indian or Alaska Native |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Caregivers |
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| Oncology Clinicians |
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| Caregivers |
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| Caregivers |
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| Caregivers |
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| Caregivers: Decision Balance |
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| Caregivers |
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| Caregivers |
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| Caregivers |
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| Caregivers |
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