Cancer
Conditions
Keywords
Cancer, Clinical trials, Informed consent, Health literacy
Brief summary
This study will update an existing health literacy intervention (decision aid) for informed consent procedures and then conduct a randomized experiment implementing the health literacy intervention at Siteman Cancer Center and evaluate its effectiveness compared to usual care. Our hypothesis is that implementing the targeted, web-based decision aid (DA) in addition to usual care will increase knowledge about cancer clinical trials. Secondary outcomes include patients' ability to communicate with health care providers about trials, willingness to participate in trials, and enrollment rates for minority participants.
Detailed description
A previously developed and pilot tested web-based decision aid (DA) based on best practices in health literacy that is well received by minority participants and significantly improved knowledge about cancer clinical trials and decision self-efficacy will be used. This study will expand the reach of the DA and test it in a larger study in a different geographic region and center (Siteman Cancer Center). An additional benefit of conducting this work at Siteman Cancer Center is that Siteman and the Program for the Elimination of Cancer Disparities (PECaD) already institute structural changes at the system level to improve minority participation in trials. This study will activate and educate patients and will complement the system-level interventions. By random 1:1 assignment, 180 participants will either receive: \*Targeted, web-based decision aid (DA) about participating in cancer clinical trials. or \*Usual care/control-Access to the Siteman Cancer Center website about clinical trials. Outcomes from the DA group will be compared to outcomes in a usual care/control group.
Interventions
BEHAVIORALDecision Aid (DA)
Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of clinical trials in addition to usual care.
Sponsors
University of Miami
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with cancer in the past 6 months * English speaking * At least 18 years old
Exclusion criteria
* Past participation in a clinical trial for treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knowledge About Cancer Clinical Trials | 1 day (Immediately following either showing the participant the experimental or control information (same day) | A questionnaire will be administered to assess outcomes of interest immediately after showing the participant either the decision aid (DA) about clinical trials or the Siteman Cancer Center website about clinical trials. The questionnaire will include eleven knowledge items such as Only very sick patients are asked to take part in a cancer research study and Cancer research studies almost never involve the use of a placebo or sugar pill alone. Participants will indicate each item as True, False, or I don't know. An overall knowledge composite score will be created with the average percentage of items participants in each condition correctly answer. Participation in study concludes upon completion of questionnaire. |
| Clarity of Values | 1 day (Immediately following either showing the participant the experimental or control information (same day) | A questionnaire will be administered to assess outcomes of interest immediately after showing the participant either the decision aid (DA) about clinical trials or the Siteman Cancer Center website about clinical trials. The questionnaire will include the Values Clarity Subscale to evaluate decisional conflict. The subscale includes two items from the ten-item Low Literacy Decisional Conflict Scale, each with three response categories. The combined score on the two items will be divided by 2 and multiplied by 25 to produce an overall values clarity score from 0 to 100. Higher values represent less clarity. Participation in study concludes upon completion of questionnaire. |
| Uncertainty in Choice | 1 day Immediately following either showing the participant the experimental or control information (same day) | A questionnaire will be administered to assess outcomes of interest immediately after showing the participant either the decision aid (DA) about clinical trials or the Siteman Cancer Center website about clinical trials. The questionnaire will include the Uncertainty Subscale to evaluate decisional conflict. The subscale includes two items from the ten-item Low Literacy Decisional Conflict Scale, each with three response categories. The combined score on the two items will be divided by 2 and multiplied by 25 to produce an overall uncertainty score from 0 to 100. Higher values represent more uncertainty. Participation in study concludes upon completion of questionnaire. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-efficacy for Communicating About Cancer Clinical Trials | 1 day (Immediately following either showing the participant the experimental or control information (same day) | A questionnaire will be administered to assess outcomes of interest immediately after showing the participant either the decision aid (DA) about clinical trials or the Siteman Cancer Center website about clinical trials. The questionnaire will include an item in which participants rank their self-efficacy for finding information about cancer clinical trials on a 5-point scale with higher numbers indicating greater self-efficacy. Participation in study concludes upon completion of questionnaire. |
| Attitudes About Cancer Clinical Trials | 1 day (Immediately following either showing the participant the experimental or control information (same day) | A questionnaire will be administered to assess outcomes of interest immediately after showing the participant either the decision aid (DA) about clinical trials or the Siteman Cancer Center website about clinical trials. The questionnaire will include two items in which participants rank their intent to participate in a cancer clinical trial and their intent to encourage others to participate in a cancer clinical trial on a 5-point scale with higher numbers indicating greater intent. Participation in study concludes upon completion of questionnaire. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Decision Aid (DA) The decision aid (DA) will be provided to patients randomized to the experimental/intervention group.
Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of clinical trials in addition to usual care. | 86 |
| Control Participants randomized to the control group will receive usual care and will be shown Siteman Cancer Center website about clinical trials. | 89 |
| Total | 175 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 7 | 5 |
| Overall Study | Screening Failure | 2 | 0 |
| Overall Study | Withdrawal by Subject | 6 | 6 |
Baseline characteristics
| Characteristic | Control | Total | Decision Aid (DA) |
|---|---|---|---|
| Age, Continuous | 53.88 years STANDARD_DEVIATION 12.05 | 54.83 years STANDARD_DEVIATION 12.16 | 55.81 years STANDARD_DEVIATION 12.26 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 4 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 86 Participants | 171 Participants | 85 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants | 35 Participants | 17 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 66 Participants | 130 Participants | 64 Participants |
| Rapid Estimate of Adult Literacy in Medicine-SF (REALM-SF) Adequate | 66 participants | 127 participants | 61 participants |
| Rapid Estimate of Adult Literacy in Medicine-SF (REALM-SF) Inadequate | 5 participants | 10 participants | 5 participants |
| Rapid Estimate of Adult Literacy in Medicine-SF (REALM-SF) Marginal | 13 participants | 33 participants | 20 participants |
| Sex: Female, Male Female | 68 Participants | 132 Participants | 64 Participants |
| Sex: Female, Male Male | 21 Participants | 43 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Clarity of Values
A questionnaire will be administered to assess outcomes of interest immediately after showing the participant either the decision aid (DA) about clinical trials or the Siteman Cancer Center website about clinical trials. The questionnaire will include the Values Clarity Subscale to evaluate decisional conflict. The subscale includes two items from the ten-item Low Literacy Decisional Conflict Scale, each with three response categories. The combined score on the two items will be divided by 2 and multiplied by 25 to produce an overall values clarity score from 0 to 100. Higher values represent less clarity. Participation in study concludes upon completion of questionnaire.
Time frame: 1 day (Immediately following either showing the participant the experimental or control information (same day)
Population: Analysis is represented as mean (standard deviation) of calculated values clarity.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Decision Aid (DA) | Clarity of Values | 16.6 units on a scale of 0 to 100 | Standard Deviation 27 |
| Control | Clarity of Values | 33 units on a scale of 0 to 100 | Standard Deviation 36.5 |
Primary
Knowledge About Cancer Clinical Trials
A questionnaire will be administered to assess outcomes of interest immediately after showing the participant either the decision aid (DA) about clinical trials or the Siteman Cancer Center website about clinical trials. The questionnaire will include eleven knowledge items such as Only very sick patients are asked to take part in a cancer research study and Cancer research studies almost never involve the use of a placebo or sugar pill alone. Participants will indicate each item as True, False, or I don't know. An overall knowledge composite score will be created with the average percentage of items participants in each condition correctly answer. Participation in study concludes upon completion of questionnaire.
Time frame: 1 day (Immediately following either showing the participant the experimental or control information (same day)
Population: Analysis is represented as mean (standard deviation) of percentage of knowledge questions answered correctly.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Decision Aid (DA) | Knowledge About Cancer Clinical Trials | 73.4 percentage questions answered correctly | Standard Deviation 21.6 |
| Control | Knowledge About Cancer Clinical Trials | 61.6 percentage questions answered correctly | Standard Deviation 18.8 |
Primary
Uncertainty in Choice
A questionnaire will be administered to assess outcomes of interest immediately after showing the participant either the decision aid (DA) about clinical trials or the Siteman Cancer Center website about clinical trials. The questionnaire will include the Uncertainty Subscale to evaluate decisional conflict. The subscale includes two items from the ten-item Low Literacy Decisional Conflict Scale, each with three response categories. The combined score on the two items will be divided by 2 and multiplied by 25 to produce an overall uncertainty score from 0 to 100. Higher values represent more uncertainty. Participation in study concludes upon completion of questionnaire.
Time frame: 1 day Immediately following either showing the participant the experimental or control information (same day)
Population: Analysis is represented as mean (standard deviation) of calculated uncertainty.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Decision Aid (DA) | Uncertainty in Choice | 23 units on a scale of 0 to 100 | Standard Deviation 30.3 |
| Control | Uncertainty in Choice | 33.2 units on a scale of 0 to 100 | Standard Deviation 33.2 |
Secondary
Attitudes About Cancer Clinical Trials
A questionnaire will be administered to assess outcomes of interest immediately after showing the participant either the decision aid (DA) about clinical trials or the Siteman Cancer Center website about clinical trials. The questionnaire will include two items in which participants rank their intent to participate in a cancer clinical trial and their intent to encourage others to participate in a cancer clinical trial on a 5-point scale with higher numbers indicating greater intent. Participation in study concludes upon completion of questionnaire.
Time frame: 1 day (Immediately following either showing the participant the experimental or control information (same day)
Population: Analysis is represented as mean (standard deviation) of participant-reported intent.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Decision Aid (DA) | Attitudes About Cancer Clinical Trials | Intent to Participate | 3.8 units on a scale of 1 to 5 | Standard Deviation 1.1 |
| Decision Aid (DA) | Attitudes About Cancer Clinical Trials | Intent to Encourage Others to Particpate | 3.7 units on a scale of 1 to 5 | Standard Deviation 1.1 |
| Control | Attitudes About Cancer Clinical Trials | Intent to Participate | 3.8 units on a scale of 1 to 5 | Standard Deviation 1.1 |
| Control | Attitudes About Cancer Clinical Trials | Intent to Encourage Others to Particpate | 3.7 units on a scale of 1 to 5 | Standard Deviation 1 |
Secondary
Self-efficacy for Communicating About Cancer Clinical Trials
A questionnaire will be administered to assess outcomes of interest immediately after showing the participant either the decision aid (DA) about clinical trials or the Siteman Cancer Center website about clinical trials. The questionnaire will include an item in which participants rank their self-efficacy for finding information about cancer clinical trials on a 5-point scale with higher numbers indicating greater self-efficacy. Participation in study concludes upon completion of questionnaire.
Time frame: 1 day (Immediately following either showing the participant the experimental or control information (same day)
Population: Analysis is represented as mean (standard deviation) of participant-reported self-efficacy for finding information about cancer clinical trials.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Decision Aid (DA) | Self-efficacy for Communicating About Cancer Clinical Trials | 4.1 units on a scale of 1 to 5 | Standard Deviation 1 |
| Control | Self-efficacy for Communicating About Cancer Clinical Trials | 3.5 units on a scale of 1 to 5 | Standard Deviation 1.1 |