The decision aid (DA) will be provided to patients randomized to the experimental/intervention group.

Participants randomized to the control group will receive usual care and will be shown Siteman Cancer Center website about clinical trials.

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.

Decision Aid (DA)

Mary C Politi, PhD

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.

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.

Health Literacy Intervention for Informed Consent of Cancer Patients Considering Clinical Trial Participation

A Mixed Methods Study to Reduce Disparities in Cancer Clinical Trials by Adapting a Health Literacy Intervention for Informed Consent and Comparing it to Usual Care in a Randomized Experiment

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.

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.

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.

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.

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.

University of Miami

Washington University School of Medicine

"Serious" and "Other" adverse events were not collected/assessed.

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.

Control

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Inadequate

Marginal

Adequate

5 participants did not complete this measure due to lack of time during enrollment.

Rapid Estimate of Adult Literacy in Medicine-SF (REALM-SF)

Mary C. Politi, PhD

Analysis is represented as mean (standard deviation) of percentage of knowledge questions answered correctly.

Knowledge About Cancer Clinical Trials

Analysis is represented as mean (standard deviation) of participant-reported self-efficacy for finding information about cancer clinical trials.

Self-efficacy for Communicating About Cancer Clinical Trials

Analysis is represented as mean (standard deviation) of calculated values clarity.

Clarity of Values

Analysis is represented as mean (standard deviation) of calculated uncertainty.

Uncertainty in Choice

Intent to Participate

Intent to Encourage Others to Particpate

Analysis is represented as mean (standard deviation) of participant-reported intent.

Attitudes About Cancer Clinical Trials

Overall Study

Part 1: online survey (quantitative) with questions on basic socio-demographic data, medical data and family characteristics (e.g. age, ethnicity, education) and information about FP.

online survey

Part 2: At the end of the online survey, participants are invited to attend one of the consecutively performed focus groups conducted according to standardized focus group methodology and moderated by a clinical psychologist and a specialist in reproductive medicine.

focus group meeting

Sibil Tschudin, PD Dr. med

This is a single center cross-sectional retrospective study with a quantitative and qualitative approach (phase 1 and 2). In phase 1 an online survey will be realized and targets male cancer survivors. Phase 2 will take a qualitative approach, in which information about patient's experiences, needs and helpful support will be collected by establishing focus groups of cancer patients who had been diagnosed during the reproductive age.

In the end, the results of this study will be integrated into the development of an online support tool concerning Fertility Preservation (FP).

Fertility Preservation in Men Affected by Cancer

Fertility Preservation in Men Affected by Cancer: Assessment of Patients' Needs and Development of an Online Decision-aid

Phase 1: exploratory online survey inquiring male cancer patients level of information with regard to FP

Phase 2: interview (strictly exploratory) in focus groups collecting data on male cancer patients level of information with regard to FP

exploratory online survey inquiring which kind of support regarding decision-making about FP do male cancer patients consider helpful

exploratory online survey inquiring how an online Decision Aid (DA) tool about FP has to be designed in order to be helpful for male cancer patients

Phase 2: interview (strictly exploratory) in focus groups evaluating which kind of support regarding decision-making about FP male cancer patients consider helpful

Phase 2: interview (strictly exploratory) in focus groups evaluating how an online DA tool about FP has to be designed in order to be helpful for male cancer patients

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Health Literacy Intervention for Informed Consent of Cancer Patients Considering Clinical Trial Participation	NCT01964222	Cancer	Decision Aid (D...	18 Years -	Washington University School of Medicine
Fertility Preservation in Men Affected by Cancer	NCT03876366	Cancer	online survey focus group mee...	18 Years -	University Hospital, Basel, Switzerland

Spots Global Cancer Trial Database for decision aid (da)