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About
This clinical trial explores and implements methods to improve informed decision making (IDM) regarding precision oncology tests amongst veterans with prostate cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Precision oncology, the use of germline genetic testing and tumor-based molecular assays to inform cancer care, has become an important aspect of evidence-based care for men with advanced prostate cancer. Veterans with metastatic castrate-resistant prostate cancer may not be carrying out IDM due to unmet decisional needs. An informed decision is a choice based on complete and accurate information. The information gained from this study will help researchers develop a decision support intervention (DSI) and implement the intervention. A DSI may serve as a valuable tool to reduce ongoing racial disparities in genetic testing and encourage enrollment to precision oncology trials.
Full description
PRIMARY OBJECTIVES:
I. To evaluate patient-participants' decisional conflict about precision oncology. (Stage I)
II. To develop a Decision Support Intervention (DSI) to improve decision-making about precision oncology. (Stage II)
III. To evaluate the percentage of invited participants who enroll. (Stage III)
SECONDARY OBJECTIVES:
I. To evaluate patient-participants' precision oncology knowledge. (Stage I).
II. To evaluate patient-participants' perceived shared decision-making effort. (Stage I)
III. To evaluate the degree of decision support provided by provider-participants during an appointment with the patient-participant. (Stage I)
IV. To evaluate patient-participants' and caregiver-participants' decisional needs, potential solutions, and potential disparities about precision oncology. (Stage I)
V. To evaluate patient-participants' decisional needs, and to identify potential disparities about precision oncology from the perspective of the provider-participant. (Stage I)
VI. To evaluate how many patient-participants receive a precision oncology intervention or testing after having an appointment and discussion with a provider-participant. (Stage I)
VII. To describe the multi-stakeholder development process of the DSI. (Stage II)
VIII. To evaluate change in participant informed decision-making about germline testing after provision of a decision support intervention. (Stage III)
IX. To evaluate the percent of intervention agents (people who deliver the intervention) who are willing to initiate the decision support intervention. (Stage III)
X. To evaluate intervention agents' (people who deliver the intervention) fidelity to the various elements of the decision support intervention. (Stage III)
XI. To evaluate patient-participant uptake of the decision support intervention. (Stage III)
XII. To measure patient-participant satisfaction with the decision support intervention. (Stage III)
XIII. To evaluate patient-participants' perceived shared decision-making effort. (Stage III)
XIV. To evaluate the degree of decision support provided by provider-participants during an appointment with the patient-participant. (Stage III)
XV. To evaluate provider-participant assessments of both provider- and patient-directed decision support interventions. (Stage III)
XVI. To evaluate barriers, facilitators, and experiences of the patient-directed decision support intervention by conducting patient/caregiver-participant interviews. (Stage III)
XVII. To evaluate barriers, facilitators, and experiences of the provider-directed components intervention by conducting a focus group with providers. (Stage III)
XVIII. To evaluate the consent rate of patient-participants to germline testing. (Stage III)
OUTLINE:
OBSERVATIONAL STUDY (CLOSED TO ENROLLMENT)
STAGE I: San Francisco Veterans Affairs Health Care System (SFVAHCS) patients and providers participate in an audio recorded discussion on study. Patients also complete surveys and participate in interviews on study. Caregivers and providers also participate in interviews on study. Participants medical records are reviewed throughout the study.
STAGE II: Subset of SFVAHCS patients, caregivers, and providers who participated in stage I participate in an interview and may be asked to participate with an advisory board on study. Non-SFVAHCS providers participate in an interview on study.
INTERVENTIONAL STUDY:
STAGE III: About 14 days prior to scheduled germline testing appointment, patients and caregivers call or meet with a coach to select decision aid genetics adviser (GA) platform preference delivery (online, print, or both online and print), review the GA online platform, and possibly undergo consultation and training for audio recording of the scheduled appointment. Patients and caregivers attend the scheduled germline testing appointment on day 1. Patients complete surveys and patients and caregivers may complete an interview on study for up to 90 days post-appointment. Providers participate in focus groups and complete surveys on study and for up to 24 months.
Enrollment
Sex
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Volunteers
Inclusion and exclusion criteria
Stage 1: Inclusion Criteria
Patient-participants:
Caregiver-participants:
Provider-participants:
Stage 2: Inclusion Criteria:
Patient participants:
Caregiver-participants:
SFVAHCS Provider-participants:
Participated in Stage 1.
Meets one of the two following criteria:
Non-SFVAHCS provider-participants:
Meets one of the three following criteria:
Note: For Non-SFVAHCS providers, fellows are not eligible.
Able to understand study procedures and to comply with them for the entire length of the study.
Stage 3: Inclusion Criteria
Patient-participants
Caregiver-participants
Provider-participants
Stage 1: Exclusion Criteria
Patient-participants:
For patient-participants undergoing genetic testing, if results of the genetic tests have already been disclosed to the participant, they are not eligible.
Caregiver and Provider-Participants
If they do not meet any of the inclusion criteria above.
Stage 2: Exclusion Criteria
Stage 3: Exclusion Criteria
Patient-participants:
Caregiver and Provider-Participants
Primary purpose
Allocation
Interventional model
Masking
250 participants in 2 patient groups
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Central trial contact
Marissa McPhaul
Data sourced from clinicaltrials.gov
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