A Multi-stage Study to Improve Informed Decision-making for Precision Oncology in Veterans With Advanced Prostate Cancer
概览
- 阶段
- 不适用
- 干预措施
- Participant Surveys
- 疾病 / 适应症
- Prostate Cancer
- 发起方
- University of California, San Francisco
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Mean score on the Decisional Conflict Scale (DCS) (Stage 1)
- 状态
- 招募中
- 最后更新
- 上个月
概览
简要总结
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.
详细描述
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.
研究者
入排标准
入选标准
- •Stage 1: Inclusion Criteria
- •Patient-participants:
- •Age 18 years or older.
- •Able to understand study procedures and to comply with them for the entire length of the study.
- •Able to understand a written informed consent document and willing to sign it.
- •Able to speak, read, and understand English.
- •Documentation of locally advanced (pelvic lymph node-positive), metastatic, or castration-resistant prostate cancer in a clinical progress note or pathology report.
- •Scheduled to attend a hematology/oncology appointment (in person or remote) during which provider anticipates discussing germline testing, somatic tumor testing, or targeted therapy.
- •Caregiver-participants:
- •Age 18 years or older.
排除标准
- •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
- •1\. Participants who do not meet the inclusion criteria above.
- •Stage 3: Exclusion Criteria
- •Patient-participants:
- •Prior receipt of germline testing.
- •Prior participation in Stage 1 for germline testing.
研究组 & 干预措施
CLOSED TO ENROLLMENT: Stage 1 & 2: Patients, Caregivers, Providers
Patient participants will be instructed to install a mobile app to record their medical appointment, which research staff will use to analyze patient-provider communication. All participants will undergo semi-structured interviews and/or focus groups. Post appointment follow-up with surveys and assessments regarding knowledge of disease information, quality of life, and other measures will be administered after the provider-patient appointment.
干预措施: Participant Surveys
CLOSED TO ENROLLMENT: Stage 1 & 2: Patients, Caregivers, Providers
Patient participants will be instructed to install a mobile app to record their medical appointment, which research staff will use to analyze patient-provider communication. All participants will undergo semi-structured interviews and/or focus groups. Post appointment follow-up with surveys and assessments regarding knowledge of disease information, quality of life, and other measures will be administered after the provider-patient appointment.
干预措施: Mobile app
Stage 3: Patients, Caregivers using developed GA platform
About 14 days prior to scheduled germline testing appointment, patients and caregivers call or meet with a coach to select decision aid 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. Providers participate in focus groups and complete surveys on study.
干预措施: Participant Surveys
Stage 3: Patients, Caregivers using developed GA platform
About 14 days prior to scheduled germline testing appointment, patients and caregivers call or meet with a coach to select decision aid 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. Providers participate in focus groups and complete surveys on study.
干预措施: Mobile app
结局指标
主要结局
Mean score on the Decisional Conflict Scale (DCS) (Stage 1)
时间窗: 6 months
The Decisional Conflict Scale measures personal perceptions of : a) uncertainty in choosing options; b) modifiable factors contributing to uncertainty such as feeling uninformed, unclear about personal values and unsupported in decision making; and c) effective decision making such as feeling the choice is informed, values-based, likely to be implemented and expressing satisfaction with the choice. Scoring and interpretation Items are given a score value ranging from 0 = 'strongly disagree' to 4 = 'strongly agree'. Total Scores are a sum of the scores of the 16 items and are scaled by divided by 16 and then multiplied by 25 for a total scale score range from 0 \[extremely high decisional conflict\] to 100 \[no decisional conflict\]. Mean score and 95% confidence interval (CI) of the total DCS as well as the 4 subscales will be calculated.
Proportion of participants with a total score of >37.5 on the DCS (Stage 1)
时间窗: 6 months
Participants who completed the DCS will be divided by their total score into those who scored \>37.5 or not. The proportion of participants with a total score of \> 37.5 will be reported.
Proportion of participants enrolled (Stage 3)
时间窗: Up to 3 years
The proportion of invited participants who consent to the study compared to the total number of participants approached will be reported as measured by study entry.
Proportion of participants providing reason for not enrolling (Stage 3)
时间窗: Up to 3 years
The proportion of invited participants who do not consent to the study will have the reason for not joining recorded and totaled.
次要结局
- Mean change in germline testing knowledge score (Stage 3)(Up to 6 months)
- Proportion of patients for whom there was 'gold standard' shared decision making (collaboRATE)(6 months)
- Mean Brief Decision Support Analysis Tool (DSAT-10) scores(6 months)
- Proportion of research staff and providers who agree to participate (Stage 3)(Up to 6 months)
- Mean score on the germline testing knowledge scale (Stage 1)(6 months)
- Mean change in score on the Decisional Conflict Scale (DCS) (Stage 3)(Up to 6 months)
- Mean score on the somatic testing knowledge scale(6 months)
- Proportion of research staff who completed all components of the decision support intervention (Stage 3)(Up to 6 months)
- Proportion of providers who completed all components of the decision support intervention (Stage 3)(Up to 6 months)
- Proportion of patient-participants who completely review the decision aid (Stage 3)(Up to 6 months)
- Proportion of participants with correct responses on germline testing knowledge scale(6 months)
- Proportion of providers who responded to yes for pre-test germline testing items(6 months)
- Proportion of patient-participants who request question list coaching (Stage 3)(Up to 6 months)
- Proportion of patient-participants who report "somewhat" or "very helpful" on evaluation of patient-directed intervention (Stage 3)(Up to 6 months)
- Proportion of participants with correct responses on the somatic testing knowledge scale(6 months)
- Proportion of providers who responded to yes for pre-test tumor testing item(6 months)
- Proportion of participants who received the precision oncology intervention or testing(6 months)
- Proportion of patient-participants who request training for audio-recording (Stage 3)(Up to 6 months)
- Proportion of patient-participants who consent to germline testing (Stage 3)(Up to 3 years)
- Proportion of participants with responses of 9-10 on the Net Promoter Score scale (Stage 3)(Up to 6 months)
- Proportion of provider-participants who report "somewhat agree" or "strongly agree" to any one of the components of the intervention (Stage 3)(Up to 6 months)