A Multi-stage Study to Improve Informed Decision-making for Precision Oncology in Veterans With Advanced Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Mean score on the Decisional Conflict Scale (DCS) (Stage 1)
研究概览
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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.
- •Identified by a patient-participant as an individual who is involved with the patient's care, and willing to join the interviews.
- •Able to provide verbal consent.
- •Able to speak and understand English.
- •Provider-participants:
- •Hematology/oncology or Genetics provider (medical doctor (MD) or nurse practitioner (NP), post-first year clinical fellows allowed).
- •Has discussed germline testing, somatic testing, or targeted therapy for an San Francisco Veteran Health Care System (SFVAHCS) patient with locally advanced or metastatic prostate cancer (as defined above) within the past 90 days of being contacted about the study.
- •Able to provide consent via email.
- •Stage 2: Inclusion Criteria:
- •Patient participants:
- •Participated in Stage
- •Completed either germline or tumor testing for prostate cancer.
- •Able to understand study procedures and to comply with them for the entire length of the study.
- •Caregiver-participants:
- •Participated in Stage
- •Partner, family-member, or friend of a Stage 2 participant (identified by the patient-participant as a caregiver).
- •SFVAHCS Provider-participants:
- •Participated in Stage
- •Meets one of the two following criteria:
- •Physician specializing in medical oncology (MD, post-first year clinical fellows allowed) who has discussed genetic testing or targeted therapy with a patient with advanced prostate cancer within the past 30 days of being contacted for this study.
- •Physician specializing in genetics who has discussed genetic testing or targeted therapy with a patient with advanced prostate cancer within the past 90 days of being contacted for this study.
- •Non-SFVAHCS provider-participants:
- •Meets one of the three following criteria:
- •Principal investigator of a Precision Oncology Program for Cancer of the Prostate (POPCaP) site.
- •Physician specializing in medical oncology who has discussed genetic testing or targeted therapy with a patient with advanced prostate cancer within the past 30 days of being contacted for this study.
- •Physician specializing in genetics who has discussed genetic testing or targeted therapy with a patient with advanced prostate cancer within the past 90 days of being contacted for this study.
- •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
- •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 high-risk localized, very high-risk localized, 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.
- •Caregiver-participants
- •Age 18 years or older.
- •Identified by a patient-participant as an individual who is involved with the patient's care, and willing to join the interview.
- •Able to provide verbal consent.
- •Able to speak and understand English.
- 另有 4 项未显示
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.
- •Caregiver and Provider-Participants
- •1. If they do not meet any of the inclusion criteria above.
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 (Other)
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 (Other)
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 (Other)
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 (Other)
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)