Back to resultsPatient Decision-making About Precision Oncology in Veterans With Advanced Prostate Cancer
Primary Purpose
Prostate Cancer, Advanced Prostate Carcinoma
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Participant Surveys
Mobile app
Sponsored by
About this trial
This is an interventional health services research trial for Prostate Cancer focused on measuring Informed Decision-Making, Precision Oncology, Military Veterans, Germline Testing, Somatic Testing, Targeted Therapy, Genetic Testing
Eligibility Criteria
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 1.
- 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 1.
- Partner, family-member, or friend of a Stage 2 participant (identified by the patient-participant as a caregiver).
SFVAHCS Provider-participants:
- Participated in Stage 1.
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 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
1. Participants who do not meet the inclusion criteria above.
Sites / Locations
- San Francisco Veterans Affairs Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Stage 1 & 2: Patients, Caregivers, Providers
Arm Description
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.
Outcomes
Primary Outcome Measures
Mean score on the Decisional Conflict Scale (DCS)
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
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.
Secondary Outcome Measures
Mean score on the germline testing knowledge scale
Proportion of participants with correct responses on where participants response with an agree or disagree to each item addressing information they have received regarding germline testing. The proportion of participants who correctly responded to each knowledge item receive a score of 1 for a total score range of 0 - 16. Mean score and 95% CI of the total knowledge scale will be reported.
Proportion of participants with correct responses on germline testing knowledge scale
The germline testing knowledge scale is a 16 item survey where participants response with an agree or disagree to each item addressing information they have received regarding germline testing. The proportion of participants who correctly responded to each knowledge item and 95% CI for each knowledge item will be reported.
Mean score on the somatic testing knowledge scale
The somatic testing knowledge scale is a 17-item survey where participants response with an True, false, or don't know to each item addressing information they have received regarding personalized cancer therapy and molecular testing (target therapy). The proportion of participants who correctly responded to each knowledge item receive a score of 1 for a total score range of 0 - 17. Mean score and 95% CI of the total knowledge scale will be reported.
Proportion of participants with correct responses on the somatic testing knowledge scale
The somatic testing knowledge scale is a 16-item survey where participants response with an True, false, or don't know to each item addressing information they have received regarding personalized cancer therapy and molecular testing (target therapy). The proportion of participants who correctly responded to each knowledge item will be reported with 95%confidence intervals.
Proportion of patients for whom there was 'gold standard' shared decision making (collaboRATE)
The collaboRATE scale is a 3 item scale with responses ranging from 0 -10 for each item which ask the participant to think about the appointment they just had. These responses will be scored using the Top Score approach which excludes cases where a response to one or more of the collaboRATE questions is missing. Each encounter is coded as either '1', if the response to all three collaboRATE items was 9, or '0' if the response to any of the three collaboRATE items was less than 9. The percentage of all encounters that were coded as '1' is the collaboRATE Score. Higher scores represent more shared decision making. This number also corresponds to the proportion of patients for whom there was 'gold standard' shared decision making. Percentage and 95% CI will be calculated.
Mean Brief Decision Support Analysis Tool (DSAT-10) scores
The Brief Decision Support Analysis Tool (DSAT-10) will be used to evaluate treating physicians' and practitioners' use of decision support and communication skills for recordings (Guimond, et al. Patient Education Counsel 2003). Encounters are reviewed and scored on 5 factors such as Decision making status, Knowledge of, Values/Preference associated with, Others' involvement with the decision, and Next Steps and given a score ranging from 1-10, with a higher score indicating a greater quality of decisional support.The DSAT-10 will be applied to calculate a mean and 95% CI of the total score (0-10) and of the 5 factors.
Proportion of providers who responded to yes for pre-test germline testing items
In addition,to the regular germline testing questionnaire, the following provider communication items will be scored as Yes or No, based on 1.2022 National Comprehensive Cancer Network (NCCN) guidelines for pre-test germline testing: Prepare patient for possible outcomes of testing, including positive, negative, and variant of uncertain significance (VUS), Discuss possible management options if a mutation is identified, Advise about possible inherited cancer risk to relatives. Discuss cost of testing, Provide overview of current legislation regarding genetic, discrimination, Provide overview of current legislation regarding privacy of genetic, information, Discuss plan for results disclosure. Proportion of providers who responded yes to each item will be reported.
Proportion of providers who responded to yes for pre-test tumor testing item
In addition,to the regular germline testing questionnaire, the following provider communication item will be scored as Yes or No, based on 1.2022 NCCN guidelines for pre-test tumor testing: Prepare patient for possible outcomes of testing. Proportion of providers who responded yes will be reported.
Proportion of participants who received the precision oncology intervention or testing
The proportion of participants who received the precision oncology intervention or testing discussed during appointment as well as the type of intervention (germline, somatic, or targeted therapy) will be reported.
Full Information
NCT ID
NCT05396872
First Posted
May 25, 2022
Last Updated
August 18, 2023
Sponsor
University of California, San Francisco
Collaborators
United States Department of Defense
1. Study Identification
Unique Protocol Identification Number
NCT05396872
Brief Title
Patient Decision-making About Precision Oncology in Veterans With Advanced Prostate Cancer
Official Title
A Multi-stage Study to Improve Informed Decision-making for Precision Oncology in Veterans With Advanced Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 12, 2022 (Actual)
Primary Completion Date
July 31, 2027 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
United States Department of Defense
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This project proposes to understand and improve Veterans' decision-making in precision oncology (germline testing, somatic tumor testing, and targeted therapy) for advanced prostate cancer. As precision oncology expands, a comprehensive strategy to support patient informed decision- making (IDM) has not been developed.
Detailed Description
PRIMARY OBJECTIVES:
Stage 1: To evaluate patient-participants' decisional conflict about precision oncology.
Stage 2: To develop a Decision Support Intervention (DSI) to improve decision-making about precision oncology
SECONDARY OBJECTIVES:
Stage 1:
To evaluate patient-participants' precision oncology knowledge
To evaluate patient-participants' perceived shared decision-making effort
To evaluate the degree of decision support provided by provider-participants' during an appointment with the patient-participant.
To evaluate patient-participants' and caregiver-participants' decisional needs, potential solutions, and potential disparities about precision oncology
To evaluate patient-participants' decisional needs and to identify potential disparities about precision oncology from the perspective of the provider-participant.
To evaluate how many patient-participants receive precision oncology intervention or testing after having an appointment and discussion with a provider-participant
Stage 2:
1. To describe the multi-stakeholder development process of the DSI
Military Veterans with an upcoming hematology/oncology visit in which germline testing, somatic testing, or targeted therapy will be discussed. Decision-making for precision oncology will be characterized and their decisional needs assessed. Patients, caregivers, and physicians will participate in both Stage 1 and Stage 2, occurring in parallel. The investigators and stakeholders will then design and evaluate a DSI based on the results and feedback received in both stages.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Advanced Prostate Carcinoma
Keywords
Informed Decision-Making, Precision Oncology, Military Veterans, Germline Testing, Somatic Testing, Targeted Therapy, Genetic Testing
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
117 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Stage 1 & 2: Patients, Caregivers, Providers
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Participant Surveys
Intervention Description
Online surveys administered post appointment
Intervention Type
Other
Intervention Name(s)
Mobile app
Intervention Description
Mobile application installed on mobile device
Primary Outcome Measure Information:
Title
Mean score on the Decisional Conflict Scale (DCS)
Description
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.
Time Frame
6 months
Title
Proportion of participants with a total score of >37.5 on the DCS
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Mean score on the germline testing knowledge scale
Description
Proportion of participants with correct responses on where participants response with an agree or disagree to each item addressing information they have received regarding germline testing. The proportion of participants who correctly responded to each knowledge item receive a score of 1 for a total score range of 0 - 16. Mean score and 95% CI of the total knowledge scale will be reported.
Time Frame
6 months
Title
Proportion of participants with correct responses on germline testing knowledge scale
Description
The germline testing knowledge scale is a 16 item survey where participants response with an agree or disagree to each item addressing information they have received regarding germline testing. The proportion of participants who correctly responded to each knowledge item and 95% CI for each knowledge item will be reported.
Time Frame
6 months
Title
Mean score on the somatic testing knowledge scale
Description
The somatic testing knowledge scale is a 17-item survey where participants response with an True, false, or don't know to each item addressing information they have received regarding personalized cancer therapy and molecular testing (target therapy). The proportion of participants who correctly responded to each knowledge item receive a score of 1 for a total score range of 0 - 17. Mean score and 95% CI of the total knowledge scale will be reported.
Time Frame
6 months
Title
Proportion of participants with correct responses on the somatic testing knowledge scale
Description
The somatic testing knowledge scale is a 16-item survey where participants response with an True, false, or don't know to each item addressing information they have received regarding personalized cancer therapy and molecular testing (target therapy). The proportion of participants who correctly responded to each knowledge item will be reported with 95%confidence intervals.
Time Frame
6 months
Title
Proportion of patients for whom there was 'gold standard' shared decision making (collaboRATE)
Description
The collaboRATE scale is a 3 item scale with responses ranging from 0 -10 for each item which ask the participant to think about the appointment they just had. These responses will be scored using the Top Score approach which excludes cases where a response to one or more of the collaboRATE questions is missing. Each encounter is coded as either '1', if the response to all three collaboRATE items was 9, or '0' if the response to any of the three collaboRATE items was less than 9. The percentage of all encounters that were coded as '1' is the collaboRATE Score. Higher scores represent more shared decision making. This number also corresponds to the proportion of patients for whom there was 'gold standard' shared decision making. Percentage and 95% CI will be calculated.
Time Frame
6 months
Title
Mean Brief Decision Support Analysis Tool (DSAT-10) scores
Description
The Brief Decision Support Analysis Tool (DSAT-10) will be used to evaluate treating physicians' and practitioners' use of decision support and communication skills for recordings (Guimond, et al. Patient Education Counsel 2003). Encounters are reviewed and scored on 5 factors such as Decision making status, Knowledge of, Values/Preference associated with, Others' involvement with the decision, and Next Steps and given a score ranging from 1-10, with a higher score indicating a greater quality of decisional support.The DSAT-10 will be applied to calculate a mean and 95% CI of the total score (0-10) and of the 5 factors.
Time Frame
6 months
Title
Proportion of providers who responded to yes for pre-test germline testing items
Description
In addition,to the regular germline testing questionnaire, the following provider communication items will be scored as Yes or No, based on 1.2022 National Comprehensive Cancer Network (NCCN) guidelines for pre-test germline testing: Prepare patient for possible outcomes of testing, including positive, negative, and variant of uncertain significance (VUS), Discuss possible management options if a mutation is identified, Advise about possible inherited cancer risk to relatives. Discuss cost of testing, Provide overview of current legislation regarding genetic, discrimination, Provide overview of current legislation regarding privacy of genetic, information, Discuss plan for results disclosure. Proportion of providers who responded yes to each item will be reported.
Time Frame
6 months
Title
Proportion of providers who responded to yes for pre-test tumor testing item
Description
In addition,to the regular germline testing questionnaire, the following provider communication item will be scored as Yes or No, based on 1.2022 NCCN guidelines for pre-test tumor testing: Prepare patient for possible outcomes of testing. Proportion of providers who responded yes will be reported.
Time Frame
6 months
Title
Proportion of participants who received the precision oncology intervention or testing
Description
The proportion of participants who received the precision oncology intervention or testing discussed during appointment as well as the type of intervention (germline, somatic, or targeted therapy) will be reported.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 1.
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 1.
Partner, family-member, or friend of a Stage 2 participant (identified by the patient-participant as a caregiver).
SFVAHCS Provider-participants:
Participated in Stage 1.
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 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
1. Participants who do not meet the inclusion criteria above.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marissa McPhaul
Phone
877-827-3222
Email
Marissa.McPhaul@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Kwon, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco Veterans Affairs Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marissa McPhaul
Phone
877-827-3222
Email
Marissa.McPhaul@ucsf.edu
Email
cancertrials@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Daniel Kwon, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Patient Decision-making About Precision Oncology in Veterans With Advanced Prostate Cancer
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