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Patient Decision-making About Precision Oncology in Veterans With Advanced Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05396872
Recruitment Status : Recruiting
First Posted : May 31, 2022
Last Update Posted : June 23, 2022
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Advanced Prostate Carcinoma Other: Participant Surveys Other: Mobile app Not Applicable

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:

  1. To evaluate patient-participants' precision oncology knowledge
  2. To evaluate patient-participants' perceived shared decision-making effort
  3. To evaluate the degree of decision support provided by provider-participants' during an appointment with the patient-participant.
  4. To evaluate patient-participants' and caregiver-participants' decisional needs, potential solutions, and potential disparities about precision oncology
  5. To evaluate patient-participants' decisional needs and to identify potential disparities about precision oncology from the perspective of the provider-participant.
  6. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 117 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Multi-stage Study to Improve Informed Decision-making for Precision Oncology in Veterans With Advanced Prostate Cancer
Actual Study Start Date : May 12, 2022
Estimated Primary Completion Date : July 31, 2027
Estimated Study Completion Date : December 31, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: 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.
Other: Participant Surveys
Online surveys administered post appointment

Other: Mobile app
Mobile application installed on mobile device




Primary Outcome Measures :
  1. Mean score on the Decisional Conflict Scale (DCS) [ Time Frame: 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.

  2. Proportion of participants with a total score of >37.5 on the DCS [ Time Frame: 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.


Secondary Outcome Measures :
  1. Mean score on the germline testing knowledge scale [ Time Frame: 6 months ]
    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.

  2. Proportion of participants with correct responses on germline testing knowledge scale [ Time Frame: 6 months ]
    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.

  3. Mean score on the somatic testing knowledge scale [ Time Frame: 6 months ]
    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.

  4. Proportion of participants with correct responses on the somatic testing knowledge scale [ Time Frame: 6 months ]
    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.

  5. Proportion of patients for whom there was 'gold standard' shared decision making (collaboRATE) [ Time Frame: 6 months ]
    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.

  6. Mean Brief Decision Support Analysis Tool (DSAT-10) scores [ Time Frame: 6 months ]
    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.

  7. Proportion of providers who responded to yes for pre-test germline testing items [ Time Frame: 6 months ]
    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.

  8. Proportion of providers who responded to yes for pre-test tumor testing item [ Time Frame: 6 months ]
    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.

  9. Proportion of participants who received the precision oncology intervention or testing [ Time Frame: 6 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Stage 1: Inclusion Criteria

Patient-participants:

  1. Age 18 years or older.
  2. Able to understand study procedures and to comply with them for the entire length of the study.
  3. Able to understand a written informed consent document and willing to sign it.
  4. Able to speak, read, and understand English.
  5. Documentation of locally advanced (pelvic lymph node-positive), metastatic, or castration-resistant prostate cancer in a clinical progress note or pathology report.
  6. 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:

  1. Age 18 years or older.
  2. Identified by a patient-participant as an individual who is involved with the patient's care, and willing to join the interviews.
  3. Able to provide verbal consent.
  4. Able to speak and understand English.

Provider-participants:

  1. Hematology/oncology or Genetics provider (medical doctor (MD) or nurse practitioner (NP), post-first year clinical fellows allowed).
  2. 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.
  3. Able to provide consent via email.

Stage 2: Inclusion Criteria:

Patient participants:

  1. Participated in Stage 1.
  2. Completed either germline or tumor testing for prostate cancer.
  3. Able to understand study procedures and to comply with them for the entire length of the study.

Caregiver-participants:

  1. Participated in Stage 1.
  2. Partner, family-member, or friend of a Stage 2 participant (identified by the patient-participant as a caregiver).

SFVAHCS Provider-participants:

  1. Participated in Stage 1.
  2. 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:

  1. 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.

  2. Able to understand study procedures and to comply with them for the entire length of the study.

Stage 1: Exclusion Criteria

Patient-participants:

  1. 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

  2. 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05396872


Contacts
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Contact: Kaitlin Zablotsky 877-827-3222 kaitlin.zablotsky@ucsf.edu

Locations
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United States, California
San Francisco Veterans Affairs Medical Center Recruiting
San Francisco, California, United States, 94121
Contact: Kaitlin Zablotsky    877-827-3222    kaitlin.zablotsky@ucsf.edu   
Principal Investigator: Daniel Kwon, MD         
Sponsors and Collaborators
University of California, San Francisco
United States Department of Defense
Investigators
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Principal Investigator: Daniel Kwon, MD University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT05396872    
Other Study ID Numbers: 22554
NCI-2022-04352 ( Registry Identifier: NCI Clinical Trials Reporting Program (CTRP) )
First Posted: May 31, 2022    Key Record Dates
Last Update Posted: June 23, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
Informed Decision-Making
Precision Oncology
Military Veterans
Germline Testing
Somatic Testing
Targeted Therapy
Genetic Testing
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases