Clinical trial NCT05396872: 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
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Advanced Prostate Carcinoma
Keywords: Informed Decision-Making
Precision Oncology
Military Veterans
Germline Testing
Somatic Testing
Targeted Therapy
Genetic Testing
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2022-05-31
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed 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.

Eligibility 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 3: 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 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.
6. Scheduled to attend a hematology/oncology appointment (in person or remote) during which provider anticipates discussing germline testing.

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 interview.
3. Able to provide verbal consent.
4. Able to speak and understand English.

Provider-participants

1. SFVAHCS physician (MD) trained in medical oncology or undergoing training as a clinical fellow.
2. Has discussed germline testing for prostate cancer with an SFVAHCS patient within the past year of being contacted about the study, or plans to discuss germline testing for prostate cancer with an SFVAHCS patient.
3. Able to provide verbal consent.

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.

Stage 3: Exclusion Criteria

Patient-participants:

1. Prior receipt of germline testing.
2. Prior participation in Stage 1 for germline testing.

Caregiver and Provider-Participants

1. If they do not meet any of the inclusion criteria above.

Primary outcomes:
measure: Mean score on the Decisional Conflict Scale (DCS) (Stage 1)
timeFrame: 6 months
measure: Proportion of participants with a total score of >37.5 on the DCS (Stage 1)
timeFrame: 6 months
measure: Proportion of participants enrolled (Stage 3)
timeFrame: Up to 3 years
measure: Proportion of participants providing reason for not enrolling (Stage 3)
timeFrame: Up to 3 years
Secondary outcomes:
measure: Mean score on the germline testing knowledge scale (Stage 1)
timeFrame: 6 months
measure: Mean change in germline testing knowledge score (Stage 3)
timeFrame: Up to 6 months
measure: Proportion of participants with correct responses on germline testing knowledge scale
timeFrame: 6 months
measure: Mean score on the somatic testing knowledge scale
timeFrame: 6 months
measure: Proportion of participants with correct responses on the somatic testing knowledge scale
timeFrame: 6 months
measure: Proportion of patients for whom there was 'gold standard' shared decision making (collaboRATE)
timeFrame: 6 months
measure: Mean Brief Decision Support Analysis Tool (DSAT-10) scores
timeFrame: 6 months
measure: Proportion of providers who responded to yes for pre-test germline testing items
timeFrame: 6 months
measure: Proportion of providers who responded to yes for pre-test tumor testing item
timeFrame: 6 months
measure: Proportion of participants who received the precision oncology intervention or testing
timeFrame: 6 months
measure: Mean change in score on the Decisional Conflict Scale (DCS) (Stage 3)
timeFrame: Up to 6 months
measure: Proportion of research staff and providers who agree to participate (Stage 3)
timeFrame: Up to 6 months
measure: Proportion of research staff who completed all components of the decision support intervention (Stage 3)
timeFrame: Up to 6 months
measure: Proportion of providers who completed all components of the decision support intervention (Stage 3)
timeFrame: Up to 6 months
measure: Proportion of patient-participants who completely review the decision aid (Stage 3)
timeFrame: Up to 6 months
measure: Proportion of patient-participants who request training for audio-recording (Stage 3)
timeFrame: Up to 6 months
measure: Proportion of patient-participants who request question list coaching (Stage 3)
timeFrame: Up to 6 months
measure: Proportion of participants with responses of 9-10 on the Net Promoter Score scale (Stage 3)
timeFrame: Up to 6 months
measure: Proportion of patient-participants who report "somewhat" or "very helpful" on evaluation of patient-directed intervention (Stage 3)
timeFrame: Up to 6 months
measure: Proportion of provider-participants who report "somewhat agree" or "strongly agree" to any one of the components of the intervention (Stage 3)
timeFrame: Up to 6 months
measure: Proportion of patient-participants who consent to germline testing (Stage 3)
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco Veterans Affairs Medical Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Daniel Kwon, MD
role: PRINCIPAL_INVESTIGATOR
References: