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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-06569 | Other Identifier | Clinical Trials Reporting Registry |
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| Name | Class |
|---|---|
| American Cancer Society, Inc. | OTHER |
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This protocol describes development and user testing of an educational shared decision making intervention to help men with prostate cancer who are on active surveillance make decisions with their health care providers about if and when to de-escalate surveillance testing. The project is important because for many patients their cancer does not progress to the point of needed curative treatment or their health status changes such that they are no longer good candidates for treatment. For these men, de-escalating ongoing surveillance (e.g., fewer biopsies or imaging studies) is a reasonable option.
Objectives:
The overall goal of this protocol is to develop and refine an educational tool for use by patients and health-care providers to help men with localized prostate cancer make informed decisions about discontinuation of active surveillance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surveys | Participants may answer questions that are sensitive in nature. |
| |
| Interviews | The interview may occur over phone, web conferencing, or in-person. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interviews | Behavioral | Participants will discuss background, such as race, education, and living situation. Participants will discuss Prostate cancer Participants will discuss feedback on the educational material |
| Measure | Description | Time Frame |
|---|---|---|
| The Ottawa Acceptability Scale | The Ottawa Acceptability scale includes 10 items to assess participant's rating of the educational material ease of use, clarity of information, length, level of detail provided, ability to hold one's interest, and satisfaction with how the materials prepared them for discussing the decision with their clinician Score Scale (Strongly agree, Agree, Neither agree nor disagree, Disagree Strongly disagree) and (Not at all, A little, Somewhat, Quite a bit, A great deal) | through study completion and average of 1 year |
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Patients
Inclusion Criteria:
Exclusion Criteria:
1. Receiving treatment for another cancer (primary or recurrence)
Caregivers
Inclusion Criteria:
Aged 18 or older
Fluent in English
Involved with the care of an eligible patient (i.e. partner, close friend, family member, companion)
Exclusion Criteria:
None
Clinicians
Inclusion Criteria:
Exclusion Criteria:
1. None
Male
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M D Anderson Cancer Center
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lisa Lowenstein, MD | Contact | 713-563-0020 | deescalatepca@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Lisa Lowenstein, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D007407 | Interviews as Topic |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Surveys | Behavioral | Participants may answer questions that are sensitive in nature. |
|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |