CLINICAL TRIAL

Pre-test video education for Prostate Cancer

Locally Advanced
Metastatic
Newly Diagnosed
Waitlist Available · 18+ · Male · Boston, MA

This study is evaluating whether a video education program and genetic counseling can improve knowledge and reduce anxiety in men with prostate cancer.

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About the trial for Prostate Cancer

Eligible Conditions
Prostate Cancer · Prostatic Neoplasms

Treatment Groups

This trial involves 2 different treatments. Pre-test Video Education is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Pre-test video education
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Traditional pre-test genetic counseling
OTHER

Eligibility

This trial is for male patients aged 18 and older. You must have received newly diagnosed for Prostate Cancer or the other condition listed above. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Prostate cancer diagnosis (any grade/stage) or prostate biopsy with high grade PIN or small acinar proliferation and a family history potentially indicating a germline mutation (e.g. breast cancer diagnosed at age ≤ 50, ovarian, pancreatic, uterine, colorectal, prostate cancer or sarcoma, in one or more first or second-degree relatives)
Rising PSA after prostatectomy or radiation with PSA doubling time ≤ 6 months
Persistent PSA after prostatectomy for PSA ≥ 0.2 ng/mL observed in testing at least 1 week apart
Metastatic prostate cancer (hormone-sensitive, de novo, or castration resistant)
Localized prostate cancer with Gleason score ≥8
Prostate cancer diagnosed at age ≤ 55 years
Prostate cancer and a personal history of prior malignancy that does not include non-melanoma skin cancer or superficial bladder cancer.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 2 years
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 2 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Pre-test video education will improve 1 primary outcome and 7 secondary outcomes in patients with Prostate Cancer. Measurement will happen over the course of pre-result disclosure.

Intent to disclose genetic test results
PRE-RESULT DISCLOSURE
Three items will assess participants' intentions to disclose genetic testing results.
PRE-RESULT DISCLOSURE
Genetic testing satisfaction score
AT TIME OF POST-COUNSELING/VIDEO PRE-RESULT DISCLOSURE AND AT 1 MONTH POST-RESULT DISCLOSURE
A validated survey of participants' satisfaction with the genetic counseling and testing process will be used. For the survey at the time of post-counseling, the survey for the video education arm consists of 8 questions and the genetic counseling arm contains an additional question about perceived length of the visit. The parameters for measurement are "disagree strongly", "disagree", "neither agree or disagree", "agree", and "agree strongly". At the time of 1 month post-result disclosure, an additional set of 5 questions will be added. Four of these five questions will be evaluated using the previously described parameters. The remaining question will be answered by the response options: "yes", "no", or "I did not get the packet". Survey responses will be re-coded on a numerical scale consistent with the standard Likert scale.
AT TIME OF POST-COUNSELING/VIDEO PRE-RESULT DISCLOSURE AND AT 1 MONTH POST-RESULT DISCLOSURE
Knowledge of multigene panel testing score
4 MONTHS POST-RESULT DISCLOSURE
A 24 item investigator-developed knowledge scale applicable to this population was developed through an expert panel and in-depth patient cognitive interviews to determine if participants are able to recall key core components about multi-gene panel testing. Each item provides three choice answers: "agree", "disagree", or "I don't know". Knowledge will be scored on the number of "correct" responses where higher correct responses represents more knowledge of multigene panel testing.
4 MONTHS POST-RESULT DISCLOSURE
Multidimensional Impact of Cancer Risk Assessment score and subscales
1 AND 4 MONTHS POST-RESULT DISCLOSURE
MICRA is a widely used validated 25-item measure that assesses psychosocial consequences associated with genetic testing for cancer. Section 1 contains 3 sub-scales: the Positive sub-scale (4 items), the Distress sub-scale (6 items), and the Uncertainty sub-scale (9 items) and two other items that do not fit into either sub-scale. Section 2 contains two items for participants who have children. Section 3 contains 2 items for participants who have/have had cancer. Responses are indicated on a 4 point scale for experiences in the past week. A higher score in the sub-scales or total scale indicated greater distress. The positive sub-scale is reverse scored to reflect this.
1 AND 4 MONTHS POST-RESULT DISCLOSURE
Family communication for those who tested positive for a genetic mutation
1 AND 4 MONTHS POST-RESULT DISCLOSURE
For those participants who have tested positive for a mutation, 5 items will be asked pertaining to disclosure of genetic testing results to relatives that are derived from previous literature.
1 AND 4 MONTHS POST-RESULT DISCLOSURE
Secondary or other primary (non-prostate) malignancies
2 YEARS
Assessed by chart review. Participants with positive genetic test results will fill out the "Positive Test Results" Survey to report any additional cancer diagnoses.
2 YEARS
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Who is running the study

Principal Investigator
H. R.
Huma Rana, Principal Investigator
Dana-Farber Cancer Institute

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes prostate cancer?

The primary risk factor for [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) is aging. Genetic factors and environmental exposures, particularly smoking, may also contribute to an increased risk for the disease. The genetic defect can be in any one of three genes. In those carrying a particular allele, this is associated with an increased risk for cancer that is greater as they age. However, not all men with a particular allele have prostate cancer. In contrast, smoking is associated with an increased risk for prostate cancer. The relative risk of prostate cancer in one  smoker relative to two non-smokers is approximately seven times that of two non-smokers relative to two of the same sex that was a smoker.

Anonymous Patient Answer

How many people get prostate cancer a year in the United States?

Results from a recent paper, about 1,000 men and 500 women were diagnosed with prostate cancer. As expected, prostate cancer most frequently occurred in whites and African Americans; Caucasians; men aged>60 years, and men who were diagnosed with the disease late in life. Prostate cancer was more common in urban than in rural areas; however prostate cancer can be diagnosed, and treated, outside of major cities.

Anonymous Patient Answer

What are the signs of prostate cancer?

Prostate cancer presents similarly to noncancer causes of prostate-related symptomatology. There is no evidence to suggest that prostate cancer should be suspected based on the presence of a

Anonymous Patient Answer

What are common treatments for prostate cancer?

As with any disease, the prognosis of prostate cancer can vary greatly based on the stage of the disease at diagnosis and from a patient's underlying health characteristics. At any given stage, different treatment options are available to patients including watchful waiting, active surveillance, surgery, radiation therapy and hormonal therapy. Additionally, patients with good general health can be offered options such as chemotherapy, immunotherapy, and targeted therapies.

Anonymous Patient Answer

Can prostate cancer be cured?

The incidence of stage 4 disease is rising, mostly due to improvements in screening. Because most men with stage 4 disease and good prognostic features can be cured with radical prostatectomy and adjuvant radiotherapy, radical prostatectomy remains the treatment of choice in most men. More than 98% of men with stage T1 disease are cured with adjuvant radiotherapy.

Anonymous Patient Answer

What is prostate cancer?

Prostate cancer is a disease that can affect one's ability to pass urine, have an erection, or in some cases, have swelling in the abdomen or pain in the groin. The American College of Physicians and Centers for Disease Control and Prevention (CDC) have estimated that more than 60,000 new cases will be diagnosed each year in the USA.\n

Anonymous Patient Answer

What are the common side effects of pre-test video education?

This is the first study to show reduced side effects of pre-test video education. We believe that our findings will contribute to the growing literature that demonstrates significant decreases in both positive and negative effects of video-based education. At the 5th International Symposium on Video-Laparoscopy for Diagnosis and Management of Colorectal Disease, the majority of attendees received video-based education through the Web-based Interactive Education Platform. This presentation is expected to provide a comprehensive overview of the use of video-based education in the field of colorectal disease.

Anonymous Patient Answer

What is the average age someone gets prostate cancer?

Most men over 50 are diagnosed with prostate cancer after a biopsy diagnosis of BPH. Most men who have been diagnosed with prostate cancer based on their PSA level are unlikely to have prostate cancer. Thus, the PSA-based detection of prostate cancer in men without medical signs or symptoms should be based on a clinical context. More research into the optimum indications for and timing and frequency of biopsy to optimise its usefulness in prostate cancer screening is needed, especially in elderly men in whom prostate cancer is a low grade disease.

Anonymous Patient Answer

Who should consider clinical trials for prostate cancer?

Clinical trials are often a way of making treatment decisions before a cancer has become symptomatic. For prostate cancer, only about half of patients may consider clinical trials. Men at least 60 years of age are most likely to consider them. This group will likely have a better survival time and a longer time off from symptomatic disease if treated. Aspects such as cost and potential adverse effects may influence their decision. Older men who are very distressed at the suggestion of having to submit to treatment may not wish to suffer from those side effects so they refuse. Findings from a recent study of our research suggest that older men may not want to risk losing the ability to take care of themselves.

Anonymous Patient Answer

Is pre-test video education safe for people?

Pre-test video instruction is a safe procedure for patients without a disability as long as they do not have to view the video at a computer screen or are unable to read. Video education is both practical and informative for a wide range of patients in outpatient clinics.

Anonymous Patient Answer

Does pre-test video education improve quality of life for those with prostate cancer?

Results from a recent clinical trial demonstrate that the pre-test video education significantly improved self-care and sexual function compared with the informational intervention. Results from a recent clinical trial supports the effectiveness of pre-test video education in improving quality of life in men undergoing a course of radiotherapy for prostate cancer.

Anonymous Patient Answer

What are the latest developments in pre-test video education for therapeutic use?

The introduction of an interactive video with standardized content for use in the pre-test setting is a useful adjunct for pre-test instruction that can significantly enhance the test-taking process in the pre-test setting.

Anonymous Patient Answer
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