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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01CA218657-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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Development and evaluation of an online intervention addressing sexual functioning in gay and bisexual men (GBM) after prostate cancer treatment.
This study advances research in three areas.
First, prostate cancer is the second most common cancer among gay, bisexual, and other men who have sex with men with documented disparities, yet it is severely under-researched. Because gay sex differs from vaginal sex, physiologically; the results from 614 studies focused on heterosexual men likely do not generalize to gay and bisexual men(GBM) with prostate cancer. There have been no rehabilitation studies specific to GBM survivors of prostate cancer, so clinicians have no relevant studies to inform best practice with their GBM patients.
Second, most prostate cancer studies have tested one or rehabilitation components. The investigators will conduct the first treatment study of a state of clinical practice comprehensive rehabilitation program on GBM's quality of life, including on both urinary and sexual function and bother measures.
Third, almost all prostate cancer studies have focused on men recently treated for prostate cancer.
The long-term objective of this research is to improve the health of gay and bisexual survivors of Prostate cancer and to provide an evidence base for rehabilitation. The Investigators will develop an online rehabilitation program tailored for GBM that addresses both the sexual and urinary effects of prostate cancer treatment. In addition, The Investigators will conduct a comparative recruitment study to identify best methods to recruit 450 GBM with Prostate cancer.
Finally, the Investigators will evaluate the effects of the tailored rehabilitation program on sexual and urinary outcomes. The Investigators will conduct a 24 month, randomized controlled trial of structured rehabilitation versus routine care. The Investigators will study both GBM recently treated (last 2 years) and GBM post-treatment (2+ years), using a stratified design. This randomized control trial will identify whether a structured rehabilitation program is effective in addressing the major sexual and urinary problems caused by Prostate cancer treatment. As the first treatment study to focus on GBM with Prostate cancer (and also on oral and anal sex), it addresses a long-standing health disparity.
The study has high potential to transform rehabilitation for GBM with Prostate cancer, provide a critical evidence base for clinicians, and inform rehabilitation outcomes for all Prostate cancer survivors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Evaluation Control Group | Experimental | Surveys at 3 month intervals |
|
| Intervention Evaluation Test Group | Experimental | We will evaluate the effects of an educational, tailored, online rehabilitation program addressing sexual and urinary outcomes after treatment by surveying at 3 month intervals |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restore Rehabilitation Program | Behavioral | Multi-component, structured, biopsychosocial, online interactive program to address the sexual and urinary effects of prostate cancer treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary Function Scores | The Urinary Function domain of the Expanded Prostate Cancer Index Composite (EPIC-50) scale was used to assess the frequency of urinary symptoms. Scores range from 0 to 100, with higher scores indicating less frequency of urinary symptoms. | 24 months |
| Sexual Functioning Scores | The Sexual Functioning domain of the Expanded Prostate Cancer Index Composite (EPIC-50) scale was used to assess the frequency of sexual functioning symptoms. Scores range from 0 to 100, with higher scores indicating less frequency of sexual functioning symptoms. | 24 months |
| Intervention Acceptability | Acceptability was measured by how much intervention group participants would recommend the intervention to a friend (if he had prostate cancer). This single Likert-type item has five response options from 1=strongly agree to 5= strongly disagree. Acceptability will be measured by adding those who answered 1=strongly agree or 2=agree on this item. | 3-month follow-up |
| Intervention Feasibility | Feasibility will be measured by monitoring the number of intervention participants who could access the intervention webpage at least once within the first three months of the study. | 3-month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
Male bodied persons at risk of prostate cancer
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| Name | Affiliation | Role |
|---|---|---|
| B. Simon Rosser, PhD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota Twin Cities Campus | Minneapolis | Minnesota | 55454 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34348045 | Derived | Rosser BRS, Polter EJ, Chandiramani N, Cahill S, Wheldon CW, Konety BR, Ryan CJ, Haggart R, Kapoor A. Acceptability and Feasibility of Collecting Sexual Orientation and Expanded Gender Identity Data in Urology and Oncology Clinics. LGBT Health. 2021 Aug-Sep;8(6):420-426. doi: 10.1089/lgbt.2020.0256. Epub 2021 Aug 4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Evaluation Control Group | Surveys at 3 month intervals Control: usual care, surveys every 3 months |
| FG001 | Intervention Evaluation Test Group | We will evaluate the effects of an educational, tailored, online rehabilitation program addressing sexual and urinary outcomes after treatment by surveying at 3 month intervals Restore Rehabilitation Program: Multi-component, structured, biopsychosocial, online interactive program to address the sexual and urinary effects of prostate cancer treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Evaluation Control Group | Surveys at 3 month intervals Control: usual care, surveys every 3 months |
| BG001 | Intervention Evaluation Test Group | We will evaluate the effects of an educational, tailored, online rehabilitation program addressing sexual and urinary outcomes after treatment by surveying at 3 month intervals Restore Rehabilitation Program: Multi-component, structured, biopsychosocial, online interactive program to address the sexual and urinary effects of prostate cancer treatment |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Urinary Function Scores | The Urinary Function domain of the Expanded Prostate Cancer Index Composite (EPIC-50) scale was used to assess the frequency of urinary symptoms. Scores range from 0 to 100, with higher scores indicating less frequency of urinary symptoms. | Posted | Mean | 95% Confidence Interval | Scores on a scale (0-100) | 24 months |
|
Adverse event data was collected for the entire 24-month trial period, beginning when the first participant accessed study materials until the last participant returned the 24-month survey.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Evaluation Control Group | Surveys at 3 month intervals Control: usual care, surveys every 3 months |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gudrun Kilian | University of Minnesota | 612-626-9568 | kilian@umn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 29, 2018 | Oct 23, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 13, 2023 | Nov 20, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 1, 2019 | Mar 5, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Control | Behavioral | usual care, surveys every 3 months |
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| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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|
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| Primary | Sexual Functioning Scores | The Sexual Functioning domain of the Expanded Prostate Cancer Index Composite (EPIC-50) scale was used to assess the frequency of sexual functioning symptoms. Scores range from 0 to 100, with higher scores indicating less frequency of sexual functioning symptoms. | Posted | Mean | 95% Confidence Interval | Scores on a scale (0-100) | 24 months |
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|
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| Primary | Intervention Acceptability | Acceptability was measured by how much intervention group participants would recommend the intervention to a friend (if he had prostate cancer). This single Likert-type item has five response options from 1=strongly agree to 5= strongly disagree. Acceptability will be measured by adding those who answered 1=strongly agree or 2=agree on this item. | Percent frequencies of those rating the intervention as acceptable | Posted | Count of Participants | Participants | 3-month follow-up |
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| Primary | Intervention Feasibility | Feasibility will be measured by monitoring the number of intervention participants who could access the intervention webpage at least once within the first three months of the study. | Percent participants who where able to access the intervention at least once. | Posted | Count of Participants | Participants | 3-month follow-up |
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| 4 |
| 197 |
| 0 |
| 197 |
| 0 |
| 197 |
| EG001 | Intervention Evaluation Test Group | We will evaluate the effects of an educational, tailored, online rehabilitation program addressing sexual and urinary outcomes after treatment by surveying at 3 month intervals Restore Rehabilitation Program: Multi-component, structured, biopsychosocial, online interactive program to address the sexual and urinary effects of prostate cancer treatment | 4 | 204 | 0 | 204 | 0 | 204 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |