Prostatic Neoplasm
Conditions
Keywords
Erectile Dysfunction
Brief summary
Development and evaluation of an online intervention addressing sexual functioning in gay and bisexual men (GBM) after prostate cancer treatment.
Detailed description
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.
Interventions
BEHAVIORALRestore Rehabilitation Program
Multi-component, structured, biopsychosocial, online interactive program to address the sexual and urinary effects of prostate cancer treatment
BEHAVIORALControl
usual care, surveys every 3 months
Sponsors
National Cancer Institute (NCI)
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Gay or Bisexual Men, defined as a biological adult male, who by self-report, has had sex with a man. 2. Treated for prostate cancer, defined as (i) having been diagnosed with prostate cancer and measured by being able to report a Prostate- Specific Antigen and Gleason score; and (ii) treated by radical prostatectomy, radiation or systemically. 3. Has recent problems with sexual and/or urinary function, by self-report. This is measured by a screener item(s) asking the enrollee to describe their current function (last 4 weeks) and validated by nurse interview. 4. Internet-using 5. Living in the US (including territories) as measured by valid US zip code 6. A unique, validated individual, as measured by our published de-duplication and cross-validation protocols,230-232 and confirmed by video or phone interview.
Exclusion criteria
1. No Nerve Sparing and Salvage therapy. 2. Medical contraindications as determined by investigators at screening 3. Heavy smoking: more than 10 cigarettes, cigars, e-cigarettes, snuff pipe or similar product on an average day (screened over last 7 days) 4. Heavy alcohol use: more than 4 drinks per day, on two or more days, last 7 days 5. Participation is limited to English speakers/readers since intervention materials and surveys are in English. 6. Cognitive impairment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urinary Function Scores | 24 months | 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. |
| Sexual Functioning Scores | 24 months | 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. |
| Intervention Acceptability | 3-month follow-up | 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. |
| Intervention Feasibility | 3-month follow-up | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Evaluation Control Group Surveys at 3 month intervals
Control: usual care, surveys every 3 months | 197 |
| 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 | 204 |
| Total | 401 |
Baseline characteristics
| Characteristic | Intervention Evaluation Test Group | Total | Intervention Evaluation Control Group |
|---|---|---|---|
| Age, Continuous | 64 years STANDARD_DEVIATION 6.7 | 63.5 years STANDARD_DEVIATION 6.6 | 62.9 years STANDARD_DEVIATION 6.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 22 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 8 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) White | 186 Participants | 365 Participants | 179 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 204 Participants | 401 Participants | 197 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 197 | 4 / 204 |
| other Total, other adverse events | 0 / 197 | 0 / 204 |
| serious Total, serious adverse events | 0 / 197 | 0 / 204 |
Outcome results
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.
Time frame: 3-month follow-up
Population: Percent frequencies of those rating the intervention as acceptable
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Evaluation Control Group | Intervention Acceptability | 156 Participants |
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.
Time frame: 3-month follow-up
Population: Percent participants who where able to access the intervention at least once.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Evaluation Control Group | Intervention Feasibility | 189 Participants |
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.
Time frame: 24 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Evaluation Control Group | Sexual Functioning Scores | 37.5 Scores on a scale (0-100) |
| Intervention Evaluation Test Group | Sexual Functioning Scores | 36.7 Scores on a scale (0-100) |
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.
Time frame: 24 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Evaluation Control Group | Urinary Function Scores | 80.1 Scores on a scale (0-100) |
| Intervention Evaluation Test Group | Urinary Function Scores | 81.4 Scores on a scale (0-100) |