Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01CA127493-01A2 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This intervention program combines biofeedback PFME with a telephone or support group intervention to treat persistent urinary incontinence (UI). The study's primary aims are to improve continence, quality of life, and mood through enhancing adherence to PFME and self-management of incontinence symptoms. The secondary aims are to examine the physiological effects and cost effectiveness of the proposed interventions.
This is a randomized, controlled longitudinal study. Patients with early-stage prostate cancer and UI for more than six months were randomly assigned to one of three study arms: (1) biofeedback PFME plus a support group (BF+SUPPORT); (2) biofeedback PFME plus telephone (BF+PHONE); and (3) usual care (UC). The BF+SUPPORT and BF+PHONE participants learned PFME through computerized biofeedback. Thereafter, the BF+SUPPORT participants attended six group meetings and the BF+PHONE participants had six phone contacts every other week for three months. The UC participants did not receive biofeedback PFME or telephone/group intervention but continued receiving usual medical care. All subjects were assessed blind at baseline, 3 months (post intervention) and 6 months (follow-up). In addition, 49 moderately to severely incontinent patients were recruited from the three study groups to undergo urodynamic testing at baseline and 3 months for the evaluation of physiological changes. Data of the costs for the interventions and the participants' medical care were collected for a cost-effectiveness analysis.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BF+SUPPORT | Experimental | a 60-minute session of biofeedback (BF) training in pelvic floor muscle exercises plus 6 biweekly peer support group sessions during 3 months to learn symptom self- management skills |
|
| BF+PHONE | Experimental | a 60-minute session of biofeedback (BF) training in pelvic floor muscle exercises plus 6 biweekly individual telephone contact with a therapist during 3 months to learn symptom self- management skills |
|
| Usual Care | No Intervention | Subjects continued receiving usual care without receiving any intervention training sessions |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BF+SUPPORT | Behavioral | A session of biofeedback-assisted pelvic floor muscle exercises (PFME) plus 6 group sessions of the Problem-Solving Therapy (teaching self-management skills). |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of Urinary Leakage | Amount of leakage measured on 1-hour pad test | Measured at baseline, 3 months after baseline, and then 6 months after the baseline assessment |
| Frequency of Daily Urinary Leakage | Average times of daily leakage measured on a 3-day diary | Measured at baseline, 3 months after baseline, and then 6 months after the baseline assessment |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Amy Zhang, Ph.D. | Case Western Reserve University | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19917835 | Background | Balch CM, Gershenwald JE, Soong SJ, Thompson JF, Atkins MB, Byrd DR, Buzaid AC, Cochran AJ, Coit DG, Ding S, Eggermont AM, Flaherty KT, Gimotty PA, Kirkwood JM, McMasters KM, Mihm MC Jr, Morton DL, Ross MI, Sober AJ, Sondak VK. Final version of 2009 AJCC melanoma staging and classification. J Clin Oncol. 2009 Dec 20;27(36):6199-206. doi: 10.1200/JCO.2009.23.4799. Epub 2009 Nov 16. | |
| 3558716 | Background | Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8. |
Not provided
Not provided
Not provided
A randomized, controlled, longitudinal clinical trial was performed from 2010 to 2013 in Cleveland, Ohio
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | BE+Support | a 60-minute session of biofeedback (BF) training in pelvic floor muscle exercises plus 6 biweekly peer support group sessions during 3 months to learn symptom self- management skills |
| FG001 | BF+PHONE | a 60-minute session of biofeedback (BF) training in pelvic floor muscle exercises plus 6 biweekly individual telephone contact with a therapist during 3 months to learn symptom self- management skills |
| FG002 | Usual Care | Subjects continued receiving usual care without receiving any intervention training sessions |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | BF+Support | a 60-minute session of biofeedback (BF) training in pelvic floor muscle exercises plus 6 biweekly peer support group sessions during 3 months to learn symptom self- management skills |
| BG001 | BF+PHONE |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age is measured in years |
| 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 | Amount of Urinary Leakage | Amount of leakage measured on 1-hour pad test | Data are reported only for those who completed the entire study. | Posted | Mean | Standard Deviation | grams | Measured at baseline, 3 months after baseline, and then 6 months after the baseline assessment |
|
7 months (study duration)
This is a behavioral study and has a low risk for study subjects. All participants' charts are reviewed and adverse events are reported.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BF+Support | a 60-minute session of biofeedback (BF) training in pelvic floor muscle exercises plus 6 biweekly peer support group sessions during 3 months to learn symptom self- management skills |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Renal and urinary disorders | serious | Systematic Assessment | Two urinary tract infection possibly associated with study procedure |
Not provided
Limitations:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amy Zhang PhD | Case Western Reserve University | 2163680968 | amy.zhang@case.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Dec 8, 2009 | Aug 19, 2022 | ICF_000.pdf |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
A biobehavioral interveniton was tested
Not provided
Not provided
Not provided
| BF+PHONE | Behavioral | A session of biofeedback-assisted pelvic floor muscle exercises (PFME) plus 6 telephone sessions of the Problem-Solving Therapy (teaching self-management skills). |
|
| 26231554 | Result | Zhang AY, Bodner DR, Fu AZ, Gunzler DD, Klein E, Kresevic D, Moore S, Ponsky L, Purdum M, Strauss G, Zhu H. Effects of Patient Centered Interventions on Persistent Urinary Incontinence after Prostate Cancer Treatment: A Randomized, Controlled Trial. J Urol. 2015 Dec;194(6):1675-81. doi: 10.1016/j.juro.2015.07.090. Epub 2015 Jul 29. |
| 27341843 | Result | Zhang AY, Fu AZ, Moore S, Zhu H, Strauss G, Kresevic D, Klein E, Ponsky L, Bodner DR. Is a behavioral treatment for urinary incontinence beneficial to prostate cancer survivors as a follow-up care? J Cancer Surviv. 2017 Feb;11(1):24-31. doi: 10.1007/s11764-016-0557-0. Epub 2016 Jun 24. |
| 30903368 | Result | Zhang AY, Ganocy S, Fu AZ, Kresevic D, Ponsky L, Strauss G, Bodner DR, Zhu H. Mood outcomes of a behavioral treatment for urinary incontinence in prostate cancer survivors. Support Care Cancer. 2019 Dec;27(12):4461-4467. doi: 10.1007/s00520-019-04745-w. Epub 2019 Mar 22. |
| 31762400 | Result | Zhang AY, Burant C, Fu AZ, Strauss G, Bodner DR, Ponsky L. Psychosocial mechanisms of a behavioral treatment for urinary incontinence of prostate cancer survivors. J Psychosoc Oncol. 2020 Mar-Apr;38(2):210-227. doi: 10.1080/07347332.2019.1678547. Epub 2019 Nov 24. |
| 25963381 | Result | Zhang AY, Fu AZ. Cost-effectiveness of a behavioral intervention for persistent urinary incontinence in prostate cancer patients. Psychooncology. 2016 Apr;25(4):421-7. doi: 10.1002/pon.3849. Epub 2015 May 12. |
a 60-minute session of biofeedback (BF) training in pelvic floor muscle exercises plus 6 biweekly individual telephone contact with a therapist during 3 months to learn symptom self- management skills
| BG002 | Usual Care | Subjects continued receiving usual care without receiving any intervention training sessions |
| BG003 | Total | Total of all reporting groups |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Self reported and verified with medical chart data | Each row represents a study arm/ group. Total participants from three study arms =244 (overall number of participants) | Count of Participants | Participants |
|
| Race (NIH/OMB) | row 1 = overall (n=244) row 2-3: each row represents a study arm/ group | Count of Participants | Participants |
|
| Marriat Status (Married) | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Employed | Count of Participants | Participants |
|
| Cancer Stage | The cancer stages were obtained from chart reviews. The stages were determined by treating physicians using the AJCC (American Joint Committee on Cancer) TNM staging system. Stage ranges from 1 to 4, with 4 indicating metastasis (worst) stage. Stage 4 was excluded from this study based on eligibility criteria. | Count of Participants | Participants |
|
| Received Surgery | Count of Participants | Participants |
|
| Received Radiation | Count of Participants | Participants |
|
| BMI | Body mass index "BMI" was collected from medical chart review. "BMI" is typically presented with Unit of Measure "kg/m^2" If your BMI is less than 18.5, it falls within the underweight range. If your BMI is 18.5 to <25, it falls within the healthy weight range. If your BMI is 25.0 to <30, it falls within the overweight range. If your BMI is 30.0 or higher, it falls within the obesity range. | Mean | Standard Deviation | kg/m^2 |
|
| PSA | Prostate-specific antigen "PSA" is typically presented with Unit of Measure ng/mL. At NIH website, https://www.cancer.gov/types/prostate/psa-fact-sheet, it says "PSA is a protein produced by normal, as well as malignant, cells of the prostate gland. This test measures the level of PSA in the blood," with a higher level indicating a potential problem. | Mean | Standard Deviation | ng/mL |
|
| Charlson comorbidity index score | The Charlson Comorbidity Index (CCI) is a checklist that comprised of 19 health conditions (dichotomously coded as "yes/ no"). The CCI score is a calculated score that assigns different weights to each possible comorbid condition (e.g., myocardial infarction scoring 1, metastatic solid tumor scoring 6). The 19 health conditions were obtained from medical chart reviews. Range of CCI adjusted for age is 0 to 37. Higher CCI scores represent more comorbid conditions and worse projected health outcomes. | Mean | Standard Deviation | score on a scale |
|
| OG002 | BF+Support | a 60-minute session of biofeedback (BF) training in pelvic floor muscle exercises plus 6 biweekly peer support group sessions during 3 months to learn symptom self- management skills |
|
|
| Primary | Frequency of Daily Urinary Leakage | Average times of daily leakage measured on a 3-day diary | Data are reported only for those who completed this measure at all three assessment points. Subjects that did not complete this measure three times were not included. | Posted | Mean | Standard Deviation | Leaks per day | Measured at baseline, 3 months after baseline, and then 6 months after the baseline assessment |
|
|
|
| 0 |
| 81 |
| 0 |
| 81 |
| 0 |
| 81 |
| EG001 | BF+PHONE | a 60-minute session of biofeedback (BF) training in pelvic floor muscle exercises plus 6 biweekly individual telephone contact with a therapist during 3 months to learn symptom self- management skills | 0 | 81 | 2 | 81 | 0 | 81 |
| EG002 | Usual Care | Subjects continued receiving usual care without receiving any intervention training sessions | 0 | 82 | 1 | 82 | 0 | 82 |
|
| Fall | General disorders | Serious | Systematic Assessment | Patient fell during 1-hour pad testing that requires walking for a few minutes. |
|
Not provided
Not provided
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D011469 | Prostatic Diseases |
|
| T3 (6 month) |
|