Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R21CA113409 | 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
The purpose of this project is to test a telephone delivered educational support program versus an education only program for improving symptom management and quality of life in men with prostate cancer and their partners.
Eligibility Criteria for men: receiving treatment for prostate cancer,over 21 years of age, English speaking, have access to and ability to talk on the phone and have a partner willing to participate in the study. Participants can live anywhere in the United States because the intervention is telephone delivered.
Partners can be anyone the man selects (friend or relative) who is over 21 years of age, English speaking and has access to or ability to speak on the phone.
Men and their partners will be assigned to one of two groups. Each survivor will receive 8 telephone calls over an 8-week period for about 30 minutes each. Each partner will receive 4 telephone calls every other week for about 30 minutes each. We will ask everyone to complete a baseline assessment over the telephone, after the 8 weeks, and then again about 8 weeks after the second assessment.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telephone Interpersonal Counseling | Experimental | Telephone delivered interpersonal counseling support intervention. Intervention was for 8 weeks. Participants were called on the telephone each week for about 30 minutes. |
|
| Telephone delivered education only | Active Comparator | Telephone delivered education only. Educational topics included prostate cancer health, side effects, physical activity, diet. Participants were called on the telephone each week for about 30 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telephone Interpersonal Counseling | Behavioral | Telephone delivered 8 week education and counseling intervention based on interpersonal psychotherapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Center for Epidemiological Studies-Depression Scale | Depression was measured by the 20-item Center for Epidemiological Studies-Depression (CES-D) scale, Range is 0-60. Scores are added together with higher score greater depression. | 3 points in time, baseline, T2=T1+8 weeks, T3=T2 plus 8 weeks |
| Perceived Stress | Perceived stress scale is a 10-item scale with a range of 0-40. Higher scores indicate more stress. | 3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks) |
| Positive Affect | Positive and Negative Affect Scale is a 20 item scale that measures positive and negative affect subscales. Scores range from 10-50 on each subscale with higher score indicating more positive affect. | 3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks) |
| Negative Affect | Positive and Negative Affect Scale is a 20 item scale that measures positive and negative affect subscales. Scores range from 10-50 on each subscale with higher score indicating more positive affect. | 3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks) |
| Multidimensional Fatigue Inventory | Measure of physical well-being, specifically fatigue, using the Multidimensional Fatigue Scale. Scores range from 0-80 with higher scores indicative of more fatigue. | 3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks) |
| Social Well Being | Measures social well-being using the 9 item Social Well-being scale, ranging from 9-90. Higher score indicates increased social well-being. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Terry Badger, PhD, RN | University of Arizona College of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona | Tucson | Arizona | 85721 | United States |
Not provided
| Label | URL |
|---|---|
| College of Nursing Webpage | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Telephone Delivered Interpersonal Counseling | Telephone delivered education and support for 8 weeks Telephone Interpersonal Counselling Intervention: Telephone delivered 8 week education and support intervention |
| FG001 | Telephone Delivered Education Only | Telephone delivered education only for 8 weeks Telephone delivered education only: Telephone delivered education for 8 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Telephone Delivered Interpersonal Counseling | Telephone delivered education and support for 8 weeks Telephone Interpersonal Counselling Intervention: Telephone delivered 8 week education and support intervention |
| BG001 | Telephone Delivered Education Only |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Center for Epidemiological Studies-Depression Scale | Depression was measured by the 20-item Center for Epidemiological Studies-Depression (CES-D) scale, Range is 0-60. Scores are added together with higher score greater depression. | Badger, T.A., Segrin, C., Figueredo, A.J., Harrington, J., Sheppard, K., Passalacqua, S., Pasvogel, A., & Bishop, M. (2011) Psychosocial Interventions to Improve Quality of Life in Prostate Cancer Survivors and their Intimate or Family Partners. Quality of Life Research. 20 (6), 833-844 [epub Dec 2010]. PMID: 21170682; PMCID: PMC3117079 | Posted | Mean | Standard Deviation | units on scale | 3 points in time, baseline, T2=T1+8 weeks, T3=T2 plus 8 weeks |
|
There were no adverse advents to report
Not provided
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 | Telephone Delivered Interpersonal Counseling | Telephone delivered education and support for 8 weeks Telephone Interpersonal Counselling Intervention: Telephone delivered 8 week education and support intervention |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Terry Badger, PhD, PMHCNS-BC, FAAN | University of Arizona College of Nursing | 520-626-6058 | tbadger@email.arizona.edu |
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Telephone delivered education only | Behavioral | Telephone delivered 8 week educational intervention on prostate cancer health, side effects, physical activity, diet, smoking cessation |
|
| 3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks) |
| Spiritual Well Being | Measures if spiritual beliefs using a 7-item scale that ranges from 7-70. Higher score equals greater spiritual wellbeing. | 3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks) |
Telephone delivered education only for 8 weeks Telephone delivered education only: Telephone delivered education for 8 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Participants were asked if they were male or female | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Telephone Delivered Education Only | Telephone delivered education only for 8 weeks Telephone delivered education only: Telephone delivered education for 8 weeks |
|
|
|
| Primary | Perceived Stress | Perceived stress scale is a 10-item scale with a range of 0-40. Higher scores indicate more stress. | Posted | Mean | Standard Deviation | units on scale | 3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks) |
|
|
|
| Primary | Positive Affect | Positive and Negative Affect Scale is a 20 item scale that measures positive and negative affect subscales. Scores range from 10-50 on each subscale with higher score indicating more positive affect. | Posted | Mean | Standard Deviation | units on scale | 3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks) |
|
|
|
|
| Primary | Negative Affect | Positive and Negative Affect Scale is a 20 item scale that measures positive and negative affect subscales. Scores range from 10-50 on each subscale with higher score indicating more positive affect. | Posted | Mean | Standard Deviation | units on scale | 3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks) |
|
|
|
|
| Primary | Multidimensional Fatigue Inventory | Measure of physical well-being, specifically fatigue, using the Multidimensional Fatigue Scale. Scores range from 0-80 with higher scores indicative of more fatigue. | Posted | Mean | Standard Deviation | units on scale | 3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks) |
|
|
|
|
| Primary | Social Well Being | Measures social well-being using the 9 item Social Well-being scale, ranging from 9-90. Higher score indicates increased social well-being. | Posted | Mean | Standard Deviation | units on scale | 3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks) |
|
|
|
|
| Primary | Spiritual Well Being | Measures if spiritual beliefs using a 7-item scale that ranges from 7-70. Higher score equals greater spiritual wellbeing. | Posted | Mean | Standard Deviation | units on scale | 3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks) |
|
|
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| EG001 | Telephone Delivered Education Only | Telephone delivered education only for 8 weeks Telephone delivered education only: Telephone delivered education for 8 weeks | 0 | 41 | 0 | 41 |
Not provided
Not provided
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| Time 3 |
|
| Time 3 |
|
| Time 3 |
|
| Time 3 |
|
| Time 3 |
|
| Time 3 |
|