Trial Outcomes & Findings for Telephone Counseling: Men With Prostate Cancer & Partners (NCT NCT00822510)
NCT ID: NCT00822510
Last Updated: 2018-05-11
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
79 participants
Primary outcome timeframe
3 points in time, baseline, T2=T1+8 weeks, T3=T2 plus 8 weeks
Results posted on
2018-05-11
Participant Flow
Participant milestones
| Measure |
Telephone Delivered Interpersonal Counseling
Telephone delivered education and support for 8 weeks
Telephone Interpersonal Counselling Intervention: Telephone delivered 8 week education and support intervention
|
Telephone Delivered Education Only
Telephone delivered education only for 8 weeks
Telephone delivered education only: Telephone delivered education for 8 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
41
|
|
Overall Study
COMPLETED
|
35
|
36
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Telephone Counseling: Men With Prostate Cancer & Partners
Baseline characteristics by cohort
| Measure |
Telephone Delivered Interpersonal Counseling
n=38 Participants
Telephone delivered education and support for 8 weeks
Telephone Interpersonal Counselling Intervention: Telephone delivered 8 week education and support intervention
|
Telephone Delivered Education Only
n=41 Participants
Telephone delivered education only for 8 weeks
Telephone delivered education only: Telephone delivered education for 8 weeks
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.7 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
68.3 years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
66.9 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=5 Participants
|
41 participants
n=7 Participants
|
79 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 points in time, baseline, T2=T1+8 weeks, T3=T2 plus 8 weeksPopulation: 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
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.
Outcome measures
| Measure |
Telephone Delivered Interpersonal Counseling
n=35 Participants
Telephone delivered education and support for 8 weeks
Telephone Interpersonal Counselling Intervention: Telephone delivered 8 week education and support intervention
|
Telephone Delivered Education Only
n=36 Participants
Telephone delivered education only for 8 weeks
Telephone delivered education only: Telephone delivered education for 8 weeks
|
|---|---|---|
|
Center for Epidemiological Studies-Depression Scale
Time 1
|
11.41 units on scale
Standard Deviation 9.0
|
12.43 units on scale
Standard Deviation 9.7
|
|
Center for Epidemiological Studies-Depression Scale
Time 2
|
11.39 units on scale
Standard Deviation 9.2
|
9.06 units on scale
Standard Deviation 9.7
|
|
Center for Epidemiological Studies-Depression Scale
Time 3
|
11.18 units on scale
Standard Deviation 13.4
|
8.86 units on scale
Standard Deviation 10
|
PRIMARY outcome
Timeframe: 3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)Perceived stress scale is a 10-item scale with a range of 0-40. Higher scores indicate more stress.
Outcome measures
| Measure |
Telephone Delivered Interpersonal Counseling
n=36 Participants
Telephone delivered education and support for 8 weeks
Telephone Interpersonal Counselling Intervention: Telephone delivered 8 week education and support intervention
|
Telephone Delivered Education Only
n=34 Participants
Telephone delivered education only for 8 weeks
Telephone delivered education only: Telephone delivered education for 8 weeks
|
|---|---|---|
|
Perceived Stress
Time 3
|
12.25 units on scale
Standard Deviation 7.1
|
9.9 units on scale
Standard Deviation 6.7
|
|
Perceived Stress
Time 1
|
12.69 units on scale
Standard Deviation 6.5
|
13.17 units on scale
Standard Deviation 9.7
|
|
Perceived Stress
Time 2
|
12.45 units on scale
Standard Deviation 6.5
|
11.23 units on scale
Standard Deviation 7.3
|
PRIMARY outcome
Timeframe: 3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)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.
Outcome measures
| Measure |
Telephone Delivered Interpersonal Counseling
n=36 Participants
Telephone delivered education and support for 8 weeks
Telephone Interpersonal Counselling Intervention: Telephone delivered 8 week education and support intervention
|
Telephone Delivered Education Only
n=34 Participants
Telephone delivered education only for 8 weeks
Telephone delivered education only: Telephone delivered education for 8 weeks
|
|---|---|---|
|
Positive Affect
Time 1
|
35.11 units on scale
Standard Deviation 6.6
|
36.71 units on scale
Standard Deviation 7.4
|
|
Positive Affect
Time 2
|
36.7 units on scale
Standard Deviation 7.7
|
37.87 units on scale
Standard Deviation 6.1
|
|
Positive Affect
Time 3
|
35.84 units on scale
Standard Deviation 8.5
|
37.52 units on scale
Standard Deviation 6.7
|
PRIMARY outcome
Timeframe: 3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)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.
Outcome measures
| Measure |
Telephone Delivered Interpersonal Counseling
n=36 Participants
Telephone delivered education and support for 8 weeks
Telephone Interpersonal Counselling Intervention: Telephone delivered 8 week education and support intervention
|
Telephone Delivered Education Only
n=34 Participants
Telephone delivered education only for 8 weeks
Telephone delivered education only: Telephone delivered education for 8 weeks
|
|---|---|---|
|
Negative Affect
Time 1
|
15.97 units on scale
Standard Deviation 6.3
|
17.03 units on scale
Standard Deviation 7.4
|
|
Negative Affect
Time 2
|
16.76 units on scale
Standard Deviation 7.1
|
14.84 units on scale
Standard Deviation 6.2
|
|
Negative Affect
Time 3
|
15.32 units on scale
Standard Deviation 6.4
|
14.07 units on scale
Standard Deviation 4.1
|
PRIMARY outcome
Timeframe: 3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)Measure of physical well-being, specifically fatigue, using the Multidimensional Fatigue Scale. Scores range from 0-80 with higher scores indicative of more fatigue.
Outcome measures
| Measure |
Telephone Delivered Interpersonal Counseling
n=36 Participants
Telephone delivered education and support for 8 weeks
Telephone Interpersonal Counselling Intervention: Telephone delivered 8 week education and support intervention
|
Telephone Delivered Education Only
n=34 Participants
Telephone delivered education only for 8 weeks
Telephone delivered education only: Telephone delivered education for 8 weeks
|
|---|---|---|
|
Multidimensional Fatigue Inventory
Time 1
|
26.78 units on scale
Standard Deviation 15.8
|
28.17 units on scale
Standard Deviation 18.1
|
|
Multidimensional Fatigue Inventory
Time 2
|
27.06 units on scale
Standard Deviation 17.5
|
24.48 units on scale
Standard Deviation 19.2
|
|
Multidimensional Fatigue Inventory
Time 3
|
26.81 units on scale
Standard Deviation 17.5
|
21.69 units on scale
Standard Deviation 17.5
|
PRIMARY outcome
Timeframe: 3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)Measures social well-being using the 9 item Social Well-being scale, ranging from 9-90. Higher score indicates increased social well-being.
Outcome measures
| Measure |
Telephone Delivered Interpersonal Counseling
n=36 Participants
Telephone delivered education and support for 8 weeks
Telephone Interpersonal Counselling Intervention: Telephone delivered 8 week education and support intervention
|
Telephone Delivered Education Only
n=34 Participants
Telephone delivered education only for 8 weeks
Telephone delivered education only: Telephone delivered education for 8 weeks
|
|---|---|---|
|
Social Well Being
Time 1
|
56.31 units on scale
Standard Deviation 17.3
|
61.13 units on scale
Standard Deviation 16.1
|
|
Social Well Being
Time 2
|
59.15 units on scale
Standard Deviation 15.7
|
62.71 units on scale
Standard Deviation 16.1
|
|
Social Well Being
Time 3
|
56.66 units on scale
Standard Deviation 19.5
|
63.1 units on scale
Standard Deviation 16
|
PRIMARY outcome
Timeframe: 3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)Measures if spiritual beliefs using a 7-item scale that ranges from 7-70. Higher score equals greater spiritual wellbeing.
Outcome measures
| Measure |
Telephone Delivered Interpersonal Counseling
n=36 Participants
Telephone delivered education and support for 8 weeks
Telephone Interpersonal Counselling Intervention: Telephone delivered 8 week education and support intervention
|
Telephone Delivered Education Only
n=34 Participants
Telephone delivered education only for 8 weeks
Telephone delivered education only: Telephone delivered education for 8 weeks
|
|---|---|---|
|
Spiritual Well Being
Time 1
|
43.64 units on scale
Standard Deviation 14.8
|
44.17 units on scale
Standard Deviation 11.6
|
|
Spiritual Well Being
Time 2
|
42.76 units on scale
Standard Deviation 14
|
46.45 units on scale
Standard Deviation 11.9
|
|
Spiritual Well Being
Time 3
|
42.09 units on scale
Standard Deviation 13.9
|
47.83 units on scale
Standard Deviation 12
|
Adverse Events
Telephone Delivered Interpersonal Counseling
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Telephone Delivered Education Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Terry Badger, PhD, PMHCNS-BC, FAAN
University of Arizona College of Nursing
Phone: 520-626-6058
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place