Telephone Counseling: Men With Prostate Cancer & Partners

Telephone Counseling With Men With Prostate Cancer and Partners

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00822510

Enrollment

Registered

2009-01-14

Start date

2006-09-30

Completion date

2009-10-31

Last updated

2018-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Psychosocial Intervention, Men with Prostate Cancer & Partners

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALTelephone Interpersonal Counseling

Telephone delivered 8 week education and counseling intervention based on interpersonal psychotherapy.

BEHAVIORALTelephone delivered education only

Telephone delivered 8 week educational intervention on prostate cancer health, side effects, physical activity, diet, smoking cessation

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

Inclusion criteria

* Receiving treatment for prostate cancer * Over 21 years * Access to and ability to talk on the phone * Speaks English and has a partner to participate with him. * Partners are anyone who the man chooses (friend or relative) who is over 21 years, English speaking and has access and ability to talk on the phone.

Exclusion criteria

* under 21 years * Does not speak English

Design outcomes

Primary

Measure	Time frame	Description
Center for Epidemiological Studies-Depression Scale	3 points in time, baseline, T2=T1+8 weeks, T3=T2 plus 8 weeks	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.
Perceived Stress	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.
Positive Affect	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.
Negative Affect	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.
Multidimensional Fatigue Inventory	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.
Social Well Being	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.
Spiritual Well Being	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Telephone Delivered Interpersonal Counseling Telephone delivered education and support for 8 weeks Telephone Interpersonal Counselling Intervention: Telephone delivered 8 week education and support intervention	38
Telephone Delivered Education Only Telephone delivered education only for 8 weeks Telephone delivered education only: Telephone delivered education for 8 weeks	41
Total	79

Baseline characteristics

Characteristic	Telephone Delivered Interpersonal Counseling	Total	Telephone Delivered Education Only
Age, Continuous	65.7 years STANDARD_DEVIATION 9.5	66.9 years STANDARD_DEVIATION 9.6	68.3 years STANDARD_DEVIATION 9.6
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	3 Participants	4 Participants	1 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	2 Participants	2 Participants
Race (NIH/OMB) White	35 Participants	73 Participants	38 Participants
Region of Enrollment United States	38 participants	79 participants	41 participants
Sex: Female, Male Female	0 Participants	0 Participants	0 Participants
Sex: Female, Male Male	38 Participants	79 Participants	41 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 38	0 / 41
serious Total, serious adverse events	0 / 38	0 / 41

Outcome results

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.

Time frame: 3 points in time, baseline, T2=T1+8 weeks, T3=T2 plus 8 weeks

Population: 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

Arm	Measure	Group	Value (MEAN)	Dispersion
Telephone Delivered Interpersonal Counseling	Center for Epidemiological Studies-Depression Scale	Time 1	11.41 units on scale	Standard Deviation 9
Telephone Delivered Interpersonal Counseling	Center for Epidemiological Studies-Depression Scale	Time 2	11.39 units on scale	Standard Deviation 9.2
Telephone Delivered Interpersonal Counseling	Center for Epidemiological Studies-Depression Scale	Time 3	11.18 units on scale	Standard Deviation 13.4
Telephone Delivered Education Only	Center for Epidemiological Studies-Depression Scale	Time 1	12.43 units on scale	Standard Deviation 9.7
Telephone Delivered Education Only	Center for Epidemiological Studies-Depression Scale	Time 2	9.06 units on scale	Standard Deviation 9.7
Telephone Delivered Education Only	Center for Epidemiological Studies-Depression Scale	Time 3	8.86 units on scale	Standard Deviation 10

p-value: <0.05ANOVA

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.