Trial Outcomes & Findings for A Couple Support Intervention for Prostate Cancer (NCT NCT01842438)

Last Updated: 2017-06-05

Results Overview

EPIC is a quality of life tool used in prostate cancer studies, focused on physical and sexual outcomes. It is validated with population norms. We used the sexual bother sub-scale as the primary outcome measure; score range 0-400. A higher score indicates better function/better outcome.

Recruitment status

COMPLETED

Study phase

Target enrollment

86 participants

Primary outcome timeframe

Basline (T0), immediate post-intervention (T1) and 6 Months (T2)

Results posted on

2017-06-05

Participant Flow

Participant milestones

Participant milestones
Measure	Behavioral: Psychosexual Intervention 6-sessions of couple support focused on relationships and psychosexual functioning Behavioral: psychosexual intervention	Control This group will not receive the intervention during the life-span of the project
T1: Immediately After the Intervention STARTED	42	44
T1: Immediately After the Intervention COMPLETED	36	36
T1: Immediately After the Intervention NOT COMPLETED	6	8
T2: 6month Follow-up STARTED	36	36
T2: 6month Follow-up COMPLETED	32	32
T2: 6month Follow-up NOT COMPLETED	4	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Behavioral: Psychosexual Intervention 6-sessions of couple support focused on relationships and psychosexual functioning Behavioral: psychosexual intervention	Control This group will not receive the intervention during the life-span of the project
T1: Immediately After the Intervention Withdrawal by Subject	6	8
T2: 6month Follow-up Withdrawal by Subject	4	3
T2: 6month Follow-up Death	0	1

Baseline Characteristics

A Couple Support Intervention for Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Behavioral: Psychosexual Intervention n=42 Participants 6-sessions of couple support focused on relationships and psychosexual functioning Behavioral: psychosexual intervention	Control n=44 Participants This group will not receive the intervention during the life-span of the project	Total n=86 Participants Total of all reporting groups
Age, Continuous	64.15 years STANDARD_DEVIATION 6.885 • n=5 Participants	63.27 years STANDARD_DEVIATION 8.800 • n=7 Participants	63.72 years STANDARD_DEVIATION 7.772 • n=5 Participants
Sex/Gender, Customized Male	22 participants n=5 Participants	22 participants n=7 Participants	44 participants n=5 Participants
Sex/Gender, Customized Female	20 participants n=5 Participants	22 participants n=7 Participants	42 participants n=5 Participants
Region of Enrollment United Kingdom	42 participants n=5 Participants	44 participants n=7 Participants	86 participants n=5 Participants
EPIC sexual bother subscale (prostate-specific quality of life)	24.11 units on a scale n=5 Participants	20.45 units on a scale n=7 Participants	22.28 units on a scale n=5 Participants

PRIMARY outcome

Timeframe: Basline (T0), immediate post-intervention (T1) and 6 Months (T2)

Population: Primary outcome was at T1, sample size at T1, n=21 intervention, n=22 control. Sample size at T2, n=13 intervention, n=14 control At T1 (immediate follow-up) 3 intervention patients had withdrawn and 4 control patients had withdrawn. The scale was completed only by patients (all of whom were men, by as study focused on prostate cancer).

Outcome measures

Outcome measures
Measure	Behavioral: Psychosexual Intervention n=21 Participants 6-sessions of couple support focused on relationships and psychosexual functioning Behavioral: psychosexual intervention	Control n=22 Participants This group will not receive the intervention during the life-span of the project	Control: Patient Group Did not receive the intervention. All males	Control: Partners Did not receive the intervention; mostly females, but one male as there was one same-sex couple participating.
EPIC (Expanded Prostate Cancer Index Composite), Sexual Bother Subscale Patients T2	30.77 units on a scale Standard Deviation 32.12	29.91 units on a scale Standard Deviation 31.41	—	—
EPIC (Expanded Prostate Cancer Index Composite), Sexual Bother Subscale Patients T0	24.11 units on a scale Standard Deviation 20.38	20.45 units on a scale Standard Deviation 21.14	—	—
EPIC (Expanded Prostate Cancer Index Composite), Sexual Bother Subscale Patients T1	44.092 units on a scale Standard Deviation 30.42833	26.3889 units on a scale Standard Deviation 23.243	—	—

SECONDARY outcome

Timeframe: Basline (T0), immediate post-intervention (T1) and 6 Months (T2)

Population: Data received at each time-point was T0: intervention, T1: immediately after intervention; T2 6months post intervention.

The HADS has two scales: one anxiety and one depression. It is validated with population norms. Results are presented for T2 (6 month follow-up) and split by Patient, Partner and again by Intervention, Control. Responses are scored on a scale of 0-3 (3 indicates higher symptom frequencies. Scores for each subscale (anxiety and depression) range from 0 to 21 with scores categorized as follows: normal 0-7, mild 8-10, moderate 11-14, and severe 15-21. Scores for the entire scale (emotional distress) range from 0 to 42, with higher scores indicating more distress.

Outcome measures

Outcome measures
Measure	Behavioral: Psychosexual Intervention n=21 Participants 6-sessions of couple support focused on relationships and psychosexual functioning Behavioral: psychosexual intervention	Control n=21 Participants This group will not receive the intervention during the life-span of the project	Control: Patient Group n=22 Participants Did not receive the intervention. All males	Control: Partners n=22 Participants Did not receive the intervention; mostly females, but one male as there was one same-sex couple participating.
HADS (Hospital Anxiety and Depression Scale) HADS total (T0)	10.67 units on a scale Standard Deviation 6.87	11.14 units on a scale Standard Deviation 5.842	9.77 units on a scale Standard Deviation 6.406	8.55 units on a scale Standard Deviation 6.69
HADS (Hospital Anxiety and Depression Scale) Anxiety subscale only (T0)	6.24 units on a scale Standard Deviation 4.146	7.71 units on a scale Standard Deviation 3.59	6.32 units on a scale Standard Deviation 4.12	5.82 units on a scale Standard Deviation 4.57
HADS (Hospital Anxiety and Depression Scale) Depression subscale only (T0)	4.43 units on a scale Standard Deviation 3.56	3.43 units on a scale Standard Deviation 2.84	3.45 units on a scale Standard Deviation 2.72	2.73 units on a scale Standard Deviation 2.95
HADS (Hospital Anxiety and Depression Scale) HADS total (T1)	7.22 units on a scale Standard Deviation 5.92	6.98 units on a scale Standard Deviation 4.95	8.94 units on a scale Standard Deviation 6.20	8.72 units on a scale Standard Deviation 6.58
HADS (Hospital Anxiety and Depression Scale) Anxiety subscale only (T1)	4.06 units on a scale Standard Deviation 3.42	5.17 units on a scale Standard Deviation 3.60	5.72 units on a scale Standard Deviation 4.11	6.33 units on a scale Standard Deviation 4.99
HADS (Hospital Anxiety and Depression Scale) Depression subscale only (T1)	3.17 units on a scale Standard Deviation 3.22	1.72 units on a scale Standard Deviation 2.02	3.22 units on a scale Standard Deviation 2.46	2.39 units on a scale Standard Deviation 2.63
HADS (Hospital Anxiety and Depression Scale) HADS total (T2)	7.93 units on a scale Standard Deviation 5.980	5.57 units on a scale Standard Deviation 4.586	10.44 units on a scale Standard Deviation 7.624	9.19 units on a scale Standard Deviation 7.250
HADS (Hospital Anxiety and Depression Scale) Anxiety subscale only (T2)	4.29 units on a scale Standard Deviation 3.197	4.07 units on a scale Standard Deviation 2.674	6.69 units on a scale Standard Deviation 5.885	6.31 units on a scale Standard Deviation 5.510
HADS (Hospital Anxiety and Depression Scale) Depression subscale only (T2)	3.64 units on a scale Standard Deviation 3.365	1.5 units on a scale Standard Deviation 3.082	3.75 units on a scale Standard Deviation 2.646	2.88 units on a scale Standard Deviation 3.324

SECONDARY outcome

Timeframe: Basline (T0), immediate post-intervention (T1) and 6 Months (T2)

Population: Data received at each time-point was T0: intervention 42, control: 43; T1: intervention 36, control 36; T2 (as above) intervention 28, control 32

SCORE15 is an index of Family Function and Change, with 15 items. The potential range of scores is 15 to 75, with a lower score indicating higher family functioning. Total scores are reported in the data below.

Outcome measures

Outcome measures
Measure	Behavioral: Psychosexual Intervention n=28 Participants 6-sessions of couple support focused on relationships and psychosexual functioning Behavioral: psychosexual intervention	Control n=32 Participants This group will not receive the intervention during the life-span of the project	Control: Patient Group Did not receive the intervention. All males	Control: Partners Did not receive the intervention; mostly females, but one male as there was one same-sex couple participating.
SCORE15 (Systemic Core Outcome Measure) Patients T0	22.14 units on a scale Standard Deviation 5.825	27.52 units on a scale Standard Deviation 10.934	—	—
SCORE15 (Systemic Core Outcome Measure) Partners T0	24.38 units on a scale Standard Deviation 9.357	25.82 units on a scale Standard Deviation 7.986	—	—
SCORE15 (Systemic Core Outcome Measure) Patients T1	22.31 units on a scale Standard Deviation 7.181	27.50 units on a scale Standard Deviation 11.377	—	—
SCORE15 (Systemic Core Outcome Measure) Partners T1	22.67 units on a scale Standard Deviation 6.221	22.11 units on a scale Standard Deviation 6.807	—	—
SCORE15 (Systemic Core Outcome Measure) Patients T2	25.14 units on a scale Standard Deviation 9.550	29.25 units on a scale Standard Deviation 12.402	—	—
SCORE15 (Systemic Core Outcome Measure) Partners T2	21.64 units on a scale Standard Deviation 6.868	24.69 units on a scale Standard Deviation 10.423	—	—

Adverse Events

Behavioral: Psychosexual Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

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

Prof Liz Forbat, PI

Australian Catholic University

Phone: +61 475978476

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place