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| Name | Class |
|---|---|
| Prostate Cancer UK | OTHER |
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Even with careful prostate surgery, men find it difficult to have an erection. Our previous research shows that couples are not often supported to cope with the effects of surgery on their sexual relationships. In this study, the investigators will design a way of supporting couples, and test how well it works.
The investigators will decide what the support should include (e.g. duration, frequency and timing of the support). The investigators will do this by looking at available literature on the subject.
The investigators will recruit 68 couples to the study, half will receive standard care and the other half will be invited to attend six sessions of psychosexual support with specially trained professionals (trained by men affected by prostate conditions and a cancer/couple support specialist). Before and after the support, men and their partners will be asked to complete questionnaires which measure quality-of-life, emotional needs, and their relationship. The investigators will ask the couples to fill out the questionnaires again six-months later to see if the support has long-term benefits. At the end of the study the investigators will also interview 10 couples to find out their views of the support, and another 10 couples about standard treatment.
When the investigators have tested this support, they expect to see men and their partners tell us that their quality of life has improved, and they have higher satisfaction with their relationship. The investigators will calculate the overall cost of providing this support, and the benefits it has on reducing the need for other health-care services (like General Practice use).
Scientific abstract
Evidence shows significant unmet psychosexual needs for couples affected by prostate cancer. Studies have identified the contribution that psychosocial interventions could have for couples, e.g. strengthening healthy adaptation and better communication, developing coping skills for distressed couples, and facilitating healthy spousal communication to address the sexual rehabilitation needs.
This is a feasibility study with a built-in pilot, which will examine the acceptability, feasibility and outcomes of a psychosexual intervention to support couples, drawing on the Medical Research Council complex intervention framework.
The intervention will be developed from the extant and our pilot work. Men in outpatient surgical follow-up clinics will be screened using EPIC, and recruited if scoring under the clinical threshold for potency. 68 couples will be randomised to two arms, one receiving six sessions of couple-support from specially trained counsellors and the others receiving standard care. The primary outcome measure is health-related quality-of-life. Pre, post and 6-month follow-up outcomes will be measured in both individual (quality of life; anxiety/depression) and in relational terms (relationship between couples). An economic analysis will identify population costs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioral: psychosexual intervention | Experimental | 6-sessions of couple support focused on relationships and psychosexual functioning |
|
| Control | No Intervention | This group will not receive the intervention during the life-span of the project |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral: psychosexual intervention | Behavioral | 6 session manualised intervention, This manual-based family-relational-psychosexual support was based on systemic principles combined with techniques from sex therapy, i.e. sensate focus. The manual offered an intermediate level of specificity, enabling practitioners to use their own therapeutic style and take some lead from the couple while meeting the objectives of the intervention. Specialist training in delivery of the intervention was provided to practitioners holding accredited counselling or psychotherapy qualifications. Practitioners engaged in routine clinical supervision with one additional team supervision session offered by one of the practitioners |
| Measure | Description | Time Frame |
|---|---|---|
| EPIC (Expanded Prostate Cancer Index Composite), Sexual Bother Subscale | 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. | Basline (T0), immediate post-intervention (T1) and 6 Months (T2) |
| Measure | Description | Time Frame |
|---|---|---|
| HADS (Hospital Anxiety and Depression Scale) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liz Forbat, PhD | University of Stirling | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Western General Hospital | Edinburgh | Lothian | EH4 2XU | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24886676 | Derived | Robertson JM, Molloy GJ, Bollina PR, Kelly DM, McNeill SA, Forbat L. Exploring the feasibility and acceptability of couple-based psychosexual support following prostate cancer surgery: study protocol for a pilot randomised controlled trial. Trials. 2014 May 24;15:183. doi: 10.1186/1745-6215-15-183. |
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Consent was not gained for data sharing in this manner
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| ID | Title | Description |
|---|---|---|
| FG000 | Behavioral: Psychosexual Intervention | 6-sessions of couple support focused on relationships and psychosexual functioning Behavioral: psychosexual intervention |
| FG001 | Control | This group will not receive the intervention during the life-span of the project |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| T1: Immediately After the Intervention |
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| ||||||||||||||||||
| T2: 6month Follow-up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Behavioral: Psychosexual Intervention | 6-sessions of couple support focused on relationships and psychosexual functioning Behavioral: psychosexual intervention |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Data was collected only for patient participants (all of whom were male) |
| 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 | EPIC (Expanded Prostate Cancer Index Composite), Sexual Bother Subscale | 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. | 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). | Posted | Mean | Standard Deviation | units on a scale | Basline (T0), immediate post-intervention (T1) and 6 Months (T2) |
|
Participants were followed for the duration of the trial, from return of consent form to completion of the T2 measures (6months following the end of the intervention)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Behavioral: Psychosexual Intervention | 6-sessions of couple support focused on relationships and psychosexual functioning Behavioral: psychosexual intervention |
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Under-recruitment means the study is not powered (though the study was designed as a pilot, so not hypothesis testing).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof Liz Forbat, PI | Australian Catholic University | +61 475978476 | elizabeth.forbat@acu.edu.au |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D020018 | Sexual Dysfunctions, Psychological |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| Basline (T0), immediate post-intervention (T1) and 6 Months (T2) |
| SCORE15 (Systemic Core Outcome Measure) | 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. | Basline (T0), immediate post-intervention (T1) and 6 Months (T2) |
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This group will not receive the intervention during the life-span of the project
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
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| Sex/Gender, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| EPIC sexual bother subscale (prostate-specific quality of life) | Higher scores indicate better outcomes (better functioning; less bother). This measure was only completed by patients (all of whom were male). | Mean | Full Range | units on a scale |
|
| OG001 | Control | This group will not receive the intervention during the life-span of the project |
|
|
| Secondary | HADS (Hospital Anxiety and Depression Scale) | 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. | Data received at each time-point was T0: intervention, T1: immediately after intervention; T2 6months post intervention. | Posted | Mean | Standard Deviation | units on a scale | Basline (T0), immediate post-intervention (T1) and 6 Months (T2) |
|
|
|
| Secondary | SCORE15 (Systemic Core Outcome Measure) | 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. | Data received at each time-point was T0: intervention 42, control: 43; T1: intervention 36, control 36; T2 (as above) intervention 28, control 32 | Posted | Mean | Standard Deviation | units on a scale | Basline (T0), immediate post-intervention (T1) and 6 Months (T2) |
|
|
|
| 0 |
| 42 |
| 0 |
| 42 |
| EG001 | Control | This group will not receive the intervention during the life-span of the project | 0 | 44 | 0 | 44 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D001523 | Mental Disorders |
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| Anxiety subscale only (T0) |
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| Depression subscale only (T0) |
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| HADS total (T1) |
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| Anxiety subscale only (T1) |
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| Depression subscale only (T1) |
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| HADS total (T2) |
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| Anxiety subscale only (T2) |
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| Depression subscale only (T2) |
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| Patients T1 |
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| Partners T1 |
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| Patients T2 |
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| Partners T2 |
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