Prostate Cancer
Conditions
Keywords
Sexual Dysfunctions, Psychological
Brief summary
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).
Detailed description
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.
Interventions
BEHAVIORALBehavioral: psychosexual intervention
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
Sponsors
Prostate Cancer UK
University of Stirling
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Score of ≤60 on EPIC (a signal of potency) (EPIC is the Expanded Prostate Cancer Index Composite) * \>11 weeks post-operative for Prostate Cancer (PCa) (to recruit people who have recovered from the immediate effects from surgery and begun to regain some functioning. Follow-ups are held at 6weeks, 12weeks, 6months from surgery, until no further follow-up is required). * Has a partner
Exclusion criteria
* Does not have a partner (this is a couple intervention, the study can therefore only include men with a partner). * Prognosis of ≤1year (Most men who have had recent surgery will have a good prognosis, consequently it is unlikely that many men will be excluded by this criteria.) * Unable to provide informed consent. * Residing in Dumfries and Galloway. The recruiting clinic sees patients from a wide catchment area. However to prevent excess burden on participants traveling to the intervention site in Edinburgh, the investigators will exclude those living in Dumfries and Galloway. * \>2 years from surgery (since long term adaptation will have commenced). * Unable to communicate in English (this is a feasibility trial, if the study moves to a full scale trial in future then it will seek to include couples and interpreters/translators).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EPIC (Expanded Prostate Cancer Index Composite), Sexual Bother Subscale | Basline (T0), immediate post-intervention (T1) and 6 Months (T2) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HADS (Hospital Anxiety and Depression Scale) | Basline (T0), immediate post-intervention (T1) and 6 Months (T2) | 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. |
| SCORE15 (Systemic Core Outcome Measure) | Basline (T0), immediate post-intervention (T1) and 6 Months (T2) | 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. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Behavioral: Psychosexual Intervention 6-sessions of couple support focused on relationships and psychosexual functioning
Behavioral: psychosexual intervention | 42 |
| Control This group will not receive the intervention during the life-span of the project | 44 |
| Total | 86 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| T1: Immediately After the Intervention | Withdrawal by Subject | 6 | 8 |
| T2: 6month Follow-up | Death | 0 | 1 |
| T2: 6month Follow-up | Withdrawal by Subject | 4 | 3 |
Baseline characteristics
| Characteristic | Behavioral: Psychosexual Intervention | Control | Total |
|---|---|---|---|
| Age, Continuous | 64.15 years STANDARD_DEVIATION 6.885 | 63.27 years STANDARD_DEVIATION 8.8 | 63.72 years STANDARD_DEVIATION 7.772 |
| EPIC sexual bother subscale (prostate-specific quality of life) | 24.11 units on a scale | 20.45 units on a scale | 22.28 units on a scale |
| Region of Enrollment United Kingdom | 42 participants | 44 participants | 86 participants |
| Sex/Gender, Customized Female | 20 participants | 22 participants | 42 participants |
| Sex/Gender, Customized Male | 22 participants | 22 participants | 44 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 42 | 0 / 44 |
| serious Total, serious adverse events | 0 / 42 | 0 / 44 |
Outcome results
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Behavioral: Psychosexual Intervention | EPIC (Expanded Prostate Cancer Index Composite), Sexual Bother Subscale | Patients T1 | 44.092 units on a scale | Standard Deviation 30.42833 |
| Behavioral: Psychosexual Intervention | EPIC (Expanded Prostate Cancer Index Composite), Sexual Bother Subscale | Patients T0 | 24.11 units on a scale | Standard Deviation 20.38 |
| Behavioral: Psychosexual Intervention | EPIC (Expanded Prostate Cancer Index Composite), Sexual Bother Subscale | Patients T2 | 30.77 units on a scale | Standard Deviation 32.12 |
| Control | EPIC (Expanded Prostate Cancer Index Composite), Sexual Bother Subscale | Patients T0 | 20.45 units on a scale | Standard Deviation 21.14 |
| Control | EPIC (Expanded Prostate Cancer Index Composite), Sexual Bother Subscale | Patients T1 | 26.3889 units on a scale | Standard Deviation 23.243 |
| Control | EPIC (Expanded Prostate Cancer Index Composite), Sexual Bother Subscale | Patients T2 | 29.91 units on a scale | Standard Deviation 31.41 |
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Behavioral: Psychosexual Intervention | HADS (Hospital Anxiety and Depression Scale) | Anxiety subscale only (T1) | 4.06 units on a scale | Standard Deviation 3.42 |
| Behavioral: Psychosexual Intervention | HADS (Hospital Anxiety and Depression Scale) | HADS total (T1) | 7.22 units on a scale | Standard Deviation 5.92 |
| Behavioral: Psychosexual Intervention | HADS (Hospital Anxiety and Depression Scale) | Depression subscale only (T0) | 4.43 units on a scale | Standard Deviation 3.56 |
| Behavioral: Psychosexual Intervention | HADS (Hospital Anxiety and Depression Scale) | HADS total (T0) | 10.67 units on a scale | Standard Deviation 6.87 |
| Behavioral: Psychosexual Intervention | HADS (Hospital Anxiety and Depression Scale) | Depression subscale only (T2) | 3.64 units on a scale | Standard Deviation 3.365 |
| Behavioral: Psychosexual Intervention | HADS (Hospital Anxiety and Depression Scale) | HADS total (T2) | 7.93 units on a scale | Standard Deviation 5.98 |
| Behavioral: Psychosexual Intervention | HADS (Hospital Anxiety and Depression Scale) | Depression subscale only (T1) | 3.17 units on a scale | Standard Deviation 3.22 |
| Behavioral: Psychosexual Intervention | HADS (Hospital Anxiety and Depression Scale) | Anxiety subscale only (T0) | 6.24 units on a scale | Standard Deviation 4.146 |
| Behavioral: Psychosexual Intervention | HADS (Hospital Anxiety and Depression Scale) | Anxiety subscale only (T2) | 4.29 units on a scale | Standard Deviation 3.197 |
| Control | HADS (Hospital Anxiety and Depression Scale) | HADS total (T1) | 6.98 units on a scale | Standard Deviation 4.95 |
| Control | HADS (Hospital Anxiety and Depression Scale) | HADS total (T0) | 11.14 units on a scale | Standard Deviation 5.842 |
| Control | HADS (Hospital Anxiety and Depression Scale) | Anxiety subscale only (T0) | 7.71 units on a scale | Standard Deviation 3.59 |
| Control | HADS (Hospital Anxiety and Depression Scale) | Depression subscale only (T0) | 3.43 units on a scale | Standard Deviation 2.84 |
| Control | HADS (Hospital Anxiety and Depression Scale) | Anxiety subscale only (T1) | 5.17 units on a scale | Standard Deviation 3.6 |
| Control | HADS (Hospital Anxiety and Depression Scale) | Depression subscale only (T1) | 1.72 units on a scale | Standard Deviation 2.02 |
| Control | HADS (Hospital Anxiety and Depression Scale) | HADS total (T2) | 5.57 units on a scale | Standard Deviation 4.586 |
| Control | HADS (Hospital Anxiety and Depression Scale) | Anxiety subscale only (T2) | 4.07 units on a scale | Standard Deviation 2.674 |
| Control | HADS (Hospital Anxiety and Depression Scale) | Depression subscale only (T2) | 1.5 units on a scale | Standard Deviation 3.082 |
| Control: Patient Group | HADS (Hospital Anxiety and Depression Scale) | Depression subscale only (T1) | 3.22 units on a scale | Standard Deviation 2.46 |
| Control: Patient Group | HADS (Hospital Anxiety and Depression Scale) | HADS total (T2) | 10.44 units on a scale | Standard Deviation 7.624 |
| Control: Patient Group | HADS (Hospital Anxiety and Depression Scale) | Depression subscale only (T2) | 3.75 units on a scale | Standard Deviation 2.646 |
| Control: Patient Group | HADS (Hospital Anxiety and Depression Scale) | Anxiety subscale only (T2) | 6.69 units on a scale | Standard Deviation 5.885 |
| Control: Patient Group | HADS (Hospital Anxiety and Depression Scale) | Depression subscale only (T0) | 3.45 units on a scale | Standard Deviation 2.72 |
| Control: Patient Group | HADS (Hospital Anxiety and Depression Scale) | Anxiety subscale only (T1) | 5.72 units on a scale | Standard Deviation 4.11 |
| Control: Patient Group | HADS (Hospital Anxiety and Depression Scale) | HADS total (T0) | 9.77 units on a scale | Standard Deviation 6.406 |
| Control: Patient Group | HADS (Hospital Anxiety and Depression Scale) | HADS total (T1) | 8.94 units on a scale | Standard Deviation 6.2 |
| Control: Patient Group | HADS (Hospital Anxiety and Depression Scale) | Anxiety subscale only (T0) | 6.32 units on a scale | Standard Deviation 4.12 |
| Control: Partners | HADS (Hospital Anxiety and Depression Scale) | HADS total (T1) | 8.72 units on a scale | Standard Deviation 6.58 |
| Control: Partners | HADS (Hospital Anxiety and Depression Scale) | Anxiety subscale only (T2) | 6.31 units on a scale | Standard Deviation 5.51 |
| Control: Partners | HADS (Hospital Anxiety and Depression Scale) | Anxiety subscale only (T1) | 6.33 units on a scale | Standard Deviation 4.99 |
| Control: Partners | HADS (Hospital Anxiety and Depression Scale) | HADS total (T0) | 8.55 units on a scale | Standard Deviation 6.69 |
| Control: Partners | HADS (Hospital Anxiety and Depression Scale) | HADS total (T2) | 9.19 units on a scale | Standard Deviation 7.25 |
| Control: Partners | HADS (Hospital Anxiety and Depression Scale) | Depression subscale only (T1) | 2.39 units on a scale | Standard Deviation 2.63 |
| Control: Partners | HADS (Hospital Anxiety and Depression Scale) | Depression subscale only (T2) | 2.88 units on a scale | Standard Deviation 3.324 |
| Control: Partners | HADS (Hospital Anxiety and Depression Scale) | Depression subscale only (T0) | 2.73 units on a scale | Standard Deviation 2.95 |
| Control: Partners | HADS (Hospital Anxiety and Depression Scale) | Anxiety subscale only (T0) | 5.82 units on a scale | Standard Deviation 4.57 |
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Behavioral: Psychosexual Intervention | SCORE15 (Systemic Core Outcome Measure) | Patients T0 | 22.14 units on a scale | Standard Deviation 5.825 |
| Behavioral: Psychosexual Intervention | SCORE15 (Systemic Core Outcome Measure) | Partners T0 | 24.38 units on a scale | Standard Deviation 9.357 |
| Behavioral: Psychosexual Intervention | SCORE15 (Systemic Core Outcome Measure) | Patients T1 | 22.31 units on a scale | Standard Deviation 7.181 |
| Behavioral: Psychosexual Intervention | SCORE15 (Systemic Core Outcome Measure) | Partners T1 | 22.67 units on a scale | Standard Deviation 6.221 |
| Behavioral: Psychosexual Intervention | SCORE15 (Systemic Core Outcome Measure) | Patients T2 | 25.14 units on a scale | Standard Deviation 9.55 |
| Behavioral: Psychosexual Intervention | SCORE15 (Systemic Core Outcome Measure) | Partners T2 | 21.64 units on a scale | Standard Deviation 6.868 |
| Control | SCORE15 (Systemic Core Outcome Measure) | Patients T2 | 29.25 units on a scale | Standard Deviation 12.402 |
| Control | SCORE15 (Systemic Core Outcome Measure) | Patients T0 | 27.52 units on a scale | Standard Deviation 10.934 |
| Control | SCORE15 (Systemic Core Outcome Measure) | Partners T1 | 22.11 units on a scale | Standard Deviation 6.807 |
| Control | SCORE15 (Systemic Core Outcome Measure) | Partners T0 | 25.82 units on a scale | Standard Deviation 7.986 |
| Control | SCORE15 (Systemic Core Outcome Measure) | Partners T2 | 24.69 units on a scale | Standard Deviation 10.423 |
| Control | SCORE15 (Systemic Core Outcome Measure) | Patients T1 | 27.50 units on a scale | Standard Deviation 11.377 |