Prostate Cancer
Conditions
Brief summary
The purpose of the protocol, is to assess the feasibility of conducting a larger trial to evaluate the effect of a psychological intervention on the well-being of patients on luteinizing hormone-releasing hormone (LHRH) analogs in the treatment of prostate cancer and their partners.
Interventions
Attendance at 7 group sessions, consisting of 5-6 couples, preceded by an intake consultation. Total intervention time: 16 weeks.
Sponsors
Ipsen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed diagnosis of prostate cancer on biopsy * Locally advanced or metastasised prostate cancer in need of hormonal treatment. * On LHRH analogue treatment for a minimum of 5 months (at inclusion) * Having a female partner * Patients and their partner are able to fill out questionnaires, attend group sessions and give consent
Exclusion criteria
* Serious psychiatric difficulties * Life expectancy \< 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sufficient interest in participation | Up to the end of 16 weeks of the intervention period | Determined by achievement of all of the following: * Number of participants (couples) recruited in 18 months in the participating centres. Achieved by recruitment of 50 couples. * Number of participants (couples) informed personally about the study consent to participate. To be achieved by 20% of couples. * Number of participants in group 1 that attend at least 70% of the sessions. To be achieved by 80% of participants. |
| Preliminary improvement in well-being | After the intervention period of 16 weeks | Improved - Group 1 improve more than group 2 on at least one of the outcome measures (includes HADS, EORTC QLQ-C30 or Maudsley Marital Questionnaire). Worsened - Group 1 should not worsen more than group 2 on any of the outcome measures. |
Secondary
| Measure | Time frame |
|---|---|
| Difference in relationship satisfaction (Maudsley Marital Questionnaire) | Baseline (T0), after the intervention period of 16 weeks (T1) and 1 year (T2) |
| Change in quality of life questionnaire QLQ-C30 scores | Baseline (T0), after the intervention period of 16 weeks (T1) and 1 year (T2) |
| Change in Hospital Anxiety and Depression Scale (HADS) scores | Baseline (T0), after the intervention period of 16 weeks (T1) |
| Difference between level of depression and anxiety (HADS) | Baseline (T0) and 1 year (T2) |
| Change in quality of life questionnaire QLQ-PR25 scores | Baseline(T0), after the intervention period of 16 weeks (T1) and 1 year (T2) |
Countries
Netherlands
Outcome results
None listed