Prostate CancerPhase 2EXPEDIENTNCT01562522
Evaluation of the Effect of Psycho-oncological Intervention on Well-being of Patients With Advanced Prostate Cancer on LHRH Analogs and Their Partners. A Randomized Controlled Pilot Study.
A Phase 2 study testing Psychological counseling in people with Prostate Cancer, run by Ipsen at 3 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Psychological counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 3 sitesNetherlands
- Study dates
- Mar 2012to Jul 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Serious psychiatric difficulties
- Life expectancy < 12 months
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
St. Antonius Hospital
Nieuwegein
Diakonessenhuis
Utrecht
Zuwe Hofpoort Ziekenhuis Woerden, Netherlands
Woerden
About this study
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.
- Conditions
- Prostate Cancer
- Being tested
- Psychological counseling
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological counselingOther
Attendance at 7 group sessions, consisting of 5-6 couples, preceded by an intake consultation. Total intervention time: 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Other: Psychological counseling |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sufficient interest in participation
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.
Measured: Up to the end of 16 weeks of the intervention period
Preliminary improvement in well-being
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.
Measured: After the intervention period of 16 weeks
Secondary outcomes (5)
Change in quality of life questionnaire QLQ-C30 scores
Measured: Baseline (T0), after the intervention period of 16 weeks (T1) and 1 year (T2)
Change in quality of life questionnaire QLQ-PR25 scores
Measured: Baseline(T0), after the intervention period of 16 weeks (T1) and 1 year (T2)
Difference in relationship satisfaction (Maudsley Marital Questionnaire)
Measured: Baseline (T0), after the intervention period of 16 weeks (T1) and 1 year (T2)
Difference between level of depression and anxiety (HADS)
Measured: Baseline (T0) and 1 year (T2)
Change in Hospital Anxiety and Depression Scale (HADS) scores
Measured: Baseline (T0), after the intervention period of 16 weeks (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionJul 2013
- Study completionJul 2013
Why it stopped: Poor enrolment; only 6 subjects enrolled and they were all screen failures.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director Oncology, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01562522
- Sponsor's protocol ID
- A-95-52014-192
- Other IDs
- 2011-004819-24
- Acronym
- EXPEDIENT
- Status last verified
- Nov 2019
- First submitted
- 21 Mar 2012
- Last updated
- 7 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Psycho-oncological Intervention on Well-being of Patients With Advanced Prostate Cancer on LHRH Analogs and Their Partners. A Randomized Controlled Pilot Study.
- ClinicalTrials.gov ID
- NCT01562522
- Acronym / sponsor ID
- EXPEDIENT / A-95-52014-192
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor enrolment; only 6 subjects enrolled and they were all screen failures.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 26 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Psychological counseling |
| Control group | No intervention | – |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Serious psychiatric difficulties
- Life expectancy < 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychological counselingAttendance at 7 group sessions, consisting of 5-6 couples, preceded by an intake consultation. Total intervention time: 16 weeks. | Other | Intervention group |
Primary outcome
Sufficient interest in participation
Time frame: 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
Time frame: 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.
5 secondary outcomes
Change in quality of life questionnaire QLQ-C30 scores
Time frame: Baseline (T0), after the intervention period of 16 weeks (T1) and 1 year (T2)
Change in quality of life questionnaire QLQ-PR25 scores
Time frame: Baseline(T0), after the intervention period of 16 weeks (T1) and 1 year (T2)
Difference in relationship satisfaction (Maudsley Marital Questionnaire)
Time frame: Baseline (T0), after the intervention period of 16 weeks (T1) and 1 year (T2)
Difference between level of depression and anxiety (HADS)
Time frame: Baseline (T0) and 1 year (T2)
Change in Hospital Anxiety and Depression Scale (HADS) scores
Time frame: Baseline (T0), after the intervention period of 16 weeks (T1)
Results and safety
The study was stopped early (reason given: Poor enrolment; only 6 subjects enrolled and they were all screen failures.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2019.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director Oncology study director
Ipsen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Psychological counseling in people with Prostate Cancer, run by Ipsen at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Poor enrolment; only 6 subjects enrolled and they were all screen failures.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sufficient interest in participation (time frame: Up to the end of 16 weeks of the intervention period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2019.