Urinary Irritative/Incontinence ProblemsPhase 2/3RePCaNCT01272648
Rehabilitation After Radiotherapy for Prostate Cancer
A Phase 2/3 study testing RePCa A in people with Urinary Irritative/Incontinence Problems and Bowel Problems, run by Odense University Hospital at 1 site in Denmark.
Trial summary
This project will test and evaluate a rehabilitation programme, which will empower the mens health and give them resources to face at new everyday life. The project examines if a focused interdisciplinary intervention has influence of the patients generic and specified quality of life after curative radiotherapy due… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Urinary Irritative/Incontinence Problems, Bowel Problems, Sexual Problems
- What is being tested?
- RePCa A
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 161 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2010to Jan 2013
- Phase
- Phase 2/3
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with localized og locally advanced prostate cancer treated with curative intended radiotherapy at Department of Oncology Odense University Hospital in the period of inclusion
Who cannot join
- Patients younger than 18
- Patients who cannot understand/read or speak danish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rehabilitation and Coping of Effects After Curative Radiotherapy for Prostate
This project will test and evaluate a rehabilitation programme, which will empower the mens health and give them resources to face at new everyday life.
The project examines if a focused interdisciplinary intervention has influence of the patients generic and specified quality of life after curative radiotherapy due to prostate cancer.
The intervention contains nursing consultation with information about late side effects, an individual plan and counselling in toilet habits, smoking cessation, weight control and psychological problems after treatment. Furthermore the patients are having physiotherapy with pelvic floor examinations. The nurse can refer to other collaborators.
Read the detailed description
More cancer patients are now being cured or living a long time with the disease. Prostate cancer (PCa) is one of the cancer diseases, where the treatment can give some late side effects and cause reduced life quality.
This project will as a part of a ph.d. study, test and evaluate a rehabilitation programme, which will empower the mens health and give them resources to face at new everyday life.
The project is consisted of a randomised controlled test of the intervention and qualitative evaluation.
More and more Danish men are diagnosed with PC, the incidence increased with 34 percent from 2005-2007. This is caused partly due to a change in the age in the society and due to earlier diagnostics. PCa is now the most known cancer occurring in men in Denmark.
If the disease has not yet been metastasized, it is possible to use radiotherapy often in combination with anti hormones. It is possible to cure the patient, íf his disease is discovered in time, but there are some late side effects bond to the treatment, and they have influence of the patients quality of life. These are: impotence, incontinence, problem with the bowels, anxiety and depression.
The project is as followed:
Rehabilitation: Examine if a focused interdisciplinary intervention has influence of the patients generic and specified quality of life after curative radiotherapy due to prostate cancer. The intervention contains nursing consultation with information about late side effects, an individual plan and counselling in toilet habits, smoking cessation, weight control and psychological problems after treatment. Furthermore the patients are having physiotherapy with pelvic floor examinations. The nurse can refer to other collaborators.
Methods: Prospective randomised controlled study. Material: 160 patients are included. 80 patients in the intervention group and 80 patients in the control group.
- Conditions
- Urinary Irritative/Incontinence Problems, Bowel Problems, Sexual Problems, Hormonal Problems, Phycological Problems
- Being tested
- RePCa A
- Keywords
- Rehabilitation, Coping, Prostate cancer, Nursing, Physiotherapy, Pelvic floor exercises, Motivational Interviewing
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RePCa ABehavioural
Intervention patients receives two consultations with a specialist oncology nurse three and six month after ended radiotherapy. The focus are on what is important for the patients at the specific time. The patient can bring his spouse.
Furthermore the patients have two physiotherapy consultations with guidance in pelvic floor exercises and an individual home-program of pelvic and functional training exercises
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation | Active comparator | note intervention Receives: Behavioral: RePCa A |
| Control | Placebo comparator | same radiotherapy but no rehabilitation Receives: Behavioral: RePCa A |
What is being measured
The primary outcome is the main question the study is designed to answer.
HRQOL urinary irritative score
The expanded prostate cancer Index Composite (EPIC)irritative score
Measured: 12 month
Secondary outcomes (1)
EMG measurement of pelvic floor muscles
Strength of pelvic floor muscles measured with electromyography
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2011 (estimated)
- Study startFeb 2010
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Irritative/Incontinence ProblemsStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe 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 2/3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Olfred Hansen, Dr. med Phd, Principal investigator, Department of Oncology Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01272648
- Sponsor's protocol ID
- S-20090142
- Acronym
- RePCa
- Status last verified
- Jan 2011
- First submitted
- 5 Jan 2011
- Last updated
- 29 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Dieperink KB, Johansen C, Hansen S, Wagner L, Andersen KK, Minet LR, Hansen O. The effects of multidisciplinary rehabilitation: RePCa-a randomised study among primary prostate cancer patients. Br J Cancer. 2013 Dec 10;109(12):3005-13. doi: 10.1038/bjc.2013.679. Epub 2013 Oct 29.
PubMed 24169342
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation and Coping of Effects After Curative Radiotherapy for Prostate
- ClinicalTrials.gov ID
- NCT01272648
- Acronym / sponsor ID
- RePCa / S-20090142
- Conditions
- Urinary Irritative/Incontinence Problems, Bowel Problems, Sexual Problems, Hormonal Problems, Phycological Problems
- Keywords
- Rehabilitation, Coping, Prostate cancer, Nursing, Physiotherapy, Pelvic floor exercises, Motivational Interviewing
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 10 Jan 2011 (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.
This project will test and evaluate a rehabilitation programme, which will empower the mens health and give them resources to face at new everyday life.
The project examines if a focused interdisciplinary intervention has influence of the patients generic and specified quality of life after curative radiotherapy due to prostate cancer.
The intervention contains nursing consultation with information about late side effects, an individual plan and counselling in toilet habits, smoking cessation, weight control and psychological problems after treatment. Furthermore the patients are having physiotherapy with pelvic floor examinations. The nurse can refer to other collaborators.
Detailed description
More cancer patients are now being cured or living a long time with the disease. Prostate cancer (PCa) is one of the cancer diseases, where the treatment can give some late side effects and cause reduced life quality.
This project will as a part of a ph.d. study, test and evaluate a rehabilitation programme, which will empower the mens health and give them resources to face at new everyday life.
The project is consisted of a randomised controlled test of the intervention and qualitative evaluation.
More and more Danish men are diagnosed with PC, the incidence increased with 34 percent from 2005-2007. This is caused partly due to a change in the age in the society and due to earlier diagnostics. PCa is now the most known cancer occurring in men in Denmark.
If the disease has not yet been metastasized, it is possible to use radiotherapy often in combination with anti hormones. It is possible to cure the patient, íf his disease is discovered in time, but there are some late side effects bond to the treatment, and they have influence of the patients quality of life. These are: impotence, incontinence, problem with the bowels, anxiety and depression.
The project is as followed:
Rehabilitation: Examine if a focused interdisciplinary intervention has influence of the patients generic and specified quality of life after curative radiotherapy due to prostate cancer. The intervention contains nursing consultation with information about late side effects, an individual plan and counselling in toilet habits, smoking cessation, weight control and psychological problems after treatment. Furthermore the patients are having physiotherapy with pelvic floor examinations. The nurse can refer to other collaborators.
Methods: Prospective randomised controlled study. Material: 160 patients are included. 80 patients in the intervention group and 80 patients in the control group.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation | Active comparator | Behavioral: RePCa Anote intervention |
| Control | Placebo comparator | Behavioral: RePCa Asame radiotherapy but no rehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with localized og locally advanced prostate cancer treated with curative intended radiotherapy at Department of Oncology Odense University Hospital in the period of inclusion
Key exclusion criteria (2 listed)
- Patients younger than 18
- Patients who cannot understand/read or speak danish
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 |
|---|---|---|
| RePCa AIntervention patients receives two consultations with a specialist oncology nurse three and six month after ended radiotherapy. The focus are on what is important for the patients at the specific time. The patient can bring his spouse. Furthermore the patients have two physiotherapy consultations with guidance in pelvic floor exercises and an individual home-program of pelvic and functional training exercises | Behavioural | Control, Rehabilitation |
Primary outcome
HRQOL urinary irritative score
Time frame: 12 month
The expanded prostate cancer Index Composite (EPIC)irritative score
1 secondary outcome
EMG measurement of pelvic floor muscles
Time frame: 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2013.
- Derived from this study: PubMed 24169342Dieperink KB, Johansen C, Hansen S, Wagner L, Andersen KK, Minet LR, Hansen O. The effects of multidisciplinary rehabilitation: RePCa-a randomised study among primary prostate cancer patients. Br J Cancer. 2013 Dec 10;109(12):3005-13. doi: 10.1038/bjc.2013.679. Epub 2013 Oct 29.
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.
Olfred Hansen, Dr. med Phd principal investigator
Department of Oncology Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing RePCa A in people with Urinary Irritative/Incontinence Problems and Bowel Problems, run by Odense University Hospital at 1 site in Denmark.
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 1 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: finished, as of the sponsor's last update on 29 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
HRQOL urinary irritative score (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01272648, which also lists 1 linked publication.
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 29 Jan 2013.