Rehabilitation After Radiotherapy for Prostate Cancer (RePCa)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Urinary Irritative/Incontinence Problems Bowel Problems Sexual Problems Hormonal Problems Phycological Problems |
Behavioral: RePCa A |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Health Services Research |
| Official Title: | Rehabilitation and Coping of Effects After Curative Radiotherapy for Prostate |
- HRQOL urinary irritative score [ Time Frame: 12 month ] [ Designated as safety issue: No ]The expanded prostate cancer Index Composite (EPIC)irritative score
- EMG measurement of pelvic floor muscles [ Time Frame: 12 month ] [ Designated as safety issue: No ]Strength of pelvic floor muscles measured with electromyography
| Enrollment: | 161 |
| Study Start Date: | February 2010 |
| Study Completion Date: | January 2013 |
| Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Rehabilitation
note intervention
|
Behavioral: RePCa A
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 |
|
Placebo Comparator: Control
same radiotherapy but no rehabilitation
|
Behavioral: RePCa A
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 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients younger than 18
- Patients who cannot understand/read or speak danish
Contacts and Locations| Denmark | |
| Department of Oncology Odense University Hospital | |
| Odense, Denmark, 5000 | |
| Principal Investigator: | Olfred Hansen, Dr. med Phd | Department of Oncology Odense University Hospital |
More Information
No publications provided
| Responsible Party: | Karin Dieperink nurse, MCN, Ph.d. student, Department of oncology Odense University Hospital |
| ClinicalTrials.gov Identifier: | NCT01272648 History of Changes |
| Other Study ID Numbers: | S-20090142 |
| Study First Received: | January 5, 2011 |
| Last Updated: | January 28, 2013 |
| Health Authority: | Denmark: Danish Dataprotection Agency Denmark: The Regional Committee on Biomedical Research Ethics |
Keywords provided by Odense University Hospital:
|
Rehabilitation Coping Prostate cancer Nursing |
Physiotherapy Pelvic floor exercises Motivational Interviewing |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013