Rehabilitation After Radiotherapy for Prostate Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Rehabilitation and Coping of Effects After Curative Radiotherapy for Prostate

Conditions
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Urinary Irritative/Incontinence Problems, Bowel Problems, Sexual Problems, Hormonal Problems, Phycological Problems

Intervention / Treatment
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* Behavioral: RePCa A


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rehabilitation<br>note intervention | Behavioral: RePCa A<br>* 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<br>|
| Placebo Comparator: Control<br>same radiotherapy but no rehabilitation | Behavioral: RePCa A<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HRQOL urinary irritative score | The expanded prostate cancer Index Composite (EPIC)irritative score | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EMG measurement of pelvic floor muscles | Strength of pelvic floor muscles measured with electromyography | 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rehabilitation, Coping, Prostate cancer, Nursing, Physiotherapy, Pelvic floor exercises, Motivational Interviewing