Rehabilitation After Radiotherapy for Prostate Cancer

Bowel Problems Clinical Trial

— RePCa  

Official title:

Rehabilitation and Coping of Effects After Curative Radiotherapy for Prostate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01272648
• Other study ID #: S-20090142
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 5, 2011
• Last updated: January 28, 2013
• Start date: February 2010
• Est. completion date: January 2013

Study information

• Verified date: January 2011
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Bowel Problems
• Hormonal Problems
• Phycological Problems
• Sexual Problems
• Urinary Irritative/Incontinence Problems

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

Locations

Country	Name	City	State
Denmark	Department of Oncology Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HRQOL urinary irritative score	The expanded prostate cancer Index Composite (EPIC)irritative score	12 month	No
Secondary	EMG measurement of pelvic floor muscles	Strength of pelvic floor muscles measured with electromyography	12 month	No