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Rehabilitation and Coping of Effects After Curative Radiotherapy for Prostate


Phase 2/Phase 3
18 Years
N/A
Not Enrolling
Male
Urinary Irritative/Incontinence Problems, Bowel Problems, Sexual Problems, Hormonal Problems, Phycological Problems

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Trial Information

Rehabilitation and Coping of Effects After Curative Radiotherapy for Prostate


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

HRQOL urinary irritative score

Outcome Description:

The expanded prostate cancer Index Composite (EPIC)irritative score

Outcome Time Frame:

12 month

Safety Issue:

No

Principal Investigator

Olfred Hansen, Dr. med Phd

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Oncology Odense University Hospital

Authority:

Denmark: Danish Dataprotection Agency

Study ID:

S-20090142

NCT ID:

NCT01272648

Start Date:

February 2010

Completion Date:

January 2013

Related Keywords:

  • Urinary Irritative/Incontinence Problems
  • Bowel Problems
  • Sexual Problems
  • Hormonal Problems
  • Phycological Problems
  • Rehabilitation
  • Coping
  • Prostate cancer
  • Nursing
  • Physiotherapy
  • Pelvic floor exercises
  • Motivational Interviewing
  • Prostatic Neoplasms

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