Clinical trial NCT01272648: Rehabilitation After Radiotherapy for Prostate Cancer
Official title: Rehabilitation and Coping of Effects After Curative Radiotherapy for Prostate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
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
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2011-01-10
Enrollment: 161
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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 criteria: 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

Primary outcomes:
measure: HRQOL urinary irritative score
timeFrame: 12 month
Secondary outcomes:
measure: EMG measurement of pelvic floor muscles
timeFrame: 12 month
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Department of Oncology Odense University Hospital
Study officials:
affiliation: Department of Oncology Odense University Hospital
name: Olfred Hansen, Dr. med Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.