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Rehabilitation After Radiotherapy for Prostate Cancer (RePCa)

This study has been completed.
Sponsor:
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01272648
First received: January 5, 2011
Last updated: January 28, 2013
Last verified: January 2011
  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

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • HRQOL urinary irritative score [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    The expanded prostate cancer Index Composite (EPIC)irritative score


Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01272648

Locations
Denmark
Department of Oncology Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Investigators
Principal Investigator: Olfred Hansen, Dr. med Phd Department of Oncology Odense University Hospital
  More Information

No publications provided by Odense University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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

ClinicalTrials.gov processed this record on November 23, 2014