Rehabilitation After Radiotherapy for Prostate Cancer

NCT01272648 | Completed Phase 2

• 1 other identifier: S-20090142
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• HRQOL urinary irritative score

  The expanded prostate cancer Index Composite (EPIC)irritative score

  12 month

Secondary Outcomes (1)

• EMG measurement of pelvic floor muscles

  12 month

Study Arms (2)

Rehabilitation

ACTIVE COMPARATOR

note intervention

Behavioral: RePCa A

Control

PLACEBO COMPARATOR

same radiotherapy but no rehabilitation

Behavioral: RePCa A

Interventions

RePCa A BEHAVIORAL

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

Control; Rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patients younger than 18
• Patients who cannot understand/read or speak danish

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Department of Oncology Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (1)

• 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.

  PMID: 24169342 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Olfred Hansen, Dr. med Phd

  Department of Oncology Odense University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 5, 2011
• First Posted: January 10, 2011
• Study Start: February 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: January 29, 2013

Record last verified: 2011-01

Locations

DK (1)