Rehabilitation After Radiotherapy for Prostate Cancer | NCT01272648

Studies
Rehabilitation After Radiotherapy for Prostate Cancer

NCT01272648

Sponsor

Odense University Hospital

Status

Completed

Last Update Posted

Jan 29, 2013Estimated

Enrollment

161Actual

Phase

Phase 2Phase 3

Conditions

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

Interventions

RePCa A

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2010

Primary Completion Date

Jan 2013Actual

Completion Date

Jan 2013Actual

First Submitted Date

Jan 5, 2011

First Submission Date that Met QC Criteria

Jan 7, 2011

First Posted Date

Jan 10, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 28, 2013

Last Update Posted Date

Jan 29, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Conditions Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

161Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rehabilitation	Active Comparator	note intervention	Behavioral: RePCa A
Control	Placebo Comparator	same radiotherapy but no rehabilitation	Behavioral: RePCa A

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HRQOL urinary irritative score	The expanded prostate cancer Index Composite (EPIC)irritative score	12 month

Secondary Outcomes

Measure	Description	Time Frame
EMG measurement of pelvic floor muscles	Strength of pelvic floor muscles measured with electromyography	12 month

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Olfred Hansen, Dr. med Phd	Department of Oncology Odense University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Oncology Odense University Hospital		Odense		5000	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24169342	Derived	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.

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms