Effects of Structured Rehabilitation Program on Quality of Life in Rectal Cancer Patients- a Randomized Controlled Trial

NCT ID: NCT00895388

Last Updated: 2024-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2019-12-02

Brief Summary

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Quality of life after rectal surgery is reported to be impaired. Side effects of surgery and/or neoadjuvant treatment as functional disturbances like sexual dysfunction, urinary incontinence, anal incontinence or stoma problems are commonly experienced. The investigators hypotheses is that structured rehabilitation program addressing these problems will improve quality of life. A RCT are performed in order to document the effects of the rehabilitation.

Detailed Description

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Conditions

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Quality of Life Sexual Function Urinary Incontinence Anal Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Structured Rehabilitation program

Group Type OTHER

Structured Rehabilitation program

Intervention Type BEHAVIORAL

Questionnaire send by post at 3, 6, 12, 18 and 24 months after operation

Controls

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Structured Rehabilitation program

Questionnaire send by post at 3, 6, 12, 18 and 24 months after operation

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Rectal cancer Surgically treated for rectal cancer Informed concent Included in national guidelines for surveillance of rectal cancer patients

Exclusion Criteria

* Older than 75 years Mentally or physically not able to participate Non curative surgical treatment
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Helse Nord

INDUSTRY

Sponsor Role collaborator

University Hospital of North Norway

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rolv-Ole Lindsetmo, MD, Phd, Mph

Role: STUDY_DIRECTOR

Dep of gastrointestinal surgery, University Hospital of North Norway

Locations

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Dep. of gastrointestinal surgery, University Hospital of North Norway

Tromsø, , Norway

Site Status

Countries

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Norway

Other Identifiers

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P REK NORD 105/2007

Identifier Type: -

Identifier Source: org_study_id

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