Nurse-or Surgeon-led Follow-up After Rectal Cancer | NCT01045200

Studies
Nurse-or Surgeon-led Follow-up After Rectal Cancer

NCT01045200

Sponsor

Centrallasarettet Västerås

Status

Completed

Last Update Posted

Jan 8, 2010Estimated

Enrollment

110Actual

Phase

Not provided

Conditions

Rectal Cancer

Interventions

Comparison of follow-up

Countries

Sweden

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 2002

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

Jan 2002

Primary Completion Date

Oct 2004Actual

Completion Date

Sep 2009Actual

First Submitted Date

Jan 6, 2010

First Submission Date that Met QC Criteria

Jan 7, 2010

First Posted Date

Jan 8, 2010Estimated

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 7, 2010

Last Update Posted Date

Jan 8, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Follow-up programmes consume a large amount of resources with less time for the surgeon to take on new patients. The aim of this randomised study was to compare patient satisfaction, resource utilisation, and medical safety in patients curatively operated for rectal cancer that were followed-up by a surgeon or a nurse.

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

110Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Follow-up		Patients curatively operated for rectal cancer	Other: Comparison of follow-up

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Comparison of follow-up	Other	Comparison of follow-up by nurse or surgeon after rectal cancer surgery	Follow-up

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patient satisfaction		At each patient visit, i.e. every 6 months during the first three years than every year after rectal cancer surgery.

Secondary Outcomes

Measure	Description	Time Frame
Resource utilisation		at each patient visit, i.e. every 6 months during the first three years than every year after rectal cancer surgery.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients curatively operated for rectal cancer.
Patients had to be more than 18 years of age and written and oral informed consent was obtained.

Exclusion Criteria:

Those with psychiatric disorders, dementia and whose general condition had deteriorated with an expected survival of less than six months were not eligible.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Operated for rectal cancer at the colorectal unit of the Central Hospital in Västerås, Sweden.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Departement of Surgery, Central Hospital		Västerås			Sweden

Condition Browse Module

MeSH Terms

ID	Term
D012004	Rectal Neoplasms

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided