Condition category
Cancer
Date applied
19/07/2006
Date assigned
19/07/2006
Last edited
07/08/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr P.D. Siersema

ORCID ID

Contact details

Erasmus MC - University Medical Center Rotterdam
Department of Gastroenterology and Hepatology
Room HS 512
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
+31 (0)10 4632748
p.siersema@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MEC-2005-176

Study information

Scientific title

Acronym

PACT study.

Study hypothesis

Does nurse-led follow-up at home lead to improved quality of life and satisfaction and a reduction in costs compared to medical follow-up at the outpatient clinic, without compromising the medical condition of patients?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

Condition

Esophageal, pancreatic or hepatobiliairy cancer

Intervention

Nurse-led follow-up at home at two-weekly and later monthly intervals until month 13 or death versus medical follow-up at the outpatient clinic at one month and thereafter every two months until month 13 or death

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Quality of life questionnaires

Secondary outcome measures

Patient satisfaction (questionnaire) costs

Overall trial start date

01/06/2006

Overall trial end date

01/01/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with irresectabel or recurrent esophageal cancer, pancreatic cancer or hepatobiliary cancer, for whom no curative treatment options are available
2. Informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150

Participant exclusion criteria

1. Not able to understand or read the Dutch language
2. Undergoing treatment with chemotherapy or radiotherapy or a combination

Recruitment start date

01/06/2006

Recruitment end date

01/01/2009

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus MC - University Medical Center Rotterdam
Rotterdam
3000 CA
Netherlands

Sponsor information

Organisation

Health Care Research Program Erasmus MC 2003 (The Netherlands)

Sponsor details

Erasmus MC - University Medical Center Rotterdam
Department of Gastroenterology and Hepatology
Room HS 512
P.O. Box 2040
Rotterdam
3000 CA
Netherlands

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Erasmus Medical Center

Alternative name(s)

Erasmus Medical Center, Erasmus MC

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Netherlands

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes