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
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