Palliative care for patients with irresectable or recurrent cancer of the upper gastrointestinal tract: a randomized study

ISRCTN	ISRCTN86515732
DOI	https://doi.org/10.1186/ISRCTN86515732
Secondary identifying numbers	MEC-2005-176, NL628, NTR687

Submission date: 19/07/2006
Registration date: 19/07/2006
Last edited: 08/01/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr P.D. Siersema
Scientific

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

Phone	+31 (0)10 4632748
Email	p.siersema@erasmusmc.nl

Study information

Study design	Randomised controlled, parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Quality of life
Scientific title	Palliative care for patients with irresectable or recurrent cancer of the upper gastrointestinal tract: a randomized study
Study acronym	PACT study.
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	Quality of life questionnaires
Secondary outcome measures	Patient satisfaction (questionnaire) costs
Overall study start date	01/06/2006
Completion date	01/01/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	150
Key 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
Key exclusion criteria	1. Not able to understand or read the Dutch language 2. Undergoing treatment with chemotherapy or radiotherapy or a combination
Date of first enrolment	01/06/2006
Date of final enrolment	01/01/2009

Locations

Countries of recruitment

Netherlands

Study participating centre

Erasmus MC - University Medical Center Rotterdam

Rotterdam
3000 CA
Netherlands

Sponsor information

Health Care Research Program Erasmus MC 2003 (The Netherlands)
University/education

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

Funders

Funder type

University/education

Erasmus Medical Center
Government organisation / Universities (academic only)

Alternative name(s): Erasmus Medical Center, Erasmus MC, Erasmus Universitair Medisch Centrum, Erasmus University Medical Center, Universitair Medisch Centrum Rotterdam, Erasmus Universitair Medisch Centrum Rotterdam, EMC
Location: Netherlands

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2014	08/01/2021	Yes	No

Editorial Notes

08/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The NTR numbers have been added.