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 |
| Protocol serial number | MEC-2005-176, NL628, NTR687 |
| Sponsor | Health Care Research Program Erasmus MC 2003 (The Netherlands) |
| Funder | Erasmus Medical Center |
- 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
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 |
|---|---|
| p.siersema@erasmusmc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Quality of life questionnaires |
| Key secondary outcome measure(s) |
Patient satisfaction (questionnaire) costs |
| Completion date | 01/01/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
3000 CA
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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.
