Tumor in Upper Gastrointestinal Canal or Patients With Colorectal Cancer Clinical Trial
— ALLANOfficial title:
Observational Study of Early Contact With Palliative Care Unit for Patients Receiving First Line Palliative Chemotherapy With Cancer in Upper Gastrointestinal Canal, or Second Line Palliative Chemotherapy in Patients With Colorectal Cancer - an Open, Randomised Investigator Initiated Trial.
| Verified date | May 2021 |
| Source | Lund University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
In this trial, patients with cancer in the upper gastrointestinal canal who are going to receive first line palliative chemotherapy and patients with colorectal cancer who are going to receive second line palliative chemotherapy will be included. Participating patients will be randomized between early contact with a palliative care unit, or contact with a palliative care unit when needed. The objectives with the trial is to investigate if an early establishment with a palliative care unit will have a positive impact on the patients quality of life, this also applies for the nearest relative, survival, and if a difference in numbers of chemotherapy cycles can be detected.
| Status | Active, not recruiting |
| Enrollment | 108 |
| Est. completion date | December 2021 |
| Est. primary completion date | December 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Patients with tumor in upper gastrointestinal canal, who is going to start treatment with first line palliative chemotherapy - Patients with colorectal cancer, who is going to start treatment with second line palliative chemotherapy - Signed written informed concent Exclusion Criteria: - Patients with neuroendocrine tumor - Patients with already ongoing chemotherapy - Patients with already established contact with palliative care unit |
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Lund University Hospital | Lund |
| Lead Sponsor | Collaborator |
|---|---|
| Lund University Hospital |
Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Numbers of chemotherapy cycles | Approximately 12 months. | ||
| Primary | Quality of Life, such as pain, anxiety. | Evaluation will be performed by different quality of life forms sent to the patient every 6th week, and by telephone contact with a study nurse every 6th week until patients death. The same also applies for the patients nearest relative; quality of life forms will be sent every 12th week for additional 1 year. | At baseline, every 6th week until death (approximately 1 year). The patients relative will be followed similarly until patients death and then every 12th week for 1 year. | |
| Secondary | Survival | Approximately 12 months. |