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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. (ALLAN)

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ClinicalTrials.gov Identifier: NCT02246725
Recruitment Status : Recruiting
First Posted : September 23, 2014
Last Update Posted : August 27, 2019
Sponsor:
Information provided by (Responsible Party):
Lund University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Tumor in Upper Gastrointestinal Canal or Patients With Colorectal Cancer Other: Contact with palliative care unit.

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Study Type : Observational
Estimated Enrollment : 108 participants
Observational Model: Other
Time Perspective: Prospective
Official 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.
Study Start Date : October 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Contact with palliative care unit versus contact when needed. Other: Contact with palliative care unit.



Primary Outcome Measures :
  1. Quality of Life, such as pain, anxiety. [ Time Frame: 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. ]
    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.


Secondary Outcome Measures :
  1. Survival [ Time Frame: Approximately 12 months. ]

Other Outcome Measures:
  1. Numbers of chemotherapy cycles [ Time Frame: Approximately 12 months. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with tumor in esophagus, stomach, pancreas liver-biliary passage receiving first line palliative chemotherapy, or patients with colorectal cancer receiving second line palliative chemotherapy.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02246725


Contacts
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Contact: Mikael Segerlantz, MD, PhD +46 46 17 70 90 mikael.segerlantz@skane.se
Contact: Eva Brun, MD, PhD +46 46 17 75 20 eva.brun@med.lu.se

Locations
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Sweden
Lund University Hospital Recruiting
Lund, Sweden, 221 85
Contact: Mikael Segerlantz, MD, PhD    +46 46 17 70 91    mikael.segerlantz@skane.se   
Contact: Eva Brun, MD, PhD    +46 46 17 75 20    eva.brun@med.lu.se   
Sponsors and Collaborators
Lund University Hospital
Investigators
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Principal Investigator: Mikael Segerlantz, MD, PhD Palliative Care and Advanced Home Health Care, Primary Health Care Skåne, Sankt lars väg 81, SE-221 85 LUND, Sweden

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Responsible Party: Lund University Hospital
ClinicalTrials.gov Identifier: NCT02246725     History of Changes
Other Study ID Numbers: MS01
First Posted: September 23, 2014    Key Record Dates
Last Update Posted: August 27, 2019
Last Verified: August 2019
Keywords provided by Lund University Hospital:
Colorectal Neoplasms
Depression
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Palliative chemotherapy
Palliative care
Palliative treatment
Quality of life
Quality of life for relatives
Survival
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases