A Trial Investigating the Effect of Specialised Palliative Care on Symptoms, Survival, Economical Factors and Satisfaction

NCT01348048 | Completed Phase 4

• 1 other identifier: DanPaCT2011
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 6

Brief Summary

Specialised palliative care (SPC) seeks to relieve suffering and improve quality of life in patients with a life threatening disease such as advanced cancer. Many patients with advanced cancer are not in contact with SPC. Previous studies have shown that among advanced cancer patients not referred to SPC there is a significant prevalence of symptoms, problems and needs. The aims of the present study are to investigate whether patients with metastatic cancer, who report palliative needs in a screening, will benefit from being referred to SPC and to investigate the economical consequences of such a referral.

Conditions

Metastatic Cancer

Keywords

palliative care; end-of-life care; randomized clinical trial; quality of life; needs assessment; patient satisfaction; cost-effectiveness; Screening

Outcome Measures

Primary Outcomes (1)

• Reduction in the EORTC QLQ-C30 scale that constitutes the patient's primary need

  The difference between the intervention and the control group in the change from baseline to the weighted mean of the 3- and 8-week follow-up (measured as AUC) for the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) scale score that constitutes the primary need. The primary need can be a need related to the following: physical function, role function, emotional function, pain, shortness of breath, lack of appetite and nausea/vomiting.

  Baseline, 3 weeks and 8 weeks

Secondary Outcomes (4)

• Patients reported symptoms and problems according to the EORTC QLQ-C30

  Baseline, 3 weeks and 8 weeks

• Survival

  From the start of the trial to minimum three months after the end of the intervention.

• Economical consequences

  From the start of the trial to minimum three months after the end of the intervention.

• Patient reported Satisfaction with services provided by the health care system measured with the questionnaire FAMCARE-p16

  8 weeks

Study Arms (2)

Specialised palliative care (SPC) group

EXPERIMENTAL

Patients continue with their standard treatment (typically they receive treatment in one or more hospitals departments and from their GP). In addition, they are offered a consultation in the SPC out-patient clinic (or at home if the patient cannot attend the hospital) as soon as possible and no more than one week after randomization. If possible, each patient will have at least two contacts to the SPC in the trial period.

Other: Specialised palliative care (SPC)

Standard care group

NO INTERVENTION

Patients continue with their standard treatment. They are instructed to contact either their GP or their hospital department if they feel that additional treatment or care is needed.

Interventions

Specialised palliative care (SPC) OTHER

The interventions given by the SPC centres follow the the WHO and the EAPC guidelines for palliative care. It is not possible in advance to describe the interventions more specifically as these will be adjusted to each particular patient. As part of the study the medical records of all patients in the intervention group will be reviewed with the purpose of describing the interventions given for the different symptoms and problems.

Specialised palliative care (SPC) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years
• Live in the area of the participating hospitals
• No contact with specialised palliative care within the previous year
• At least one palliative need defined as a EORTC QLQ-C30 scale score of at least 50% of the score corresponding to maximal symptomatology or maximal functional impairment
• Four additional symptoms (defined as patients answering, on average, at least 'a little' in any of the 14 function or symptom scales in the EORTC QLQ-C30 questionnaire)
• Written informed consent

You may not qualify if:

• Do not understand Danish well enough to participate in the study
• Are judged incapable of co-operating with the trial protocol

Sponsors & Collaborators

• Bispebjerg Hospital: lead
• TRYG Foundation: collaborator
• Danish Cancer Society: collaborator

Study Sites (6)

The Palliative Team, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Section of Acute Pain Management and Palliative Medicine, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Department of Palliative Medicine, Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

Palliative Team Herning

Herning, 7400, Denmark

Location

Palliative Team Fyn, Odense University hospital

Nyborg, 5800, Denmark

Location

Palliative Team Vejle

Vejle, 7100, Denmark

Location

Related Publications (5)

• Johnsen AT, Damkier A, Vejlgaard TB, Lindschou J, Sjogren P, Gluud C, Neergaard MA, Petersen MA, Lundorff LE, Pedersen L, Fayers P, Stromgren AS, Higginson IJ, Groenvold M. A randomised, multicentre clinical trial of specialised palliative care plus standard treatment versus standard treatment alone for cancer patients with palliative care needs: the Danish palliative care trial (DanPaCT) protocol. BMC Palliat Care. 2013 Oct 24;12(1):37. doi: 10.1186/1472-684X-12-37.

  PMID: 24152880 BACKGROUND

• Johnsen AT, Petersen MA, Gluud C, Lindschou J, Fayers P, Sjogren P, Pedersen L, Neergaard MA, Vejlgaard TB, Damkier A, Nielsen JB, Stromgren AS, Higginson IJ, Groenvold M. Detailed statistical analysis plan for the Danish Palliative Care Trial (DanPaCT). Trials. 2014 Sep 26;15:376. doi: 10.1186/1745-6215-15-376.

  PMID: 25257804 BACKGROUND

• Skjoedt N, Johnsen AT, Sjogren P, Neergaard MA, Damkier A, Gluud C, Lindschou J, Fayers P, Higginson IJ, Stromgren AS, Groenvold M. Early specialised palliative care: interventions, symptoms, problems. BMJ Support Palliat Care. 2021 Dec;11(4):444-453. doi: 10.1136/bmjspcare-2019-002043. Epub 2020 Mar 27.

  PMID: 32220944 DERIVED

• Johnsen AT, Petersen MA, Sjogren P, Pedersen L, Neergaard MA, Damkier A, Gluud C, Fayers P, Lindschou J, Stromgren AS, Nielsen JB, Higginson IJ, Groenvold M. Exploratory analyses of the Danish Palliative Care Trial (DanPaCT): a randomized trial of early specialized palliative care plus standard care versus standard care in advanced cancer patients. Support Care Cancer. 2020 May;28(5):2145-2155. doi: 10.1007/s00520-019-05021-7. Epub 2019 Aug 13.

  PMID: 31410598 DERIVED

• Groenvold M, Petersen MA, Damkier A, Neergaard MA, Nielsen JB, Pedersen L, Sjogren P, Stromgren AS, Vejlgaard TB, Gluud C, Lindschou J, Fayers P, Higginson IJ, Johnsen AT. Randomised clinical trial of early specialist palliative care plus standard care versus standard care alone in patients with advanced cancer: The Danish Palliative Care Trial. Palliat Med. 2017 Oct;31(9):814-824. doi: 10.1177/0269216317705100. Epub 2017 May 12.

  PMID: 28494643 DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis; Patient Satisfaction

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Mogens Groenvold, MD, PhD, DMSc

  Department of Palliative Medicine, Bispebjerg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, DMSc

Study Record Dates

• First Submitted: May 2, 2011
• First Posted: May 5, 2011
• Study Start: May 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: October 1, 2014
• Last Updated: March 3, 2015

Record last verified: 2015-02

Locations

DK (6)