NCT01631565

Brief Summary

There is recent evidence that early palliative care administered to patients helps for their quality of life (QoL). It is however not part of the standard multidisciplinary treatment. This study intents to evaluate the effect of early palliative care in patients with advanced Non-Small Cell Lung Cancer (NSCLC) compared to the standard of care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
201

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2012

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 11, 2012

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 29, 2012

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

November 25, 2016

Status Verified

November 1, 2016

Enrollment Period

3.5 years

First QC Date

June 11, 2012

Last Update Submit

November 23, 2016

Conditions

Lung Neoplasms

Keywords

Palliative CareSurvivalQuality of life

Outcome Measures

Primary Outcomes (1)

  • Global survival

    Overall survival will be determined from the date of commencement of treatment to date of death, regardless of the cause of death. In patients who did not die at the time of final analysis will use the date of last contact.

    from inclusion until at least 6 months after

Secondary Outcomes (2)

  • Progression Free Survival

    from inclusion until at least 6 months after

  • Quality of life

    from inclusion until at least 6 months after

Study Arms (2)

Standard care

NO INTERVENTION

Usual care given to the patients. Treatment, follow-up.

Early Palliative Care

EXPERIMENTAL

Intervention: Early allocation to palliative care. Intervention: Nutritional counseling. Intervention: patient and care-taker psychoeducation, depression and anxiety evaluation. Standard of care: Oncological treatment according to stage of disease (IIIb/IV). Treatment: Chemotherapy (platins, taxans, TKIs) Baseline: BMI, and anthropometric characteristics (weight, height). Follow-up: During 6 chemotherapy circles with: Quality of Life (EORTC qlq-c30), HADS, ESAS and ZARIT.

Behavioral: Early allocation to palliative careBehavioral: Nutritional counselingBehavioral: Psychoeducation.

Interventions

Early allocation to palliative careBEHAVIORAL

Symptoms management (e.g. Pain, nausea, dehydration management).

Also known as: experimental
Early Palliative Care
Nutritional counselingBEHAVIORAL

Nutritional status evaluation and dietary supplementation according to the patient requirements.

Early Palliative Care
Psychoeducation.BEHAVIORAL

Patient and care-taker psychoeducation, depression and anxiety evaluation.

Early Palliative Care

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical stage IV
  • ECOG 0-2
  • Patients treated virgin
  • Receive platinum-based chemotherapy

You may not qualify if:

  • Suicide Risk
  • Delirium
  • Cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Institute- México

Mexico City, Mexico City, 0, Mexico

Location

Related Publications (7)

  • Gore JM, Brophy CJ, Greenstone MA. How well do we care for patients with end stage chronic obstructive pulmonary disease (COPD)? A comparison of palliative care and quality of life in COPD and lung cancer. Thorax. 2000 Dec;55(12):1000-6. doi: 10.1136/thorax.55.12.1000.

    PMID: 11083884BACKGROUND

  • Nieder C, Norum J. Early palliative care in patients with metastatic non-small cell lung cancer. Ann Palliat Med. 2012 Apr;1(1):84-6. doi: 10.3978/j.issn.2224-5820.2012.03.05. No abstract available.

    PMID: 25841435BACKGROUND

  • Follwell M, Burman D, Le LW, Wakimoto K, Seccareccia D, Bryson J, Rodin G, Zimmermann C. Phase II study of an outpatient palliative care intervention in patients with metastatic cancer. J Clin Oncol. 2009 Jan 10;27(2):206-13. doi: 10.1200/JCO.2008.17.7568. Epub 2008 Dec 8.

    PMID: 19064979BACKGROUND

  • Jordhoy MS, Fayers P, Loge JH, Ahlner-Elmqvist M, Kaasa S. Quality of life in palliative cancer care: results from a cluster randomized trial. J Clin Oncol. 2001 Sep 15;19(18):3884-94. doi: 10.1200/JCO.2001.19.18.3884.

    PMID: 11559726BACKGROUND

  • Ferris FD, Bruera E, Cherny N, Cummings C, Currow D, Dudgeon D, Janjan N, Strasser F, von Gunten CF, Von Roenn JH. Palliative cancer care a decade later: accomplishments, the need, next steps -- from the American Society of Clinical Oncology. J Clin Oncol. 2009 Jun 20;27(18):3052-8. doi: 10.1200/JCO.2008.20.1558. Epub 2009 May 18.

    PMID: 19451437BACKGROUND

  • Akechi T, Okuyama T, Akizuki N, Azuma H, Sagawa R, Furukawa TA, Uchitomi Y. Course of psychological distress and its predictors in advanced non-small cell lung cancer patients. Psychooncology. 2006 Jun;15(6):463-73. doi: 10.1002/pon.975.

    PMID: 16173112BACKGROUND

  • Allende S, Turcott JG, Verastegui E, Rodriguez-Mayoral O, Flores-Estrada D, Perez Camargo DA, Ramos-Ramirez M, Martinez-Hernandez JN, Onate-Ocana LF, Pina PS, Cardona AF, Arrieta O. Early Incorporation to Palliative Care (EPC) in Patients With Advanced Non-Small Cell Lung Cancer: The PACO Randomized Clinical Trial. Oncologist. 2024 Oct 3;29(10):e1373-e1385. doi: 10.1093/oncolo/oyae050.

    PMID: 38558247DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Oscar G Arrieta, MD Msc

    Mexico. Nacional Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
SNI II

Study Record Dates

First Submitted

June 11, 2012

First Posted

June 29, 2012

Study Start

May 1, 2012

Primary Completion

November 1, 2015

Study Completion

January 1, 2016

Last Updated

November 25, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will share

Locations

ME(1)