search
Back to results

Early Incorporation of Patient and Family to Attention and Care Program in Oncology Versus Standard of Care (PACO)

Primary Purpose

Lung Neoplasms

Status
Completed
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
Early allocation to palliative care
Nutritional counseling
Psychoeducation.
Sponsored by
Instituto Nacional de Cancerologia de Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Neoplasms focused on measuring Palliative Care, Survival, Quality of life

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Suicide Risk
  • Delirium
  • Cognitive impairment

Sites / Locations

  • National Cancer Institute- México

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard care

Early Palliative Care

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Progression Free Survival
Is defined as the time from start of treatment until the date of the first documented evidence of progression (RECIST criteria) or the date of death for any reason in the absence of disease progression (EP). For patients who have died or progressed at the time of final analysis, use the date of last contact.
Quality of life
by EORTC QLQ C30, QLQ LC13

Full Information

First Posted
June 11, 2012
Last Updated
November 23, 2016
Sponsor
Instituto Nacional de Cancerologia de Mexico
search

1. Study Identification

Unique Protocol Identification Number
NCT01631565
Brief Title
Early Incorporation of Patient and Family to Attention and Care Program in Oncology Versus Standard of Care
Acronym
PACO
Official Title
Management of Symptoms in Patients With Advanced Lung Cancer: Early Incorporation of Patient and Family to Attention and Care Program in Oncology
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Cancerologia de Mexico

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The multidisciplinary approach of palliative care for symptom management has an impact on the quality of life (QoL) of patients and their families. The World Health Organization (WHO) and the American Society of Clinical Oncology (ASCO) recommend incorporating early palliative care, simultaneously with cancer treatment. Unfortunately, this recommendation has not been followed in many cancer centers and late referrals to hospice are still frequent. Patients with lung cancer have more symptoms than patients with other cancer. The impact on QoL and symptom management has acquired a great relevance. However, few studies demonstrating the benefit of early incorporation of palliative care in the management of patients with advanced lung cancer have been shown. Palliative care is defined as the care given to patients with progressive active and advanced disease, and its main purpose is the relief and prevention of suffering and improving QoL. In Mexico, the law defines palliative care as comprehensive care for those illnesses not responsive to curative treatment and include, but are not limited, to pain and other symptoms associated with the disease and psychological care, social and spiritual, of the patients and their families. Psychological aspects The psychological manifestations in patients with lung cancer are determined by several factors. Depression and anxiety are the most common psychological reactions. It has been identified that 25% of cancer patients suffer from major depression at some point during the course of the disease and has been associated with decreased survival and QoL. Patients with anxiety disorders become more attached to medical treatment but seek alternative treatments more often. The main objective of psychological interventions is reducing maladaptive emotional reactions. In advanced stages, caregivers also confront stress and depression that could lead to health problems. Nutritional aspects Malnutrition is reported in 60 to 79% in patients with lung cancer and is the largest contribution to morbidity and mortality. Cachexia is responsible directly or indirectly to death in one third of patients. The objectives of nutritional support are: improving tolerance to specific cancer treatment, decreasing the incidence of complications and, improving the QoL. Thus, it is necessary to conduct an early diagnosis of nutritional status in order to design nutritional intervention and improve their sense of comfort and QoL.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms
Keywords
Palliative Care, Survival, Quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
201 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Usual care given to the patients. Treatment, follow-up.
Arm Title
Early Palliative Care
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Early allocation to palliative care
Other Intervention Name(s)
experimental
Intervention Description
Symptoms management (e.g. Pain, nausea, dehydration management).
Intervention Type
Behavioral
Intervention Name(s)
Nutritional counseling
Intervention Description
Nutritional status evaluation and dietary supplementation according to the patient requirements.
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation.
Intervention Description
Patient and care-taker psychoeducation, depression and anxiety evaluation.
Primary Outcome Measure Information:
Title
Global survival
Description
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.
Time Frame
from inclusion until at least 6 months after
Secondary Outcome Measure Information:
Title
Progression Free Survival
Description
Is defined as the time from start of treatment until the date of the first documented evidence of progression (RECIST criteria) or the date of death for any reason in the absence of disease progression (EP). For patients who have died or progressed at the time of final analysis, use the date of last contact.
Time Frame
from inclusion until at least 6 months after
Title
Quality of life
Description
by EORTC QLQ C30, QLQ LC13
Time Frame
from inclusion until at least 6 months after

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical stage IV ECOG 0-2 Patients treated virgin Receive platinum-based chemotherapy Exclusion Criteria: Suicide Risk Delirium Cognitive impairment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oscar G Arrieta, MD Msc
Organizational Affiliation
Mexico. Nacional Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Institute- México
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
0
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
11083884
Citation
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.
Results Reference
background
PubMed Identifier
25841435
Citation
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.
Results Reference
background
PubMed Identifier
19064979
Citation
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.
Results Reference
background
PubMed Identifier
11559726
Citation
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.
Results Reference
background
PubMed Identifier
19451437
Citation
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.
Results Reference
background
PubMed Identifier
16173112
Citation
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.
Results Reference
background

Learn more about this trial

Early Incorporation of Patient and Family to Attention and Care Program in Oncology Versus Standard of Care

We'll reach out to this number within 24 hrs