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

Lung Neoplasms Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01631565
• Other study ID #: PACO2012
• Status: Completed
• Phase: Phase 3
• First received: June 11, 2012
• Last updated: November 23, 2016
• Start date: May 2012
• Est. completion date: January 2016

Study information

• Verified date: November 2016
• Source: Instituto Nacional de Cancerologia de Mexico
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: January 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Clinical stage IV

• ECOG 0-2

• Patients treated virgin

• Receive platinum-based chemotherapy

Exclusion Criteria:

• Suicide Risk

• Delirium

• Cognitive impairment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Neoplasms

Intervention

Behavioral:
• Early allocation to palliative care
Symptoms management (e.g. Pain, nausea, dehydration management).
• Nutritional counseling
Nutritional status evaluation and dietary supplementation according to the patient requirements.
• Psychoeducation.
Patient and care-taker psychoeducation, depression and anxiety evaluation.

Locations

Country	Name	City	State
Mexico	National Cancer Institute- México	Mexico City	Distrito Federal

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Cancerologia de Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View Citation

Jordhøy 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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.	from inclusion until at least 6 months after	Yes
Secondary	Quality of life	by EORTC QLQ C30, QLQ LC13	from inclusion until at least 6 months after	Yes