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Lung NeoplasmsPhase 3PACONCT01631565

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

A Phase 3 study testing Early allocation to palliative care, Nutritional counseling and Psychoeducation. in people with Lung Neoplasms, run by Instituto Nacional de Cancerologia de Mexico at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Lung Neoplasms
What is being tested?
Early allocation to palliative care, Nutritional counseling and Psychoeducation.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
201 participants
Where
1 siteMexico
Study dates
May 2012to Jan 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Suicide Risk
  • Delirium
  • Cognitive impairment

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • National Cancer Institute- México

    Mexico City, Mexico City, 0

Other trials in Mexico

About this study

Official title: Management of Symptoms in Patients With Advanced Lung Cancer: Early Incorporation of Patient and Family to Attention and Care Program in Oncology

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.

Read the 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.

Conditions
Lung Neoplasms
Being tested
Early allocation to palliative care, Nutritional counseling, Psychoeducation.
Keywords
Palliative Care, Survival, Quality of life
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Early allocation to palliative careBehavioural

    Also called experimental

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

  • Nutritional counselingBehavioural

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

  • Psychoeducation.Behavioural

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

Study groups in NCT01631565
Study groupRoleWhat they receive
Standard careNo interventionUsual care given to the patients. Treatment, follow-up.
Early Palliative CareExperimentalIntervention: 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.
Receives: Behavioral: Early allocation to palliative care; Behavioral: Nutritional counseling; Behavioral: Psychoeducation.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: from inclusion until at least 6 months after

Secondary outcomes (2)

  1. 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.

    Measured: from inclusion until at least 6 months after

  2. Quality of life

    by EORTC QLQ C30, QLQ LC13

    Measured: from inclusion until at least 6 months after

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2012 (estimated)
  2. Study startMay 2012
  3. Primary completionNov 2015
  4. Study completionJan 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
201 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01631565
Sponsor's protocol ID
PACO2012
Acronym
PACO
Status last verified
Nov 2016
First submitted
11 Jun 2012
Last updated
25 Nov 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes

Publications

  • 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.

    PubMed 11083884

  • 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.

    PubMed 25841435

  • 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.

    PubMed 19064979

  • 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.

    PubMed 11559726

  • 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.

    PubMed 19451437

  • 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.

    PubMed 16173112

  • 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.

    PubMed 38558247

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Early allocation to palliative care, Nutritional counseling and Psychoeducation. in people with Lung Neoplasms, run by Instituto Nacional de Cancerologia de Mexico at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Global survival (time frame: from inclusion until at least 6 months after). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01631565, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2016.

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