Study of Stepped Palliative Care in Patients With Advanced Lung Cancer DF/HCC SOCIAL-BEHAVIORAL RESERACH PROTOCOL

NCT03220100 | Terminated

• 1 other identifier: 17-284
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is evaluating a new way to provide palliative care to patients who have recently been diagnosed with lung cancer. . Palliative care is a medical specialty focused on lessening (or "palliating") patients' symptoms and helping patients and their families cope with a serious illness.

Conditions

Lung Cancer

Keywords

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Proportion of participants who complete the study protocol

  The investigators will determine that the study protocol is feasible if at least 75% of participants on step 2 of the intervention complete at least 70% of the scheduled palliative care visits.

  2 years

Study Arms (1)

Stepped Palliative Care

EXPERIMENTAL

All participants will receive palliative care Participants will complete the Functional Assessment of Cancer Therapy-Lung (FACT-L) every six weeks FACT-L scores will be used to determine which patients need to step up to every 6 week palliative care visits Patients on step 1 of the intervention will have a palliative care visit every 9 weeks Patients on step 2 of the intervention will have a palliative care visit every 6 weeks

Other: Stepped Palliative Care

Interventions

Stepped Palliative Care OTHER

Palliative care clinicians will develop a therapeutic relationship with participants and address their symptoms, coping, prognostic awareness and illness understanding, treatment decision-making, and end of life care needs and preferences.

Stepped Palliative Care

Eligibility Criteria

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

You may qualify if:

• Diagnosed with advanced non-small cell lung cancer, small cell lung cancer, or mesothelioma, being treated with non-curative intent, and informed of advanced disease within the prior eight weeks
• Eastern Cooperative Oncology Group (ECOG) Performance Status from 0 (asymptomatic) to 2 (symptomatic and in bed \<50% of the day)
• The ability to read and respond to questions in English or with minimal help from a family member or medical interpreter.
• Primary cancer care at the MGH Cancer Center
• Age \> 18 years

You may not qualify if:

• They are already receiving PC or hospice services
• They have cognitive or psychiatric conditions as determined by the treating oncologist that prohibits study consent or participation

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jennifer Temel, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Cancer Outcomes Research

Study Record Dates

• First Submitted: July 10, 2017
• First Posted: July 18, 2017
• Study Start: July 18, 2017
• Primary Completion: January 22, 2018
• Study Completion: January 29, 2018
• Last Updated: March 8, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)