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

Primary Purpose

Lung Cancer

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stepped Palliative Care
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lung Cancer focused on measuring Lung Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stepped Palliative Care

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 10, 2017
Last Updated
March 7, 2019
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03220100
Brief Title
Study of Stepped Palliative Care in Patients With Advanced Lung Cancer DF/HCC SOCIAL-BEHAVIORAL RESERACH PROTOCOL
Official Title
Pilot Study of Stepped Palliative Care in Patients With Advanced Lung Cancer DF/HCC SOCIAL-BEHAVIORAL RESERACH PROTOCOL
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Terminated
Why Stopped
Received funding for larger randomized study so terminated pilot study
Study Start Date
July 18, 2017 (Actual)
Primary Completion Date
January 22, 2018 (Actual)
Study Completion Date
January 29, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Patients with serious cancers, like advanced lung cancer, often experience physical symptoms, such as pain or shortness of breath. Both patients and their families often feel worried and/or sad about this diagnosis. Research has shown that early involvement of a team of clinicians that specialize in lessening (or palliating) many of these distressing physical and emotional symptoms, and in helping patients and their families' cope with serious illnesses, improves patients' quality of life and mood, and can help their loved ones' feel less depressed or sad. This team is called "palliative care," and consists of physicians and advanced practice nurses who work closely and collaboratively with the oncology team to care for the patient and their loved ones. While the investigators know having palliative care clinicians care for patients along with their oncology team is helpful for the participant and their loved ones, the investigators do not know the optimal timing of the visits with palliative care. The purpose of this study is to see if the investigators can closely monitor participants' health condition and quality of life and use these metrics as indications of when the participant should see the palliative care team. This study will monitor participants' health condition and schedule the participant to see the palliative care team if the participants' cancer grows or after the participant have been admitted to the hospital. The investigators will also monitor participants' quality of life every six weeks and schedule the participant to see the palliative care monthly if the participant quality of life decreases during the study. This study will also monitor participants' mood, coping, and understanding of the participant illness and prognosis. The investigators will ask the participant to fill out questionnaires asking about these topics every 12 weeks. The participant will be able to complete these questionnaires in clinic, via email, using a mailed paper copy, or over the phone with a member of the research team.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Lung Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stepped Palliative Care
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Stepped Palliative Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of participants who complete the study protocol
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Temel, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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