Stepped Palliative Care Versus Early Integrated Palliative Care in Patients With Advanced Lung Cancer

Lung Cancer Clinical Trial

— STEP PC  

Official title:

Randomized Trial of Stepped Palliative Care Versus Early Integrated Palliative Care in Patients With Advanced Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03337399
• Other study ID #: 17-471
• Secondary ID: R01CA215188
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2024
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research study is evaluating ways to provide palliative care to patients who have recently been diagnosed with lung cancer

Description:

Patients with serious cancers, like advanced lung cancer, often experience physical symptoms, such as pain or shortness of breath. In addition, both patients and their loved ones (family and friends) often feel worried or sad about their cancer 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 family cope with a serious illness improves patients' and their loved ones' experience with their cancer. This team is called "palliative care," and consists of physicians and advanced practice nurses (or "nurse practitioners") who work closely and collaboratively with your oncology team to care for the participant and the participant's loved ones. Research shows that when the palliative care team works closely with the oncology team to care for patients with advanced cancer, they may have better symptom control, quality of life, and mood and their loved ones feel less distressed.

This study will compare two different strategies for scheduling participant's visits with the palliative care clinician. The first strategy is to schedule the participant to meet with the palliative care clinician regularly each month. The investigators call this strategy "early integrated palliative care".

The second strategy is to schedule the participant to meet with the palliative care clinician after the participant is admitted to the hospital or if the participant's oncology team needs to change the participant cancer treatment, as these are times when the participant is likely to have health issues that the palliative care clinician can help with. The investigators will also monitor the participant's quality of life regularly. If the study team determines that the participant quality of life worsens, the investigators will increase the frequency of the participant's visits with the palliative care clinician to monthly appointments. The investigators call this strategy "stepped palliative care" because the investigators step up the frequency of the participant palliative care visits if the participant's quality of life worsens during the participant cancer treatment.

No matter which strategy the participant is taking part in, the participant will still be able to request additional palliative care visits outside of the study schedule if the participant feel they need them.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 510
• Est. completion date: December 31, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 twelve 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 Spanish

• Primary cancer care at one of the three participating sites

• Age > 18 years

Exclusion Criteria:

• Already receiving outpatient PC or hospice services

• Cognitive or psychiatric conditions as determined by the treating oncologist to prohibit study consent or participation

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• Stepped PC
Palliative Care is 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 family cope with a serious illness improves patients' and their loved ones' experience with their cancer
• Early Integrated PC
Palliative Care is 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 family cope with a serious illness improves patients' and their loved ones' experience with their cancer

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Duke University	Durham	North Carolina
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Compare the superiority of stepped PC versus early integrated PC with respect to cost effectiveness	Cost effectiveness as assessed by data collection from the medical record, hospital cost accounting systems, and patient report as per the EuroQOL	up to 5 years
Other	Compare patients' coping as measured by the Brief Cope between stepped PC and early integrated PC	Coping as measured by the Brief Cope	up to 48 weeks
Other	Compare patients' prognostic understanding as measured by the Perception of Treatment and Prognosis Questionnaire between stepped PC and early integrated PC	Prognostic understanding as per the Perception of Treatment and Prognosis Questionnaire (PTPQ)	up to 48 weeks
Other	Compare patients' depression as measured by the Patient Health Questionnaire-9 (PHQ-9) between stepped PC and early integrated PC	Depression as measured by the Patient Health Questionnaire-9 (PHQ-9)	up to 48 weeks
Other	Health care utilization	Healthcare utilization as measured the means and proportion of patients who experience emergency department visits, hospital admission, and chemotherapy administration at the end of life between the two groups.	up to 5 years
Primary	Establish that stepped PC is non-inferior to early integrated PC in improving patients' QOL, as measured by the FACT-L	Quality of life as measured by the Functional Assessment of Cancer Therapy-Lung	24 Weeks
Secondary	Assess whether stepped PC is non-inferior to early integrated PC with respect to patient-clinician communication about EOL care preferences	Communication about EOL care preferences as measured by patient self-report of communication about their wishes if they were dying	up to 5 years
Secondary	Assess whether stepped PC is non-inferior to early integrated PC with respect to length of stay in hospice	Length of stay in hospice as collected per medical record review	up to 5 years
Secondary	Compare the superiority of stepped PC versus early integrated PC with respect to resource utilization	Utilization of PC services as per medical record review	up to 5 years
Secondary	Evaluate whether stepped PC is non-inferior to early integrated PC in improving patients' QOL, as measured by the FACT-L	Quality of life as measured by the Functional Assessment of Cancer Therapy-Lung	up to 48 weeks