Stepped Palliative Care Versus Early Integrated Palliative Care in Patients With Advanced Lung Cancer (STEP PC)

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

Primary Outcome Measures

  • Establish that stepped PC is non-inferior to early integrated PC in improving patients’ QOL, as measured by the FACT-L [ Time Frame: 24 Weeks ]
  • Quality of life as measured by the Functional Assessment of cancer therapy-Lung

Secondary Outcome Measures

  • Assess whether stepped PC is non-inferior to early integrated PC with respect to patient-clinician communication about EOL care preferences [ Time Frame: up to 5 years ]
    Communication about EOL care preferences as measured by patient self-report of communication about their wishes if they were dying

  • Assess whether stepped PC is non-inferior to early integrated PC with respect to length of stay in hospice [ Time Frame: up to 5 years ]
    Length of stay in hospice as collected per medical record review

  • Compare the superiority of stepped PC versus early integrated PC with respect to resource utilization [ Time Frame: up to 5 years ]
    Utilization of PC services as per medical record review

  • Evaluate whether stepped PC is non-inferior to early integrated PC in improving patients’ depression [ Time Frame: up to 48 weeks ]
    Depression as measured by the Patient Health Questionnaire-9 (PHQ-9)

  • Evaluate whether stepped PC is non-inferior to early integrated PC in improving patients’ QOL, as measured by the FACT-L [ Time Frame: up to 48 weeks ]
    Quality of life as measured by the Functional Assessment of cancer therapy-Lung

Other Outcome Measures

  • Compare the superiority of stepped PC versus early integrated PC with respect to cost effectiveness [ Time Frame: up to 5 years ]
    Cost effectiveness as assessed by data collection from the medical record, hospital cost accounting systems, and patient report as per the EuroQOL

  • Establish that stepped PC is non-inferior to early integrated PC in improving patients’ coping as measured by the Brief Cope [ Time Frame: up to 48 weeks ]
    Coping as measured by the Brief Cope

  • Establish that stepped PC is non-inferior to early integrated PC in improving patient’s prognostic understanding as measured by the Perception of Treatment and prognosis Questionnaire [ Time Frame: up to 48 weeks ] Prognostic understanding as per the Perception of Treatment and prognosis Questionnaire (PTPQ)

Detailed 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.

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 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 Spanish

Primary cancer care at one of the three participating sites

Age > 18 years
Exclusion Criteria
Already receiving PC or hospice services

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

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Source: the U.S. National Institutes of Health via ClinicalTrials.gov. Last updated: April 20th, 2018.

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Last update: January 19, 2018. 04:57:31 pm.