NCT Number: NCT03375489
This research study is evaluating ways to provide palliative care to patients who have recently been diagnosed with lung cancer and their families.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
University of Alabama at Birmingham, Birmingham, Alabama, United States
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 the 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 families 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 the 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 have better symptom control, quality of life, and mood, and their loved ones feel less distressed. the investigators call this model of care, "early integrated palliative care."
While the investigators know that having palliative care clinicians work closely with the oncology team is helpful for patients and their loved ones, many patients do not have access to these specialists because hospitals and cancer clinics lack enough staff and because some patients and family members live in distant regions that make attending clinic visits difficult and expensive. One way to overcome these barriers is to have patients meet with palliative care clinicians using secure video-conferencing technology.
The purpose of this study is to determine if meeting with a palliative care clinician through video-conferencing is just as beneficial for patients and their families as meeting with a palliative care clinician in person. Specifically, this study will compare these two different strategies for meeting with the palliative care clinician. The first strategy is to schedule the participant to meet with the palliative care clinician regularly each month in person at the clinic. The investigators call this strategy "In-person palliative care."
The second strategy is to schedule the participant to meet with the palliative care clinician regularly each month using secure video-conferencing, such as through a smart phone or tablet computer. If the participant do not have this form of technology, the investigators will provide it for the participant. The investigators call this strategy "telehealth palliative care." The primary goals of this study are to learn if telehealth palliative care is just as effective as in-person palliative care for improving quality of life, mood symptoms, and satisfaction with care for patients with advanced lung cancer and their families.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Teleconference meeting with the palliative care team. Palliative care is a medical specialty focused on lessening (or "palliating") patients' symptoms and helping patients and their families cope with a serious illness.
In-person meeting with the palliative care team. Palliative care is a medical specialty focused on lessening (or "palliating") patients' symptoms and helping patients and their families cope with a serious illness.
Time frame: 24 Weeks
Compare the difference between study groups in patient-reported quality of life as measured by the Functional Assessment of Cancer Therapy - Lung Questionnaire, which has a total scale score range from 0-136 with higher scores indicating better overall quality of life.
Time frame: 48 weeks (or last assessment prior to death if before 48 weeks)
Compare the difference between study groups in the proportion of patients who reported that they discussed their end-of-life care preferences with their clinicians based on a single item from the Prognosis and Treatment Perceptions Questionnaire (PTPQ). The PTPQ includes a self-report item that assesses whether the patient communicated with their clinicians about their wishes for care if they were dying (i.e., scored dichotomously as "yes vs. no").
Time frame: From hospice enrollment until patient death during study period
Compare the difference between study groups in the length of stay in hospice (as measured in days) among patients who died during study period per medical record review.
Time frame: 24 weeks
Compare the difference between study groups in the proportion of palliative care visits that had a caregiver present as documented by the palliative care clinician using a study visit summary form.
Time frame: 24 weeks
Compare the difference between study groups in patient-reported satisfaction with care as measured by the Satisfaction and Care Delivery Questionnaire, which has a total scale score range from 0-52 with higher scores indicating greater satisfaction.
Time frame: 24 weeks
Compare the difference between study groups in caregiver-reported satisfaction with care as measured by the Satisfaction and Care Delivery Questionnaire (caregiver version), which has a total scale score range from 0-48 with higher scores indicating greater satisfaction.
Time frame: up to 48 weeks
Compare the difference between study groups in patient-reported coping strategies as measured by the Brief Cope (approach-oriented coping score range: 6-24, with higher scores indicating greater use of approach-oriented coping strategies; avoidant coping score range: 4-16, with higher scores indicating greater use of avoidant coping strategies).
Time frame: up to 48 weeks
Compare the difference between study groups in patient-reported prognostic understanding as measured by the Prognosis and Treatment Perceptions Questionnaire, in which patients rate two items about the goal of their cancer care (i.e., scored dichotomously as either "to cure my cancer" vs any other option) and whether their cancer is curable (i.e., scored dichotomously as "yes or no").
Time frame: up to 48 weeks
Compare the difference between study groups in caregiver-reported prognostic understanding as measured by the Prognosis and Treatment Perceptions Questionnaire, in which caregivers rate two items about the goal of their loved one's cancer care (i.e., scored dichotomously as either "to cure his/her cancer" vs any other option) and whether their loved one's cancer is curable (i.e., scored dichotomously as "yes or no").
Time frame: up to 48 weeks
Compare the difference between study groups in caregiver-reported quality of life as measured by the Caregiver Oncology Quality of Life Questionnaire, which has a total scale score range of 0-100 with higher scores indicating better quality of life.
Time frame: up to 48 weeks
Compare the difference between study groups in caregiver-reported mood symptoms as measured by the Hospital Anxiety and Depression Scale (anxiety subscale score range, 0-21, with higher scores indicating greater anxiety symptoms; depression subscale score range, 0-21, with higher scores indicating greater depression symptoms).
Time frame: up to 48 weeks
Compare the difference between study groups in patient-reported mood symptoms as measured by the Hospital Anxiety and Depression Scale (anxiety subscale score range, 0-21, with higher scores indicating greater anxiety symptoms; depression subscale score range, 0-21, with higher scores indicating greater depression symptoms).
Time frame: up to 48 weeks
Compare the difference between study groups in patient-reported depression as measured by the Patient Health Questionnaire-9, which has a total scale score range from 0-27 with higher scores indicating more significant depression symptoms.
Time frame: Through study completion, average of 18 month follow up
Compare the difference between study groups in health care utilization as per medical record review of emergency department visits, hospital admissions, chemotherapy administration at the end of life, and hospice service use.
Time frame: Up to 6 months after patient death during study period
Compare the difference between study groups in caregiver-reported quality of patient death as measured by the After Death Assessment, which includes three items that ask the caregiver to rate the quality of the patient's death (from 1 "worst possible" to 10 "best possible"), the degree of physical distress the patient experienced in their last week of life (from 1 "none" to 10 "extremely distressed"), and the degree of psychological distress the patient experienced in their last week of life (from 1 "none" to 10 "extremely upset").
Time frame: up to 48 weeks
Compare the difference between study groups in patient-reported quality of life across all study assessment time points as measured by the Functional Assessment of Cancer Therapy - Lung Questionnaire, which has a total scale score range from 0-136 with higher scores indicating better quality of life.
Massachusetts General Hospital
Other
Comparative Effectiveness of Early Integrated Telehealth Versus In-Person Palliative Care for Patients With Advanced Lung Cancer
Acronym: REACH PC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT00340405
Lung Cancer, Lung Diseases
Beijing, China
View Trial DetailsNCT03117946
Head and Neck Cancer, Head and Neck Neoplasms
Besançon, France
View Trial DetailsNCT05832008
Adherence, Patient, Behavior
Philadelphia, Pennsylvania, United States
View Trial DetailsNCT06084208
Lung Cancer, Lung Diseases
Nijmegen, Netherlands
View Trial Details