This research study will help our understanding of whether additional support for Veterans with lung cancer can improve their quality of life.
This study aims to evaluate whether a lay health worker who provides education and support regarding goals of care and symptom management can improve health-related quality of life among Veterans with newly diagnosed lung cancer and those receiving treatment or who have completed treatment within 12 months as compared to usual care. We will also determine whether the intervention reduces acute care use and explore effects on anxiety and depression, patient activation, and goals of care communication. This knowledge is important as it will help to improve care for Veterans with lung cancer. PRIMARY OBJECTIVES: i.) Health-related quality of life SECONDARY OBJECTIVES: i.) acute care use ii.) patient activation iii.) anxiety and depression iv.) documentation of goals of care (GoC) v.) palliative care use vi.) hospice use OUTLINE: The study will enroll and randomize 1:1 a total of 194 Veterans diagnosed with lung cancer (any stage). Arm A: Participants randomized to the usual care group will receive usual care provided by their oncology clinical team. Arm B: Participants randomized to the LHW group will receive usual care provided by their oncology clinical team and also receive weekly telephone calls with a trained lay health worker to assist with healthcare planning, symptom management, and discussions about care preferences and goals for 6 months. All participants regardless of group randomization, will be required to complete surveys at the start of the study and at 3-month intervals for 12 months (i.e., at enrollment, 3 months, 6 months, 9 months, and 12 months).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE
Enrollment
194
Patients randomized to the LHW group will receive usual care provided by their oncology (or primary) clinical team along with an initial 30-minute telephone call with the LHW from Palo Alto, followed by weekly 15-minute phone calls (or as needed) for 6months. These calls are designed to assist with healthcare planning, symptom management, and discussions about care preferences and goals.
Participants randomized to the usual care group will receive usual care provided by their oncology clinical team. These teams have been trained in symptom assessment, goals-of-care (GoC) discussions, and documentation of such clinical services. As part of usual care, participants may engage in symptom and GoC discussions at any time, initiated by either the patient or the clinician.
Veterans Affairs Palo Alto Health Care System (VAPAHCS)
Palo Alto, California, United States
RECRUITINGHealth-Related Quality of Life
Change in Health-related quality of life using the 36-item validated Functional Assessment of Cancer Therapeutics-Lung (FACT-L) survey.
Time frame: At Baseline (time of enrollment), 3, 6, 9, and 12 months post-enrollment
Emergency Department Visits (Self-reported and Chart Review)
Emergency Department use will be self-reported by each patient or abstracted by electronic medical record at 3, 6, 9 and 12 months after enrollment.
Time frame: From baseline (time of enrollment) to 12 Months post-enrollment
Hospitalization Visits (Self-reported and Chart Review)
Hospital use for each patient will be self-reported by each patient or abstracted by electronic medical record at 3, 6, 9 and 12 months after enrollment.
Time frame: From baseline (time of enrollment) to 12 months post-enrollment
Patient Activation Measure (PAM-10).
Change in patient activation using 10-item validated survey Patient Activation Measure (PAM-10) assessing patient activation in their health and health care .
Time frame: At baseline (time of enrollment), 3, 6, 9 and 12 months post-enrollment
Patient-reported anxiety and depression
Patient-reported anxiety and depression using the validated Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety and Depression scales
Time frame: At baseline, 3, 6, 9 and 12 months post-enrollment
Documentation of goals of care discussions (Chart Review)
Documentation of goals of care discussions will be abstracted by electronic medical record chart review for each patient at 3, 6, 9 and 12 months after enrollment.
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Time frame: At baseline, 3, 6, 9 and 12 months post-enrollment
Palliative Care Use (Self-reported and Chart Review)
Palliative care use will be self-reported by each patient or abstracted by electronic medical record at 3, 6, 9 and 12 months after patient enrollment.
Time frame: From baseline (time of enrollment) to 12 months post-enrollment
Hospice Care Use (Self-reported and Chart Review)
Hospice care use will be self-reported by each patient or abstracted by electronic medical record at 3, 6, 9 and 12 months after patient enrollment.
Time frame: From baseline (time of enrollment) to 12 months post-enrollment