Veterans Affairs Palo Alto Health Care System (VAPAHCS)
Palo Alto, California, 94304, United States
Location status: Recruiting
NCT Number: NCT07219251
This research study will help our understanding of whether additional support for Veterans with lung cancer can improve their quality of life.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Palo Alto, California, 94304, United States
Location status: Recruiting
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Usual Care
Time frame: At Baseline (time of enrollment), 3, 6, 9, and 12 months post-enrollment
Change in Health-related quality of life using the 36-item validated Functional Assessment of Cancer Therapeutics-Lung (FACT-L) survey.
Time frame: From baseline (time of enrollment) to 12 Months post-enrollment
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
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: At baseline (time of enrollment), 3, 6, 9 and 12 months post-enrollment
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, 3, 6, 9 and 12 months post-enrollment
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 will be abstracted by electronic medical record chart review for each patient at 3, 6, 9 and 12 months after enrollment.
Time frame: From baseline (time of enrollment) to 12 months post-enrollment
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 will be self-reported by each patient or abstracted by electronic medical record at 3, 6, 9 and 12 months after patient enrollment.
Contact information is provided by the study sponsor or research team.
Madhuri Agrawal, MS
CONTACT
Manali I Patel, MD MPH MS
CONTACT
Palo Alto Veterans Institute for Research
Other
Engagement of Veterans With Lung Cancer (EVLC)
Acronym: EVLC
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.
NCT07341737
Adenocarcinoma, Adenocarcinoma of Lung
Adelaide, South Australia, Australia
View Trial DetailsNCT06228326
Advanced Cancer, Bronchial Neoplasms
Dothan, Alabama, United States
View Trial DetailsNCT07002788
Adenocarcinoma, Adenocarcinoma of Lung
Ankara, Turkey (Türkiye)
View Trial DetailsNCT07127874
Advanced Cancer, Advanced Solid Tumors
Los Angeles, California, United States
View Trial Details