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| ID | Type | Description | Link |
|---|---|---|---|
| LC240650 | Other Grant/Funding Number | Department of Defense |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
| US Department of Veterans Affairs | FED |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care - Arm A | Active Comparator | Patients randomized to this group will receive usual care provided by their oncology(or primary) clinical team. |
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| Intervention Lay Health Worker (LHW) - Arm B | Experimental | Participants randomized to this arm of the study will receive usual care with supplemental education and support provided by a lay health worker (LHW) to assist with healthcare planning, symptom management, and discussions about care preferences and goals. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lay Health Worker (LHW) Planning | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Health-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. | At Baseline (time of enrollment), 3, 6, 9, and 12 months post-enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline (time of enrollment) to 12 Months post-enrollment |
| Hospitalization Visits (Self-reported and Chart Review) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manali I Patel, MD MPH MS | Contact | 6504935000 | manalip@stanford.edu | |
| Madhuri Agrawal, MS | Contact | 650-304-7744 | madhuri.agrawal@va.gov |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veterans Affairs Palo Alto Health Care System (VAPAHCS) | Recruiting | Palo Alto | California | 94304 | United States |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D000077192 | Adenocarcinoma of Lung |
| D055752 | Small Cell Lung Carcinoma |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
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intervention vs. usual care
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The statistician analyzing the data will be masked from the randomization assignment. The principal investigator overseeing the trial will have access to the data but will also be masked from randomization assignment.
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| Usual Care Group | Other | 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. |
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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. |
| 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 . | 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 | 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. | 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. | 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. | From baseline (time of enrollment) to 12 months post-enrollment |
| D012140 |
| Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |