Vets Helping Vets Pilot Study

NCT02616588 | Completed DMC

• 1 other identifier: 15-2137
• Study Type: interventional
• Target: 17
• Locations: 0 countries
• Sites: N/A

Brief Summary

The overall goal of this study is to evaluate the feasibility of a veteran patient navigator and social work counseling intervention in veterans with advanced stage cancer at the Denver VA Medical Center. This is a tiered intervention: patients first receive the veteran patient navigator component of the intervention, and then if additional patient needs are present they receive the social work counseling component of the intervention. The overall intervention will help veterans communicate their care preferences with their providers.This is a study of behavioral and care strategy interventions and involves no investigational drugs or devices.

Conditions

Advanced Stage Cancer

Keywords

advanced stage cancer,; patient navigator,; social work

Outcome Measures

Primary Outcomes (3)

• Aim 1A. Examine intervention feasibility.

  The intervention will be feasible if: A. The participation rate is above 40% and the retention rate is above 60%.

  1 year

• Aim 1B. Examine intervention feasibility.

  The intervention will be feasible if: B. Oncology providers and patient participants find the intervention acceptable as defined by mean ratings of above "somewhat" useful/helpful/satisfied (i.e., above 3 on a 1 to 5 Likert scale, where 5 is "extremely" and 1 is "not at all."

  1 year

• Aim 1C. Examine intervention feasibility.

  The intervention will be feasible if: C. There is less than 10% missing data on patient-reported survey measures.

  1 year

Secondary Outcomes (6)

• Aim 2A. aTrack intervention process in order to improve the intervention

  1 year

• Aim 2Ab. Track intervention process in order to improve the intervention

  1 year

• Aim 2Ac. Track intervention process in order to improve the intervention

  1 year

• Aim 2Ad. Track intervention process in order to improve the intervention

  1 year

• Aim 2Ae. Track intervention process in order to improve the intervention

  1 year

Study Arms (1)

Intervention Arm

EXPERIMENTAL

All participants are enrolled into the intervention arm and receive the Veteran Patient Navigator and Social Work Intervention.

Behavioral: Veteran Patient Navigator and Social Work Intervention

Interventions

Veteran Patient Navigator and Social Work Intervention BEHAVIORAL

Each study participant will receive a veteran patient navigator intervention which consists of five study visits consisting of advance care planning, pain/symptom management, and education about hospice and palliative care. When clinically indicated, patients will be referred to a social work intervention providing psychosocial care and support.

Intervention Arm

Eligibility Criteria

• Age: 18 Years - 108 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (over 18 years of age)
• Patient has an oncology provider within the VA ECHCS
• English is patient's primary language
• Has a reliable telephone
• Diagnosis of cancer deemed as incurable by oncology provider
• Oncology provider answers "no" to the question, "Would you be surprised if this patient dies in the next year?"

You may not qualify if:

• Already receiving specialist palliative care or receiving hospice care

Sponsors & Collaborators

• VA Eastern Colorado Health Care System: lead

Related Publications (14)

• Arrieta O, Angulo LP, Nunez-Valencia C, Dorantes-Gallareta Y, Macedo EO, Martinez-Lopez D, Alvarado S, Corona-Cruz JF, Onate-Ocana LF. Association of depression and anxiety on quality of life, treatment adherence, and prognosis in patients with advanced non-small cell lung cancer. Ann Surg Oncol. 2013 Jun;20(6):1941-8. doi: 10.1245/s10434-012-2793-5. Epub 2012 Dec 22.

  PMID: 23263699 BACKGROUND

• Mack JW, Weeks JC, Wright AA, Block SD, Prigerson HG. End-of-life discussions, goal attainment, and distress at the end of life: predictors and outcomes of receipt of care consistent with preferences. J Clin Oncol. 2010 Mar 1;28(7):1203-8. doi: 10.1200/JCO.2009.25.4672. Epub 2010 Feb 1.

  PMID: 20124172 BACKGROUND

• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

  PMID: 16717171 BACKGROUND

• Zimmermann C, Swami N, Krzyzanowska M, Hannon B, Leighl N, Oza A, Moore M, Rydall A, Rodin G, Tannock I, Donner A, Lo C. Early palliative care for patients with advanced cancer: a cluster-randomised controlled trial. Lancet. 2014 May 17;383(9930):1721-30. doi: 10.1016/S0140-6736(13)62416-2. Epub 2014 Feb 19.

  PMID: 24559581 BACKGROUND

• Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, Dahlin CM, Blinderman CD, Jacobsen J, Pirl WF, Billings JA, Lynch TJ. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med. 2010 Aug 19;363(8):733-42. doi: 10.1056/NEJMoa1000678.

  PMID: 20818875 BACKGROUND

• Block SD, Billings JA. A need for scalable outpatient palliative care interventions. Lancet. 2014 May 17;383(9930):1699-700. doi: 10.1016/S0140-6736(13)62676-8. Epub 2014 Feb 19. No abstract available.

  PMID: 24559580 BACKGROUND

• Freeman HP. Patient navigation: a community based strategy to reduce cancer disparities. J Urban Health. 2006 Mar;83(2):139-41. doi: 10.1007/s11524-006-9030-0. No abstract available.

  PMID: 16736361 BACKGROUND

• Freeman HP, Muth BJ, Kerner JF. Expanding access to cancer screening and clinical follow-up among the medically underserved. Cancer Pract. 1995 Jan-Feb;3(1):19-30.

  PMID: 7704057 BACKGROUND

• Steinberg ML, Fremont A, Khan DC, Huang D, Knapp H, Karaman D, Forge N, Andre K, Chaiken LM, Streeter OE Jr. Lay patient navigator program implementation for equal access to cancer care and clinical trials: essential steps and initial challenges. Cancer. 2006 Dec 1;107(11):2669-77. doi: 10.1002/cncr.22319.

  PMID: 17078056 BACKGROUND

• Wells KJ, Battaglia TA, Dudley DJ, Garcia R, Greene A, Calhoun E, Mandelblatt JS, Paskett ED, Raich PC; Patient Navigation Research Program. Patient navigation: state of the art or is it science? Cancer. 2008 Oct 15;113(8):1999-2010. doi: 10.1002/cncr.23815.

  PMID: 18780320 BACKGROUND

• Calhoun EA, Whitley EM, Esparza A, Ness E, Greene A, Garcia R, Valverde PA. A national patient navigator training program. Health Promot Pract. 2010 Mar;11(2):205-15. doi: 10.1177/1524839908323521. Epub 2008 Dec 30.

  PMID: 19116415 BACKGROUND

• Freeman HP, Chu KC. Determinants of cancer disparities: barriers to cancer screening, diagnosis, and treatment. Surg Oncol Clin N Am. 2005 Oct;14(4):655-69, v. doi: 10.1016/j.soc.2005.06.002.

  PMID: 16226685 BACKGROUND

• Freeman HP. Patient navigation: a community centered approach to reducing cancer mortality. J Cancer Educ. 2006 Spring;21(1 Suppl):S11-4. doi: 10.1207/s15430154jce2101s_4.

  PMID: 17020496 BACKGROUND

• Fischer SM, Cervantes L, Fink RM, Kutner JS. Apoyo con Carino: a pilot randomized controlled trial of a patient navigator intervention to improve palliative care outcomes for Latinos with serious illness. J Pain Symptom Manage. 2015 Apr;49(4):657-65. doi: 10.1016/j.jpainsymman.2014.08.011. Epub 2014 Sep 18.

  PMID: 25240788 BACKGROUND

MeSH Terms

Interventions

Social Work

Intervention Hierarchy (Ancestors)

Health Services; Health Care Facilities Workforce and Services

Study Officials

• David Bekelman, MPH, MD

  Eastern Colorado Health Care System, Department of Veterans Affairs, Denver, CO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2015
• First Posted: November 30, 2015
• Study Start: February 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: May 11, 2017

Record last verified: 2017-05