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| ID | Type | Description | Link |
|---|---|---|---|
| R01NR011871-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
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| National Institute of Nursing Research (NINR) | NIH |
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ENABLE III is a randomized clinical trial that evaluates a phone-based palliative care intervention designed to improve quality of life, mood, and symptom management for patients with an advanced stage cancer and their caregivers.
The primary aims of this clinical trial are to determine whether a palliative care intervention (introduced immediately or 12 weeks after diagnosis) can improve survival, quality of life, mood, symptom intensity and end-of-life care.
In 2008, cancer claimed more than 565,000 American lives -1,500 people a day. Palliative care strives to improve quality of life (QOL) and to prevent "bad deaths" by providing expert, interdisciplinary care to manage the effects of disease and treatment. Effective end-of-life (EOL) care depends upon proactive, patient-centered interventions to prepare patients and families for the challenges of terminal illness. We were able to demonstrate the feasibility and efficacy of a concurrent oncology palliative care (COPC) intervention in improving quality of life and mood in our previous studies ENABLE I and ENABLE II; however, a number of gaps in our knowledge remain.
Patients will be randomized to begin the intervention either immediately or 12 weeks after a new diagnosis of advanced or recurrent cancer. This phone-based intervention consists of: 1) an Advanced Practice Palliative Care Nurse Interventionist instituting 1a) a 6-session manualized patient curriculum- Charting Your Course (CYC), 1b) a 3-session manualized, caregiver curriculum- the Creativity Optimism Planning Expert information (COPE) program, and 1c) on-going patient and caregiver follow up; and 2) Palliative Care Team Comprehensive Assessment & Management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early entry group | Active Comparator | Early entry group will begin the intervention at time of diagnosis of advanced cancer |
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| Later entry group | Active Comparator | Later entry group will begin the intervention 12 weeks after enrollment in the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Later entry group | Behavioral |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in patient's quality of living over time | Quality of living assessments will include quality of life (QOL), mood, and symptom intensity measures using the following measures:
| baseline, 6,12,18,24,36 and every 12 weeks until death or end of study |
| Quality of end of life care | End of life (EOL) Care Data Collection Form: This form is used to collect information about the quality of EOL care and circumstances surrounding the last 48 hours of life for patients who die in hospital, nursing home, or home. Quality of Dying and Death Measure (QODD). The QODD is a structured interview conducted with a caregiver to measure the quality of a patient's last week of life. The interview assesses the caregiver's perception of patient symptoms, preferences, and satisfaction with care. | chart review at time of death and caregiver proxy interview 2-3 months after patient death |
| Estimate and compare the hazard ratios and median survival before and after 1 year from enrollment | We hypothesize that Early entry patients will have longer overall survival at one year compared with Later entry patients. | From enrollment until patient death or end of study |
| Change in caregiver quality of life, burden and grief over time | Caregiver burden and QOL will be measured using:
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| Measure | Description | Time Frame |
|---|---|---|
| Mediating mechanisms and moderators of the concurrent palliative care intervention. | Mediating mechanisms measured will include patient activation, decision support, goal setting, problem solving, care coordination. Moderators measures will include: decision control and treatment goals, self-efficacy, optimism, coping style, social support. | baseline, 6,12,18,24,36 weeks and every 12 weeks until death or end of study |
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INCLUSION CRITERIA FOR PATIENTS:
Able to speak and understand English
Over age 18
NEW diagnosis, recurrence, or progression of an advanced stage cancer within THIRTY days of the date the patient was informed of the diagnosis by his/her oncology clinician.
Estimated survival of 2 years or less
Diagnosed with an advanced stage cancer such as one of the following:
Completion of baseline interview
INCLUSION CRITERIA FOR PATIENTS FOR BIOMARKER SUB-STUDY:
1. Only patients with lung, breast, GI, GU cancer are eligible
INCLUSION CRITERIA FOR CAREGIVERS:
PATIENT EXCLUSION CRITERIA:
PATIENT BIOMARKER SUBSTUDY EXCLUSION CRITERIA:
CAREGIVER EXCLUSION CRITERIA:
1. Unwilling to participate in study.
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| Name | Affiliation | Role |
|---|---|---|
| Marie A. Bakitas, DNSc, APRN | Dartmouth-Hitchcock Medical Center | Principal Investigator |
| Jennifer P. Frost, RN, MS | Dartmouth-Hitchcock Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Hitchcock Medical Center - Lebanon | Lebanon | New Hampshire | 03756 | United States | ||
| Dartmouth-Hitchcock Clinic - Manchester |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20875202 | Background | O'Hara RE, Hull JG, Lyons KD, Bakitas M, Hegel MT, Li Z, Ahles TA. Impact on caregiver burden of a patient-focused palliative care intervention for patients with advanced cancer. Palliat Support Care. 2010 Dec;8(4):395-404. doi: 10.1017/S1478951510000258. Epub 2010 Sep 28. | |
| 15130218 | Background | Bakitas M, Stevens M, Ahles T, Kirn M, Skalla K, Kane N, Greenberg ER; Project Enable Co-Investigators. Project ENABLE: a palliative care demonstration project for advanced cancer patients in three settings. J Palliat Med. 2004 Apr;7(2):363-72. doi: 10.1089/109662104773709530. |
| Label | URL |
|---|---|
| Dartmouth-Hitchcock Norris Cotton Cancer Center home page | View source |
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| Early palliative care intervention | Behavioral |
|
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| baseline, 6,12,18,24,36, and every 12 weeks until patient death or end of study |
| Determine feasibility of enrolling less common solid tumors and hematologic malignancies. | ENABLE II recruited patients only with lung, breast, GI, and GU tumors. We will attempt to also recruit patients with less common "poor prognosis" solid tumors (e.g. brain) and hematologic malignancies and their caregivers for this concurrent oncology palliative care intervention. | Estimated recruitment period of 2 years |
| Explore patterns of stress (diurnal salivary and plasma cortisol) and immune biomarkers (lymphocyte subsets and cytokines) | We will explore patterns of stress (diurnal salivary and plasma cortisol) and immune biomarkers (lymphocyte subsets and cytokines)at baseline, 12, and 24 weeks after intervention in a subset of 50 patients with breast, lung, GI, and GU cancer. We hypothesize that stabilized or improved biomarkers of stress and immune function will be evident after Early and Later entry intervention participation. | Baseline, 12, and 24 weeks |
| Examine the relations among quality of life, mood, symptoms, survival, stress and immune biomarkers. | We hypothesize that higher quality of life,mood, lower symptom intensity, and longer survival will be associated with stable or improved stress and immune biomarkers (e.g. normal plasma cortisol and diurnal salivary cortisol variability, lymphocyte subsets and cytokines | Baseline, 12, and 24 weeks |
| Manchester |
| New Hampshire |
| 03102 |
| United States |
| St. Joseph Hospital | Nashua | New Hampshire | 03060 | United States |
| Dartmouth-Hitchcock NCCC Nashua | Nashua | New Hampshire | 03063 | United States |
| Providence VA Medical Center | Providence | Rhode Island | 02908 | United States |
| Mountainview Medical | Berlin Corners | Vermont | 05061 | United States |
| Veteran's Administration Hospital | White River Junction | Vermont | 05001 | United States |
| 18306393 | Background | Bakitas M, Ahles TA, Skalla K, Brokaw FC, Byock I, Hanscom B, Lyons KD, Hegel MT; ENABLE project team. Proxy perspectives regarding end-of-life care for persons with cancer. Cancer. 2008 Apr 15;112(8):1854-61. doi: 10.1002/cncr.23381. |
| 19619377 | Background | Bakitas M, Lyons KD, Hegel MT, Balan S, Barnett KN, Brokaw FC, Byock IR, Hull JG, Li Z, McKinstry E, Seville JL, Ahles TA. The project ENABLE II randomized controlled trial to improve palliative care for rural patients with advanced cancer: baseline findings, methodological challenges, and solutions. Palliat Support Care. 2009 Mar;7(1):75-86. doi: 10.1017/S1478951509000108. |
| 19690306 | Background | Bakitas M, Lyons KD, Hegel MT, Balan S, Brokaw FC, Seville J, Hull JG, Li Z, Tosteson TD, Byock IR, Ahles TA. Effects of a palliative care intervention on clinical outcomes in patients with advanced cancer: the Project ENABLE II randomized controlled trial. JAMA. 2009 Aug 19;302(7):741-9. doi: 10.1001/jama.2009.1198. |
| 18504093 | Background | Lyons KD, Bakitas M, Hegel MT, Hanscom B, Hull J, Ahles TA. Reliability and validity of the Functional Assessment of Chronic Illness Therapy-Palliative care (FACIT-Pal) scale. J Pain Symptom Manage. 2009 Jan;37(1):23-32. doi: 10.1016/j.jpainsymman.2007.12.015. Epub 2008 May 27. |
| 35802350 | Derived | Ryan RE, Connolly M, Bradford NK, Henderson S, Herbert A, Schonfeld L, Young J, Bothroyd JI, Henderson A. Interventions for interpersonal communication about end of life care between health practitioners and affected people. Cochrane Database Syst Rev. 2022 Jul 8;7(7):CD013116. doi: 10.1002/14651858.CD013116.pub2. |
| 34613617 | Derived | Corn BW, Feldman DB, Hull JG, O'Rourke MA, Bakitas MA. Dispositional hope as a potential outcome parameter among patients with advanced malignancy: An analysis of the ENABLE database. Cancer. 2022 Jan 15;128(2):401-409. doi: 10.1002/cncr.33907. Epub 2021 Oct 6. |
| 29048177 | Derived | Prescott AT, Hull JG, Dionne-Odom JN, Tosteson TD, Lyons KD, Li Z, Li Z, Dragnev KH, Hegel MT, Steinhauser KE, Ahles TA, Bakitas MA. The role of a palliative care intervention in moderating the relationship between depression and survival among individuals with advanced cancer. Health Psychol. 2017 Dec;36(12):1140-1146. doi: 10.1037/hea0000544. Epub 2017 Oct 19. |
| 28952887 | Derived | Bagcivan G, Dionne-Odom JN, Frost J, Plunkett M, Stephens LA, Bishop P, Taylor RA, Li Z, Tucker R, Bakitas M. What happens during early outpatient palliative care consultations for persons with newly diagnosed advanced cancer? A qualitative analysis of provider documentation. Palliat Med. 2018 Jan;32(1):59-68. doi: 10.1177/0269216317733381. Epub 2017 Sep 27. |
| 25800768 | Derived | Bakitas MA, Tosteson TD, Li Z, Lyons KD, Hull JG, Li Z, Dionne-Odom JN, Frost J, Dragnev KH, Hegel MT, Azuero A, Ahles TA. Early Versus Delayed Initiation of Concurrent Palliative Oncology Care: Patient Outcomes in the ENABLE III Randomized Controlled Trial. J Clin Oncol. 2015 May 1;33(13):1438-45. doi: 10.1200/JCO.2014.58.6362. Epub 2015 Mar 23. |
| 25800762 | Derived | Dionne-Odom JN, Azuero A, Lyons KD, Hull JG, Tosteson T, Li Z, Li Z, Frost J, Dragnev KH, Akyar I, Hegel MT, Bakitas MA. Benefits of Early Versus Delayed Palliative Care to Informal Family Caregivers of Patients With Advanced Cancer: Outcomes From the ENABLE III Randomized Controlled Trial. J Clin Oncol. 2015 May 1;33(13):1446-52. doi: 10.1200/JCO.2014.58.7824. Epub 2015 Mar 23. |