Clinical trial · Interventional
Study of Palliative Care Intervention for Advanced Cancer Patients and Their Caregivers -Educate Nurture Advise Before Life Ends (ENABLE III)
Early vs. Later Palliative Cancer Care: Clinical and Biobehavioral Outcomes
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Early palliative care intervention | Behavioral | — | UNRESOLVED |
| Later entry group | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Early entry group
- description
- Early entry group will begin the intervention at time of diagnosis of advanced cancer
- interventionNames
- Behavioral: Early palliative care intervention
- type
- ACTIVE_COMPARATOR
- label
- Later entry group
- description
- Later entry group will begin the intervention 12 weeks after enrollment in the study.
- interventionNames
- Behavioral: Later entry group
Primary outcomes (4)
- measure
- Change in patient's quality of living over time
- timeFrame
- baseline, 6,12,18,24,36 and every 12 weeks until death or end of study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
INCLUSION CRITERIA FOR PATIENTS: 1. Able to speak and understand English 2. Over age 18 3. 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. 4. Estimated survival of 2 years or less 5. Diagnosed with an advanced stage cancer such as one of the following: * Lung Cancer: Stage IIIB or IV non-small cell, or extensive stage small cell * Breast Cancer: Stage IV with poor prognostic indicators including but not limited to: a) \>2 cytotoxic regimens for MBC; b) diagnosis of MBC less then or equal to 12 months since completion of adjuvant or neoadjuvant treatment; c) triple negative disease (ER/PR - and Her 2-);d) parenchymal brain mets and/or carcinomatous meningitis * Gastrointestinal (GI) Cancers: Unresectable stage III or IV * Genitourinary (GU) Cancers: Stage IV (for prostate cancer inclusion is limited to persons with hormone refractory prostate cancer) * Brain Cancer: Unresectable, Grade IV * Melanoma, Stage IV * Hematologic Malignancies -Leukemia (e.g. acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myeloid leukemia (CML), chronic lymphocytic leukemia (CLL) - advanced stage, treatment refractory, poor prognosis cell type or chromosomal abnormalities, "older age" -Lymphoma- Stage IV or treatment refractory Hodgkin's disease or non-Hodgkin's lymphoma -Multiple Myeloma - elevated β2-microglobulin, albumin \<3.5, PCLI \>1%, CRP \>6µg/mL, elevated LDH, plasmablastic morphology, abnormal. chromosome 13. 6. 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: 1. Able to read and understand English 2. Anyone identified by the patient as "a person who knows you well \& is involved in your medical care". PATIENT EXCLUSION CRITERIA: 1. Dementia or significant confusion (Impaired cognitive status as indicated by a score of 3 or less on the Callahan six-item cognitive screening tool 18) 2. Axis I psychiatric diagnosis of severe mental illness (DSM-IV) (e.g. schizophrenia, bipolar disorder, or active substance use disorder) 3. Patients will not be excluded if they do not identify a caregiver 4. Prior involvement with palliative care service within the last year 5. Minimum predicted survival of less than 12 weeks (3 months) PATIENT BIOMARKER SUBSTUDY EXCLUSION CRITERIA: 1. Receiving chronic steroid hormones or unable to schedule specimen collection distant from chemotherapy from steroid pre-medications 2. Unable to come to Norris Cotton Cancer Center (NCCC) for specimen collection times. CAREGIVER EXCLUSION CRITERIA: 1\. Unwilling to participate in study.
References
Publications (12)
- BACKGROUNDO'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. PMID 20875202
- BACKGROUNDBakitas 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. PMID 15130218
- BACKGROUNDBakitas 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. PMID 18306393
- BACKGROUNDBakitas 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. PMID 19619377
- BACKGROUNDBakitas 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. PMID 19690306
- BACKGROUNDLyons 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. PMID 18504093