Study of Palliative Care Intervention for Advanced Cancer Patients and Their Caregivers -Educate Nurture Advise Before Life Ends (ENABLE III)

NCT01245621 | Completed DMC

• 2 other identifiers: NCCC-BAKI: D0946R01NR011871-01
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 7

Brief Summary

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

Advanced Cancer

Keywords

palliative care; end of life care; quality of life; caregivers

Outcome Measures

Primary Outcomes (4)

• 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: * Functional Assessment of Chronic Illness Therapy-Palliative Care (FACIT-Pal): * Quality of Life at End of Life (QUAL-E). * Center for Epidemiological Study- Depression (CES-D).

  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: * Quality of Life- Cancer- a self-report measure of QOL for caregivers of patients with cancer. * Montgomery Borgatta Caregiver Burden Scale -a self-report measure of caregiver burden. * Center for Epidemiological Study- Depression CESD is a measure of depressive symptoms. * Functional Assessment of Chronic Illness Therapy - Spiritual Module (FACIT-Sp) - a measure of spiritual well-being developed for persons with chronic illness. * Prigerson Inventory of Complicated Grief-Short form (ICG-SF) embedded in the Quality of Death and Dying (QODD).

  baseline, 6,12,18,24,36, and every 12 weeks until patient death or end of study

Secondary Outcomes (4)

• Mediating mechanisms and moderators of the concurrent palliative care intervention.

  baseline, 6,12,18,24,36 weeks and every 12 weeks until death or end of study

• Determine feasibility of enrolling less common solid tumors and hematologic malignancies.

  Estimated recruitment period of 2 years

• Explore patterns of stress (diurnal salivary and plasma cortisol) and immune biomarkers (lymphocyte subsets and cytokines)

  Baseline, 12, and 24 weeks

• Examine the relations among quality of life, mood, symptoms, survival, stress and immune biomarkers.

  Baseline, 12, and 24 weeks

Study Arms (2)

Early entry group

ACTIVE COMPARATOR

Early entry group will begin the intervention at time of diagnosis of advanced cancer

Behavioral: Early palliative care intervention

Later entry group

ACTIVE COMPARATOR

Later entry group will begin the intervention 12 weeks after enrollment in the study.

Behavioral: Later entry group

Interventions

Later entry group BEHAVIORAL

1. Advanced Practice Palliative Care Nurse Interventionist instituting a phone-based: a) Charting Your Course (CYC)-Patient Curriculum (6-session manualized); b) Creativity Optimism Planning Expert Information (COPE) Caregiver Curriculum (3 session manualized) and c) ongoing contact as determined by the Palliative Care Team assessment/plan; and 2. Comprehensive Palliative Care Team Assessment \& Management Plan.

Later entry group

Early palliative care intervention BEHAVIORAL

1. Advanced Practice Palliative Care Nurse Interventionist instituting a phone-based: a) Charting Your Course (CYC)-Patient Curriculum (6-session manualized); b) Creativity Optimism Planning Expert information(COPE) Caregiver Curriculum (3 session manualized) and c) ongoing contact as determined by the Palliative Care Team assessment/plan; and 2. Comprehensive Palliative Care Team Assessment \& Management Plan.

Early entry group

Eligibility Criteria

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

You may qualify if:

• 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:
• 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
• 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.
• Completion of baseline interview
• \. Only patients with lung, breast, GI, GU cancer are eligible
• Able to read and understand English
• Anyone identified by the patient as "a person who knows you well \& is involved in your medical care".

You may not qualify if:

• 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)
• Axis I psychiatric diagnosis of severe mental illness (DSM-IV) (e.g. schizophrenia, bipolar disorder, or active substance use disorder)
• Patients will not be excluded if they do not identify a caregiver
• Prior involvement with palliative care service within the last year
• Minimum predicted survival of less than 12 weeks (3 months)
• Receiving chronic steroid hormones or unable to schedule specimen collection distant from chemotherapy from steroid pre-medications
• Unable to come to Norris Cotton Cancer Center (NCCC) for specimen collection times.
• \. Unwilling to participate in study.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (7)

Dartmouth-Hitchcock Medical Center - Lebanon

Lebanon, New Hampshire, 03756, United States

Location

Dartmouth-Hitchcock Clinic - Manchester

Manchester, New Hampshire, 03102, United States

Location

St. Joseph Hospital

Nashua, New Hampshire, 03060, United States

Location

Dartmouth-Hitchcock NCCC Nashua

Nashua, New Hampshire, 03063, United States

Location

Providence VA Medical Center

Providence, Rhode Island, 02908, United States

Location

Mountainview Medical

Berlin Corners, Vermont, 05061, United States

Location

Veteran's Administration Hospital

White River Junction, Vermont, 05001, United States

Location

Related Publications (12)

• 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.

  PMID: 20875202 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.

  PMID: 15130218 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.

  PMID: 18306393 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.

  PMID: 19619377 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.

  PMID: 19690306 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.

  PMID: 18504093 BACKGROUND

• 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.

  PMID: 35802350 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.

  PMID: 34613617 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.

  PMID: 29048177 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.

  PMID: 28952887 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.

  PMID: 25800768 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.

  PMID: 25800762 DERIVED

Related Links

• Dartmouth-Hitchcock Norris Cotton Cancer Center home page

Study Officials

• Marie A. Bakitas, DNSc, APRN

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

• Jennifer P. Frost, RN, MS

  Dartmouth-Hitchcock Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2010
• First Posted: November 22, 2010
• Study Start: October 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: January 3, 2014

Record last verified: 2013-10

Locations

US (7)