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Advanced CancerENABLE IIINCT01245621

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

A study testing Later entry group and Early palliative care intervention in people with Advanced Cancer, run by Dartmouth-Hitchcock Medical Center at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Cancer
What is being tested?
Later entry group and Early palliative care intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
360 participants
Where
7 sitesUnited States
Study dates
Oct 2010to Sep 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 27Show fewer
  • 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.
  • Completion of baseline interview
  • 1. 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".
  • PATIENT EXCLUSION CRITERIA:
  • 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)
  • PATIENT BIOMARKER SUBSTUDY EXCLUSION CRITERIA:
  • 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.
  • CAREGIVER EXCLUSION CRITERIA:
  • 1. Unwilling to participate in study.

Who cannot join

None listed.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Mountainview Medical

    Berlin Corners, Vermont, 05061

  • Dartmouth-Hitchcock Medical Center - Lebanon

    Lebanon, New Hampshire, 03756

  • Dartmouth-Hitchcock Clinic - Manchester

    Manchester, New Hampshire, 03102

  • St. Joseph Hospital

    Nashua, New Hampshire, 03060

  • Dartmouth-Hitchcock NCCC Nashua

    Nashua, New Hampshire, 03063

  • Providence VA Medical Center

    Providence, Rhode Island, 02908

  • Veteran's Administration Hospital

    White River Junction, Vermont, 05001

Other trials in United States

About this study

Official title: Early vs. Later Palliative Cancer Care: Clinical and Biobehavioral Outcomes

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.

Read the detailed description

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.

Conditions
Advanced Cancer
Being tested
Later entry group, Early palliative care intervention
Keywords
palliative care, end of life care, quality of life, caregivers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Later entry groupBehavioural

    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 palliative care interventionBehavioural

    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.
Study groups in NCT01245621
Study groupRoleWhat they receive
Early entry groupActive comparatorEarly entry group will begin the intervention at time of diagnosis of advanced cancer
Receives: Behavioral: Early palliative care intervention
Later entry groupActive comparatorLater entry group will begin the intervention 12 weeks after enrollment in the study.
Receives: Behavioral: Later entry group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

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

  2. 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.

    Measured: chart review at time of death and caregiver proxy interview 2-3 months after patient death

  3. 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.

    Measured: From enrollment until patient death or end of study

  4. 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).

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

Secondary outcomes (4)

  1. 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.

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

  2. 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.

    Measured: Estimated recruitment period of 2 years

  3. 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.

    Measured: Baseline, 12, and 24 weeks

  4. 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

    Measured: Baseline, 12, and 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2010 (estimated)
  2. Study startOct 2010
  3. Primary completionSep 2013
  4. Study completionSep 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
360 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01245621
Sponsor's protocol ID
NCCC-BAKI: D0946
Other IDs
R01NR011871-01
Acronym
ENABLE III
Status last verified
Oct 2013
First submitted
15 Nov 2010
Last updated
3 Jan 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 20875202

  • 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.

    PubMed 15130218

  • 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.

    PubMed 18306393

  • 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.

    PubMed 19619377

  • 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.

    PubMed 19690306

  • 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.

    PubMed 18504093

  • 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.

    PubMed 35802350

  • 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.

    PubMed 34613617

  • 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.

    PubMed 29048177

  • 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.

    PubMed 28952887

  • 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.

    PubMed 25800768

  • 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.

    PubMed 25800762

Questions about this trial

What is this clinical trial studying?

A study testing Later entry group and Early palliative care intervention in people with Advanced Cancer, run by Dartmouth-Hitchcock Medical Center at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in patient's quality of living over time (time frame: baseline, 6,12,18,24,36 and every 12 weeks until death or end of study). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01245621, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2014.

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