NCT00253383

Brief Summary

RATIONALE: Palliative care may help patients with advanced cancer live more comfortably. PURPOSE: This randomized clinical trial is studying an early intervention palliative care program to see how well it works compared to a standard care program in improving end-of-life care in patients with advanced lung , gastrointestinal, genitourinary, or breast cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
329

participants targeted

Target at P75+ for not_applicable cancer

Timeline
Completed

Started Jan 2003

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

November 11, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 15, 2005

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

December 19, 2014

Status Verified

December 1, 2014

Enrollment Period

10.7 years

First QC Date

November 11, 2005

Last Update Submit

December 18, 2014

Conditions

Cancer

Keywords

transitional care planningstage IIIB non-small cell lung cancerstage IV non-small cell lung cancerextensive stage small cell lung cancerstage IV breast cancerrecurrent breast cancermale breast cancerstage IIIB anal cancerstage IV anal cancercarcinoma of the appendixstage III colon cancerstage IV colon cancerstage III rectal cancerstage IV rectal cancerstage III esophageal cancerstage IV esophageal cancerunresectable extrahepatic bile duct cancerunresectable gallbladder cancerstage III gastric cancerstage IV gastric cancermetastatic gastrointestinal carcinoid tumorregional gastrointestinal carcinoid tumorgastrointestinal stromal tumoradvanced adult primary liver cancerlocalized unresectable adult primary liver cancerstage III pancreatic cancerrecurrent small intestine cancersmall intestine adenocarcinomasmall intestine leiomyosarcomasmall intestine lymphomastage IV bladder cancerstage IV renal cell cancerclear cell sarcoma of the kidneyperipheral primitive neuroectodermal tumor of the kidneyrhabdoid tumor of the kidneymetastatic transitional cell cancer of the renal pelvis and ureteranterior urethral cancerposterior urethral cancerurethral cancer associated with invasive bladder cancerstage IV penile cancerstage IV prostate cancerstage III malignant testicular germ cell tumorstage IV endometrial carcinomafallopian tube cancerovarian sarcomaovarian stromal cancerstage IV pancreatic cancer

Outcome Measures

Primary Outcomes (4)

  • Quality of life as measured by Functional Assessment of Cancer Therapy-Palliative care version (FACT-Pal) at baseline, one month, and every three months thereafter

    Baseline, one month, every three months

  • Symptom management as measured by Edmunton Symptom Assessment Scale at baseline, one month, and every three months thereafter

    Baseline, one month, every three months

  • Health care utilization by a chart review of days in hospital, ICU, ER visits at baseline, one month, and every three months thereafter

    Baseline, one month, every three months

  • Correlate preferences for care and care received as measured by After Death Bereaved Family Member Interview with a family member of the deceased

    Baseline, one month, every three months

Secondary Outcomes (3)

  • Depression as measured by Center for Epidemiological Studies-Depression (CES-D) at baseline, one month, and every three months thereafter

    Baseline, one month, every three months

  • Problem solving skills as measured by Social Problem-Solving Skills Inventory-revised at baseline and one month

    Baseline, one month, every three months

  • Caregiver burden as measured by Montgomery-Borgatta Caregiver Burden Scale at baseline, one month, and every three months thereafter (given to caregivers of patients)

    Baseline, one month, every three months

Study Arms (2)

ENABLE (concurrent palliative care)

EXPERIMENTAL

telephone based ENABLE educational intervention

Other: counseling interventionOther: educational interventionProcedure: psychosocial assessment and careProcedure: quality-of-life assessment

Usual Care

ACTIVE COMPARATOR

Supportive and palliative usual care services at DHMC, Behavioral

Other: counseling interventionProcedure: psychosocial assessment and careProcedure: quality-of-life assessment

Interventions

counseling interventionOTHER
ENABLE (concurrent palliative care)Usual Care
educational interventionOTHER
ENABLE (concurrent palliative care)
psychosocial assessment and carePROCEDURE
ENABLE (concurrent palliative care)Usual Care
quality-of-life assessmentPROCEDURE
ENABLE (concurrent palliative care)Usual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of 1 of the following advanced cancers: * Stage IIIB or IV non-small cell lung cancer * Extensive stage small cell lung cancer * Stage IV breast cancer * Poor prognostic indicators (conferring likelihood of ≤ 2 years survival), including, but not limited to, any of the following: * Visceral crisis * Lung or liver metastasis * Estrogen receptor-negative disease * HER2/neu-positive disease * Progressive or recurrent disease during or within 2 years of first treatment * Unresectable stage III or stage IV gastrointestinal cancers * Stage IV genitourinary cancers * Prostate cancer must be hormone refractory * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Sex * Not specified Menopausal status * Not specified Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * No dementia or significant confusion (i.e., Mini Mental Exam score \< 25) * No Axis I psychiatric disorders (DSM-IV), including any of the following: * Schizophrenia * Bipolar disorder * Active substance use disorder PRIOR CONCURRENT THERAPY: Endocrine therapy * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756-0002, United States

Location

Veterans Affairs Medical Center - White River Junction

White River Junction, Vermont, 05009, United States

Location

Related Publications (3)

  • 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: 19690306RESULT

  • 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: 34613617DERIVED

  • 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: 29048177DERIVED

MeSH Terms

Conditions

NeoplasmsCarcinoma, Non-Small-Cell LungBreast NeoplasmsBreast Neoplasms, MaleAnus NeoplasmsAppendiceal NeoplasmsColonic NeoplasmsRectal NeoplasmsEsophageal NeoplasmsStomach NeoplasmsGastrointestinal Stromal TumorsPancreatic NeoplasmsUrinary Bladder NeoplasmsCarcinoma, Renal CellPenile NeoplasmsProstatic NeoplasmsTesticular NeoplasmsEndometrial NeoplasmsFallopian Tube Neoplasms

Interventions

CounselingEarly Intervention, EducationalPsychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesAnus DiseasesRectal DiseasesCecal NeoplasmsCecal DiseasesColonic DiseasesHead and Neck NeoplasmsEsophageal DiseasesStomach DiseasesNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialKidney NeoplasmsKidney DiseasesGenital Neoplasms, MaleGenital Diseases, MaleGenital DiseasesPenile DiseasesProstatic DiseasesTesticular DiseasesGonadal DisordersUterine NeoplasmsGenital Neoplasms, FemaleUterine DiseasesGenital Diseases, FemaleFallopian Tube DiseasesAdnexal Diseases

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesChild Health ServicesPreventive Health ServicesRehabilitationTherapeutics

Study Officials

  • Marie A Bakitas, PhD

    Norris Cotton Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2005

First Posted

November 15, 2005

Study Start

January 1, 2003

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

December 19, 2014

Record last verified: 2014-12

Locations

US(2)