Clinical trial · Interventional

Early Intervention vs. Standard Palliative Care in Improving End-of-Life Care in Advanced Cancer Patients

Improving Palliative Care for Patients With Cancer

NCT00253383CI-TRIAL-00016400completedN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

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
Cancer	Malignant Neoplasm	ALIAS	0.90

Interventions

Interventions (4)

Intervention	Type	Mapped drug	Match
counseling intervention	Other	—	UNRESOLVED
educational intervention	Other	—	UNRESOLVED
psychosocial assessment and care	Procedure	—	UNRESOLVED
quality-of-life assessment	Procedure	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
ENABLE (concurrent palliative care)
description
telephone based ENABLE educational intervention
interventionNames
1. Other: counseling intervention
2. Other: educational intervention
3. Procedure: psychosocial assessment and care
4. Procedure: quality-of-life assessment
type
ACTIVE_COMPARATOR
label
Usual Care
description
Supportive and palliative usual care services at DHMC, Behavioral
interventionNames
1. Other: counseling intervention
2. Procedure: psychosocial assessment and care
3. Procedure: quality-of-life assessment

Primary outcomes (4)

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (3)

RESULTBakitas 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
DERIVEDCorn 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
DERIVEDPrescott 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

Registry

Dates and enrollment