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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA101704 | U.S. NIH Grant/Contract | View source | |
| P30CA023108 | U.S. NIH Grant/Contract | View source | |
| DMS-0226 | |||
| DMS-CPHS-16004 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to cancer diagnosis (lung vs breast vs gastrointestinal vs genitourinary) and participating center. Patients are randomized to 1 of 2 intervention arms.
Patients complete Functional Assessment of Chronic Illness Therapy-Palliative Care at baseline and every 3 months thereafter. Patients and caregivers complete surveys measuring their perception of the quality of the patient's cancer care at baseline and at 1 month.
A caregiver or family member completes the After-Death Bereaved Family Member Interview to evaluate the adequacy of patient care at 3 months post-patient death.
PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ENABLE (concurrent palliative care) | Experimental | telephone based ENABLE educational intervention |
|
| Usual Care | Active Comparator | Supportive and palliative usual care services at DHMC, Behavioral |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| counseling intervention | Other |
| ||
| educational intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
Unresectable stage III or stage IV gastrointestinal cancers
Stage IV genitourinary cancers
Hormone receptor status:
PATIENT CHARACTERISTICS:
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
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:
PRIOR CONCURRENT THERAPY:
Endocrine therapy
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| Name | Affiliation | Role |
|---|---|---|
| Marie A Bakitas, PhD | Norris Cotton Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756-0002 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19690306 | Result | 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. | |
| 34613617 | 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. |
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| Other |
|
| psychosocial assessment and care | Procedure |
|
| quality-of-life assessment | Procedure |
|
| 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 |
| Veterans Affairs Medical Center - White River Junction |
| White River Junction |
| Vermont |
| 05009 |
| United States |
| 29048177 | 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. |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D001943 | Breast Neoplasms |
| D018567 | Breast Neoplasms, Male |
| D001005 | Anus Neoplasms |
| D001063 | Appendiceal Neoplasms |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| D004938 | Esophageal Neoplasms |
| D013274 | Stomach Neoplasms |
| D046152 | Gastrointestinal Stromal Tumors |
| D010190 | Pancreatic Neoplasms |
| D001749 | Urinary Bladder Neoplasms |
| D002292 | Carcinoma, Renal Cell |
| D010412 | Penile Neoplasms |
| D011471 | Prostatic Neoplasms |
| D013736 | Testicular Neoplasms |
| D016889 | Endometrial Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D001004 | Anus Diseases |
| D012002 | Rectal Diseases |
| D002430 | Cecal Neoplasms |
| D002429 | Cecal Diseases |
| D003108 | Colonic Diseases |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |
| D013272 | Stomach Diseases |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D007680 | Kidney Neoplasms |
| D007674 | Kidney Diseases |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D010409 | Penile Diseases |
| D011469 | Prostatic Diseases |
| D013733 | Testicular Diseases |
| D006058 | Gonadal Disorders |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D005184 | Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| D018479 | Early Intervention, Educational |
| D000067250 | Psychiatric Rehabilitation |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D002662 | Child Health Services |
| D011314 | Preventive Health Services |
| D012046 | Rehabilitation |
| D013812 | Therapeutics |
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