Study of Palliative Care Intervention for Advanced Cancer Patients and Their Caregivers -Educate Nurture Advise Before Life Ends (ENABLE III) (ENABLE III)
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.
Behavioral: Later entry group
Behavioral: Early palliative care intervention
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
|Official Title:||Early vs. Later Palliative Cancer Care: Clinical and Biobehavioral Outcomes|
- 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 ] [ Designated as safety issue: No ]
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).
- Quality of end of life care [ Time Frame: chart review at time of death and caregiver proxy interview 2-3 months after patient death ] [ Designated as safety issue: No ]
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.
- Estimate and compare the hazard ratios and median survival before and after 1 year from enrollment [ Time Frame: From enrollment until patient death or end of study ] [ Designated as safety issue: No ]We hypothesize that Early entry patients will have longer overall survival at one year compared with Later entry patients.
- Change in caregiver quality of life, burden and grief over time [ Time Frame: baseline, 6,12,18,24,36, and every 12 weeks until patient death or end of study ] [ Designated as safety issue: No ]
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).
- Mediating mechanisms and moderators of the concurrent palliative care intervention. [ Time Frame: baseline, 6,12,18,24,36 weeks and every 12 weeks until death or end of study ] [ Designated as safety issue: No ]
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.
- Determine feasibility of enrolling less common solid tumors and hematologic malignancies. [ Time Frame: Estimated recruitment period of 2 years ] [ Designated as safety issue: No ]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.
- Explore patterns of stress (diurnal salivary and plasma cortisol) and immune biomarkers (lymphocyte subsets and cytokines) [ Time Frame: Baseline, 12, and 24 weeks ] [ Designated as safety issue: No ]
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.
- Examine the relations among quality of life, mood, symptoms, survival, stress and immune biomarkers. [ Time Frame: Baseline, 12, and 24 weeks ] [ Designated as safety issue: No ]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
|Study Start Date:||October 2010|
|Study Completion Date:||September 2013|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Early entry group
Early entry group will begin the intervention at time of diagnosis of advanced cancer
Behavioral: Early palliative care intervention
Active Comparator: Later entry group
Later entry group will begin the intervention 12 weeks after enrollment in the study.
Behavioral: Later entry group
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01245621
|United States, New Hampshire|
|Dartmouth-Hitchcock Medical Center - Lebanon|
|Lebanon, New Hampshire, United States, 03756|
|Dartmouth-Hitchcock Clinic - Manchester|
|Manchester, New Hampshire, United States, 03102|
|St. Joseph Hospital|
|Nashua, New Hampshire, United States, 03060|
|Dartmouth-Hitchcock NCCC Nashua|
|Nashua, New Hampshire, United States, 03063|
|United States, Rhode Island|
|Providence VA Medical Center|
|Providence, Rhode Island, United States, 02908|
|United States, Vermont|
|Berlin, Vermont, United States, 05061|
|Veteran's Administration Hospital|
|White River Junction, Vermont, United States, 05001|
|Principal Investigator:||Marie A. Bakitas, DNSc, APRN||Dartmouth-Hitchcock Medical Center|
|Study Director:||Jennifer P. Frost, RN, MS||Dartmouth-Hitchcock Medical Center|