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2003-01
2013-09
2013-09
329
NCT00253383
Dartmouth-Hitchcock Medical Center
Dartmouth-Hitchcock Medical Center
INTERVENTIONAL
Early Intervention vs. Standard Palliative Care in Improving End-of-Life Care in Advanced Cancer Patients
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: * Determine the efficacy of an early intervention palliative care program comprising a phone-based nurse educator and shared medical appointments in improving end-of-life care of patients with advanced lung, gastrointestinal, genitourinary, or breast cancer. * Compare symptom management, quality of life, and the match between preference of care and the care received in patients treated with an early intervention palliative care program vs a standard care program. * Compare health care utilization by patients treated with these interventions. 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. * Arm I (early-intervention palliative care program): Patients complete the Medical Care Questionnaire and receive a computer-generated prescription letter that outlines the problems they have identified; the patient's physician also receives a copy of the letter. Patients receive a series of phone calls weekly for 4 weeks and then at least monthly from a nurse educator. The phone calls address 3 major areas: coordination of palliative care options in the cancer center and the patient's community, including referrals for psychological or spiritual counseling, social work consultation, financial guidance, home health, palliative care or hospice services, and bereavement counseling for the family; problem-solving therapy, focusing on the identification of problems, definition of achievable goals, a plan for reaching those goals, and evaluation of success; and tailored psycho-educational modules from Ȭharting Your Course", covering end-of-life topics such as symptom management, advanced care planning, communication with the health care team and family members, spirituality, and nutrition. Patients also receive information regarding the purpose and time/location of symptom management, shared medical appointments (SMAs), which they can attend in person or call in to participate via speaker phone. SMAs are 1.5-hour monthly sessions conducted by a physician and a nurse practitioner that can accommodate 10-12 patients and their caregivers. The sessions include a welcome/social period, a question and answer/peer discussion, an interactive educational session, and an opportunity for one-on-one nurse practitioner appointments with a focus on a brief review of the patients' medical treatment plans. * Arm II (standard palliative care program): Patients receive standard palliative care from their physician/nurse practitioner team and have access to the palliative care nurse at the discretion of the treating physician. 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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2005-11-11 | N/A | 2014-12-18 |
2005-11-11 | N/A | 2014-12-19 |
2005-11-15 | N/A | 2014-12 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Supportive Care
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: ENABLE (concurrent palliative care) telephone based ENABLE educational intervention | OTHER: counseling intervention OTHER: educational intervention PROCEDURE: psychosocial assessment and care PROCEDURE: quality-of-life assessment |
| ACTIVE_COMPARATOR: Usual Care Supportive and palliative usual care services at DHMC, Behavioral | OTHER: counseling intervention PROCEDURE: psychosocial assessment and care PROCEDURE: quality-of-life assessment |
| Primary Outcome Measures | 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 |
| Secondary Outcome Measures | 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 | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
