Early Intervention vs. Standard Palliative Care in Improving End-of-Life Care in Advanced Cancer … (NCT00253383) | Clinical Trial Compass
CompletedNot Applicable
Early Intervention vs. Standard Palliative Care in Improving End-of-Life Care in Advanced Cancer Patients
United States329 participantsStarted 2003-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
Timeframe: Baseline, one month, every three months
2
Symptom management as measured by Edmunton Symptom Assessment Scale at baseline, one month, and every three months thereafter
Timeframe: Baseline, one month, every three months
3
Health care utilization by a chart review of days in hospital, ICU, ER visits at baseline, one month, and every three months thereafter
Timeframe: Baseline, one month, every three months
4
Correlate preferences for care and care received as measured by After Death Bereaved Family Member Interview with a family member of the deceased
Timeframe: Baseline, one month, every three months