- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00608738
Using Whole-Person-Care Guide in Patients Receiving Care for Cancer or Complications From Cancer Treatment
Developing a Nested Whole-Person-Care Guide: Screening and Evaluation Steps (American Cancer Society) ACS
RATIONALE: Gathering information about patients with cancer and cancer-related conditions may help doctors learn more about a patient's needs and help doctors plan the best treatment.
PURPOSE: This clinical trial is studying how well a whole-person-care guide works in identifying patient needs in patients with cancer or complications from cancer treatment.
Study Overview
Status
Conditions
Detailed Description
OBJECTIVES:
- To determine what patient needs are detected from NEST13+ interviews of cancer patients and their caregivers.
- To determine the concordance among patient, caregiver, and team goals.
- To determine palliative care services provided.
OUTLINE: Participants are assigned sequentially to 1 of 2 intervention groups.
- Group 1 (NEST13+): Patients and caregivers undergo NEST13+ interviews at the time of admission to Northwestern Memorial Hospital (caregivers answer the NEST13+ interviews from the patient's perspective). A NEST13+ care plan is then derived from both patient and caregiver responses. Research MD or RN presents patient's NEST13+ findings and recommended interventions for integration with actual care. On the day of discharge, patients and caregivers undergo a second NEST13+ interview.
- Group 2 (control): Patients and caregivers undergo a sham interview at the time of admission to Northwestern Memorial Hospital. On the day of discharge, patients and caregivers undergo a NEST13+ interview as in group 1.
Medical charts for all patients are reviewed by a member of the research staff to document needs assessments in domains covered by NEST and to document palliative care-related decisions. Abstracted chart review by blinded experts is also performed to evaluate palliative care quality based on National Comprehensive Cancer Network guidelines.
PROJECTED ACCRUAL: A total of 500 patients and 250 caregivers will be accrued for this study.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
- Confirmed diagnosis of cancer
Admitted to one of the two oncology units at Northwestern Memorial Hospital either for treatment of cancer or treatment-related complications
Complications include, but are not limited to, any of the following:
- Febrile neutropenia
- Infection
- Esophagitis from radiochemotherapy
- Malnutrition
- Spinal cord compression
- Bone pain secondary to metastatic bone disease
- Thrombocytopenia
PATIENT CHARACTERISTICS:
- Able to read and understand English
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Patient needs detected
|
Concordance among patient, caregiver, and team goals
|
Qualitative and quantitative evaluation of palliative care services provided
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Linda Emanuel, MD, PhD, Robert H. Lurie Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACS 03CC1
- NU-0931-005
- NU-200708-1439
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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