Using Whole-Person-Care Guide in Patients Receiving Care for Cancer or Complications From Cancer Treatment
Primary Purpose
Chemotherapeutic Agent Toxicity, Infection, Malnutrition
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
informational intervention
medical chart review
questionnaire administration
assessment of therapy complications
management of therapy complications
Sponsored by
About this trial
This is an interventional health services research trial for Chemotherapeutic Agent Toxicity focused on measuring neutropenia, infection, radiation toxicity, chemotherapeutic agent toxicity, malnutrition, musculoskeletal complications, thrombocytopenia, unspecified adult solid tumor, protocol specific
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
Patient needs detected
Concordance among patient, caregiver, and team goals
Qualitative and quantitative evaluation of palliative care services provided
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00608738
Brief Title
Using Whole-Person-Care Guide in Patients Receiving Care for Cancer or Complications From Cancer Treatment
Official Title
Developing a Nested Whole-Person-Care Guide: Screening and Evaluation Steps (American Cancer Society) ACS
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
July 2001 (undefined)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
January 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwestern University
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapeutic Agent Toxicity, Infection, Malnutrition, Musculoskeletal Complications, Neutropenia, Radiation Toxicity, Thrombocytopenia, Unspecified Adult Solid Tumor, Protocol Specific
Keywords
neutropenia, infection, radiation toxicity, chemotherapeutic agent toxicity, malnutrition, musculoskeletal complications, thrombocytopenia, unspecified adult solid tumor, protocol specific
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Masking
None (Open Label)
Enrollment
750 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
informational intervention
Intervention Type
Other
Intervention Name(s)
medical chart review
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Type
Procedure
Intervention Name(s)
assessment of therapy complications
Intervention Type
Procedure
Intervention Name(s)
management of therapy complications
Primary Outcome Measure Information:
Title
Patient needs detected
Title
Concordance among patient, caregiver, and team goals
Title
Qualitative and quantitative evaluation of palliative care services provided
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda Emanuel, MD, PhD
Organizational Affiliation
Robert H. Lurie Cancer Center
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Using Whole-Person-Care Guide in Patients Receiving Care for Cancer or Complications From Cancer Treatment
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