Using Whole-Person-Care Guide in Patients Receiving Care for Cancer or Complications From Cancer Treatment
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Chemotherapeutic Agent Toxicity Infection Malnutrition Musculoskeletal Complications Neutropenia Radiation Toxicity Thrombocytopenia Unspecified Adult Solid Tumor, Protocol Specific |
Other: informational intervention Other: medical chart review Other: questionnaire administration Procedure: assessment of therapy complications Procedure: management of therapy complications |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | Developing a Nested Whole-Person-Care Guide: Screening and Evaluation Steps (American Cancer Society) ACS |
- Patient needs detected [ Designated as safety issue: No ]
- Concordance among patient, caregiver, and team goals [ Designated as safety issue: No ]
- Qualitative and quantitative evaluation of palliative care services provided [ Designated as safety issue: No ]
| Estimated Enrollment: | 750 |
| Study Start Date: | July 2001 |
| Study Completion Date: | January 2005 |
| Primary Completion Date: | January 2005 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00608738 History of Changes |
| Other Study ID Numbers: | ACS 03CC1, NU-0931-005, NU-200708-1439 |
| Study First Received: | February 5, 2008 |
| Last Updated: | July 9, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Northwestern University:
|
neutropenia infection radiation toxicity chemotherapeutic agent toxicity |
malnutrition musculoskeletal complications thrombocytopenia unspecified adult solid tumor, protocol specific |
Additional relevant MeSH terms:
|
Neutropenia Thrombocytopenia Malnutrition Radiation Injuries Agranulocytosis Leukopenia |
Leukocyte Disorders Hematologic Diseases Blood Platelet Disorders Nutrition Disorders Wounds and Injuries |
ClinicalTrials.gov processed this record on May 19, 2013