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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00608738
Other study ID # ACS 03CC1
Secondary ID NU-0931-005NU-20
Status Completed
Phase N/A
First received February 5, 2008
Last updated July 9, 2012
Start date July 2001
Est. completion date January 2005

Study information

Verified date July 2012
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 750
Est. completion date January 2005
Est. primary completion date January 2005
Accepts healthy volunteers No
Gender Both
Age group 21 Years and older
Eligibility 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 Design

Masking: Open Label, Primary Purpose: Health Services Research


Intervention

Other:
informational intervention

medical chart review

questionnaire administration

Procedure:
assessment of therapy complications

management of therapy complications


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Northwestern University

Outcome

Type Measure Description Time frame Safety issue
Primary Patient needs detected No
Primary Concordance among patient, caregiver, and team goals No
Primary Qualitative and quantitative evaluation of palliative care services provided No
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