Using Whole-Person-Care Guide in Patients Receiving Care for Cancer or Complications From Cancer Treatment

NCT ID: NCT00608738

Last Updated: 2012-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

750 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-07-31

Study Completion Date

2005-01-31

Brief Summary

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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

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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.

Conditions

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Chemotherapeutic Agent Toxicity Infection Malnutrition Musculoskeletal Complications Neutropenia Radiation Toxicity Thrombocytopenia Unspecified Adult Solid Tumor, Protocol Specific

Keywords

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neutropenia infection radiation toxicity chemotherapeutic agent toxicity malnutrition musculoskeletal complications thrombocytopenia unspecified adult solid tumor, protocol specific

Study Design

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Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Interventions

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informational intervention

Intervention Type OTHER

medical chart review

Intervention Type OTHER

questionnaire administration

Intervention Type OTHER

assessment of therapy complications

Intervention Type PROCEDURE

management of therapy complications

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Linda Emanuel, MD, PhD

Role: STUDY_CHAIR

Robert H. Lurie Cancer Center

Other Identifiers

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NU-0931-005

Identifier Type: -

Identifier Source: secondary_id

NU-200708-1439

Identifier Type: -

Identifier Source: secondary_id

ACS 03CC1

Identifier Type: -

Identifier Source: org_study_id