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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
Northwestern University
About
Eligibility
Locations
Outcomes
Full info

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

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    February 5, 2008
    Last Updated
    July 9, 2012
    Sponsor
    Northwestern University
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    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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