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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00608738
Recruitment Status : Completed
First Posted : February 6, 2008
Last Update Posted : July 10, 2012
Information provided by (Responsible Party):
Northwestern University

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.

Condition or disease Intervention/treatment Phase
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 Not Applicable

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Developing a Nested Whole-Person-Care Guide: Screening and Evaluation Steps (American Cancer Society) ACS
Study Start Date : July 2001
Actual Primary Completion Date : January 2005
Actual Study Completion Date : January 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Patient needs detected
  2. Concordance among patient, caregiver, and team goals
  3. Qualitative and quantitative evaluation of palliative care services provided

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • Able to read and understand English


  • See Disease Characteristics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00608738

Sponsors and Collaborators
Northwestern University
Study Chair: Linda Emanuel, MD, PhD Robert H. Lurie Cancer Center

Responsible Party: Northwestern University Identifier: NCT00608738     History of Changes
Other Study ID Numbers: ACS 03CC1
First Posted: February 6, 2008    Key Record Dates
Last Update Posted: July 10, 2012
Last Verified: July 2012

Keywords provided by Northwestern University:
radiation toxicity
chemotherapeutic agent toxicity
musculoskeletal complications
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Radiation Injuries
Nutrition Disorders
Blood Platelet Disorders
Hematologic Diseases
Leukocyte Disorders
Wounds and Injuries