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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Northwestern University
ClinicalTrials.gov Identifier:
NCT00608738
First received: February 5, 2008
Last updated: July 9, 2012
Last verified: July 2012
  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

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • 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)
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00608738

Sponsors and Collaborators
Northwestern University
Investigators
Study Chair: Linda Emanuel, MD, PhD Robert H. Lurie Cancer Center
  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:
Infection
Malnutrition
Neutropenia
Nutrition Disorders
Radiation Injuries
Thrombocytopenia
Agranulocytosis
Blood Platelet Disorders
Hematologic Diseases
Leukocyte Disorders
Leukopenia
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014