Clinical trial NCT00608738: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2008-02-06
Enrollment: 750
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Patient needs detected
measure: Concordance among patient, caregiver, and team goals
measure: Qualitative and quantitative evaluation of palliative care services provided
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Robert H. Lurie Cancer Center
name: Linda Emanuel, MD, PhD
role: STUDY_CHAIR
References: