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

Sponsor

Northwestern University (Other)

Overall Status

Completed

CT.gov ID

NCT00608738

Collaborator

(none)

750

Enrollment

42.1

Duration (Months)

Study Details

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.

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	N/A

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Jul 1, 2001

Actual Primary Completion Date :

Jan 1, 2005

Actual Study Completion Date :

Jan 1, 2005

Outcome Measures

Primary Outcome Measures

Patient needs detected []
Concordance among patient, caregiver, and team goals []
Qualitative and quantitative evaluation of palliative care services provided []

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts 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