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

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

Official title:

Developing a Nested Whole-Person-Care Guide: Screening and Evaluation Steps (American Cancer Society) ACS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00608738
• Other study ID #: ACS 03CC1
• Secondary ID: NU-0931-005NU-20
• Status: Completed
• Phase: N/A
• First received: February 5, 2008
• Last updated: July 9, 2012
• Start date: July 2001
• Est. completion date: January 2005

Study information

• Verified date: July 2012
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: January 2005
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Chemotherapeutic Agent Toxicity
• Infection
• Malnutrition
• Musculoskeletal Complications
• Neutropenia
• Radiation Injuries
• Radiation Toxicity
• Thrombocytopenia
• Thrombocytosis
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Other:
• informational intervention

• medical chart review

• questionnaire administration

Procedure:
• assessment of therapy complications

• management of therapy complications

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient needs detected			No
Primary	Concordance among patient, caregiver, and team goals			No
Primary	Qualitative and quantitative evaluation of palliative care services provided			No