Chemotherapeutic Agent ToxicityNCT00608738
Using Whole-Person-Care Guide in Patients Receiving Care for Cancer or Complications From Cancer Treatment
A study testing informational intervention, medical chart review and questionnaire administration in people with Chemotherapeutic Agent Toxicity and Infection, run by Northwestern University.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Chemotherapeutic Agent Toxicity, Infection, Malnutrition
- What is being tested?
- informational intervention, medical chart review and questionnaire administration
- Type of treatment
- Surgery or procedure
- How many people
- 750 participants
- Where
- No sites listed yet
- Study dates
- Jul 2001to Jan 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
About this study
Official title: Developing a Nested Whole-Person-Care Guide: Screening and Evaluation Steps (American Cancer Society) ACS
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.
Read the 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.
- Conditions
- Chemotherapeutic Agent Toxicity, Infection, Malnutrition, Musculoskeletal Complications, Neutropenia, Radiation Toxicity
- Being tested
- informational intervention, medical chart review, questionnaire administration, assessment of therapy complications, management of therapy complications
- Keywords
- neutropenia, infection, radiation toxicity, chemotherapeutic agent toxicity, malnutrition, musculoskeletal complications, thrombocytopenia, unspecified adult solid tumor, protocol specific
- Medical subject headings
- Infections, Malnutrition, Neutropenia, Radiation Injuries, Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
informational interventionOther
medical chart reviewOther
questionnaire administrationOther
assessment of therapy complicationsProcedure or surgery
management of therapy complicationsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient needs detected
Concordance among patient, caregiver, and team goals
Qualitative and quantitative evaluation of palliative care services provided
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2008 (estimated)
- Study startJul 2001
- Primary completionJan 2005
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapeutic Agent ToxicityStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Masking
- None (open label)
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Linda Emanuel, MD, PhD, Study chair, Robert H. Lurie Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00608738
- Sponsor's protocol ID
- ACS 03CC1
- Other IDs
- NU-0931-005, NU-200708-1439
- Status last verified
- Jul 2012
- First submitted
- 5 Feb 2008
- Last updated
- 10 Jul 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Nested Whole-Person-Care Guide: Screening and Evaluation Steps (American Cancer Society) ACS
- ClinicalTrials.gov ID
- NCT00608738
- Acronym / sponsor ID
- ACS 03CC1
- Conditions
- Chemotherapeutic Agent Toxicity, Infection, Malnutrition, Musculoskeletal Complications, Neutropenia, Radiation Toxicity
- Keywords
- neutropenia, infection, radiation toxicity, chemotherapeutic agent toxicity, malnutrition, musculoskeletal complications, thrombocytopenia, unspecified adult solid tumor, protocol specific
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Jul 2001
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 6 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Masking
- None (open label)
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| informational intervention | Other | – |
| medical chart review | Other | – |
| questionnaire administration | Other | – |
| assessment of therapy complications | Procedure or surgery | – |
| management of therapy complications | Procedure or surgery | – |
Primary outcome
Patient needs detected
Concordance among patient, caregiver, and team goals
Qualitative and quantitative evaluation of palliative care services provided
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda Emanuel, MD, PhD study chair
Robert H. Lurie Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing informational intervention, medical chart review and questionnaire administration in people with Chemotherapeutic Agent Toxicity and Infection, run by Northwestern University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient needs detected. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2012.