CancerNCT00921713
Testing an Optimal Model of Patient-Centered Cancer Care
A study testing Oncology Nurse Care Management and Patient-centered materials in people with Cancer, run by Kaiser Permanente.
Trial summary
The purpose of this proposal is to develop and test the efficacy in a randomized, controlled clinical trial of an Oncology Nurse Care Management (ONCM) program to support cancer patients early in their course. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Oncology Nurse Care Management and Patient-centered materials
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to Aug 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- On the panel of an eligible and consenting primary care physician;
- Diagnosed with a new occurrence of breast (females only) , colorectal, or lung cancer within the past three weeks;
- Age 18 or older; and
- Able to complete the baseline questionnaire.
Who cannot join
- They plan to disenroll from GH or be out of the area in the coming year; or
- Primary care physician or specialty physician expects survival to be less than 12 months; or
- Don't speak English; or
- Have moderate cognitive impairment (a score of 3 or more on a six-item validated instrument, or psychosis as assessed by ICD-9 codes from GH medical record data.
About this study
The purpose of this proposal is to develop and test the efficacy in a randomized, controlled clinical trial of an Oncology Nurse Care Management (ONCM) program to support cancer patients early in their course. The ONCM program will be compared with an Enhanced Usual Care (EUC) program that will provide education materials and treatment resources for patients. Efficacy will be measured by differences over time in participant-reported Quality of Life, Symptoms and Emotional Distress, and Quality of Care between patients receiving ONCM versus EUC.
Read the detailed description
Overall Goal:
Our primary goal is to assess the impact on quality of life, quality of care, and other outcomes of two programs designed to support patients newly diagnosed with breast, colorectal, and lung cancer patients. The Oncology Nurse Care Management (ONCM) and Enhanced Usual Care (EUC) interventions will be implemented and evaluated among enrollees of Group Health.
Specific Aims:
A.1. To develop a robust early cancer notification system based on automated data to facilitate intervention shortly after cancer diagnosis.
A.2. To implement an Oncology Nurse Care Management program that addresses patient questions, symptoms, psychosocial needs, and facilitates timely, coordinated care.
A.3. To compare the impact of the Oncology Nurse Care Manager Program with Enhanced Usual Care in Group Health cancer patients using a randomized clinical trial design. Our two primary outcomes are quality of life and patients' perspectives of quality of care. As secondary outcomes, we will evaluate the impact of the intervention on psychosocial distress and depression.
- Conditions
- Cancer
- Being tested
- Oncology Nurse Care Management, Patient-centered materials
- Keywords
- Early cancer care
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oncology Nurse Care ManagementOther
Patient-centered materialsOther
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Usual Care | Active comparator | An extensive packet of information including cancer education materials and treatment resources will be mailed to patients. Receives: Other: Patient-centered materials |
| Oncology Nurse Care Management | Experimental | In addition to this mailed information packet, patients in OCNM will be contacted by an experienced Oncology nurse with additional training in self-management support and psychosocial care. The intervention nurse, supported by a Medical Oncologist and Clinical Psychologist, will work closely with patients, their primary care physicians, and other clinicians to assure that patient needs discussed are met. The nurses will be trained in and employ proven counseling and psychotherapeutic approaches-behavioral activation and problem-solving treatment. The multi-component intervention will be based on the Chronic Care Model's six elements (health care organization, community resources, self-management support, delivery system design, decision support, and clinical information system). Receives: Other: Oncology Nurse Care Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life and satisfaction with care between patients in Oncology Nurse Care Management versus Enhanced Usual Care
Measured: 5/2009 - 8/2011
Secondary outcomes (1)
Treatment adherence and treatment outcomes of patients in Oncology Nurse Care Management versus Enhanced Usual Care
Measured: 5/2009 - 8/2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2009 (estimated)
- Study startSep 2008
- Primary completionJul 2011
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edward Wagner, MD, MPH, Principal investigator, Group Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00921713
- Sponsor's protocol ID
- 1P20CA137219NN
- Other IDs
- 1P20CA137219
- Status last verified
- Oct 2017
- First submitted
- 4 Jun 2009
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing an Optimal Model of Patient-Centered Cancer Care
- ClinicalTrials.gov ID
- NCT00921713
- Acronym / sponsor ID
- 1P20CA137219NN
- Conditions
- Cancer
- Keywords
- Early cancer care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jul 2011 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 16 Jun 2009 (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.
The purpose of this proposal is to develop and test the efficacy in a randomized, controlled clinical trial of an Oncology Nurse Care Management (ONCM) program to support cancer patients early in their course. The ONCM program will be compared with an Enhanced Usual Care (EUC) program that will provide education materials and treatment resources for patients. Efficacy will be measured by differences over time in participant-reported Quality of Life, Symptoms and Emotional Distress, and Quality of Care between patients receiving ONCM versus EUC.
Detailed description
Overall Goal:
Our primary goal is to assess the impact on quality of life, quality of care, and other outcomes of two programs designed to support patients newly diagnosed with breast, colorectal, and lung cancer patients. The Oncology Nurse Care Management (ONCM) and Enhanced Usual Care (EUC) interventions will be implemented and evaluated among enrollees of Group Health.
Specific Aims:
A.1. To develop a robust early cancer notification system based on automated data to facilitate intervention shortly after cancer diagnosis.
A.2. To implement an Oncology Nurse Care Management program that addresses patient questions, symptoms, psychosocial needs, and facilitates timely, coordinated care.
A.3. To compare the impact of the Oncology Nurse Care Manager Program with Enhanced Usual Care in Group Health cancer patients using a randomized clinical trial design. Our two primary outcomes are quality of life and patients' perspectives of quality of care. As secondary outcomes, we will evaluate the impact of the intervention on psychosocial distress and depression.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Usual Care | Active comparator | Other: Patient-centered materialsAn extensive packet of information including cancer education materials and treatment resources will be mailed to patients. |
| Oncology Nurse Care Management | Experimental | Other: Oncology Nurse Care ManagementIn addition to this mailed information packet, patients in OCNM will be contacted by an experienced Oncology nurse with additional training in self-management support and psychosocial care. The intervention nurse, supported by a Medical Oncologist and Clinical Psychologist, will work closely with patients, their primary care physicians, and other clinicians to assure that patient needs discussed are met. The nurses will be trained in and employ proven counseling and psychotherapeutic approaches-behavioral activation and problem-solving treatment. The multi-component intervention will be based on the Chronic Care Model's six elements (health care organization, community resources, self-management support, delivery system design, decision support, and clinical information system). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- On the panel of an eligible and consenting primary care physician;
- Diagnosed with a new occurrence of breast (females only) , colorectal, or lung cancer within the past three weeks;
- Age 18 or older; and
- Able to complete the baseline questionnaire.
Key exclusion criteria (4 listed)
- They plan to disenroll from GH or be out of the area in the coming year; or
- Primary care physician or specialty physician expects survival to be less than 12 months; or
- Don't speak English; or
- Have moderate cognitive impairment (a score of 3 or more on a six-item validated instrument, or psychosis as assessed by ICD-9 codes from GH medical record data.
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 |
|---|---|---|
| Oncology Nurse Care Management | Other | Oncology Nurse Care Management |
| Patient-centered materials | Other | Enhanced Usual Care |
Primary outcome
Quality of life and satisfaction with care between patients in Oncology Nurse Care Management versus Enhanced Usual Care
Time frame: 5/2009 - 8/2011
1 secondary outcome
Treatment adherence and treatment outcomes of patients in Oncology Nurse Care Management versus Enhanced Usual Care
Time frame: 5/2009 - 8/2011
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 13 Oct 2017.
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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.
Edward Wagner, MD, MPH principal investigator
Group Health Research Institute
Questions about this trial
What is this clinical trial studying?
A study testing Oncology Nurse Care Management and Patient-centered materials in people with Cancer, run by Kaiser Permanente.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. 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 13 Oct 2017. 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?
Quality of life and satisfaction with care between patients in Oncology Nurse Care Management versus Enhanced Usual Care (time frame: 5/2009 - 8/2011). 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 13 Oct 2017.