Addressing Areas of Public Health Emphasis

Improving the Quality of Cancer Care

The Challenge

The nine million Americans living today who have had cancer, including the 1.3 million who will be diagnosed in 2002 and the 500,000 who are in the last year of life, all hope that they receive the best medical treatment and care possible. Unfortunately, far too many will not receive this caliber of care. The Institute of Medicine's National Cancer Policy Board (NCPB) recently reported that the "ad hoc and fragmented cancer care system" in the United States "does not ensure access to care, lacks coordination, and is inefficient in its use of resources." The report emphasizes problems of underuse, overuse, and misuse of existing interventions that have also been underscored by the President's Cancer Panel. Testimony by cancer patients, families, and providers summarized in the Panel's 2001 report, Voices of a Broken System: Real People, Real Problems, points to a number of barriers to high-quality cancer care. These include system and financial limitations, the inadequacy of patient information and provider education, poor management of cancer-related symptoms, and lack of timely referral to palliative and hospice care.

Drawing from the NCPB report, we define quality cancer care to mean the provision of evidence-based, patient-centered services throughout the continuum of care in a timely and technically competent manner, with good communication, shared decision making, and cultural sensitivity, with the aim of improving clinical outcomes, including patient survival and health-related quality of life. The reasons why some patients with cancer do not receive the newer, more effective treatments or adequate palliative and end-of-life care are poorly understood. Substantial disagreement exists about what constitutes optimal care, especially from the patient's perspective. Therefore, it is critical that we advance understanding of how to measure, monitor, and improve the quality of cancer care. To meet this research challenge, we must:

• Define core outcome measures to better compare interventions across studies and over time.
• Standardize core process measures to identify those interventions that have been convincingly shown to improve cancer care outcomes.
• Build a stronger data and methods "infrastructure" for conducting quality of care analyses including studies at both the individual and population levels.
• Incorporate symptom management and palliative care across the cancer continuum through cancer quality improvement research and translation efforts.
• Ensure that effective therapies demonstrated in clinical trials are incorporated into community practice.
• Enhance cancer communications for patients, their families, and caregivers.
• Strengthen collaborative relationships with Federal agencies and private organizations to ensure that the best available scientific evidence guides cancer care decisions.

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Progress Toward Meeting the Challenge

Developing Core Measurements

In 2001, NCI convened the Cancer Outcomes Measurement Working Group, composed of 35 internationally recognized experts in measurement, oncology, and the social sciences, to assess alternative approaches to improve validity, reliability, feasibility, and comparability of patient centered outcome measures such as quality of life, economic burden, and satisfaction with care. In its forthcoming book, Outcomes Assessment in Cancer (Cambridge University Press), members of this working group advance a number of compelling recommendations. A major barrier to comparing findings across studies and assessing progress over time is the lack of standardization in measuring outcomes like health-related quality of life. In response, working group members recommend that outcome measures should be selected from the small set that have been adequately validated. In addition, NCI should support "cross-walk" analyses that facilitate the transformation of scores on competing instruments and "item banks" populated by items from multiple high-quality instruments. These elements would enhance our ability to compare study findings and conduct sound meta analyses and user-friendly computer adaptive survey administration.

A monograph analyzing recent literature in cancer outcomes research will be published in 2003. The volume will highlight and illustrate a wide range of applications of cancer outcome measures, including national-level surveillance, the evaluation of prevention and treatment interventions in trials and observation studies, and methodology for monitoring the progress of adults and children (and their families) undergoing cancer therapy or receiving palliative care.

Standards for process measures of quality cancer care are being developed through a major new NCI collaboration with other Federal agencies and the private sector. The Cancer Care Quality Measurement Project (CanQual), conducted under the auspices of the non-profit National Quality Forum, is identifying core process measures for treatment, survivorship, and end-of-life care for the major tumor sites, as well as measures that apply to all tumor sites, such as palliative care. CanQual exemplifies partnerships that can accelerate the adoption of evidence-based process measures by a broad range of decision makers. CanQual and the core outcome measures working group are linked conceptually; they concur that a candidate process measure would be regarded as quality-enhancing when there is convincing evidence it improves outcomes that are important to decision makers. Moreover, for some interventions (e.g., palliative care), demonstrated improvement in patient-centered outcome measures constitutes direct evidence of good quality care.

Strengthening the Science Base

NCI established the Cancer Care Outcomes Research and Surveillance Consortium (CanCORS) in 2001, launching a single study of treatment patterns and quality of care over time in large cohorts of newly identified cancer patients. CanCORS investigators are combining data from registries, medical records, insurance claims, and patient and provider surveys to assess the care received by a population-based sample of 5,000 colorectal and 5,000 lung cancer patients across the United States. This research will investigate the impact of selected interventions on patient-centered outcomes, dissemination of state-of-the-art therapies in the community, modifiable risk factors, and disparities in cancer care and outcomes by racial/ethnic group and socioeconomic status.

Recognizing the potential value of large cohort studies, the American Society of Clinical Oncology (ASCO) is conducting a similar study, focusing on breast and colorectal cancer, as part of its National Initiative on Cancer Care Quality. NCI and ASCO have signed a Memorandum of Understanding (MOU) that stresses sharing information and progress on complementary efforts to improve the quality of care. The forerunner to CanCORS is the landmark Prostate Cancer Outcomes Study (PCOS), the first longitudinal study of quality of life for men living with prostate cancer.

NCI's recently established Patterns of Care/Quality of Care Program (POC/QOC) is drawing from the Surveillance, Epidemiology, and End Results (SEER) registry data to investigate adoption of recommended treatments for the most common cancers. Recently published POC/QOC studies provide the most authoritative data on trends in treatment patterns for breast, colorectal, and ovarian cancer and results will be disseminated through professional education activities in collaboration with professional societies. In addition, SEER Rapid Response Special Studies (RRSS) make it possible to support methodological and pilot investigations targeted to NCI quality-of-care research priorities. For example, two new RRSS studies focus on evaluating non-Hodgkins lymphoma patients for satisfaction with quality of care.

Studies linking SEER and Medicare data continue to provide insight into quality-of-care issues including:

• Nearly equivalent costs of breast conserving surgery vs. mastectomy for early-stage breast cancer.
• Potential disparities by race, ethnicity or age in the receipt of chemotherapy for colon and ovarian cancer.
• Significantly reduced rates of postoperative and late urinary complications for men undergoing prostatectomy, when performed in a high-volume hospital by a surgeon who performs a high number of such procedures.

The Cancer Research Network (CRN), a consortium of researchers affiliated with 10 major not-for-profit HMOs, has provided the mechanism for NCI to obtain better data more quickly on patterns of cancer care from multiple perspectives. Currently, the CRN is conducting three major projects designed to improve the organization and delivery of tobacco cessation services in the context of primary care delivery, evaluate and improve processes of care associated with the optimal delivery of cervical and breast cancer screening procedures, and evaluate the effectiveness of prophylactic mastectomy and early screening for women at elevated risk for breast cancer. Additional CRN projects focus on identifying organizational barriers to clinical trial participation in the HMO settings, investigating the utility of HMO administrative records for conducting cancer-related health services research, and examining long-term quality-of-life issues following breast cancer treatment.

The work of the Breast Cancer Surveillance Consortium investigates factors associated with the performance of high-quality screening mammography in community practice, including the roles of hormone replacement therapy and breast density, family history, age, and examination technique.

Improving Symptom Management and Palliative Care across the Cancer Continuum

The Improving Palliative Care for Cancer report from the Institute of Medicine's National Cancer Policy Board identified gaps in symptom management and palliative care (end-of-life) research, and also highlighted the under recognition, under diagnosis, and under treatment of cancer patients with significant distress. Information on how to better measure, evaluate, and improve palliative care is now emerging from a variety of initiatives:

• Research supported by NCI through the Cancer Outcomes Measurement Working Group, CanQual, CanCORS, and the Quality of Cancer Care Committee projects.
• The 2002 NIH State-of-the-Science Conference on Symptom Management in Cancer: Pain, Depression, and Fatigue.
• Clinical trials on supportive and palliative care topics such as cachexia, pain, and symptom reduction as well as new research concepts that examine depression in cancer patients through the NCI Community Clinical Oncology Program.
• NCI- and NIH-supported studies on complementary and alternative medicine at the end of life.

Enhancing Quality of Care Research within the NCI Clinical Trials Program

The NCI National Clinical Trials Program provides an ideal venue to assess quality of care through the incorporation of valid and reliable health-related quality-of-life endpoints into clinical study design. A workshop on the diffusion of medical innovations will be held in 2003, setting the stage for studies to examine why some highly promising therapies successfully move into clinical practice while others do not.

Strengthening Cancer Communications

Ultimately, improved cancer care depends on our ability to communicate messages about prevention, treatment, patient care, survivorship, and end-of-life issues to the research community, providers, patients, and payers. As part of NCI's investment in Cancer Communications as an Extraordinary Opportunity, several current efforts focus directly on the quality of cancer care. See Cancer Communications.

Ensuring That the Best Available Science Informs Decision Making

NCI established the Quality of Cancer Care Committee (QCCC) in 2000 to improve the quality of Federal-level decision making about cancer care. Its membership includes the Federal agencies involved in cancer care delivery, coverage, regulation, standards setting, or conducting research on the quality of cancer care.

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The Plan - Quality of Cancer Care

Goal
Improve the quality of cancer care by strengthening the scientific basis for public and private decision making on care delivery, coverage, purchasing, regulation, and standards setting.

Objectives, Milestones, and Funding Increases Required for Fiscal Year 2004

1.	Develop core process and outcome measures for assessing the quality of cancer care.	$5.5 M
2.	Strengthen the methodological and empirical foundations of quality of cancer care assessment.	$15.0 M
3.	Incorporate symptom management and palliative care into the full spectrum of cancer quality improvement research and translation efforts, from initial treatment, through survivorship, and at the end of life.	$1.0 M
4.	Enhance quality of care research within, and beyond, the NCI clinical trials program.	$1.5 M
5.	Improve quality of care by strengthening cancer communications. (Budgeted in Cancer Communications plan)
6.	Ensure that the best available scientific evidence about quality measures and assessment informs Federal decision-making. Share new knowledge with public and private partners and collaborate to identify, develop, and monitor progress on core measures of cancer care quality.	$3.0 M
Management and Support		$1.0 M
Total		$27.0 M

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Objective 2: Strengthen the methodological and empirical foundations of quality of cancer care assessment.
Sustain support at $7.5 million per year for Cancer Care Outcomes Research and Surveillance Consortium (CanCORS) studies.
Sustain support for Cancer Research Network population laboratories at $5 million per year for cancer control research, with additional emphasis on studies of the quality of cancer care in community settings.
Provide sustained support for Pattern of Care/Quality of Care (POC/QOC) studies on levels, trends, variations, and dissemination of effective treatments and conduct professional education activities in collaboration with other Federal agencies and professional societies. Provide support for new Rapid Response Special Studies (RRSS) to facilitate methodological and pilot investigations responsive to NCI's quality of care program needs. Integrate results from these studies with Cancer Intervention Surveillance Modeling Network (CISNET) models to predict the effects of treatment dissemination on trends in cancer survival and mortality.	$3.00 M
Increase support for analyses of the Surveillance, Epidemiology, and End Results and Medicare (SEER-Medicare) database to investigate the use and outcomes of selected cancer interventions.	$2.0 M
Based on results of completed and ongoing POC/QOC, SEER-Medicare, and RRSS studies, support intervention studies and demonstration programs for improving referral patterns and treatment where sub-optimal performance has been documented, such as in cervical and ovarian cancer.	$2.0 M
Based on ongoing feasibility studies, link tumor registry information to Medicaid and private payer administrative data to investigate whether interventions are reaching and improving the health of individuals aged 65 or younger. Assist private insurers in creating and analyzing claims linked to tumor registry data by leading a workshop based on the experience of SEER-Medicare and Medicaid investigators.	$2.0 M
Continue to support innovative research on economic and delivery system determinants of quality of and return on investment for new clinical approaches to prevention, screening, and treatment services.	$2.5 M
Sponsor new studies to strengthen the methodological foundations of outcomes research and quality of care assessment, including studies on the integration of evidence-based structure, process, and outcome performance measures at both the provider and health system level.	$2.0 M
Support the establishment of physician networks and databases for tracking and monitoring cancer screening practices.	$1.5 M
TOTAL	$15.0 M

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Objective 3: Incorporate symptom management and palliative care into the full spectrum of cancer quality improvement research and translation efforts, from initial treatment, through survivorship, and at the end of life.
Integrate existing and newly developed knowledge about best practice standards and population disparities for symptom management and palliative care.
Incorporate evidence-based palliative care practices more fully into NCI's education and information products and spotlight Internet accessible information sources.
Educate health professionals on ways to better integrate and deliver symptom management and palliative care, using best-practice standards.
TOTAL	$1.0 M

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Objective 5: Improve quality of care by strengthening cancer communications. (See Cancer Communication plan)
Conduct research to enhance communication between doctors and patients.
Develop new tools and products to facilitate cancer communications for the public, patients and their caregivers, underserved populations, advocacy groups, health professionals, and cancer communicators.
Support the diffusion and dissemination of NCI-funded evidence-based interventions to providers.

Objective 6: Ensure that the best available scientific evidence about quality measures and assessment informs Federal decision-making. Share new knowledge with public and private partners and collaborate to identify, develop, and monitor progress on core measures of cancer care quality.
Continue to support interagency demonstration projects organized through the Quality of Cancer Care Committee (QCCC), a forum for coordinating Federal activities.	$2.00 M
Capitalize on the collective clinical and policy expertise of the QCCC to provide technical assistance and advice to public agencies and private organizations upon request.
Foster collaboration among QCCC members (particularly the Centers for Disease Control and Prevention and the Agency for Healthcare Research and Quality), the states, and private organizations to support ongoing development of a national cancer data system for monitoring trends in cancer care and identifying population disparities.	$1.00 M
TOTAL	$3.0 M

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Prostate Cancer Outcomes Study Sheds Light on Treatment Choices

The Prostate Cancer Outcomes Study (PCOS), the most comprehensive survey ever undertaken on prostate cancer outcomes, was initiated in 1994 to evaluate variations in practice and the impact of therapies on health-related quality of life. Study findings are helping men, their families, and clinicians make more informed choices about treatment alternatives. They include:

• Reports showing that, while physicians order bone scans on approximately two thirds of all new prostate cancer patients and computed tomography (CT) exams on about one-third of new patients, less than five percent of the imaging studies done for newly diagnosed prostate cancer patients show evidence of metastases. In contrast, for men with serum PSA levels greater than 50ng/ml and Gleason scores ranging from 8-10, the imaging studies were positive in over 60 percent of the cases.
• Evidence that men with clinically localized prostate cancer, who are treated with radical prostatectomy, are more likely to experience urinary and sexual dysfunction than those treated with external beam radiation therapy. Bowel dysfunction, on the other hand, is more common among men receiving external radiation therapy.
• Evidence that men aged 75 or older more often received conservative treatment, such as hormonal therapy alone or watchful waiting, than aggressive treatment such as radical prostatectomy or radiation therapy.
• Finding that for men younger than 60, use of aggressive treatment was similar among white, African-American, and Hispanic men. Among men 60 years old and older, African American men underwent aggressive treatment less often than did white men or Hispanic men.

NCI plans to follow the 3,500 PCOS participants for 10 years after diagnosis to ascertain and verify deaths, maintain contact with respondents, and conduct a survey ten years out to assess long-term changes in disease-related quality of life.

NCI Collaborates with Federal Partners to Ensure That the Best Available Evidence Informs Decision Making

Through the Quality of Cancer Care Committee, NCI currently supports three interagency projects:

• The Health Resources and Services Administration and Centers for Disease Control and Prevention collaborative to build on a chronic care model to develop "breakthrough changes" to improve screening, referral, and follow-up for breast, cervical, and colorectal cancer for underserved populations.
• The Centers for Medicare and Medicaid Services collaborative to increase awareness and improve delivery of the Medicare colorectal cancer screening benefit among Medicare beneficiaries and their physicians. The Department of Veterans Affairs (VA) collaborative to use evidence about good practice for ongoing improvements in screening, surveillance, treatment, and end-of-life care for colorectal cancer in the VA healthcare system.