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Observational Cohort Study: Chemotherapy Decisions and Outcomes in Women Age 65 or Older With Operable, Newly Diagnosed Breast Cancer


N/A
65 Years
N/A
Open (Enrolling)
Female
Breast Cancer, Psychosocial Effects of Cancer and Its Treatment

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Trial Information

Observational Cohort Study: Chemotherapy Decisions and Outcomes in Women Age 65 or Older With Operable, Newly Diagnosed Breast Cancer


OBJECTIVES:

- Determine the relationship between preferences and chemotherapy decisions in women age
65 and over with operable, newly diagnosed breast cancer.

- Determine how factors that could be targets for intervention affect the relationship
between preferences and chemotherapy decisions in these patients.

- Determine the relationships between preference-based chemotherapy decisions, quality of
life, and satisfaction with treatment decisions in these patients.

- Determine the disease-free survival and competing causes of mortality of these
patients.

- Determine the types of physician providers who care for older breast cancer survivors
after initial cancer treatment is completed and explore how women decide about which
physicians to see.

- Measure quality indicators for the survivorship phase of care and evaluate if quality
varies by type of physician provider model.

- Determine if long-term patient-reported satisfaction varies as a function of physician
model for providing follow-up care post-treatment.

- Determine whether physician-patient communication and coordination of care after
treatment ends mediate follow-up quality and outcomes post-treatment.

OUTLINE: This is a cohort study.

Patients participate in interviews over 30-45 minutes at baseline, at 6 months, and at 1 and
2 years.

Patients are followed annually for at least 5 years.

PROJECTED ACCRUAL: A total of 1,296 patients will be accrued for this study within 18-24
months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed primary adenocarcinoma of the breast

- Operable disease

- Invasive and unilateral tumor

- No more than 20 weeks since diagnosis

- T1-4 (tumor size ≥ 1 cm), N0, M0 OR

- T1-4, N1-3, M0

- No prior carcinoma in situ, lobular carcinoma in situ, ductal carcinoma in situ, or
invasive breast cancer

- Hormone receptor status:

- Any estrogen receptor status

PATIENT CHARACTERISTICS:

Age

- 65 and over

Sex

- Female

Menopausal status

- Not specified

Performance status

- Any performance status

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- Not specified

Renal

- Not specified

Other

- No other malignancy except those for which the patient has completed treatment AND is
considered to be at less than 30% risk of recurrence

- History of non-melanoma skin cancer allowed

- Sufficient cognitive function to consent to and complete interviews

- English or Spanish speaking

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Not specified

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified

Type of Study:

Interventional

Study Design:

N/A

Principal Investigator

Jeanne Mandelblatt, MD, MPH

Investigator Role:

Study Chair

Investigator Affiliation:

Lombardi Cancer Research Center

Authority:

United States: Federal Government

Study ID:

CDR0000321396

NCT ID:

NCT00068328

Start Date:

August 2003

Completion Date:

Related Keywords:

  • Breast Cancer
  • Psychosocial Effects of Cancer and Its Treatment
  • psychosocial effects of cancer and its treatment
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • stage IA breast cancer
  • stage IB breast cancer
  • estrogen receptor-negative breast cancer
  • estrogen receptor-positive breast cancer
  • Breast Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
University of Chicago Cancer Research CenterChicago, Illinois  60637
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Memorial Hospital of South BendSouth Bend, Indiana  46601
Cape Cod HospitalHyannis, Massachusetts  02601
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
CCOP - Grand RapidsGrand Rapids, Michigan  49503
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
Louis A. Weiss Memorial HospitalChicago, Illinois  60640
Queens Cancer Center of Queens HospitalJamaica, New York  11432
Fletcher Allen Health Care - University Health Center CampusBurlington, Vermont  05401
Maine Center for Cancer Medicine and Blood Disorders - ScarboroughScarborough, Maine  04074
Washington Cancer Institute at Washington Hospital CenterWashington, District of Columbia  20010
Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital CenterBaltimore, Maryland  21237
CCOP - Hematology-Oncology Associates of Central New YorkEast Syracuse, New York  13057
Battle Creek Health System Cancer Care CenterBattle Creek, Michigan  49017
Munson Medical CenterTraverse City, Michigan  49684
UNMC Eppley Cancer Center at the University of Nebraska Medical CenterOmaha, Nebraska  68198-7680
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Butterworth Hospital at Spectrum HealthGrand Rapids, Michigan  49503-2560
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
CCOP - Nevada Cancer Research FoundationLas Vegas, Nevada  89109-2306
St. Barnabas Medical Center Cancer CenterLivingston, New Jersey  07039
Elkhart General HospitalElkhart, Indiana  46515
Howard Community HospitalKokomo, Indiana  46904
South Bend ClinicSouth Bend, Indiana  46617
Lakeland Regional Cancer Care Center - St. JosephSt. Joseph, Michigan  49085
University Medical Center of Southern NevadaLas Vegas, Nevada  89102
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
Sturdy Memorial HospitalAttleboro, Massachusetts  02703
Mecosta County Medical CenterBig Rapids, Michigan  49307
Saint Francis Cancer Treatment Center at Saint Francis Memorial Health CenterGrand Island, Nebraska  68803
Mountainview MedicalBerlin, Vermont  05602
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Palo Alto Medical FoundationPalo Alto, California  94301
Saint Luke's HospitalChesterfield, Missouri  63017
Michiana Hematology-Oncology, PC - ElkhartElkhart, Indiana  46514
Elkhart Clinic, LLCElkhart, Indiana  46514-2098
Michiana Hematology Oncology PC - La PorteLa Porte, Indiana  46350
Michiana Hematology-Oncology, PC - South BendMishawaka, Indiana  46545-1470
Michiana Hematology Oncology PC - PlymouthPlymouth, Indiana  46563
Michiana Hematology Oncology PC - NilesNiles, Michigan  49120
Lakeside Cancer Specialists, PLLCSaint Joseph, Michigan  49085
Norris Cotton Cancer Center at Catholic Medical CenterManchester, New Hampshire  03102
FirstHealth Moore Regional Community Hospital Comprehensive Cancer CenterPinehurst, North Carolina  28374
Lowell General HospitalLowell, Massachusetts  01854
Elliot Regional Cancer Center at Elliot HospitalManchester, New Hampshire  03103
Dana-Farber/Brigham and Women's Cancer CenterBoston, Massachusetts  02115
La Grange Memorial HospitalLa Grange, Illinois  60525
Lacks Cancer Center at Saint Mary's Health CareGrand Rapids, Michigan  49503
Metro Health HospitalGrand Rapids, Michigan  49506
Lakes Region General HospitalLaconia, New Hampshire  03246
Lipson Cancer and Blood Center at Rochester General HospitalRochester, New York  14621
Center for Cancer Care at OSF Saint Anthony Medical CenterRockford, Illinois  61108
South Carolina Oncology Associates, PAColumbia, South Carolina  29210
Mercy General Health PartnersMuskegon, Michigan  49443
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer CareConcord, New Hampshire  03301
Center for Cancer Care at Exeter HospitalExeter, New Hampshire  03833
New Hampshire Oncology - Hematology, PA - HooksettHooksett, New Hampshire  03106
Fountain Valley, California  92708
St. Anthony's Cancer CenterSt. Louis, Missouri  63128
Suniti Medical CorporationMerrillville, Indiana  46410
Oncology Center at St. Joseph HospitalNashua, New Hampshire  03060
St. Mary's Regional Cancer Center at St. Mary's Medical CenterHuntington, West Virginia  25702
Callahan Cancer Center at Great Plains Regional Medical CenterNorth Platte, Nebraska  69103
Addison Gilbert HospitalGloucester, Massachusetts  01930
Cape Fear Valley Medical Center Cancer CenterFayetteville, North Carolina  28302-2000
Maria Parham Medical CenterHenderson, North Carolina  27536
Southeastern Regional Medical CenterLumberton, North Carolina  28359
Granville Medical CenterOxford, North Carolina  27565
Duke Health Raleigh HospitalRaleigh, North Carolina  27609
Person Memorial HospitalRoxboro, North Carolina  27573
Marion L. Shepard Cancer Center at Beaufort County HospitalWashington, North Carolina  27889
Camino Medical Group - Treatment CenterMountain View, California  94040
Coastal Cancer Center - Myrtle BeachMyrtle Beach, South Carolina  29572
Bendheim Cancer Center at Greenwich HospitalGreenwich, Connecticut  06830
Cancer Center of South Florida Foundation, IncorporatedLake Worth, Florida  33461
Foundation Medical PartnersNashua, New Hampshire  03060
Keyserling Cancer Center at Beaufort Memorial HospitalBeaufort, South Carolina  29902
Medical Oncology and Hematology Associates of North Virginia - FairfaxFairfax, Virginia  22031