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OpenTrials
Completed

NCT Number: NCT00068328

Chemotherapy Decisions and Outcomes in Older Women With Newly Diagnosed Breast Cancer

RATIONALE: Studying how older women make treatment decisions and how these decisions affect the outcome of treatment may help doctors plan more effective treatments and improve patient quality of life.

PURPOSE: This clinical trial is studying how a patient's treatment preferences and decisions about chemotherapy affect the outcome of treatment in older women with newly diagnosed breast cancer.

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Key information

Age range

65 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Camino Medical Group - Treatment Center, Mountain View, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

psychosocial assessment and care

Procedure

quality-of-life assessment

Procedure

Primary outcomes

  1. quality of life

    Time frame: Up to 5 years

Secondary outcomes

  1. disease free survival

    Time frame: Up to 5 years

  2. mortality rate

    Time frame: Up to 5 years

Sponsors and collaborators

Lead sponsor

Alliance for Clinical Trials in Oncology

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2006
Study completion
2016
First posted
Sep 11, 2003
Registry last updated
Aug 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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