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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-00935 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2020-1125 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This trial studies the effect of a geriatric care survivorship intervention in improving the overall health of older adults who have completed curative treatment for stage I-III breast cancer. Geriatric assessment is the complete examination of an elderly individual, which includes a full valuation of the physical and mental conditions, as well as a check of emotional state. Geriatric assessment and survivorship visits after treatment may reduce health burdens and improve the well-being and quality of life of elderly patients with breast cancer. Researchers hope to improve the overall health of older adults who have undergone curative treatment for stage I-III breast cancer.
PRIMARY OBJECTIVE:
I. Determine the feasibility of implementing the geriatric care survivorship intervention in older adults who have completed curative-intent chemotherapy.
SECONDARY OBJECTIVES:
I. Assess the impact of a Geriatric Assessment (GA)-guided intervention on patient-reported quality-of-life/physical function (assessed by the Functional Assessment of Cancer Therapy-Breast [FACT-B]), geriatric assessment measures (assessed by GA) and objective physical function (assessed by the Short Physical Performance Battery [SPPB]) in older survivors from baseline to 6- and 12-months +/- 4-weeks post-chemotherapy.
II. Determine the impact of intervention on patient reported cognitive function (FACT-Cog) and objective cognitive function (Mini-Cog) from baseline to 6- and 12-months +/- 4-weeks post-chemotherapy.
III. Estimate the effect of the intervention on completion of referral appointments and contacts with primary care providers.
IV. Estimate the effect of the intervention on emergent healthcare utilization (emergency room [ER] visits and hospitalizations) at 6- and 12-months +/- 4 weeks post-chemotherapy.
V. Determine the impact of the intervention on both patient and caregiver satisfaction with care ("Health Care Climate Questionnaire") from baseline to 6- and 12-months +/- 4-weeks post-chemotherapy.
VI. Determine the impact of intervention on caregiver distress ("Burden Scale for Family Caregivers") and satisfaction with care ("Health Care Climate Questionnaire") from baseline to 6- and 12-months +/- 4-weeks post-chemotherapy.
OUTLINE:
Patients complete geriatric assessments at baseline, 6 months, and 12 months later. Based on the assessments, patients may receive further intervention at survivorship visit. Patients also receive survivorship care educational materials and wear a wearable activity tracking device for 1 year on study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive Care (GA-guided intervention) | Experimental | Patients complete geriatric assessments at baseline, 6 months, and 12 months later. Based on the assessments, patients may receive further intervention at survivorship visit. Patients also receive survivorship care educational materials and wear a wearable activity tracking device for 1 year on study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comprehensive Geriatric Assessment | Other | Complete geriatric assessments |
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| Measure | Description | Time Frame |
|---|---|---|
| Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaires | The FACT-G is a 27-item instrument that uses a 5-point Likert-type scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). | through study completion; an average of 1 year. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Meghan Karuturi, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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| Health Education | Behavioral | Receive survivorship care education |
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| Medical Device Usage and Evaluation | Other | Wear activity tracking device |
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| Supportive Care | Other | Receive geriatric assessment-guided interventions |
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| ID | Term |
|---|---|
| D015577 | Geriatric Assessment |
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D006304 | Health Status |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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