Geriatric Care Survivorship Intervention for Improving the Overall Health of Older Adults With Stage I-III Breast Cancer Who Have Completed Curative Treatment
NCT ID: NCT05928325
Last Updated: 2025-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2021-06-17
2027-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Supportive Care (GA-guided intervention)
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.
Comprehensive Geriatric Assessment
Complete geriatric assessments
Health Education
Receive survivorship care education
Medical Device Usage and Evaluation
Wear activity tracking device
Supportive Care
Receive geriatric assessment-guided interventions
Interventions
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Comprehensive Geriatric Assessment
Complete geriatric assessments
Health Education
Receive survivorship care education
Medical Device Usage and Evaluation
Wear activity tracking device
Supportive Care
Receive geriatric assessment-guided interventions
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed Stage I, II or III breast cancer (if the patient has had more than one breast cancer, the most recent diagnosis)
* Within 8 (+/- 14 days) weeks of completing a chemotherapy regimen for breast cancer either as standard-of-care or on a study (can be receiving concomitant radiation, HER-2 targeted agents and/or endocrine therapy)
* English or Spanish speaking
* Able to provide written, informed consent
* Willing and able to meet all study requirement
* CAREGIVER ELIGIBILITY: \>= 18-years-old
* CAREGIVER ELIGIBILITY: Ability to complete required study procedures
Exclusion Criteria
65 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Meghan Karuturi, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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MD Anderson Cancer Center
Other Identifiers
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NCI-2022-00935
Identifier Type: REGISTRY
Identifier Source: secondary_id
2020-1125
Identifier Type: OTHER
Identifier Source: secondary_id
2020-1125
Identifier Type: -
Identifier Source: org_study_id
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