Geriatric Care Survivorship Intervention for Improving the Overall Health of Older Adults With Stage I-III Breast Cancer Who Have Completed Curative Treatment

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Implementation of a Geriatric Care Survivorship Intervention in Older Adults Who Have Completed Curative Intent Therapy for Early-Stage Breast Cancer

Conditions
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Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8

Intervention / Treatment
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* Other: Comprehensive Geriatric Assessment
* Behavioral: Health Education
* Other: Medical Device Usage and Evaluation
* Other: Supportive Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >= 65-years-old 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: The presence of significant medical conditions that in the physician's (either the patient's primary oncologist of the study principal investigator) judgement preclude participation in the exercise intervention

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive Care (GA-guided intervention)<br>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. | Other: Comprehensive Geriatric Assessment<br>* Complete geriatric assessments<br>Behavioral: Health Education<br>* Receive survivorship care education<br>Other: Medical Device Usage and Evaluation<br>* Wear activity tracking device<br>Other: Supportive Care<br>* Receive geriatric assessment-guided interventions<br>* Other names: Therapy, Supportive;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. |