NCT05928325

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Anatomic Stage I Breast Cancer AJCC v8
• Anatomic Stage II Breast Cancer AJCC v8
• Anatomic Stage III Breast Cancer AJCC v8

Interventions

Type	Name	Description
OTHER	Comprehensive Geriatric Assessment	Complete geriatric assessments
BEHAVIORAL	Health Education	Receive survivorship care education
OTHER	Medical Device Usage and Evaluation	Wear activity tracking device
OTHER	Supportive Care	Receive geriatric assessment-guided interventions

Timeline

• Start date: 2021-06-17
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2023-07-03
• Last updated: 2026-02-19

Locations

1 site across 1 country: United States