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

Anatomic Stage III Breast Cancer AJCC v8 Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT05928325
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Contact: Meghan Karuturi, MD
• Phone: (713) 563-0714
• Email: mskaruturi@mdanderson.org
• Status: Recruiting
• Phase: N/A
• Start date: June 17, 2021
• Completion date: December 31, 2024