M.D. Anderson Cancer Center
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.
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer Ajc V8
Anatomic Stage III Breast Cancer AJCC v8
Comprehensive Geriatric Assessment
Health Education
Medical Device Usage and Evaluation
Supportive Care
NA
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.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 30 participants |
| Masking : | NONE |
| Primary Purpose : | SUPPORTIVE_CARE |
| Official Title : | Implementation of a Geriatric Care Survivorship Intervention in Older Adults Who Have Completed Curative Intent Therapy for Early-Stage Breast Cancer |
| Actual Study Start Date : | 2021-06-17 |
| Estimated Primary Completion Date : | 2027-12-31 |
| Estimated Study Completion Date : | 2027-12-31 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 65 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: | 1 |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
M D Anderson Cancer Center
Houston, Texas, United States, 77030