Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
Conditions
Brief 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.
Interventions
OTHERComprehensive Geriatric Assessment
Complete geriatric assessments
BEHAVIORALHealth Education
Receive survivorship care education
OTHERMedical Device Usage and Evaluation
Wear activity tracking device
OTHERSupportive Care
Receive geriatric assessment-guided interventions
Sponsors
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaires | through study completion; an average of 1 year. | 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). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMeghan Karuturi, MD
M.D. Anderson Cancer Center
Outcome results
None listed