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Trial Title:
Geriatric Care Survivorship Intervention for Improving the Overall Health of Older Adults With Stage I-III Breast Cancer Who Have Completed Curative Treatment
NCT ID:
NCT05928325
Condition:
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Comprehensive Geriatric Assessment
Description:
Complete geriatric assessments
Arm group label:
Supportive Care (GA-guided intervention)
Intervention type:
Behavioral
Intervention name:
Health Education
Description:
Receive survivorship care education
Arm group label:
Supportive Care (GA-guided intervention)
Intervention type:
Other
Intervention name:
Medical Device Usage and Evaluation
Description:
Wear activity tracking device
Arm group label:
Supportive Care (GA-guided intervention)
Intervention type:
Other
Intervention name:
Supportive Care
Description:
Receive geriatric assessment-guided interventions
Arm group label:
Supportive Care (GA-guided intervention)
Other name:
Supportive Therapy
Other name:
Symptom Management
Other name:
Therapy, Supportive
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
65 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
M D Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Meghan Karuturi, MD
Phone:
713-563-0714
Email:
mskaruturi@mdanderson.org
Investigator:
Last name:
Meghan Karuturi, MD
Email:
Principal Investigator
Start date:
June 17, 2021
Completion date:
December 31, 2024
Lead sponsor:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
M.D. Anderson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05928325
http://mdanderson.org
