Anatomic Stage I Breast Cancer AJCC v8NCT05928325
Geriatric Care Survivorship Intervention for Improving the Overall Health of Older Adults With Stage I-III Breast Cancer Who Have Completed Curative Treatment
A study testing Comprehensive Geriatric Assessment, Health Education and Medical Device Usage and Evaluation in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by M.D. Anderson Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
- What is being tested?
- Comprehensive Geriatric Assessment, Health Education and Medical Device Usage and Evaluation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2021to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- >= 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementation of a Geriatric Care Survivorship Intervention in Older Adults Who Have Completed Curative Intent Therapy for Early-Stage Breast Cancer
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.
Read the detailed description
PRIMARY OBJECTIVE:
- Determine the feasibility of implementing the geriatric care survivorship intervention in older adults who have completed curative-intent chemotherapy.
SECONDARY OBJECTIVES:
- 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.
- 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
- Being tested
- Comprehensive Geriatric Assessment, Health Education, Medical Device Usage and Evaluation, Supportive Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Geriatric AssessmentOther
Complete geriatric assessments
Health EducationBehavioural
Receive survivorship care education
Medical Device Usage and EvaluationOther
Wear activity tracking device
Supportive CareOther
Also called Supportive Therapy, Symptom Management, Therapy, Supportive
Receive geriatric assessment-guided interventions
| Study group | Role | What they receive |
|---|---|---|
| Supportive Care (GA-guided intervention) | Experimental | 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. Receives: Other: Comprehensive Geriatric Assessment; Behavioral: Health Education; Other: Medical Device Usage and Evaluation; Other: Supportive Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaires
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).
Measured: through study completion; an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start17 Jun 2021
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage I Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Meghan Karuturi, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05928325
- Sponsor's protocol ID
- 2020-1125
- Other IDs
- NCI-2022-00935, 2020-1125
- Status last verified
- Apr 2026
- First submitted
- 23 Jun 2023
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Geriatric Care Survivorship Intervention in Older Adults Who Have Completed Curative Intent Therapy for Early-Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT05928325
- Acronym / sponsor ID
- 2020-1125
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 17 Jun 2021 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Determine the feasibility of implementing the geriatric care survivorship intervention in older adults who have completed curative-intent chemotherapy.
SECONDARY OBJECTIVES:
- 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.
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care (GA-guided intervention) | Experimental | Other: Comprehensive Geriatric Assessment, Behavioral: Health Education, Other: Medical Device Usage and Evaluation, Other: Supportive CarePatients 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- >= 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive Geriatric AssessmentComplete geriatric assessments | Other | Supportive Care (GA-guided intervention) |
| Health EducationReceive survivorship care education | Behavioural | Supportive Care (GA-guided intervention) |
| Medical Device Usage and EvaluationWear activity tracking device | Other | Supportive Care (GA-guided intervention) |
| Supportive CareAlso: Supportive Therapy, Symptom Management, Therapy, SupportiveReceive geriatric assessment-guided interventions | Other | Supportive Care (GA-guided intervention) |
Primary outcome
Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaires
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meghan Karuturi, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive Geriatric Assessment, Health Education and Medical Device Usage and Evaluation in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaires (time frame: through study completion; an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.