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NCT Number: NCT05928325

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comprehensive Geriatric Assessment

Other

Complete geriatric assessments

Health Education

Behavioral

Receive survivorship care education

Medical Device Usage and Evaluation

Other

Wear activity tracking device

Supportive Care

Other

Receive geriatric assessment-guided interventions

Other names: Supportive Therapy, Symptom Management, Therapy, Supportive

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jul 3, 2023
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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