Geriatric Oncology Assessment and Coping Skills Training for Older Women on Aromatase Inhibitor Therapy

NCT ID: NCT07232056

Last Updated: 2025-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

452 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-06-01

Study Completion Date

2030-11-30

Brief Summary

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Older women (≥65 years) with HR+ non-metastatic breast cancer experience high symptom burden and reduced quality of life during aromatase inhibitor (AI) therapy. This hierarchical 2×2 factorial randomized controlled trial will test two interventions: (1) a clinic-level geriatric oncology assessment and support program (GOAL-AI) and (2) a patient-level CBT-based coping skills training (CST-AI). The study aims to improve pain, symptom burden, and health-related quality of life compared to enhanced usual care.

Detailed Description

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Conditions

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Breast Cancer, Hormone Receptor Positive, Aromatase Inhibitor-Associated Arthralgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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GOAL-AI + CST-AI

Combination of clinic-level geriatric assessment and CBT-based coping skills training.

Group Type EXPERIMENTAL

GOAL-AI

Intervention Type BEHAVIORAL

Clinic-level geriatric assessment and support program.

CST-AI

Intervention Type BEHAVIORAL

CBT-based coping skills training via telehealth.

GOAL-AI alone

Clinic-level geriatric assessment and support only.

Group Type EXPERIMENTAL

GOAL-AI

Intervention Type BEHAVIORAL

Clinic-level geriatric assessment and support program.

CST-AI alone

CBT-based coping skills training only.

Group Type EXPERIMENTAL

CST-AI

Intervention Type BEHAVIORAL

CBT-based coping skills training via telehealth.

Enhanced Usual Care

Standard care with educational materials.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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GOAL-AI

Clinic-level geriatric assessment and support program.

Intervention Type BEHAVIORAL

CST-AI

CBT-based coping skills training via telehealth.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Female, age ≥65 years
* HR+ non-metastatic breast cancer
* Within 12 months of starting AI therapy
* English-speaking
* Able to provide consent

Exclusion Criteria

* Age \<65 years
* Metastatic cancer
* Cognitive impairment preventing consent
* Receiving care at multiple participating sites
Minimum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rebecca Shelby, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Central Contacts

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Smrithi Divakaran, MBBS, MSPH

Role: CONTACT

919-681-7695

Michael W Willis, BA

Role: CONTACT

919-681-8437

Other Identifiers

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Pro00118528

Identifier Type: -

Identifier Source: org_study_id

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