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NCT Number: NCT07232056

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

GOAL-AI

Behavioral

Clinic-level geriatric assessment and support program.

CST-AI

Behavioral

CBT-based coping skills training via telehealth.

Primary outcomes

  1. Change in pain severity and interference as measured by the Brief Pain Inventory - Short Form

    Time frame: Baseline, 6 months, 12 months

    The Brief Pain Inventory-Short Form (BPI-SF) will be used to assess pain severity and interference from pain across important life domains (e.g., general activity, work, relations with others). To calculate a pain severity score, the BPI-SF averages worst, least, average and current pain severity ratings on a 0 to 10 scale, with higher scores indicating more severe pain. To calculate a pain interference score, 7 items asking about interference from pain across different life domains will be averaged, with higher scores indicating higher pain interference.

Secondary outcomes

  1. Change in emotional distress, as measured by the PROMIS® Anxiety and Depression 4-item Short Forms

    Time frame: Baseline, 6 months, 12 months

    For the PROMIS® Anxiety and Depression 4-item Short Forms (4a, v1.0) items are summed to create a raw score from 4 to 20 that is converted to a T-score. Responses are on a 5-point scale from "never" (1) to "always" (5). Higher scores indicate higher emotional distress.

  2. Change in fatigue, as measured by the PROMIS® Fatigue 6-item Short Form

    Time frame: Baseline, 6 months, 12 months

    For the PROMIS® Fatigue 6-item Short Form (6a, v1.0) items are summed to create a raw score that is converted to a T-score. Participants are asked to think about the last week when responding to each item (e.g., "In the past 7 days, how run-down did you feel, on average?"), providing ratings on a scale from "not at all" (1) to "very much" (5). Sum scores may range from 6 to 30, with higher scores indicating higher fatigue.

  3. Change in physical function, as measured by the Five Times Sit to Stand Test (5xSST)

    Time frame: Baseline, 6 months, 12 months

    The Five Times Sit to Stand Test (5xSST) assesses functional lower extremity strength, balance, risk of fall, functional decline, and frailty. The amount of time it takes a patient to sit and stand five times in succession with arms folded across their chest is averaged across three trials.

Study contacts

Contact information is provided by the study sponsor or research team.

Michael W Willis, BA

CONTACT

[email protected]

919-681-8437

Smrithi Divakaran, MBBS, MSPH

CONTACT

[email protected]

919-681-7695

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Geriatric Oncology Assessment to Link With Support for Older Women Taking Adjuvant Aromatase Inhibitor Therapy

Acronym: GOAL-AI

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Nov 18, 2025
Registry last updated
Nov 18, 2025

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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