Breast Cancer, Hormone Receptor Positive, Aromatase Inhibitor-Associated ArthralgiaGOAL-AINCT07232056
Geriatric Oncology Assessment and Coping Skills Training for Older Women on Aromatase Inhibitor Therapy
A study testing GOAL-AI and CST-AI in people with Breast Cancer, Hormone Receptor Positive, Aromatase Inhibitor-Associated Arthralgia, run by Duke University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Breast Cancer, Hormone Receptor Positive, Aromatase Inhibitor-Associated Arthralgia
- What is being tested?
- GOAL-AI and CST-AI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 452 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to 30 Nov 2030
- 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
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- Female, age ≥65 years
- HR+ non-metastatic breast cancer
- Within 12 months of starting AI therapy
- English-speaking
- Able to provide consent
Who cannot join
- Age <65 years
- Metastatic cancer
- Cognitive impairment preventing consent
- Receiving care at multiple participating sites
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Geriatric Oncology Assessment to Link With Support for Older Women Taking Adjuvant 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.
- Being tested
- GOAL-AI, CST-AI
- Keywords
- Breast Neoplasms, Geriatric Oncology, Aromatase Inhibitors
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GOAL-AIBehavioural
Clinic-level geriatric assessment and support program.
CST-AIBehavioural
CBT-based coping skills training via telehealth.
| Study group | Role | What they receive |
|---|---|---|
| GOAL-AI + CST-AI | Experimental | Combination of clinic-level geriatric assessment and CBT-based coping skills training. Receives: Behavioral: GOAL-AI; Behavioral: CST-AI |
| GOAL-AI alone | Experimental | Clinic-level geriatric assessment and support only. Receives: Behavioral: GOAL-AI |
| CST-AI alone | Experimental | CBT-based coping skills training only. Receives: Behavioral: CST-AI |
| Enhanced Usual Care | No intervention | Standard care with educational materials. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain severity and interference as measured by the Brief Pain Inventory - Short Form
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.
Measured: Baseline, 6 months, 12 months
Secondary outcomes (3)
Change in emotional distress, as measured by the PROMIS® Anxiety and Depression 4-item Short Forms
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.
Measured: Baseline, 6 months, 12 months
Change in fatigue, as measured by the PROMIS® Fatigue 6-item Short Form
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.
Measured: Baseline, 6 months, 12 months
Change in physical function, as measured by the Five Times Sit to Stand Test (5xSST)
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.
Measured: Baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study startDec 2026 (estimated)
- Primary completion30 Nov 2030 (estimated)
- Study completion30 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer, Hormone Receptor Positive, Aromatase Inhibitor-Associated ArthralgiaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 452 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Rebecca Shelby, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07232056
- Sponsor's protocol ID
- Pro00118528
- Acronym
- GOAL-AI
- Status last verified
- Nov 2026
- First submitted
- 14 Nov 2025
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The following data will be preserved and shared: patient-reported data from study assessments, healthcare utilization data collected from the health record, AI adherence data collected via self-report and from the health record, physical function and geriatric assessment data collected by study staff in clinic and from the health record, and socio-demographic and medical data collected via patient report and health record.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Geriatric Oncology Assessment to Link With Support for Older Women Taking Adjuvant Aromatase Inhibitor Therapy
- ClinicalTrials.gov ID
- NCT07232056
- Acronym / sponsor ID
- GOAL-AI / Pro00118528
- Keywords
- Breast Neoplasms, Geriatric Oncology, Aromatase Inhibitors
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 452 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2026 (estimated)
- Primary completion
- 30 Nov 2030 (estimated)
- Study completion
- 30 Nov 2030 (estimated)
- First posted
- 18 Nov 2025 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GOAL-AI + CST-AI | Experimental | Behavioral: GOAL-AI, Behavioral: CST-AICombination of clinic-level geriatric assessment and CBT-based coping skills training. |
| GOAL-AI alone | Experimental | Behavioral: GOAL-AIClinic-level geriatric assessment and support only. |
| CST-AI alone | Experimental | Behavioral: CST-AICBT-based coping skills training only. |
| Enhanced Usual Care | No intervention | –Standard care with educational materials. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Female, age ≥65 years
- HR+ non-metastatic breast cancer
- Within 12 months of starting AI therapy
- English-speaking
- Able to provide consent
Key exclusion criteria (4 listed)
- Age <65 years
- Metastatic cancer
- Cognitive impairment preventing consent
- Receiving care at multiple participating sites
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 |
|---|---|---|
| GOAL-AIClinic-level geriatric assessment and support program. | Behavioural | GOAL-AI + CST-AI, GOAL-AI alone |
| CST-AICBT-based coping skills training via telehealth. | Behavioural | CST-AI alone, GOAL-AI + CST-AI |
Primary outcome
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.
3 secondary outcomes
Change in emotional distress, as measured by the PROMIS® Anxiety and Depression 4-item Short Forms
Time frame: Baseline, 6 months, 12 months
Change in fatigue, as measured by the PROMIS® Fatigue 6-item Short Form
Time frame: Baseline, 6 months, 12 months
Change in physical function, as measured by the Five Times Sit to Stand Test (5xSST)
Time frame: Baseline, 6 months, 12 months
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 6 Nov 2026.
- Individual participant dataSharing planned: Yes. The following data will be preserved and shared: patient-reported data from study assessments, healthcare utilization data collected from the health record, AI adherence data collected via self-report and from the health record, physical function and geriatric assessment data collected by study staff in clinic and from the health record, and socio-demographic and medical data collected via patient report and health record.
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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.
Rebecca Shelby, PhD principal investigator
Duke University
Questions about this trial
What is this clinical trial studying?
A study testing GOAL-AI and CST-AI in people with Breast Cancer, Hormone Receptor Positive, Aromatase Inhibitor-Associated Arthralgia, run by Duke University.
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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Smrithi Divakaran, MBBS, MSPH (919-681-7695, smrithi.divakaran@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain severity and interference as measured by the Brief Pain Inventory - Short Form (time frame: Baseline, 6 months, 12 months). 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 6 Nov 2026.