NCT05715255 Adaptive Symptom Self-Management Immunotherapy Study
| NCT ID | NCT05715255 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Arizona |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2023-05-08 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 400 participants in total. It began in 2023-05-08 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The use of immune checkpoint inhibitors (ICIs), alone or in combination with other cancer treatments is increasing dramatically with immune-related adverse events (irAEs) common (90%) during ICI treatment. Most irAEs are symptomatic and symptom self-management with timely reporting of moderate or severe symptoms to health care providers (HCPs) may reduce irAE severity by early recognition and management, resulting in fewer treatment interruptions and unscheduled health services.
Eligibility Criteria
Inclusion Criteria: * Age 18 or older * Within 12 weeks after starting ICI treatment for cancer * Cognitively oriented to person, place and time (determined by recruiter) * Able to speak and understand English or Spanish * Access to a telephone * Severity score of 1 (mild) or higher on at least 1 of the 3 indicators of psychological distress from the PRO-CTCAE (i.e., the three items of anxious, discouraged, sad) library Exclusion Criteria: * Currently receiving regular behavioral counseling
Contact & Investigator
Terry Badger, PhD
PRINCIPAL INVESTIGATOR
University of Arizona
Frequently Asked Questions
Who can join the NCT05715255 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05715255 currently recruiting?
Yes, NCT05715255 is actively recruiting participants. Contact the research team at mcbarry@arizona.edu for enrollment information.
Where is the NCT05715255 trial being conducted?
This trial is being conducted at Phoenix, United States, Tucson, United States, Ann Arbor, United States.
Who is sponsoring the NCT05715255 clinical trial?
NCT05715255 is sponsored by University of Arizona. The principal investigator is Terry Badger, PhD at University of Arizona. The trial plans to enroll 400 participants.
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