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Behavioral Intervention
Symptom Self-Management for Lung Cancer
N/A
Recruiting
Led By Terry Badger, PhD
Research Sponsored by University of Arizona
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up promis short form 8 for depression and anxiety will be administered at baseline (week 0) and again at week 17 as part of the final follow-up.
Awards & highlights
Study Summary
This trial found that timely reporting of cancer treatment side effects to HCPs can reduce severity, leading to fewer interruptions & fewer medical services.
Who is the study for?
This trial is for adults over 18 who have started treatment with immune checkpoint inhibitors (ICIs) for various cancers within the last 12 weeks. Participants must be able to communicate in English or Spanish, have access to a phone, and show mild psychological distress. Those already receiving regular behavioral counseling cannot join.Check my eligibility
What is being tested?
The study tests two support methods for managing symptoms during ICI cancer treatment: Automated Telephone Symptom Management (ATMS) and Telephone Interpersonal Counseling (TIP-C), compared against an active control group.See study design
What are the potential side effects?
While this trial focuses on symptom management rather than drug side effects, ICIs can cause immune-related adverse events like fatigue, skin reactions, digestive issues, hormonal changes, and inflammation of organs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ promis short form 8 for depression and anxiety will be administered at baseline (week 0) and again at week 17 as part of the final follow-up.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~promis short form 8 for depression and anxiety will be administered at baseline (week 0) and again at week 17 as part of the final follow-up.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in patient reported psychological distress in Interviews.
Change in reported PRO-CTCAE Symptoms
Secondary outcome measures
Change in cancer treatment interruptions
Change in unscheduled health care visits
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Adaptive InterventionExperimental Treatment1 Intervention
The adaptive intervention sequence is assumed to affect psychological distress (depression and anxiety) severity of other symptoms and irAEs, as tested in Aim 1. Both the Automated Telephone Symptom Management (ATSM) system and the Telephone Interpersonal Counseling (TIP-C) interventions help participants to identify and understand troublesome symptoms, with suggestions to effectively self-manage these symptoms. The proposed interventions are expected to alleviate burdensome symptoms through several key mediating variables, as tested in Aim 2.
Group II: Active ControlActive Control1 Intervention
Survivors in the active control will receive weekly AVR assessments of PROCTCAE symptoms, and summary of these assessments will be sent securely to HCPs. Survivors will not receive the Handbook and will not be prompted by the AVR to contact HCPs unless the symptoms are severe. An active control comparator was purposively selected to enable a more rigorous testing of intervention effectiveness in Aims 1 and 2. Also, the study team will be better able to address the question about which channel of communication (automated versus survivor initiated) results in better outcomes.
Find a Location
Who is running the clinical trial?
University of ArizonaLead Sponsor
515 Previous Clinical Trials
148,314 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,672 Previous Clinical Trials
40,926,041 Total Patients Enrolled
Terry Badger, PhDPrincipal InvestigatorUniversity of Arizona
2 Previous Clinical Trials
1,406 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I started immunotherapy for cancer less than 12 weeks ago.I am currently undergoing regular counseling sessions.I am mentally aware of who I am, where I am, and the current time.I can speak and understand English or Spanish.
Research Study Groups:
This trial has the following groups:- Group 1: Active Control
- Group 2: Adaptive Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are researchers currently recruiting participants for this investigation?
"According to records found on clinicaltrials.gov, this research endeavor is not currently looking for participants. It was first posted on May 1st 2023 and the last edit was made February 6th of that same year. Nevertheless, there are a plethora of other trials actively seeking volunteers at present with 2180 in total."
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