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

No Placebo-Only Group

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.

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.

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in patient reported psychological distress in Interviews.

Change in reported PRO-CTCAE Symptoms

Secondary study objectives

Change in cancer treatment interruptions

Change in unscheduled health care visits

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

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