Adaptive Symptom Self-Management Immunotherapy Study

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
University of Arizona
Study ID
NCT05715255
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Automated Telephone Symptom Management (ATMS) and Telephone Interpersonal Counseling (TIP-C) — BEHAVIORAL
    Participants randomized to the adaptive intervention are telephoned weekly and asked to enter by pin-pad or voice the severity of the PRO-CTCAE items on a 0-4 scale, with 0 being none and 4 being very severe. Participants are mailed the Symptom Management and Survivorship Handbook in their preferred language (English or Spanish). Survivors who rated any item at moderate or higher (2-4) will be referred by the ATSM to read the corresponding chapters in the Handbook and given a call back in 24 hours to inquire about the severity of the reported symptom, whether it has improved or worsened, and whether the participant reported it to their HCP, or the HCP has contacted the survivor. Participants that report elevated symptoms for two consecutive weeks are rerandomized to continue the ATSM alone or continue the ATSM with TIP-C added for 8 weeks. TIP-C is delivered by a masters prepared counselor with cancer expertise via weekly 30-minute phone calls using interpersonal techniques.
  • Active control comparator — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
May 8, 2023
Status verified
May 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Adaptive 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.
  • Active Comparator: Active Control
    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.

Primary Outcome Measure

Change in patient reported psychological distress in Interviews. [ Time Frame: 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. ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Valleywise Health Medical CenterPhoenixArizona85008-
University of Arizona Cancer CenterTucsonArizona85724
Molly Hadeed
[email protected]
520-626-0583
UACC IIT
[email protected]
Terry Badger, PhD (PRINCIPAL_INVESTIGATOR)
University of MichiganAnn ArborMichigan48109-

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