Adaptive Symptom Self-Management Immunotherapy Study

Trial Title: Adaptive Symptom Self-Management Immunotherapy Study

NCT ID: NCT05715255

Condition: Breast Cancer
Colon Cancer
Lung Cancer
Skin Cancer
Rectum Cancer

Conditions: Official terms:
Rectal Neoplasms

Conditions: Keywords:
Cancer
Cancer Survivors
Immunotherapy
Immune Checkpoint Inhibitors
Symptom Management
Psychosocial Oncology
Telephone Intervention

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Sequential Assignment

Primary purpose: Supportive Care

Masking: Double (Care Provider, Outcomes Assessor)

Intervention:

Intervention type: Behavioral
Intervention name: Automated Telephone Symptom Management (ATMS) and Telephone Interpersonal Counseling (TIP-C)
Description: 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.
Arm group label: Adaptive Intervention

Intervention type: Behavioral
Intervention name: Active control comparator
Description: 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.
Arm group label: Active Control

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.

Detailed description: Using a sequential multiple assignment randomized trial (SMART) design, the study team will initially randomize 286 diverse survivors (30% Hispanic) who are within 12 weeks of starting ICIs and who also have elevated psychological distress to an Automated Telephone Symptom Management (ATSM) or to an active control condition. ATSM consists of weekly telephone symptom monitoring using the Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) items by an automated voice response technology. Participants are referred to a printed Handbook with information about symptoms, evidence-based self-management strategies, and when to report symptoms to HCPs. ATSM automatically sends a weekly symptom summary to HCPs. Active control survivors will receive automated symptom monitoring only with reports sent to HCPs. Survivors in ATSM whose psychological distress is still elevated for 2 consecutive weeks during weeks 2-8 (nonresponders) will be randomized for the second time to add TIPC for 8 weeks or continue with ATSM alone. The study team hypothesizes adding TIPC will improve self-efficacy for symptom self-management, including communication with HCPs and increase social support resulting in lower indices of psychological distress, other PRO-CTCAE symptoms, clinician-documented irAES (primary outcomes), and unscheduled health services use and ICI treatment interruptions (secondary outcomes). With total intervention time of 16 weeks, all survivors will be interviewed at baseline and week 17 post-intervention, and electronic health record data will be extracted for the participation period. Specific aims: Aim 1. Determine if primary and secondary outcomes over weeks 1-17 are lower (better) in the group created by the first randomization: the adaptive intervention that begins with ATSM with the need-based addition of TIPC vs. active control group. Aim 2. Among those not responding to ATSM on psychological distress during weeks 2-8 who enter the second randomization, determine: a) if primary and secondary outcomes over weeks 8-17 are lower (better) in TIPC+ATSM vs. ATSM alone group; b) the extent to which the effects of adding TIPC to ATSM on primary and secondary outcomes are mediated by increased social support, self-efficacy for symptom management and for communication with HCP. Aim 3. Explore which baseline characteristics of the survivor, cancer, and cancer treatment are associated with optimal primary and secondary outcomes resulting from three supportive care options: 1) symptom monitoring only with automated reports to HCPs (active control); 2) ATSM alone for 16 weeks; or 3) addition of 8 weeks of TIPC to ATSM if no response on psychological distress during weeks 2-8.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University of Arizona Cancer Center

Address:
City: Tucson
Zip: 85724
Country: United States

Status: Recruiting

Contact:
Last name: Molly Hadeed

Phone: 520-626-0583
Email: mcbarry@arizona.edu

Contact backup:
Last name: UACC IIT
Email: UACC-IIT@uacc.arizona.edu

Investigator:
Last name: Terry Badger, PhD
Email: Principal Investigator

Facility:
Name: University of Michigan

Address:
City: Ann Arbor
Zip: 48109
Country: United States

Status: Recruiting

Contact:
Last name: Samantha Holmes

Phone: 734-998-4425
Email: samhol@med.umich.edu

Investigator:
Last name: John Krauss, MD
Email: Principal Investigator

Start date: May 8, 2023

Completion date: April 30, 2027

Lead sponsor:
Agency: University of Arizona
Agency class: Other

Collaborator:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Source: University of Arizona

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05715255