Adaptive Symptom Self-Management Immunotherapy Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Arizona
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Currently receiving regular behavioral counseling
Trial design
Design model
Sequential
Treatments tested in this trial
Automated Telephone Symptom Management (ATMS) and Telephone Interpersonal Counseling (TIP-C)
BehavioralParticipants 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
BehavioralSurvivors 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.
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: Adaptive InterventionExperimental treatment 1 intervention
Group B: Active ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in patient reported psychological distress in Interviews.
Patient Reported Outcomes Measurement Information System (PROMIS) has been developed using sophisticated measurement techniques, tested with over 21,000 individuals, calibrated to produce t-scores based on the general population and are available in either English or Spanish. The available short forms have evidence of good reliability and validity. PROMIS-short form 8 for depression and anxiety will be administered at baseline and 17-week telephone interviews to provide greater detail and precision in the measurement of severity of these symptoms, as compared to three PRO-CTCAE items (anxious, discouraged, sad). Each question is rated on a five-point scale from 1=Never to 5=Always. A higher score indicates higher anxiety or depression.The study team chose 8-item short forms to minimize respondent burden while maintaining measurement precision.
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.2
Change in reported PRO-CTCAE Symptoms
Psychological distress and other symptoms will be measured weekly using PRO-CTCAE severity items at weeks 0-17. Severity is rated 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe. The 3 items reflecting psychological distress are anxious, discouraged, and sad. Other items relevant to ICI treatment were selected from the PRO-CTCAE library for a total of 23 items (e.g., nausea, vomiting, constipation, diarrhea, swelling, rash, increased sweating, heart palpitations, etc.). In addition to PRO-CTCAE, the study team will use data on the grades of irAEs documented by clinicians in the HER. Each of 3 item sets, the three PRO-CTCAE items of psychological distress, 23 other PRO-CTCAE items, and clinician documented irAEs will be summarized into three toxicity indices (TIs). All grades of the included items will be ordered from highest to lowest, and the weighted sum will be calculated.
Time frame
PRO-CTCAE will be administered weekly at baseline (week 0) through week 17.Secondary outcomes
1
Change in cancer treatment interruptions
Cancer treatment interruptions (dose reductions and stoppages) along with their dates will be extracted from EHRs and summarized as the number and duration of temporary stoppages and dose reductions, and whether or not a premature permanent or temporary stoppage of the ICI occurred during the 17-week study period.
Time frame
Cancer treatment interruptions will be measured after the final week 17 follow-up and take into account the participant's time on study (consent date through week 17 interview date).2
Change in unscheduled health care visits
Unscheduled health care visits, hospitalizations and emergency department visits will be summarized as the number of events and number of days spent in the hospital if admitted.
Time frame
Unscheduled health care visits will be measured at baseline and week 17.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Arizona
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov