Adaptive Symptom Self-Management Immunotherapy Study for Cancer Patients
This study is for people with breast, colon, lung, skin, or rectum cancer who are starting treatment with immune checkpoint inhibitors (ICIs). ICIs are a type of immunotherapy that helps your immune system fight cancer. The study is testing two ways to help you manage symptoms: Automated Telephone Symptom Management (ATSM) and Telephone Interpersonal Counseling (TIP-C). ATSM involves weekly phone calls where you report your symptoms. Some participants will also receive a handbook with symptom management tips. The study aims to see if these methods can reduce psychological distress and improve how you manage symptoms. You can join if you are 18 or older, have started ICI treatment within the last 12 weeks, and have some psychological distress. The current status of this study is unclear.
- Study design
- This is an interventional study with a planned enrollment of 400 participants. It uses a sequential multiple assignment randomized trial (SMART) design, meaning participants may be randomized to different groups at different times.
- What's involved
- You will have weekly automated phone calls to report your symptoms for 17 weeks. If you are in the ATSM group, you will also receive a Symptom Management and Survivorship Handbook.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your psychological distress will be measured at the start of the study and again at week 17. Your symptoms will be measured weekly for 17 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Adaptive Symptom Self-Management Immunotherapy Study
At a glance
Conditions
Where it's being run
3 sites across 2 statesStudy leadership
- Terry Badger, PhD · PRINCIPAL_INVESTIGATOR · University of Arizona
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Change in patient reported psychological distress in Interviews.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.
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.
- Change in reported PRO-CTCAE SymptomsPRO-CTCAE will be administered weekly at baseline (week 0) through week 17.
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.