Adaptive Symptom Self-Management Immunotherapy Study

BEHAVIORAL

Automated Telephone Symptom Management (ATMS) and Telephone Interpersonal Counseling (TIP-C)

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.

BEHAVIORAL

Active control comparator

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.

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.

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 Symptoms

Time frame: PRO-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.

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.