Pain patterns and opioid use in adolescent and young adult sarcoma survivors

Brief Title Mechanisms of Cancer-Related Pain and Opioid Use Among Adolescents and Young Adult Sarcoma Survivors: Pilot Feasibility Study

This project tests whether a 3-month smartphone-based daily survey can work for adolescents and young adult sarcoma survivors who have ongoing pain or use opioids.

Quick facts

• Study type: Observational
• Enrollment: 40 (estimated)
• Ages: 12 Years to 70 Years
• Sex: All
• Sponsor: Roswell Park Cancer Institute (other)
• Locations: 1 site (Buffalo, New York)
• Trial ID: NCT07402577 on ClinicalTrials.gov

What this trial studies

This is an observational pilot that asks eligible sarcoma survivors to complete baseline questionnaires, daily ecological momentary assessments (EMAs) via smartphone for three months, and a brief interview about the experience. The EMA protocol records real-time pain intensity, opioid use, and contextual factors multiple times per day. The study aims to measure feasibility and acceptability, quantify day-to-day variability in pain and opioid use, and explore links between biopsychosocial factors (for example, pain beliefs and worry) and pain/opioid outcomes. Findings will inform whether this approach can be used in larger studies or clinical monitoring.

Who should consider this trial

Good fit: Ideal candidates are sarcoma survivors who were aged 12–24 at diagnosis, are currently cancer-free and in survivorship care, report clinically meaningful pain (≥3/10), can attend an in-person baseline visit, and are willing to use an internet-capable smartphone for daily surveys for three months.

Not a fit: Patients currently receiving active cancer-directed therapy, those with significant cognitive impairment or who cannot read or speak English fluently, people without smartphone or internet access, and those with low pain (<3/10) are unlikely to receive benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could help clinicians track pain and opioid use more closely in AYA sarcoma survivors and support more personalized pain management and safer opioid use.

How similar studies have performed: EMA methods have been used successfully to track pain and opioid use in other chronic pain populations, but applying them specifically to adolescent and young adult sarcoma survivors is relatively novel.

Eligibility criteria

Inclusion Criteria:

* All genders between the ages of 12-24 (inclusive) at sarcoma diagnosis.
* Any age \< 70 at the time of study enrollment.
* No evidence of disease and/or enrolled in survivorship care.
* Clinically meaningful pain related to disease or its treatments at baseline (defined as 3 or greater on a 0-10 Numerical Rating Scale).
* Willing to attend the baseline appointment in person.
* Access to internet-capable smartphone.
* Access to internet on an occasional basis.
* Willing and able to complete Ecological Momentary Assessments (EMAs) on internet-capable smartphone for a 3-month period after enrollment.
* Ability to understand and provide informed consent/assent.

Exclusion Criteria:

* \* Currently receiving active cancer-directed therapy.

  * Unable to read or fluently speak English.
  * Determined by clinical staff to have preexisting or cancer-associated cognitive impairment that could interfere with study participation.
  * Acutely suicidal (e.g. intent or plan) or, with unstable medical or psychiatric condition verified by licensed study staff.
  * Characteristics related to inability to complete the study protocol.

Where this trial is running

Buffalo, New York

• Roswell Park Comprehensive Cancer Center — Buffalo, New York, United States (RECRUITING)

Study contacts

• Principal investigator: Andrew Rogers — Roswell Park
• Study coordinator: Andrew Rogers

Conditions: Sarcoma, Childhood Sarcoma of Soft Tissue