NCT07402577 · Roswell Park Cancer Institute
Brief Title Mechanisms of Cancer-Related Pain and Opioid Use Among Adolescents and Young Adult Sarcoma Survivors: Pilot Feasibility Study
What this study is about
This study generates information on the feasibility and acceptability of a 3-month ecological momentary assessment (EMA) protocol to assess chronic pain and opioid use in adolescent and young adult (AYA) sarcoma survivors.
View original scientific description
This study generates information on the feasibility and acceptability of a 3-month ecological momentary assessment (EMA) protocol to assess chronic pain and opioid use in adolescent and young adult (AYA) sarcoma survivors.
Interventions
OTHER
Non Intervention Study
Non intervention study
Primary outcome measures
Feasibility of recruitment
Time frame: Up to 12 months
Feasibility of recruitment will be based on number eligible per medical record
Feasibility of assessment
Time frame: Up to 12 months
will be indexed by number completing 80% of EMA assessments
Feasibility of recruitment
Time frame: up to 12 months
will be indexed by number attending baseline interview
Feasibility of recruitment
Time frame: Up to 12 months
will be indexed by retention throughout EMA period
Reasons for nonparticipation
Time frame: UP to 12 months
Semi structured qualitive interviews will focus on factors that influenced participation
Acceptability of EMA Study Design
Time frame: Up to 12 months
self-reported difficulty of participating in daily EMA surveys (0-19) .
Acceptability of EMA Design
Time frame: Up to 12 months
Acceptability of the protocol will be assessed by responses on the System Usability Scale - A 10 question scale from 1 to 5 with 1 being strongly disagree and 5 being strongly agree.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Buffalo, New York
Collaborators
University at Buffalo
Related conditions & keywords
Frequently asked questions
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.
Data: ClinicalTrials.gov · synced Apr 15, 2026 · Source of record for eligibility and locations