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NCT Number: NCT07402577

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

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.

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Key information

Age range

12 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263, United States

Location status: Recruiting

Location contact

Andrew Rogers

CONTACT

[email protected]

176-845-2300

About this study

PRIMARY OBJECTIVES:

I. Evaluate the feasibility and acceptability of a 3-month EMA protocol in AYA sarcoma survivors.

II. Quantify variability in pain and opioid use over a 3-month period for AYA sarcoma survivors.

III. Identify associations between biopsychosocial mechanisms (e.g., pain beliefs, worry) and pain and opioid use outcomes.

OUTLINE: This is an observational study.

Patients complete baseline questionnaires, daily EMA surveys and an interview on study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

non intervention study

Other

Non intervention study

Primary outcomes

  1. Feasibility of recruitment

    Time frame: Up to 12 months

    Feasibility of recruitment will be based on number eligible per medical record

  2. Feasibility of assessment

    Time frame: Up to 12 months

    will be indexed by number completing 80% of EMA assessments

  3. Feasibility of recruitment

    Time frame: up to 12 months

    will be indexed by number attending baseline interview

  4. Feasibility of recruitment

    Time frame: Up to 12 months

    will be indexed by retention throughout EMA period

  5. Reasons for nonparticipation

    Time frame: UP to 12 months

    Semi structured qualitive interviews will focus on factors that influenced participation

  6. Acceptability of EMA Study Design

    Time frame: Up to 12 months

    self-reported difficulty of participating in daily EMA surveys (0-19) .

  7. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrew Rogers

CONTACT

[email protected]

1-800-767-9355

Sponsors and collaborators

Lead sponsor

Roswell Park Cancer Institute

Other

Collaborators

  • University at Buffalo

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Feb 11, 2026
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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