Recruiting

Observational Study

Sponsor:

Roswell Park Cancer Institute

Code:

NCT07402577

Conditions

Sarcoma

Childhood Sarcoma of Soft Tissue

Eligibility Criteria

Sex: All

Age: 12 - 70

Healthy Volunteers: Not accepted

Interventions

Non Intervention Study

Study Details

Brief summary:

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.

Conditions

Sarcoma

Childhood Sarcoma of Soft Tissue

Study ID

NCT07402577

Start date

Mar 30, 2026

Status verified date

Apr, 2026

Completion date

Feb 1, 2028

Anticipated

Primary completion date

Feb 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Interventions

Non Intervention Study

Non intervention study

Primary outcome measure

  • Feasibility of recruitment [ Time Frame: Up to 12 months ]
  • Feasibility of assessment [ Time Frame: Up to 12 months ]
  • Feasibility of recruitment [ Time Frame: up to 12 months ]
  • Feasibility of recruitment [ Time Frame: Up to 12 months ]
  • Reasons for nonparticipation [ Time Frame: UP to 12 months ]
  • Acceptability of EMA Study Design [ Time Frame: Up to 12 months ]
  • Acceptability of EMA Design [ Time Frame: Up to 12 months ]

Central Contacts and Locations

Locations

Roswell Park Comprehensive Cancer Center

Recruiting

Buffalo, New York, United States, 14263

Contacts

More Information

Sponsor

Roswell Park Cancer Institute

Last update posted

Apr 15, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Roswell Park Cancer Institute on 2026-04-15.