Childhood Sarcoma of Soft Tissue, Sarcoma
Conditions
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.
Detailed description
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.
Interventions
Non intervention study
Sponsors
Roswell Park Cancer Institute
University at Buffalo
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of recruitment | Up to 12 months | Feasibility of recruitment will be based on number eligible per medical record |
| Feasibility of assessment | Up to 12 months | will be indexed by number completing 80% of EMA assessments |
| Reasons for nonparticipation | UP to 12 months | Semi structured qualitive interviews will focus on factors that influenced participation |
| Acceptability of EMA Study Design | Up to 12 months | self-reported difficulty of participating in daily EMA surveys (0-19) . |
| Acceptability of EMA Design | 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. |
Countries
United States
Contacts
CONTACTAndrew Rogers
PRINCIPAL_INVESTIGATORAndrew Rogers
Roswell Park
Outcome results
None listed