SarcomaNCT07402577
Brief Title Mechanisms of Cancer-Related Pain and Opioid Use Among Adolescents and Young Adult Sarcoma Survivors: Pilot Feasibility Study
An observational study of Sarcoma and Childhood Sarcoma of Soft Tissue, run by Roswell Park Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Sarcoma, Childhood Sarcoma of Soft Tissue
- What is being tested?
- Non Intervention Study
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2026to 1 Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients younger than 70 years old who were diagnosed with sarcoma between the ages of 12-24 and have no evidence of disease and/or are enrolled in survivorship care.
Who may be able to join
- 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.
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- 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.
Who cannot join
- * 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263
Andrew Rogers, 176-845-2300, andrew.rogers@roswellpark.org
About this 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Sarcoma, Childhood Sarcoma of Soft Tissue
- Being tested
- Non Intervention Study
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non Intervention StudyOther
Non intervention study
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of recruitment
Feasibility of recruitment will be based on number eligible per medical record
Measured: Up to 12 months
Feasibility of assessment
will be indexed by number completing 80% of EMA assessments
Measured: Up to 12 months
Feasibility of recruitment
will be indexed by number attending baseline interview
Measured: up to 12 months
Feasibility of recruitment
will be indexed by retention throughout EMA period
Measured: Up to 12 months
Reasons for nonparticipation
Semi structured qualitive interviews will focus on factors that influenced participation
Measured: UP to 12 months
Acceptability of EMA Study Design
self-reported difficulty of participating in daily EMA surveys (0-19) .
Measured: Up to 12 months
Acceptability of EMA Design
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.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start30 Mar 2026
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University at Buffalo
- Responsible party
- Sponsor
- Investigators
- Andrew Rogers, Principal investigator, Roswell Park
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07402577
- Sponsor's protocol ID
- I-4720925
- Status last verified
- Apr 2026
- First submitted
- 28 Jan 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Title Mechanisms of Cancer-Related Pain and Opioid Use Among Adolescents and Young Adult Sarcoma Survivors: Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT07402577
- Acronym / sponsor ID
- I-4720925
- Conditions
- Sarcoma, Childhood Sarcoma of Soft Tissue
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Collaborators
- University at Buffalo
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients younger than 70 years old who were diagnosed with sarcoma between the ages of 12-24 and have no evidence of disease and/or are enrolled in survivorship care.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (5 listed)
- * Currently receiving active cancer-directed therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non Intervention StudyNon intervention study | Other | – |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrew Rogers principal investigator
Roswell Park
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoma and Childhood Sarcoma of Soft Tissue, run by Roswell Park Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew Rogers (1-800-767-9355, Andrew.Rogers@roswellpark.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of recruitment (time frame: Up to 12 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.