SarcomaNCT03258892
Sarcoma Treatment Guide in Improving Self-Monitoring in Patients With Sarcoma Receiving Chemotherapy
A study testing Educational Intervention, Quality-of-Life Assessment and Survey Administration in people with Sarcoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This randomized pilot clinical trial studies how well the Sarcoma Treatment Guide works in improving self-monitoring in patients with sarcoma who are receiving chemotherapy. The Sarcoma Treatment Guide may help patients with sarcoma to be better informed, become more engaged with care, encourage communication, and to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma
- What is being tested?
- Educational Intervention, Quality-of-Life Assessment and Survey Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2017to 15 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be able to read, write, and understand English
- Sarcoma clinic patient
- About to begin either oral or cytotoxic chemotherapy
Who cannot join
- Received previous chemotherapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: Sarcoma Treatment Guide Pilot Study
This randomized pilot clinical trial studies how well the Sarcoma Treatment Guide works in improving self-monitoring in patients with sarcoma who are receiving chemotherapy. The Sarcoma Treatment Guide may help patients with sarcoma to be better informed, become more engaged with care, encourage communication, and to better manage side effects associated with chemotherapy treatments in order to improve quality of life.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate whether symptom management and communication are improved in patients who are chemotherapy naive who receive a Sarcoma Treatment Guide as compared to those that have not.
SECONDARY OBJECTIVES:
- To explore whether patients who have previously undergone chemotherapy benefit from a Sarcoma Treatment Guide (STG) in regard to symptom management and have improved communication between patient and providers.
II. To assess patient satisfaction with using the STG at the end of the trial.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive the STG before completing 4 courses of standard of care chemotherapy.
ARM B: Patients complete 2 courses of standard of care chemotherapy and then receive the STG before completing 2 additional courses of standard of care chemotherapy.
- Conditions
- Sarcoma
- Being tested
- Educational Intervention, Quality-of-Life Assessment, Survey Administration
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive STG
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm A (STG pre-chemotherapy) | Experimental | Patients receive the STG before completing 4 courses of standard of care chemotherapy. Receives: Other: Educational Intervention; Other: Quality-of-Life Assessment; Other: Survey Administration |
| Arm B (STG post-chemotherapy initiation) | Experimental | Patients complete 2 courses of standard of care chemotherapy and then receive the STG before completing 2 additional courses of standard of care chemotherapy. Receives: Other: Educational Intervention; Other: Quality-of-Life Assessment; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom management and communication improvement in chemotherapy naive patients as measured by participant survey and tracking telephone calls
Will keep notes of qualitative feedback provided by participants regarding the Sarcoma Treatment Guide (STG) obtained from the survey. Notes will be reviewed to identify common themes that will be considered when making revisions to the STG to be used by chemotherapy patients in the Sarcoma Clinic. Telephone calls will be calculated for each participant associated with symptoms such as nausea, vomiting, diarrhea, constipation, and pain. The calls will be logged to track quantity, reason and outcome of all participants. Symptoms ratings self-reported by patients will be tracked using the Numeri
Measured: Up to 1 year
Secondary outcomes (2)
Patient satisfaction with Sarcoma Treatment Guide (STG) as measured by participant survey and tracking telephone calls
Will keep notes of qualitative feedback provided by participants regarding the STG obtained from the survey. Notes will be reviewed to identify common themes that will be considered when making revisions to the STG to be used by chemotherapy patients in the Sarcoma Clinic. Telephone calls will be calculated for each participant associated with symptoms such as nausea, vomiting, diarrhea, constipation, and pain. The calls will be logged to track quantity, reason and outcome of all participants. Symptoms ratings self-reported by patients will be tracked using the NRS. Secondary analysis will inc
Measured: Up to 1 year
Sarcoma Treatment Guide (STG) benefit in patients who have undergone chemotherapy as measured by participant survey and tracking telephone calls
Will keep notes of qualitative feedback provided by participants regarding the STG obtained from the survey. Notes will be reviewed to identify common themes that will be considered when making revisions to the STG to be used by chemotherapy patients in the Sarcoma Clinic. Telephone calls will be calculated for each participant associated with symptoms such as nausea, vomiting, diarrhea, constipation, and pain. The calls will be logged to track quantity, reason and outcome of all participants. Symptoms ratings self-reported by patients will be tracked using the NRS (Numeric Ratings Scale). Secondary analysis will inc
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2017
- Study start16 May 2017
- Primary completion5 Jun 2019
- Study completion15 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Chen, Ohio State University Comprehensive Cancer Center
- Investigators
- James Chen, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03258892
- Sponsor's protocol ID
- OSU-16301
- Other IDs
- NCI-2017-01277
- Status last verified
- Sep 2022
- First submitted
- 17 Aug 2017
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Speece NJ, Xu M, Tinoco G, Liebner DA, Chen JL. Randomized Prospective Trial Exploring the Impact of Structured Journaling in Patients With Sarcoma on the Management of Treatment-Related Adverse Events. JCO Oncol Pract. 2022 Feb;18(2):e250-e260. doi: 10.1200/OP.21.00309. Epub 2021 Sep 24.
PubMed 34559571
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sarcoma Treatment Guide Pilot Study
- ClinicalTrials.gov ID
- NCT03258892
- Acronym / sponsor ID
- OSU-16301
- Conditions
- Sarcoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 16 May 2017 (actual)
- Primary completion
- 5 Jun 2019 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 23 Aug 2017 (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 randomized pilot clinical trial studies how well the Sarcoma Treatment Guide works in improving self-monitoring in patients with sarcoma who are receiving chemotherapy. The Sarcoma Treatment Guide may help patients with sarcoma to be better informed, become more engaged with care, encourage communication, and to better manage side effects associated with chemotherapy treatments in order to improve quality of life.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate whether symptom management and communication are improved in patients who are chemotherapy naive who receive a Sarcoma Treatment Guide as compared to those that have not.
SECONDARY OBJECTIVES:
- To explore whether patients who have previously undergone chemotherapy benefit from a Sarcoma Treatment Guide (STG) in regard to symptom management and have improved communication between patient and providers.
II. To assess patient satisfaction with using the STG at the end of the trial.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive the STG before completing 4 courses of standard of care chemotherapy.
ARM B: Patients complete 2 courses of standard of care chemotherapy and then receive the STG before completing 2 additional courses of standard of care chemotherapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (STG pre-chemotherapy) | Experimental | Other: Educational Intervention, Other: Quality-of-Life Assessment, Other: Survey AdministrationPatients receive the STG before completing 4 courses of standard of care chemotherapy. |
| Arm B (STG post-chemotherapy initiation) | Experimental | Other: Educational Intervention, Other: Quality-of-Life Assessment, Other: Survey AdministrationPatients complete 2 courses of standard of care chemotherapy and then receive the STG before completing 2 additional courses of standard of care chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Be able to read, write, and understand English
- Sarcoma clinic patient
- About to begin either oral or cytotoxic chemotherapy
Key exclusion criteria (1 listed)
- Received previous chemotherapy
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 |
|---|---|---|
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReceive STG | Other | Arm A (STG pre-chemotherapy), Arm B (STG post-chemotherapy initiation) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm A (STG pre-chemotherapy), Arm B (STG post-chemotherapy initiation) |
| Survey AdministrationAncillary studies | Other | Arm A (STG pre-chemotherapy), Arm B (STG post-chemotherapy initiation) |
Primary outcome
Symptom management and communication improvement in chemotherapy naive patients as measured by participant survey and tracking telephone calls
Time frame: Up to 1 year
Will keep notes of qualitative feedback provided by participants regarding the Sarcoma Treatment Guide (STG) obtained from the survey. Notes will be reviewed to identify common themes that will be considered when making revisions to the STG to be used by chemotherapy patients in the Sarcoma Clinic. Telephone calls will be calculated for each participant associated with symptoms such as nausea, vomiting, diarrhea, constipation, and pain. The calls will be logged to track quantity, reason and outcome of all participants. Symptoms ratings self-reported by patients will be tracked using the Numeri
2 secondary outcomes
Patient satisfaction with Sarcoma Treatment Guide (STG) as measured by participant survey and tracking telephone calls
Time frame: Up to 1 year
Sarcoma Treatment Guide (STG) benefit in patients who have undergone chemotherapy as measured by participant survey and tracking telephone calls
Time frame: Up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Derived from this study: PubMed 34559571Speece NJ, Xu M, Tinoco G, Liebner DA, Chen JL. Randomized Prospective Trial Exploring the Impact of Structured Journaling in Patients With Sarcoma on the Management of Treatment-Related Adverse Events. JCO Oncol Pract. 2022 Feb;18(2):e250-e260. doi: 10.1200/OP.21.00309. Epub 2021 Sep 24.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
James Chen, MD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention, Quality-of-Life Assessment and Survey Administration in people with Sarcoma, run by Ohio State University Comprehensive Cancer Center 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 28 Sep 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom management and communication improvement in chemotherapy naive patients as measured by participant survey and tracking telephone calls (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03258892, which also lists 1 linked publication.
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 28 Sep 2022.