Sarcoma Treatment Guide in Improving Self-Monitoring in Patients With Sarcoma Receiving Chemotherapy

Sarcoma Clinical Trial

Official title:

Sarcoma Treatment Guide Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03258892
• Other study ID #: OSU-16301
• Secondary ID: NCI-2017-01277
• Status: Completed
• Phase: N/A
• Start date: May 16, 2017
• Est. completion date: December 15, 2020

Study information

• Verified date: September 2022
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 better manage side effects associated with chemotherapy treatments in order to improve quality of life.

Description:

PRIMARY OBJECTIVES:

I. 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:

I. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 15, 2020
• Est. primary completion date: June 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Be able to read, write, and understand English

• Sarcoma clinic patient

• About to begin either oral or cytotoxic chemotherapy

Exclusion Criteria:

• Received previous chemotherapy

Related Conditions & MeSH terms

• Sarcoma

Intervention

Other:
• Educational Intervention
Receive STG
• Quality-of-Life Assessment
Ancillary studies
• Survey Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Up to 1 year
Secondary	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	Up to 1 year
Secondary	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	Up to 1 year

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