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

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ClinicalTrials.gov Identifier: NCT03258892
Recruitment Status : Recruiting
First Posted : August 23, 2017
Last Update Posted : August 23, 2017
Sponsor:
Information provided by (Responsible Party):
James Chen, Ohio State University Comprehensive Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Sarcoma Other: Educational Intervention Other: Quality-of-Life Assessment Other: Survey Administration Not Applicable

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Sarcoma Treatment Guide Pilot Study
Actual Study Start Date : May 16, 2017
Estimated Primary Completion Date : May 16, 2020
Estimated Study Completion Date : May 16, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm A (STG pre-chemotherapy)
Patients receive the STG before completing 4 courses of standard of care chemotherapy.
Other: Educational Intervention
Receive STG
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Survey Administration
Ancillary studies

Experimental: Arm B (STG post-chemotherapy initiation)
Patients complete 2 courses of standard of care chemotherapy and then receive the STG before completing 2 additional courses of standard of care chemotherapy.
Other: Educational Intervention
Receive STG
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Survey Administration
Ancillary studies




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Patient satisfaction with Sarcoma Treatment Guide (STG) 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 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

  2. 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 ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03258892


Contacts
Contact: The Ohio State University Comprehensive Cancer Center 800-293-5066 OSUCCCClinicaltrials@osumc.edu

Locations
United States, Ohio
Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210
Contact: James L. Chen, MD    614-293-0463    James.Chen@osumc.edu   
Principal Investigator: James L. Chen, MD         
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
Principal Investigator: James Chen, MD Ohio State University Comprehensive Cancer Center

Additional Information:
Responsible Party: James Chen, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03258892     History of Changes
Other Study ID Numbers: OSU-16301
NCI-2017-01277 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: August 23, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms