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

NCT03258892 | Completed DMC

• 2 other identifiers: OSU-16301NCI-2017-01277
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Patient satisfaction with Sarcoma Treatment Guide (STG) as measured by participant survey and tracking telephone calls

  Up to 1 year

• Sarcoma Treatment Guide (STG) benefit in patients who have undergone chemotherapy as measured by participant survey and tracking telephone calls

  Up to 1 year

Study Arms (2)

Arm A (STG pre-chemotherapy)

EXPERIMENTAL

Patients receive the STG before completing 4 courses of standard of care chemotherapy.

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.

Other: Educational Intervention; Other: Quality-of-Life Assessment; Other: Survey Administration

Interventions

Educational Intervention OTHER

Receive STG

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Arm A (STG pre-chemotherapy); Arm B (STG post-chemotherapy initiation)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm A (STG pre-chemotherapy); Arm B (STG post-chemotherapy initiation)

Survey Administration OTHER

Ancillary studies

Arm A (STG pre-chemotherapy); Arm B (STG post-chemotherapy initiation)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be able to read, write, and understand English
• Sarcoma clinic patient
• About to begin either oral or cytotoxic chemotherapy

You may not qualify if:

• Received previous chemotherapy

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• 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.

  PMID: 34559571 DERIVED

Related Links

• The Jamesline

MeSH Terms

Conditions

Sarcoma

Interventions

Early Intervention, Educational; Educational Status; Methods

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques

Study Officials

• James Chen, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 17, 2017
• First Posted: August 23, 2017
• Study Start: May 16, 2017
• Primary Completion: June 5, 2019
• Study Completion: December 15, 2020
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)