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

The Ohio State University

Status: Completed

Conditions: Sarcoma

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03258892

NCI-2017-01277 (Registry Identifier)

OSU-16301

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Arm A (STG pre-chemotherapy)

Experimental group

Description:

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

Treatment:

Other: Quality-of-Life Assessment

Other: Survey Administration

Other: Educational Intervention

Arm B (STG post-chemotherapy initiation)

Experimental group

Description:

Patients complete 2 courses of standard of care chemotherapy and then receive the STG before completing 2 additional courses of standard of care chemotherapy.

Treatment:

Other: Quality-of-Life Assessment

Other: Survey Administration

Other: Educational Intervention