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

Study Overview
=================
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.

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.

Official Title
-----------------
Sarcoma Treatment Guide Pilot Study

Conditions
-----------------
Sarcoma

Intervention / Treatment
-----------------
* Other: Educational Intervention
* Other: Quality-of-Life Assessment
* Other: Survey Administration


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A (STG pre-chemotherapy)<br>Patients receive the STG before completing 4 courses of standard of care chemotherapy. | Other: Educational Intervention<br>* Receive STG<br>* Other names: Intervention, Educational;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Survey Administration<br>* Ancillary studies<br>|
| Experimental: Arm B (STG post-chemotherapy initiation)<br>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<br>* Receive STG<br>* Other names: Intervention, Educational;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Survey Administration<br>* Ancillary studies<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |