Validation of the Screen of Cancer Survivorship - Occupational Therapy Services (SOCS-OTS) Tool for Use in a Physical Medicine Rehabilitation Clinic

Cancer Clinical Trial

Official title:

Validation of the Screen of Cancer Survivorship - Occupational Therapy Services (SOCS-OTS) Tool for Use in a Physical Medicine Rehabilitation Clinic

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06329531
• Other study ID #: 2022-0992
• Secondary ID: NCI-2024-02555
• Status: Not yet recruiting
• Start date: April 15, 2024
• Est. completion date: April 22, 2025

Study information

• Verified date: March 2024
• Source: M.D. Anderson Cancer Center
• Contact: Ekta Gupta, MD
• Phone: (713) 745-2327
• Email: egupta[@]mdanderson.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To compare the results of the SOCS-OTS to another standardized screening measure that is currently being used by rehabilitation services at MD Anderson Cancer Center and to ensure that the SOCS-OTS correctly identifies those individuals needing OT services in cancer care.

Description:

Primary Aim

1. Explore the SOCS-OTS for use in the Physical Medicine and Rehabilitation (PM&R) clinic by means of diagnostic testing including sensitivity and specificity.

Secondary Aims

1. Explore whether the SOCS-OTS identifies the likelihood that the presence or absence of OT referral is correctly predicted. To accomplish this, the likelihood ratios, and predictive values of the SOCS-OTS will be assessed.

2. Determine associations between the need for OT and demographic factors such as stage of cancer, cancer treatment etc.

3. Establish test-retest reliability of the SOCS-OTS.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: April 22, 2025
• Est. primary completion date: April 22, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Must be 18 years an older

2. Currently medically followed in the PMR clinic (with or without acute disease)

3. Must speak and read English. The AM-PAC is currently validated in adults only. Additionally, the assessment tools are in English without translation into other languages, therefore only clients who do speak and read English will be included. Pregnant participants are not excluded.

Exclusion Criteria:

1. Potential participants with confusion and cognitive impairments that might hinder their ability to sign an informed consent form or participate in the study.

Related Conditions & MeSH terms

• Cancer
• Occupational Therapy

Intervention

Other:
• Screen of Cancer Survivorship - Occupational Therapy Services (SOCS-OTS)
Given by Questionnaire

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and adverse events (AEs)	Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)	Through study completion; an average of 1 year.

External Links

•   MD Anderson Cancer Center