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NCT06329531 Clinical Trial

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
Phase
First received
Last updated
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
Health authority
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.

Study Design

Related Conditions & MeSH terms

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.
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