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

Recruiting

• Conditions: Occupational Therapy; Cancer
• Interventions: Other: Screen of Cancer Survivorship - Occupational Therapy Services (SOCS-OTS)

• Registration Number: NCT06329531
• Lead Sponsor: M.D. Anderson Cancer Center

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-03-19
• Study First Submitted QC: 2024-03-19
• Study First Posted: 2024-03-26
• Study Start: 2024-07-12
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-01
• Primary Completion: 2027-12-01
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Screen of Cancer Survivorship - Occupational Therapy Services (SOCS-OTS)	Screen of Cancer Survivorship - Occupational Therapy Services (SOCS-OTS)	You will be asked to complete three questionnaires and a short interview about yourself and how well you are able to complete your daily tasks. The SOCS-OTS, which is a 20-item questionnaire.

Primary Outcome Measures

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

Trial Locations

Locations (1)

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States