CancerNCT06329531
Validation of the Screen of Cancer Survivorship - Occupational Therapy Services (SOCS-OTS) Tool for Use in a Physical Medicine Rehabilitation Clinic
An observational study of Cancer and Occupational Therapy, run by M.D. Anderson Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Occupational Therapy
- What is being tested?
- Screen of Cancer Survivorship - Occupational Therapy Services (SOCS-OTS)
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2024to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cancer Participants
Who may be able to join
- Must be 18 years an older
- Currently medically followed in the PMR clinic (with or without acute disease)
- 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.
Who cannot join
- 1. Potential participants with confusion and cognitive impairments that might hinder their ability to sign an informed consent form or participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Ekta Gupta, MD, 713-745-2327, egupta@mdanderson.org
Ekta Gupta, MD
About this study
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.
Read the detailed description
Primary Aim
- 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
- 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.
- Determine associations between the need for OT and demographic factors such as stage of cancer, cancer treatment etc.
- Establish test-retest reliability of the SOCS-OTS.
- Conditions
- Cancer, Occupational Therapy
- Being tested
- Screen of Cancer Survivorship - Occupational Therapy Services (SOCS-OTS)
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screen of Cancer Survivorship - Occupational Therapy Services (SOCS-OTS)Other
Given by Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Screen of Cancer Survivorship - Occupational Therapy Services (SOCS-OTS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and adverse events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
Measured: Through study completion; an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start12 Jul 2024
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ekta Gupta, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06329531
- Sponsor's protocol ID
- 2022-0992
- Other IDs
- NCI-2024-02555
- Status last verified
- Oct 2026
- First submitted
- 19 Mar 2024
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Screen of Cancer Survivorship - Occupational Therapy Services (SOCS-OTS) Tool for Use in a Physical Medicine Rehabilitation Clinic
- ClinicalTrials.gov ID
- NCT06329531
- Acronym / sponsor ID
- 2022-0992
- Conditions
- Cancer, Occupational Therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 12 Jul 2024 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 26 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
- 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.
- Determine associations between the need for OT and demographic factors such as stage of cancer, cancer treatment etc.
- Establish test-retest reliability of the SOCS-OTS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screen of Cancer Survivorship - Occupational Therapy Services (SOCS-OTS) | – | Other: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer Participants
Key inclusion criteria (3 listed)
- Must be 18 years an older
- Currently medically followed in the PMR clinic (with or without acute disease)
- 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.
Key exclusion criteria (1 listed)
- 1. Potential participants with confusion and cognitive impairments that might hinder their ability to sign an informed consent form or participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screen of Cancer Survivorship - Occupational Therapy Services (SOCS-OTS)Given by Questionnaire | Other | Screen of Cancer Survivorship - Occupational Therapy Services (SOCS-OTS) |
Primary outcome
Safety and adverse events (AEs)
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ekta Gupta, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Occupational Therapy, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ekta Gupta, MD ((713) 745-2327, egupta@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and adverse events (AEs) (time frame: Through study completion; an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.