Remote Assessment of Physical Function

Cancer Survivors Clinical Trial

Official title:

Remote Assessment of Physical Function in Older Cancer Survivors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04339959
• Other study ID #: UNM HSC IRB 17-334
• Secondary ID: K07CA215937-02
• Status: Active, not recruiting
• Start date: November 20, 2019
• Est. completion date: March 30, 2024

Study information

• Verified date: February 2024
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary objective is to evaluate the validity and reliability of using videoconferencing to assess physical performance tests self-administered by older cancer survivors in their own homes. This remote assessment will be compared to the traditional face-to-face (i.e., in-person) assessment and to accelerometer data.

Description:

The ultimate goal of this research study is to develop a test protocol to allow older cancer survivors to self-administer physical performance tests in the survivor's own home, while an investigator remotely assesses the tests via videoconferencing. The test protocol includes written and video instructions and the test kit. To achieve this objective, the study will proceed with a series of phases. A similar concept of "saturation" will be applied, as is done in qualitative studies. In qualitative studies, the number of focus groups or interviews is based on the saturation point, i.e., the point at which no new information is learned. For the current study, each study phase will include a range in the number of participants enrolled. At the point at which no new information is being learned, i.e., no further adjustments are needed to the test protocol, the study will proceed to the next phase.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 33
• Est. completion date: March 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Residence in New Mexico
• Previous diagnosis of cancer, completed primary treatment (surgery, radiation, chemotherapy), and not currently being treated for a recurrence.
• Mild-to-moderate physical functional impairment (=2 functions limited a lot or limited a little on the Short Form 36-item Physical Function Subscale)
• Able to speak, read, & understand English
• Participating in less than 120 minutes per week of moderate-to-vigorous intensity physical activity
• Living independently and capable of walking 3 blocks without stopping to rest.
• Availability of a family member or friend to be present (for safety) during remote assessment of performance tests (Phases III and IV only)
• No severe impairments or pre-existing medical limitations for engaging in daily light-intensity physical activity (e.g., severe orthopedic conditions, pending hip/knee replacement, chronic vertigo, dementia)
• No severe hearing or vision deficits that would inhibit communication with the research team via videoconferencing and tablet use.
• Willing to use a tablet computer and videoconferencing software to communicate with a study team member during the assessment.
• Enough space (14 feet by 3 feet) to safely conduct the physical function tests.
• Not at high risk for falls

Related Conditions & MeSH terms

• Cancer Survivors

Intervention

Other:
• Remote Assessment of Physical Function with Direct Observation
An android tablet with Wi-Fi and cellular will be used to compare videoconferencing with face-to-face assessment of 2 timed, physical performance tests. The physical performance tests include the 30-second chair stand test (30s-CST) and the Timed Up & Go (TUG) test. The TUG test is measured as the time to stand from a standard arm chair, walk 10 feet, turn around, return to start and sit down. The 30s-CST is measured as the number of times a person comes to a full standing position from a chair in 30 seconds, as quickly as possible, without using ones' hands.
• Remote Assessment of Physical Function
An android tablet with Wi-Fi and cellular will be mailed to study participants to remotely assess 2 timed, physical performance tests. The physical performance tests include the 30-second chair stand test (30s-CST) and the Timed Up & Go (TUG) test. The TUG test is measured as the time to stand from a standard arm chair, walk 10 feet, turn around, return to start and sit down. The 30s-CST is measured as the number of times a person comes to a full standing position from a chair in 30 seconds, as quickly as possible, without using ones' hands.

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico

Sponsors (2)

Lead Sponsor	Collaborator
University of New Mexico	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validation - 30-second Chair Stand Test	Comparison of remote assessment to the traditional face-to-face (i.e., in-person; direct observer) assessment. Phase 2 will enroll 10-20 participants, depending on the point at which no new information is learned about the use of the toolkit (including instructions). Comparisons will be made between the direct observer and the remote assessor. The 30-second chair stand test involves standing up from a chair and sitting down as quickly and safely as possible, preferably without the use of upper extremity support. It is measured by the number of times a person comes to a full standing position from a chair in 30 seconds. The outcome is the difference in the number of chair stands counted between the direct observer and the remote assessor.	2-3 months
Primary	Validation - Timed Up & Go Test	Comparison of remote assessment to the traditional face-to-face (i.e., in-person; direct observer) assessment. Phase 2 will enroll 10-20 participants, depending on the point at which no new information is learned about the use of the toolkit (including instructions). The Timed Up & Go test involves standing up from a standard armchair, walking 10 feet, turning around (180° turn), and walking back to the chair and sitting down. Comparisons will be made between the direct observer and the remote assessor. The outcome is the difference in the number of seconds counted between the direct observer and the remote assessor.	2-3 months
Secondary	Reliability - Percentage of Participants Who Successfully Completed the Revised Protocol.	Test of whether a sample of participants from Phases I & II can repeat the test protocol 2-3 months later. This phase will enroll 5-10 participants. The outcome is subjective -- whether the participant could successfully receive the test kit, follow the instructions, communicate with the remote assessor, and perform the two measure of physical performance.	3 months