Remote Assessment of Physical Function

NCT ID: NCT04339959

Last Updated: 2024-05-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 33 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-20
• Study Completion Date: 2021-11-13

Brief 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.

Detailed 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.

Conditions

Cancer Survivors

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Phase I

First, we will test proof-of-concept that participants will be able to follow the testing protocol and use the tablet computer to communicate with the investigator (10-12 participants). The test protocol will be refined based on what is learned after a minimum of 10 participants. We anticipate no more than 12 participants needed for this phase.

Remote Assessment of Physical Function with Direct Observation

Intervention Type: OTHER

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.

Phase II

Next, 10-20 new participants will be enrolled to evaluate the validity of videoconference vs. face-to-face assessment (i.e., direct observation) of physical performance. Communication will occur between the remote assessor and the participant. The direct observer will not communicate directly to the participant, unless there is a safety issue. After completing 10 participants without a major change in the test protocol, we will proceed to the next phase.

Remote Assessment of Physical Function with Direct Observation

Intervention Type: OTHER

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.

Phase III

This phase involves participants repeating the test protocol, but without the face-to-face assessment (i.e., direct observation). This will test the ability of the participant to receive the box of test instructions and materials in the mail, unpack the box, communicate with the remote assessor via videoconferencing, pack up the box, and return it (postage paid) to the study team. This step will involve 5-10 participants from Phases 1 and 2, who have provided approval for future contact (see approved Future Contact form). Once 5 participants have successfully and safely completed the test protocol, we will proceed to Phase 4.

Remote Assessment of Physical Function

Intervention Type: OTHER

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.

Phase IV

This phase is the same as Phase 3, except it includes newly enrolled participants, i.e., representing the first-time participants have enrolled/participated in this study. This will eliminate the practice effect that will occur in phase 3. This step will enroll 5-10 participants.

Remote Assessment of Physical Function

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of New Mexico

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cindy K Blair, PhD

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico

Locations

University of New Mexico

Albuquerque, New Mexico, United States

Countries

United States

References

Blair CK, Harding E, Herman C, Boyce T, Demark-Wahnefried W, Davis S, Kinney AY, Pankratz VS. Remote Assessment of Functional Mobility and Strength in Older Cancer Survivors: Protocol for a Validity and Reliability Study. JMIR Res Protoc. 2020 Sep 1;9(9):e20834. doi: 10.2196/20834.

Reference Type: DERIVED

PMID: 32769075 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

K07CA215937-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UNM HSC IRB 17-334

Identifier Type: -

Identifier Source: org_study_id