Remote Assessment of Physical Function

Completed

Conditions: Cancer Survivors

Interventions: Other: Remote Assessment of Physical Function with Direct Observation
Other: Remote Assessment of Physical Function

Registration Number: NCT04339959

Lead Sponsor: University of New Mexico

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 33

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

Exclusion Criteria

Not provided

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Phase I	Remote Assessment of Physical Function with Direct Observation	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.
Phase IV	Remote Assessment of Physical Function	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.
Phase II	Remote Assessment of Physical Function with Direct Observation	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.
Phase III	Remote Assessment of Physical Function	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.

Primary Outcome Measures

Name	Time	Method
Validation - 30-second Chair Stand Test	1 day	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.
Validation - Timed Up & Go Test	1 day	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.

Secondary Outcome Measures

Name	Time	Method
Reliability - Percentage of Participants Who Successfully Completed the Revised Protocol.	3 months	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.