Clinical trial NCT04339959: Remote Assessment of Physical Function
Official title: Remote Assessment of Physical Function in Older Cancer Survivors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer Survivors
Keywords: physical function
physical performance
video conferencing
Lead sponsor: University of New Mexico
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-04-09
Enrollment: 33
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Older cancer survivors

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.

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

Primary outcomes:
measure: Validation - 30-second Chair Stand Test
timeFrame: 1 day
measure: Validation - Timed Up & Go Test
timeFrame: 1 day
Secondary outcomes:
measure: Reliability - Percentage of Participants Who Successfully Completed the Revised Protocol.
timeFrame: 3 months
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Cindy K Blair, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.