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Completed

NCT Number: NCT04339959

Remote Assessment of Physical Function

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.

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Key information

Conditions

Cancer Survivors

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remote Assessment of Physical Function with Direct Observation

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.

Remote Assessment of Physical Function

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.

Primary outcomes

  1. Validation - 30-second Chair Stand Test

    Time frame: 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.

  2. Validation - Timed Up & Go Test

    Time frame: 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 outcomes

  1. Reliability - Percentage of Participants Who Successfully Completed the Revised Protocol.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of New Mexico

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Remote Assessment of Physical Function in Older Cancer Survivors

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 9, 2020
Registry last updated
May 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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