Cancer SurvivorsNCT04339959
Remote Assessment of Physical Function
An observational study of Cancer Survivors, run by University of New Mexico at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cancer Survivors
- What is being tested?
- Remote Assessment of Physical Function with Direct Observation and Remote Assessment of Physical Function
- Type of treatment
- Pill or oral medicine
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2019to 13 Nov 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Older cancer survivors
Who may be able to join
- 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.
Show all 12Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico
Albuquerque, New Mexico, 87131
About this study
Official title: Remote Assessment of Physical Function in Older Cancer Survivors
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.
Read the 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
- Being tested
- Remote Assessment of Physical Function with Direct Observation, Remote Assessment of Physical Function
- Keywords
- physical function, physical performance, video conferencing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Assessment of Physical Function with Direct ObservationOther
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 FunctionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Remote Assessment of Physical Function with Direct Observation | |
| 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. Receives: Other: Remote Assessment of Physical Function with Direct Observation | |
| 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. Receives: Other: Remote Assessment of Physical Function | |
| 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. Receives: Other: Remote Assessment of Physical Function |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
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.
Measured: 1 day
Secondary outcomes (1)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start20 Nov 2019
- Primary completion13 Nov 2021
- Study completion13 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer SurvivorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Cindy K Blair, PhD, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04339959
- Sponsor's protocol ID
- UNM HSC IRB 17-334
- Other IDs
- K07CA215937-02
- Status last verified
- May 2024
- First submitted
- 1 Apr 2020
- Last updated
- 24 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32769075
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Assessment of Physical Function in Older Cancer Survivors
- ClinicalTrials.gov ID
- NCT04339959
- Acronym / sponsor ID
- UNM HSC IRB 17-334
- Conditions
- Cancer Survivors
- Keywords
- physical function, physical performance, video conferencing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 13 Nov 2021 (actual)
- Study completion
- 13 Nov 2021 (actual)
- First posted
- 9 Apr 2020 (actual)
- Results
- Posted 6 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase I | – | Other: Remote Assessment of Physical Function with Direct ObservationFirst, 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 II | – | Other: Remote Assessment of Physical Function with Direct ObservationNext, 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 | – | Other: Remote Assessment of Physical FunctionThis 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. |
| Phase IV | – | Other: Remote Assessment of Physical FunctionThis 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Older cancer survivors
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote Assessment of Physical Function with Direct ObservationAn 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. | Other | Phase I, Phase II |
| Remote Assessment of Physical FunctionAn 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. | Other | Phase III, Phase IV |
Primary outcome
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.
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.
1 secondary outcome
Reliability - Percentage of Participants Who Successfully Completed the Revised Protocol.
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32769075Blair 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.
- Individual participant dataSharing planned: No
Related trials for Cancer Survivors
Recruiting
Developing a Scalable Tobacco Cessation Program for Cancer Survivors and Caregivers
Nicotine Use, Tobacco Use
Recruiting
Pilot SMART of a Remotely Delivered, Physical Activity Intervention for Breast Cancer Survivors
Breast Cancer
Active, not recruiting
Testing Counseling and Mobile Health Interventions to Improve Physical Activity and Diet Quality in Survivors of Childhood Cancer
Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
Active, not recruiting
Electroacupuncture for the Management of Symptom Clusters in Cancer Patients and Survivors
Cancer
Active, not recruiting
Dance Study for Post-surgical Pain in Breast Cancer Survivors
Breast Cancer, Survivorship
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cindy K Blair, PhD principal investigator
University of New Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Survivors, run by University of New Mexico at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation - 30-second Chair Stand Test (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04339959, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2024.