Breast CancerNCT05868746
An Observational Pilot Study to Test a Smartwatch-based EMA Method During Exercise With Breast Cancer Survivors
An observational study of Breast Cancer, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
The goal of this pilot study is to evaluate the feasibility and acceptability of collecting ecological momentary assessment data regarding feeling states during physical activity among a cohort of breast cancer survivors, using a novel smartwatch app created by the study team called "PHITbit." Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2023to 18 Jun 2024
- How long will I take part?
- 3 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients under the care of a Dartmouth Cancer Center oncology provider.
Who may be able to join
- Within 5 years of completing primary cancer treatment (surgery, chemotherapy, and radiation) for Stage 0-III breast cancer.
- Own an Android or iPhone smartphone and willing to use the smartphone to complete app-based surveys during the assessment period.
- Willing to wear the ActiGraph monitor during the assessment period.
- Willing to wear the study issued Fitbit Versa 3 smartwatch during the assessment period.
- Access to internet to complete REDCap survey assessments.
Who cannot join
- Non-English speaking/not able to read English.
- Evidence of major contraindications for exercise per the 2020 Physical Activity Readiness-Questionnaire (PAR-Q)+.
- Currently pregnant.
- History of severe mental illness or currently taking mood stabilizing medications (antipsychotics, anticonvulsants, or lithium).
- Evidence of moderate-severe depressive symptoms (indicated by a score ≥ 10 on Patient Health Questionnaire-8). -Evidence of moderate-severe cognitive impairment (indicated by a score < 3 on a 6- item cognitive screener).
- Evidence of clinically significant substance use as indicated by a score of ≥ 2 on the CAGE-AID screener.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Clinic
Lebanon, New Hampshire, 03756
About this study
Official title: Measuring Breast Cancer Survivor's Subjective Responses to Exercise Using a Novel, Smartwatch-based EMA Method: A Pilot Study
The goal of this pilot study is to evaluate the feasibility and acceptability of collecting ecological momentary assessment data regarding feeling states during physical activity among a cohort of breast cancer survivors, using a novel smartwatch app created by the study team called "PHITbit."
- Conditions
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of using a smartwatch-based ecological momentary assessment (EMA) method during exercise measured as the proportion of participants who use the data collection app and provided at least 3 responses to EMAs during a single exercise session.
The number of participants who use the smartwatch data collection app and respond to at least 3 EMAs during a single exercise session at least once during the 10-day data collection period out of the total number of participants enrolled at the end of the10-day data collection period.
Measured: 10 day data collection period
Acceptability of collecting during-exercise feeling state data using a smartwatch-based ecological momentary assessment method measured using the System Usability Scale.
The System Usability Scale (SUS) is a 10-item self-report scale used to measure perceived usability of a system, method, or tool. Responses on the SUS range from 1 = strongly disagree to 5 = strongly agree. Higher scores indicate greater acceptability.
Measured: End of study follow-up (post 10-day data collection period)
Acceptability of collecting during-exercise feeling state data using a smartwatch-based ecological momentary assessment method measured via a semi-structured interview.
Semi-structured interview to assess participants' perceptions regarding their experience using the smartwatch-based ecological momentary assessment method.
Measured: End of study follow-up (post 10-day data collection period)
Secondary outcomes (3)
Proportion of the sample with valid accelerometer data at the end of the 10-day data collection period.
The number of participants with valid accelerometer data out of the total number of participants in the sample during the 10-day data collection period.
Measured: 10 day data collection period
Rate of phone-based ecological momentary assessment (EMA) prompt completion.
The number of phone-based EMA survey prompts completed by participants during the 10-day data collection period out of the total number of phone-based EMA survey prompts delivered to participants.
Measured: 10 day data collection period
Rate of electronic daily dairy completion.
The number of electronic daily dairies completed by participants during the 10-day data collection period out of the total number of electronic daily dairies delivered to participants.
Measured: 10 day data collection period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start16 Jun 2023
- Primary completion18 Jun 2024
- Study completion18 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 27 participants (actual)
- Target duration
- 3 Weeks
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Principal investigator, Courtney J. Stevens, Dartmouth-Hitchcock Medical Center
- Investigators
- Courtney J Stevens, PhD, Principal investigator, Dartmouth-Hitchcock Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05868746
- Sponsor's protocol ID
- STUDY02000934_1B
- Other IDs
- IRG-21-136-36-IRG
- Status last verified
- Jun 2024
- First submitted
- 9 May 2023
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Breast Cancer Survivor's Subjective Responses to Exercise Using a Novel, Smartwatch-based EMA Method: A Pilot Study
- ClinicalTrials.gov ID
- NCT05868746
- Acronym / sponsor ID
- STUDY02000934_1B
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 16 Jun 2023 (actual)
- Primary completion
- 18 Jun 2024 (actual)
- Study completion
- 18 Jun 2024 (actual)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this pilot study is to evaluate the feasibility and acceptability of collecting ecological momentary assessment data regarding feeling states during physical activity among a cohort of breast cancer survivors, using a novel smartwatch app created by the study team called "PHITbit."
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Weeks
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients under the care of a Dartmouth Cancer Center oncology provider.
Key inclusion criteria (5 listed)
- Within 5 years of completing primary cancer treatment (surgery, chemotherapy, and radiation) for Stage 0-III breast cancer.
- Own an Android or iPhone smartphone and willing to use the smartphone to complete app-based surveys during the assessment period.
- Willing to wear the ActiGraph monitor during the assessment period.
- Willing to wear the study issued Fitbit Versa 3 smartwatch during the assessment period.
- Access to internet to complete REDCap survey assessments.
Key exclusion criteria (6 listed)
- Non-English speaking/not able to read English.
- Evidence of major contraindications for exercise per the 2020 Physical Activity Readiness-Questionnaire (PAR-Q)+.
- Currently pregnant.
- History of severe mental illness or currently taking mood stabilizing medications (antipsychotics, anticonvulsants, or lithium).
- Evidence of moderate-severe depressive symptoms (indicated by a score ≥ 10 on Patient Health Questionnaire-8). -Evidence of moderate-severe cognitive impairment (indicated by a score < 3 on a 6- item cognitive screener).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Feasibility of using a smartwatch-based ecological momentary assessment (EMA) method during exercise measured as the proportion of participants who use the data collection app and provided at least 3 responses to EMAs during a single exercise session.
Time frame: 10 day data collection period
The number of participants who use the smartwatch data collection app and respond to at least 3 EMAs during a single exercise session at least once during the 10-day data collection period out of the total number of participants enrolled at the end of the10-day data collection period.
Acceptability of collecting during-exercise feeling state data using a smartwatch-based ecological momentary assessment method measured using the System Usability Scale.
Time frame: End of study follow-up (post 10-day data collection period)
The System Usability Scale (SUS) is a 10-item self-report scale used to measure perceived usability of a system, method, or tool. Responses on the SUS range from 1 = strongly disagree to 5 = strongly agree. Higher scores indicate greater acceptability.
Acceptability of collecting during-exercise feeling state data using a smartwatch-based ecological momentary assessment method measured via a semi-structured interview.
Time frame: End of study follow-up (post 10-day data collection period)
Semi-structured interview to assess participants' perceptions regarding their experience using the smartwatch-based ecological momentary assessment method.
3 secondary outcomes
Proportion of the sample with valid accelerometer data at the end of the 10-day data collection period.
Time frame: 10 day data collection period
Rate of phone-based ecological momentary assessment (EMA) prompt completion.
Time frame: 10 day data collection period
Rate of electronic daily dairy completion.
Time frame: 10 day data collection period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- Individual participant dataSharing planned: No
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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.
Courtney J Stevens, PhD principal investigator
Dartmouth-Hitchcock Health
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 Breast Cancer, run by Dartmouth-Hitchcock Medical Center 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 5 inclusion and 6 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 28 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility of using a smartwatch-based ecological momentary assessment (EMA) method during exercise measured as the proportion of participants who use the data collection app and provided at least 3 responses to EMAs during a single exercise session. (time frame: 10 day data collection period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jun 2024.