Breast CancerNCT03612596
Narrative Visualization for Breast Cancer Survivors' Physical Activity
A study testing Narrative visualization and Standard self-regulation in people with Breast Cancer, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
This study tests the feasibility and acceptability of a physical activity intervention that combines use of a wearable activity monitor with a scrapbook. Half of the participants will receive this enhanced intervention, while the other half will receive a wearable activity monitor with a standard step log. Read more about this study
- Who is it for?
- Ages 55 to 79 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Narrative visualization and Standard self-regulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 31 Mar 2022
- Phase
- Interventional
- 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 55 to 79 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 55 and 79 years
- Female
- Self-reported diagnosis of breast cancer
- BMI between 18 and 40 kg/m2
- Willingness to be randomized to any condition
- Participant is able to walk for exercise
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- Able to read and understand English
- Daily access to a smartphone or similar device compatible with Garmin app
- PAR-Q+ indicates that physical activity would be safe (with note from physician required if any heart-related questions are endorsed)
Who cannot join
- Participant is active (150 minutes or more activity per week)
- Major health interventions (surgery, radiation, chemo) within the past 6 months
- Stroke, hip fracture, hip or knee replacement, or spinal surgery in the past 6 months
- History of orthopedic complications that would prevent optimal participation
- No active recurrence of cancer
- Self-reported smoker
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- Reports psychological issues that would interfere with study completion (dementia, schizophrenia)
- Reports hospitalization within the past year due to psychiatric problem(s)
- Plans to be out of town for more than 2 weeks at a time during study period
- Clinical judgement concerning safety
- Currently participating in an organized commercial or research exercise program
- Another member of the household is a participant or staff member on this trial
- Current use of a wearable activity monitor
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Medical Branch
Galveston, Texas, 77550
About this study
This study tests the feasibility and acceptability of a physical activity intervention that combines use of a wearable activity monitor with a scrapbook. Half of the participants will receive this enhanced intervention, while the other half will receive a wearable activity monitor with a standard step log.
Read the detailed description
Women breast cancer survivors could benefit from increased physical activity but are in need of greater motivation to be active. Interventions that use wearable activity monitors and mobile apps have shown promise in the short-term, but use drops off over time. Reports have suggested that users find the step data provided to be unclear and not very personally meaningful. The ultimate purpose of this line of research is to test whether enhanced motivational feedback, using scrapbooks, can increase motivation for activity. The scrapbooks will target integrated regulation, which is a type of motivation related to personal identity and values. Participants who receive this intervention will draw their step graph, add photographs and stickers an explanations to the graph, and answer reflection questions daily. Before testing the effects of this intervention on physical activity, the investigators must first ensure that the materials and procedures are feasible and acceptable. This small pilot study will allow the research team to iteratively test scrapbook materials and improve upon them for use in future studies. The investigators will compare an intervention using the enhanced materials to an intervention using only the wearable device, app, and a standard step log without scrapbook or reflection components. In addition to the primary outcome of feasibility (use of the scrapbook), the investigators will also explore the effects of the intervention on steps, motivational and values-related outcomes, and various aspects of feasibility and acceptability.
- Conditions
- Breast Cancer
- Being tested
- Narrative visualization, Standard self-regulation
- Keywords
- wearable, mobile app, physical activity, survivorship, narrative, identity
- Medical subject headings
- Breast Neoplasms, Motor Activity, Narration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrative visualizationBehavioural
Participants use narrative visualization procedures to connect their step data to important events or feelings that occurred at the same time, then reflect on their behavior
Standard self-regulationBehavioural
Participants self-monitor steps using a wearable device, app, and a hand-written step log
| Study group | Role | What they receive |
|---|---|---|
| Narrative visualization | Experimental | Wearable activity monitor, app, and enhanced motivational scrapbook materials (instant camera, stickers, markers, enhanced content) Receives: Behavioral: Narrative visualization |
| Standard self-regulation | Active comparator | Wearable activity monitor, app, and standard workbook materials (markers, a workbook with a calendar log to keep track of steps over time) Receives: Behavioral: Standard self-regulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Daily Workbook Entries Completed
Percentage of daily workbook entries completed out of the total possible number, measured by photography of intervention materials at 12 week assessment and then assessment of each page.
Measured: 12 weeks
Secondary outcomes (13)
Physical Activity as Measured by Steps Per Day During Intervention Period
Mean of daily steps taken from accelerometers worn for 7 days
Measured: Change from 0 to 12 weeks
Physical Activity as Measured by Daily Steps During No-intervention Maintenance Period
Mean of steps per day taken from accelerometers worn for 7 days
Measured: Change from 12 to 24 weeks
Intrinsic Regulation
Self-reported intrinsic regulation on a scale from 0 (least motivated) to 4 (most motivated) using the Behavioral Regulation in Exercise Questionnaire - 3. Reported here are results from the intrinsic regulation subscale. Higher results on the scale indicate greater intrinsic regulation.
Measured: Change from 0 to 12 weeks
Integrated Regulation
Self-reported integrated regulation on a scale from 0 (least motivated) to 4 (most motivated) using the Behavioral Regulation in Exercise Questionnaire - 3. Here, results from the integrated regulation subscale are reported. Higher numbers on the scale indicate greater integrated regulation.
Measured: Change from 0 to 12 weeks
Basic Psychological Needs: Autonomy
Self-reported fulfillment of basic psychological needs on a scale from 1 (least fulfilled) to 5 (most fulfilled) using the Basic Psychological Needs in Exercise Questionnaire. The three subscales are perceived autonomy, competence, and relatedness. Here, autonomy is reported. A higher score means greater perceived autonomy.
Measured: Change from 0 to 12 weeks
Exercise Identity
Self-reported identity as an exerciser on a scale from 1 (strongly disagree) to 7 (strongly agree) as measured by the Exercise Identity Scale. The two subscales are exercise beliefs and exercise role identity. Here, exercise role identity is reported. A higher score means greater exercise role identity.
Measured: Change from 0 to 12 weeks
Basic Psychological Needs: Competence
Self-reported fulfillment of basic psychological needs on a scale from 1 (least fulfilled) to 5 (most fulfilled) using the Basic Psychological Needs in Exercise Questionnaire. The three subscales are perceived autonomy, competence, and relatedness. Here, competence is reported. A higher score means greater perceived competence.
Measured: 0 to 12 weeks
Basic Psychological Needs: Relatedness
Self-reported fulfillment of basic psychological needs on a scale from 1 (least fulfilled) to 5 (most fulfilled) using the Basic Psychological Needs in Exercise Questionnaire. The three subscales are perceived autonomy, competence, and relatedness. Here, relatedness is reported. A higher score means greater perceived relatedness.
Measured: 0 to 12 weeks
Self-reflection
Self-reported self-reflection on a scale from 1 (strongly disagree) to 5 (strongly agree) using the Self-Reflection and Insight Scale. Here, we report changes in the insight subscale, which has 8 items and a range of 5-40. For this scale, higher values indicate greater levels of insight.
Measured: Change from 0 to 12 weeks
Quality of Life (Physical, Social, Emotional, Functional, and Breast Cancer-specific)
Self-reported quality of life on a scale from 0 (not at all) to 4 (very much) using the Functional Assessment of Cancer Therapy - Breast measure. Reported here is the change in total score for the entire measure (with the total ranging from 0-123). Better quality of life is indicated by a lower score.
Measured: Change from 0 to 12 weeks
Importance of Valued Domains
Self-reported importance of family, intimate relationships, friends, work, health, and growth values domains on a scale from 0 (not at all important) to 5 (extremely important) using the Chronic Pain Values Inventory. Reported here is the change in total across all domains, which is an average of the individual items (range: 0-5). A higher score indicates stronger endorsement of importance of the valued domains.
Measured: Change from 0 to 12 weeks
Success in Living According to Valued Domains
Self-reported success in living according to values related to family, intimate relations, friends, work, health, and growth on a scale from 0 (not at all successful) to 5 (extremely successful) using the Chronic Pain Values Inventory. Reported here is the change in total across all domains, as an average across items (range: 0-5). A higher score indicates stronger endorsement of success in the valued domains.
Measured: Change from 0 to 12 weeks
Engaged Living
Self-reported perception of living in accordance with one's values on a scale from 1 (completely disagree) to 5 (completely agree) using the Engaged Living Scale. The two subscales are valued living and life fulfillment. Reported here is the change in total results for the scale (which ranges from 16-80). Higher scores on this scale indicate higher levels of engaged living.
Measured: Change from 0 to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start1 Sep 2018
- Primary completion30 Dec 2021
- Study completion31 Mar 2022
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.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Elizabeth J Lyons, PhD, MPH, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03612596
- Sponsor's protocol ID
- 17-0310
- Other IDs
- 1R21CA218543-01A1
- Status last verified
- Jun 2023
- First submitted
- 25 Jul 2018
- Last updated
- 9 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will provide access to all data, regardless of publication, collected as a part of this project. All external investigators must submit a written request identifying their research question(s) and specifying the data they would like to analyze. The request must include a data security plan and explanation of how the data will be stored and who will have access. All requests will be reviewed by the investigators in conjunction with UTMB's Institute for Translational Sciences key resources (in particular, the regulatory and ethics resources) to be sure appropriate NIH requirements are followed.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Narrative Visualization for Breast Cancer Survivors' Physical Activity
- ClinicalTrials.gov ID
- NCT03612596
- Acronym / sponsor ID
- 17-0310
- Conditions
- Breast Cancer
- Keywords
- wearable, mobile app, physical activity, survivorship, narrative, identity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 2 Aug 2018 (actual)
- Results
- Posted 9 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study tests the feasibility and acceptability of a physical activity intervention that combines use of a wearable activity monitor with a scrapbook. Half of the participants will receive this enhanced intervention, while the other half will receive a wearable activity monitor with a standard step log.
Detailed description
Women breast cancer survivors could benefit from increased physical activity but are in need of greater motivation to be active. Interventions that use wearable activity monitors and mobile apps have shown promise in the short-term, but use drops off over time. Reports have suggested that users find the step data provided to be unclear and not very personally meaningful. The ultimate purpose of this line of research is to test whether enhanced motivational feedback, using scrapbooks, can increase motivation for activity. The scrapbooks will target integrated regulation, which is a type of motivation related to personal identity and values. Participants who receive this intervention will draw their step graph, add photographs and stickers an explanations to the graph, and answer reflection questions daily. Before testing the effects of this intervention on physical activity, the investigators must first ensure that the materials and procedures are feasible and acceptable. This small pilot study will allow the research team to iteratively test scrapbook materials and improve upon them for use in future studies. The investigators will compare an intervention using the enhanced materials to an intervention using only the wearable device, app, and a standard step log without scrapbook or reflection components. In addition to the primary outcome of feasibility (use of the scrapbook), the investigators will also explore the effects of the intervention on steps, motivational and values-related outcomes, and various aspects of feasibility and acceptability.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Narrative visualization | Experimental | Behavioral: Narrative visualizationWearable activity monitor, app, and enhanced motivational scrapbook materials (instant camera, stickers, markers, enhanced content) |
| Standard self-regulation | Active comparator | Behavioral: Standard self-regulationWearable activity monitor, app, and standard workbook materials (markers, a workbook with a calendar log to keep track of steps over time) |
Who may qualify
- Ages
- 55 to 79 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age between 55 and 79 years
- Female
- Self-reported diagnosis of breast cancer
- BMI between 18 and 40 kg/m2
- Willingness to be randomized to any condition
Key exclusion criteria (13 listed)
- Participant is active (150 minutes or more activity per week)
- Major health interventions (surgery, radiation, chemo) within the past 6 months
- Stroke, hip fracture, hip or knee replacement, or spinal surgery in the past 6 months
- History of orthopedic complications that would prevent optimal participation
- No active recurrence of cancer
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 |
|---|---|---|
| Narrative visualizationParticipants use narrative visualization procedures to connect their step data to important events or feelings that occurred at the same time, then reflect on their behavior | Behavioural | Narrative visualization |
| Standard self-regulationParticipants self-monitor steps using a wearable device, app, and a hand-written step log | Behavioural | Standard self-regulation |
Primary outcome
Percentage of Daily Workbook Entries Completed
Time frame: 12 weeks
Percentage of daily workbook entries completed out of the total possible number, measured by photography of intervention materials at 12 week assessment and then assessment of each page.
13 secondary outcomes
Physical Activity as Measured by Steps Per Day During Intervention Period
Time frame: Change from 0 to 12 weeks
Physical Activity as Measured by Daily Steps During No-intervention Maintenance Period
Time frame: Change from 12 to 24 weeks
Intrinsic Regulation
Time frame: Change from 0 to 12 weeks
Integrated Regulation
Time frame: Change from 0 to 12 weeks
Basic Psychological Needs: Autonomy
Time frame: Change from 0 to 12 weeks
Exercise Identity
Time frame: Change from 0 to 12 weeks
Basic Psychological Needs: Competence
Time frame: 0 to 12 weeks
Basic Psychological Needs: Relatedness
Time frame: 0 to 12 weeks
Self-reflection
Time frame: Change from 0 to 12 weeks
Quality of Life (Physical, Social, Emotional, Functional, and Breast Cancer-specific)
Time frame: Change from 0 to 12 weeks
Importance of Valued Domains
Time frame: Change from 0 to 12 weeks
Success in Living According to Valued Domains
Time frame: Change from 0 to 12 weeks
Engaged Living
Time frame: Change from 0 to 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The investigators will provide access to all data, regardless of publication, collected as a part of this project. All external investigators must submit a written request identifying their research question(s) and specifying the data they would like to analyze. The request must include a data security plan and explanation of how the data will be stored and who will have access. All requests will be reviewed by the investigators in conjunction with UTMB's Institute for Translational Sciences key resources (in particular, the regulatory and ethics resources) to be sure appropriate NIH requirements are followed.
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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.
Elizabeth J Lyons, PhD, MPH principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Narrative visualization and Standard self-regulation in people with Breast Cancer, run by The University of Texas Medical Branch, Galveston 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 9 inclusion and 13 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 9 Jun 2023. 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 9 Jun 2023). 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?
Percentage of Daily Workbook Entries Completed (time frame: 12 weeks). 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 9 Jun 2023.