Breast Cancer
Conditions
Keywords
wearable, mobile app, physical activity, survivorship, narrative, identity
Brief 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.
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.
Interventions
BEHAVIORALNarrative visualization
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
BEHAVIORALStandard self-regulation
Participants self-monitor steps using a wearable device, app, and a hand-written step log
Sponsors
National Cancer Institute (NCI)
The University of Texas Medical Branch, Galveston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
55 Years to 79 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 * 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)
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Daily Workbook Entries Completed | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Basic Psychological Needs: Autonomy | Change from 0 to 12 weeks | 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. |
| Basic Psychological Needs: Relatedness | 0 to 12 weeks | 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. |
| Self-reflection | Change from 0 to 12 weeks | 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. |
| Quality of Life (Physical, Social, Emotional, Functional, and Breast Cancer-specific) | Change from 0 to 12 weeks | 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. |
| Importance of Valued Domains | Change from 0 to 12 weeks | 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. |
| Success in Living According to Valued Domains | Change from 0 to 12 weeks | 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. |
| Engaged Living | Change from 0 to 12 weeks | 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. |
| Physical Activity as Measured by Steps Per Day During Intervention Period | Change from 0 to 12 weeks | Mean of daily steps taken from accelerometers worn for 7 days |
| Physical Activity as Measured by Daily Steps During No-intervention Maintenance Period | Change from 12 to 24 weeks | Mean of steps per day taken from accelerometers worn for 7 days |
| Intrinsic Regulation | Change from 0 to 12 weeks | 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. |
| Integrated Regulation | Change from 0 to 12 weeks | 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. |
| Exercise Identity | Change from 0 to 12 weeks | 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. |
| Basic Psychological Needs: Competence | 0 to 12 weeks | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Participant Attrition | 24 weeks | Number of participants in each group who are lost to follow-up |
| Number of Serious Adverse Events | Up to 24 weeks | The number of serious adverse events that occur during the intervention (0 - 12 weeks) and follow-up period (12 - 24 weeks) |
| Days the Activity Monitor Was Worn | 12 weeks | The number of days the activity monitor was worn, as assessed via review of the mobile app |
| Completion of Values Clarification Activity | 12 weeks | From photographs taken of the intervention materials at the 12 week assessment, the investigators will assess whether participants in the enhanced intervention group completed their values clarification activity |
| Receipt of Study Materials | 12 weeks | Self-reported percent of study materials received out of total supplied |
| Usefulness of Study Materials | 12 weeks | Self-reported usefulness of study materials, on a scale from 1 (strongly disagree they were useful) to 5 (strongly agree they were useful) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Narrative Visualization Wearable activity monitor, app, and enhanced motivational scrapbook materials (instant camera, stickers, markers, enhanced content)
Narrative visualization: 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 | 20 |
| Standard Self-regulation Wearable activity monitor, app, and standard workbook materials (markers, a workbook with a calendar log to keep track of steps over time)
Standard self-regulation: Participants self-monitor steps using a wearable device, app, and a hand-written step log | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Narrative Visualization | Total | Standard Self-regulation |
|---|---|---|---|
| Age, Continuous | 61 years STANDARD_DEVIATION 6.21 | 62 years STANDARD_DEVIATION 5.4 | 63 years STANDARD_DEVIATION 4.86 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 5 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants | 35 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) White | 14 Participants | 27 Participants | 13 Participants |
| Region of Enrollment United States | 20 participants | 40 participants | 20 participants |
| Sex: Female, Male Female | 20 Participants | 40 Participants | 20 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
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.
Time frame: 12 weeks
Population: This outcome was only analyzed in the intervention group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Narrative Visualization | Percentage of Daily Workbook Entries Completed | 44 percent | Standard Deviation 45 |
Secondary
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.
Time frame: Change from 0 to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Narrative Visualization | Basic Psychological Needs: Autonomy | 0.96 units on a scale | Standard Deviation 1.17 |
| Standard Self-regulation | Basic Psychological Needs: Autonomy | 0.50 units on a scale | Standard Deviation 0.79 |
p-value: 0.17t-test, 2 sided
Secondary
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.
Time frame: 0 to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Narrative Visualization | Basic Psychological Needs: Competence | 1.04 units on a scale | Standard Deviation 1.25 |
| Standard Self-regulation | Basic Psychological Needs: Competence | 0.77 units on a scale | Standard Deviation 0.83 |
p-value: 0.44t-test, 2 sided
Secondary
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.
Time frame: 0 to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Narrative Visualization | Basic Psychological Needs: Relatedness | 0.12 units on a scale | Standard Deviation 1.36 |
| Standard Self-regulation | Basic Psychological Needs: Relatedness | 0.41 units on a scale | Standard Deviation 1.94 |
p-value: 0.93t-test, 2 sided
Secondary
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.
Time frame: Change from 0 to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Narrative Visualization | Engaged Living | 2.56 units on a scale | Standard Deviation 6.64 |
| Standard Self-regulation | Engaged Living | 3.39 units on a scale | Standard Deviation 6.99 |
p-value: 0.71t-test, 2 sided
Secondary
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.
Time frame: Change from 0 to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Narrative Visualization | Exercise Identity | 0.73 units on a scale | Standard Deviation 1.42 |
| Standard Self-regulation | Exercise Identity | 0.48 units on a scale | Standard Deviation 0.95 |
p-value: 0.53t-test, 2 sided
Secondary
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.
Time frame: Change from 0 to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Narrative Visualization | Importance of Valued Domains | -0.23 units on a scale | Standard Deviation 0.38 |
| Standard Self-regulation | Importance of Valued Domains | 0.15 units on a scale | Standard Deviation 0.56 |
p-value: 0.02t-test, 2 sided
Secondary
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.
Time frame: Change from 0 to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Narrative Visualization | Integrated Regulation | 0.39 units on a scale | Standard Deviation 1.13 |
| Standard Self-regulation | Integrated Regulation | 0.17 units on a scale | Standard Deviation 1.17 |
p-value: 0.58t-test, 2 sided
Secondary
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.
Time frame: Change from 0 to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Narrative Visualization | Intrinsic Regulation | 0.49 units on a scale | Standard Deviation 1.24 |
| Standard Self-regulation | Intrinsic Regulation | 0.46 units on a scale | Standard Deviation 1.03 |
p-value: 0.94t-test, 2 sided
Secondary
Physical Activity as Measured by Daily Steps During No-intervention Maintenance Period
Mean of steps per day taken from accelerometers worn for 7 days
Time frame: Change from 12 to 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Narrative Visualization | Physical Activity as Measured by Daily Steps During No-intervention Maintenance Period | -829.37 steps per day | Standard Deviation 1320.5 |
| Standard Self-regulation | Physical Activity as Measured by Daily Steps During No-intervention Maintenance Period | -893.73 steps per day | Standard Deviation 1191.96 |
p-value: 0.88t-test, 2 sided
Secondary
Physical Activity as Measured by Steps Per Day During Intervention Period
Mean of daily steps taken from accelerometers worn for 7 days
Time frame: Change from 0 to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Narrative Visualization | Physical Activity as Measured by Steps Per Day During Intervention Period | 936.22 steps per day | Standard Deviation 1332.46 |
| Standard Self-regulation | Physical Activity as Measured by Steps Per Day During Intervention Period | 913.68 steps per day | Standard Deviation 1613.03 |
p-value: 0.94t-test, 2 sided
Secondary
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.
Time frame: Change from 0 to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Narrative Visualization | Quality of Life (Physical, Social, Emotional, Functional, and Breast Cancer-specific) | 4.04 units on a scale | Standard Deviation 8.04 |
| Standard Self-regulation | Quality of Life (Physical, Social, Emotional, Functional, and Breast Cancer-specific) | 8.92 units on a scale | Standard Deviation 12.13 |
p-value: 0.16t-test, 2 sided
Secondary
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.
Time frame: Change from 0 to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Narrative Visualization | Self-reflection | 0.56 units on a scale | Standard Deviation 2.38 |
| Standard Self-regulation | Self-reflection | 1.63 units on a scale | Standard Deviation 3.58 |
p-value: 0.29t-test, 2 sided
Secondary
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.
Time frame: Change from 0 to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Narrative Visualization | Success in Living According to Valued Domains | 0.37 units on a scale | Standard Deviation 0.74 |
| Standard Self-regulation | Success in Living According to Valued Domains | 0.48 units on a scale | Standard Deviation 0.94 |
p-value: 0.7t-test, 2 sided
Other Pre-specified
Completion of Values Clarification Activity
From photographs taken of the intervention materials at the 12 week assessment, the investigators will assess whether participants in the enhanced intervention group completed their values clarification activity
Time frame: 12 weeks
Other Pre-specified
Days the Activity Monitor Was Worn
The number of days the activity monitor was worn, as assessed via review of the mobile app
Time frame: 12 weeks
Other Pre-specified
Number of Serious Adverse Events
The number of serious adverse events that occur during the intervention (0 - 12 weeks) and follow-up period (12 - 24 weeks)
Time frame: Up to 24 weeks
Other Pre-specified
Participant Attrition
Number of participants in each group who are lost to follow-up
Time frame: 24 weeks
Other Pre-specified
Receipt of Study Materials
Self-reported percent of study materials received out of total supplied
Time frame: 12 weeks
Other Pre-specified
Usefulness of Study Materials
Self-reported usefulness of study materials, on a scale from 1 (strongly disagree they were useful) to 5 (strongly agree they were useful)
Time frame: 12 weeks