Trial Outcomes & Findings for Narrative Visualization for Breast Cancer Survivors' Physical Activity (NCT NCT03612596)
NCT ID: NCT03612596
Last Updated: 2023-06-09
Results Overview
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.
COMPLETED
NA
40 participants
12 weeks
2023-06-09
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
0 - 12 Weeks
STARTED
|
20
|
20
|
|
0 - 12 Weeks
COMPLETED
|
18
|
19
|
|
0 - 12 Weeks
NOT COMPLETED
|
2
|
1
|
|
12 - 24 Weeks
STARTED
|
18
|
19
|
|
12 - 24 Weeks
COMPLETED
|
18
|
19
|
|
12 - 24 Weeks
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Narrative Visualization for Breast Cancer Survivors' Physical Activity
Baseline characteristics by cohort
| Measure |
Narrative Visualization
n=20 Participants
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
|
Standard Self-regulation
n=20 Participants
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
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 6.21 • n=99 Participants
|
63 years
STANDARD_DEVIATION 4.86 • n=107 Participants
|
62 years
STANDARD_DEVIATION 5.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=99 Participants
|
20 participants
n=107 Participants
|
40 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: This outcome was only analyzed in the intervention group
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.
Outcome measures
| Measure |
Narrative Visualization
n=20 Participants
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
|
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
|
|---|---|---|
|
Percentage of Daily Workbook Entries Completed
|
44 percent
Standard Deviation 45
|
—
|
SECONDARY outcome
Timeframe: Change from 0 to 12 weeksMean of daily steps taken from accelerometers worn for 7 days
Outcome measures
| Measure |
Narrative Visualization
n=19 Participants
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
|
Standard Self-regulation
n=18 Participants
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
|
|---|---|---|
|
Physical Activity as Measured by Steps Per Day During Intervention Period
|
936.22 steps per day
Standard Deviation 1332.46
|
913.68 steps per day
Standard Deviation 1613.03
|
SECONDARY outcome
Timeframe: Change from 12 to 24 weeksMean of steps per day taken from accelerometers worn for 7 days
Outcome measures
| Measure |
Narrative Visualization
n=19 Participants
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
|
Standard Self-regulation
n=18 Participants
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
|
|---|---|---|
|
Physical Activity as Measured by Daily Steps During No-intervention Maintenance Period
|
-829.37 steps per day
Standard Deviation 1320.50
|
-893.73 steps per day
Standard Deviation 1191.96
|
SECONDARY outcome
Timeframe: Change from 0 to 12 weeksSelf-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.
Outcome measures
| Measure |
Narrative Visualization
n=18 Participants
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
|
Standard Self-regulation
n=19 Participants
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
|
|---|---|---|
|
Intrinsic Regulation
|
0.49 units on a scale
Standard Deviation 1.24
|
0.46 units on a scale
Standard Deviation 1.03
|
SECONDARY outcome
Timeframe: Change from 0 to 12 weeksSelf-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.
Outcome measures
| Measure |
Narrative Visualization
n=18 Participants
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
|
Standard Self-regulation
n=19 Participants
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
|
|---|---|---|
|
Integrated Regulation
|
0.39 units on a scale
Standard Deviation 1.13
|
0.17 units on a scale
Standard Deviation 1.17
|
SECONDARY outcome
Timeframe: Change from 0 to 12 weeksSelf-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.
Outcome measures
| Measure |
Narrative Visualization
n=18 Participants
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
|
Standard Self-regulation
n=19 Participants
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
|
|---|---|---|
|
Basic Psychological Needs: Autonomy
|
0.96 units on a scale
Standard Deviation 1.17
|
0.50 units on a scale
Standard Deviation 0.79
|
SECONDARY outcome
Timeframe: Change from 0 to 12 weeksSelf-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.
Outcome measures
| Measure |
Narrative Visualization
n=18 Participants
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
|
Standard Self-regulation
n=19 Participants
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
|
|---|---|---|
|
Exercise Identity
|
0.73 units on a scale
Standard Deviation 1.42
|
0.48 units on a scale
Standard Deviation 0.95
|
SECONDARY outcome
Timeframe: 0 to 12 weeksSelf-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.
Outcome measures
| Measure |
Narrative Visualization
n=19 Participants
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
|
Standard Self-regulation
n=18 Participants
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
|
|---|---|---|
|
Basic Psychological Needs: Competence
|
1.04 units on a scale
Standard Deviation 1.25
|
0.77 units on a scale
Standard Deviation 0.83
|
SECONDARY outcome
Timeframe: 0 to 12 weeksSelf-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.
Outcome measures
| Measure |
Narrative Visualization
n=19 Participants
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
|
Standard Self-regulation
n=18 Participants
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
|
|---|---|---|
|
Basic Psychological Needs: Relatedness
|
0.12 units on a scale
Standard Deviation 1.36
|
0.41 units on a scale
Standard Deviation 1.94
|
SECONDARY outcome
Timeframe: Change from 0 to 12 weeksSelf-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.
Outcome measures
| Measure |
Narrative Visualization
n=18 Participants
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
|
Standard Self-regulation
n=19 Participants
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
|
|---|---|---|
|
Self-reflection
|
0.56 units on a scale
Standard Deviation 2.38
|
1.63 units on a scale
Standard Deviation 3.58
|
SECONDARY outcome
Timeframe: Change from 0 to 12 weeksSelf-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.
Outcome measures
| Measure |
Narrative Visualization
n=18 Participants
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
|
Standard Self-regulation
n=19 Participants
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
|
|---|---|---|
|
Quality of Life (Physical, Social, Emotional, Functional, and Breast Cancer-specific)
|
4.04 units on a scale
Standard Deviation 8.04
|
8.92 units on a scale
Standard Deviation 12.13
|
SECONDARY outcome
Timeframe: Change from 0 to 12 weeksSelf-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.
Outcome measures
| Measure |
Narrative Visualization
n=18 Participants
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
|
Standard Self-regulation
n=19 Participants
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
|
|---|---|---|
|
Importance of Valued Domains
|
-0.23 units on a scale
Standard Deviation 0.38
|
0.15 units on a scale
Standard Deviation 0.56
|
SECONDARY outcome
Timeframe: Change from 0 to 12 weeksSelf-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.
Outcome measures
| Measure |
Narrative Visualization
n=18 Participants
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
|
Standard Self-regulation
n=19 Participants
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
|
|---|---|---|
|
Success in Living According to Valued Domains
|
0.37 units on a scale
Standard Deviation 0.74
|
0.48 units on a scale
Standard Deviation 0.94
|
SECONDARY outcome
Timeframe: Change from 0 to 12 weeksSelf-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.
Outcome measures
| Measure |
Narrative Visualization
n=18 Participants
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
|
Standard Self-regulation
n=19 Participants
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
|
|---|---|---|
|
Engaged Living
|
2.56 units on a scale
Standard Deviation 6.64
|
3.39 units on a scale
Standard Deviation 6.99
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksSelf-reported percent of study materials received out of total supplied
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksSelf-reported usefulness of study materials, on a scale from 1 (strongly disagree they were useful) to 5 (strongly agree they were useful)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 weeksNumber of participants in each group who are lost to follow-up
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 24 weeksThe number of serious adverse events that occur during the intervention (0 - 12 weeks) and follow-up period (12 - 24 weeks)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksThe number of days the activity monitor was worn, as assessed via review of the mobile app
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksFrom 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
Outcome measures
Outcome data not reported
Adverse Events
Narrative Visualization
Standard Self-regulation
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place