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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

12 weeks

Results posted on

2023-06-09

Participant Flow

Participant milestones

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

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 weeks

Population: 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

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 weeks

Mean of daily steps taken from accelerometers worn for 7 days

Outcome measures

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 weeks

Mean of steps per day taken from accelerometers worn for 7 days

Outcome measures

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 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.

Outcome measures

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 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.

Outcome measures

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 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.

Outcome measures

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 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.

Outcome measures

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 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.

Outcome measures

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 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.

Outcome measures

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 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.

Outcome measures

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 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.

Outcome measures

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 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.

Outcome measures

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 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.

Outcome measures

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 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.

Outcome measures

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 weeks

Self-reported percent of study materials received out of total supplied

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 weeks

Number 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 weeks

The 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 weeks

The 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 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

Outcome measures

Outcome data not reported

Adverse Events

Narrative Visualization

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Standard Self-regulation

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Eloisa Martinez

The University of Texas Medical Branch

Phone: 409-266-9643

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place