Last reviewed · How we verify

NCT03612596

Narrative Visualization for Breast Cancer Survivors' Physical Activity

Completed NA Results posted Last updated 9 June 2023
What this trial tests

NA trial testing Narrative visualization in Breast Cancer in 40 participants. Completed in 31 March 2022.

Timeline
1 September 2018
Primary endpoint
30 December 2021
31 March 2022

Quick facts

Lead sponsorThe University of Texas Medical Branch, Galveston
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeother
Enrollment40
Start date1 September 2018
Primary completion30 December 2021
Estimated completion31 March 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

The University of Texas Medical Branch, Galveston

Who can join

Adults 55 to 79, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Daily Workbook Entries Completed Primary · 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.

GroupValue95% CI
Narrative Visualization44± 45
Physical Activity as Measured by Steps Per Day During Intervention Period Secondary · Change from 0 to 12 weeks

Mean of daily steps taken from accelerometers worn for 7 days

GroupValue95% CI
Narrative Visualization936.22± 1332.46
Standard Self-regulation913.68± 1613.03
Physical Activity as Measured by Daily Steps During No-intervention Maintenance Period Secondary · Change from 12 to 24 weeks

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

GroupValue95% CI
Narrative Visualization-829.37± 1320.50
Standard Self-regulation-893.73± 1191.96
Intrinsic Regulation Secondary · 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.

GroupValue95% CI
Narrative Visualization0.49± 1.24
Standard Self-regulation0.46± 1.03
Integrated Regulation Secondary · 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.

GroupValue95% CI
Narrative Visualization0.39± 1.13
Standard Self-regulation0.17± 1.17
Basic Psychological Needs: Autonomy Secondary · 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.

GroupValue95% CI
Narrative Visualization0.96± 1.17
Standard Self-regulation0.50± 0.79
Exercise Identity Secondary · 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.

GroupValue95% CI
Narrative Visualization0.73± 1.42
Standard Self-regulation0.48± 0.95
Basic Psychological Needs: Competence Secondary · 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.

GroupValue95% CI
Narrative Visualization1.04± 1.25
Standard Self-regulation0.77± 0.83
Basic Psychological Needs: Relatedness Secondary · 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.

GroupValue95% CI
Narrative Visualization0.12± 1.36
Standard Self-regulation0.41± 1.94
Self-reflection Secondary · 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.

GroupValue95% CI
Narrative Visualization0.56± 2.38
Standard Self-regulation1.63± 3.58
Quality of Life (Physical, Social, Emotional, Functional, and Breast Cancer-specific) Secondary · 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.

GroupValue95% CI
Narrative Visualization4.04± 8.04
Standard Self-regulation8.92± 12.13
Importance of Valued Domains Secondary · 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.

GroupValue95% CI
Narrative Visualization-0.23± 0.38
Standard Self-regulation0.15± 0.56

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Application of wearables for remote monitoring of oncology patients: A scoping review.
    Cloß K, Verket M, Müller-Wieland D, Marx N, et al · · 2024 · cited 16× · PMID 38481796 · DOI 10.1177/20552076241233998
  2. Integrating Artificial Intelligence-Driven Wearable Technology in Oncology Decision-Making: A Narrative Review.
    Birla M, Rajan, Roy PG, Gupta I, et al · · 2025 · cited 14× · PMID 39072365 · DOI 10.1159/000540494
  3. Acceptability of Narrative Visualization with Physical Activity Monitoring Among Breast Cancer Survivors
    Bentley J, Yu X, Karmarkar A, Downer B, et al · · 2021 · DOI 10.21203/rs.3.rs-435122/v1

Verify or expand the search:

Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

Other The University of Texas Medical Branch, Galveston trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03612596.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing