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Completed

NCT Number: NCT03612596

Narrative Visualization for Breast Cancer Survivors' Physical Activity

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.

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Key information

Conditions

Breast Cancer Behavior Breast Diseases Breast Neoplasms Communication Motor Activity Narration Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

55 year–79 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Medical Branch

Galveston, Texas, 77550, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Narrative visualization

Behavioral

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

Behavioral

Participants self-monitor steps using a wearable device, app, and a hand-written step log

Primary outcomes

  1. 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.

Secondary outcomes

  1. Physical Activity as Measured by Steps Per Day During Intervention Period

    Time frame: Change from 0 to 12 weeks

    Mean of daily steps taken from accelerometers worn for 7 days

  2. Physical Activity as Measured by Daily Steps During No-intervention Maintenance Period

    Time frame: Change from 12 to 24 weeks

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

  3. Intrinsic Regulation

    Time frame: 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.

  4. Integrated Regulation

    Time frame: 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.

  5. Basic Psychological Needs: Autonomy

    Time frame: 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.

  6. Exercise Identity

    Time frame: 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.

  7. Basic Psychological Needs: Competence

    Time frame: 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.

  8. Basic Psychological Needs: Relatedness

    Time frame: 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.

  9. Self-reflection

    Time frame: 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.

  10. Quality of Life (Physical, Social, Emotional, Functional, and Breast Cancer-specific)

    Time frame: 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.

  11. Importance of Valued Domains

    Time frame: 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.

  12. Success in Living According to Valued Domains

    Time frame: 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.

  13. Engaged Living

    Time frame: 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.

Other outcomes

  1. Receipt of Study Materials

    Time frame: 12 weeks

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

  2. Usefulness of Study Materials

    Time frame: 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)

  3. Participant Attrition

    Time frame: 24 weeks

    Number of participants in each group who are lost to follow-up

  4. Number of Serious Adverse Events

    Time frame: 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)

  5. Days the Activity Monitor Was Worn

    Time frame: 12 weeks

    The number of days the activity monitor was worn, as assessed via review of the mobile app

  6. Completion of Values Clarification Activity

    Time frame: 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

Sponsors and collaborators

Lead sponsor

The University of Texas Medical Branch, Galveston

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Aug 2, 2018
Registry last updated
Jun 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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