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Completed

NCT Number: NCT07160439

Evaluating Digital Micro-Interventions to Reduce Distress and Increase Wellbeing in Breast Cancer Survivors

Digital mental and behavioral health interventions have potential to significantly improve accessibility for the large number of breast cancer survivors who need treatments. However, the landscape of digital interventions tested in this population remains limited, with the few that have been tested primarily focused on reducing symptoms of mental disorders. This is problematic given the range of psychosocial needs among breast cancer survivors, including those who may not have active mental health symptoms, yet could benefit from learning effective coping skills. Moreover, all of these interventions follow a "one size fits all" approach, lacking precision in terms of when, where, and to whom they should be given. The overarching goals of this project are to develop and pilot a variety of digital micro-interventions (DMIs) for breast cancer survivors - highly focused, technology-enabled interventions that can be delivered in the context of a person's daily life with little burden on the individual.

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Key information

Conditions

Mental Health Issue Anxiety Disorders Behavior Behavioral Symptoms Breast Cancer Breast Diseases Breast Neoplasms Depression Mental Disorders Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Virginia

Charlottesville, Virginia, 22904, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age = 18 years.
  • 0-5 years post-diagnosis of Stage I, II, or III female breast cancer.
  • Elevated symptoms of depression and/or anxiety as measured by the PHQ-8 (score > 9) or GAD-7 (score > 7).

Exclusion criteria

  • Receiving individual (1 on 1) treatment for depression and/or anxiety to avoid treatment interference (note, individuals will be permitted to enroll if they are taking antidepressant medication and have not had an appointment to adjust the dosage over the past 2 weeks)
  • Active suicidal ideation during the enrollment/screening call based on a trained staff member orally administering the suicidality item from the PHQ-9 to individuals on the phone ("In the last 2 weeks, have you had thoughts that you would be better off dead, or thoughts of hurting yourself in some way?"). If an individual responds in any way other than "not at all" based on the available response options (i.e., either "several days", "more than half the days", or "nearly every day"), or if they mention having suicidal ideation or thoughts of death during the enrollment/screening call, the Pitt-Optimum risk assessment tool will be administered. Only participants deemed low risk may proceed in enrollment; all will be given additional resources.
  • Do not have an app-compatible phone (i.e., iOS 10.3 or later or Android 4.0.3 or later).
  • Cannot read and speak English (interventions only available in English).

Treatment and study plan

Digital Micro-Interventions

Behavioral

Digital Micro-Interventions are brief interventions that target specific behavioral and cognitive mechanisms of mental health, designed for brief periods of engagement.

Primary outcomes

  1. Evaluation of Digital Micro-Intervention

    Time frame: Post 1 week

    12 item scale measuring satisfaction and acceptability. Each question is scored on a 0-4 scale with a total raw summed score range of 0-48. Higher scores indicate greater satisfaction and acceptability.

Secondary outcomes

  1. PROMIS-29 Profile

    Time frame: Baseline

    28 items that measure aspects of physical and mental health. Each question is scored on a 1-5 scale with a total raw score range of 28-140. Higher scores indicate worse overall health. A 29th item that assesses pain from 1-10 was omitted to limit redundancy with another pain measure.

  2. PROMIS-29 Profile

    Time frame: Post 1 week

    28 items that measure aspects of physical and mental health. Each question is scored on a 1-5 scale with a total raw score range of 28-140. Higher scores indicate worse overall health. A 29th item that assesses pain from 1-10 was omitted to limit redundancy with another pain measure.

  3. Pain, Enjoyment of Life and General Activity (PEG) Scale

    Time frame: Baseline

    Assesses chronic pain based on 3 items, each one ranging from 0-10. Scores range from 0-30, with higher scores indicating more pain severity and interference.

  4. Pain, Enjoyment of Life and General Activity (PEG) Scale

    Time frame: Post 1 week

    Assesses chronic pain based on 3 items, each one ranging from 0-10. Scores range from 0-30, with higher scores indicating more pain severity and interference.

  5. Emotion Regulation Questionnaire

    Time frame: Baseline

    A 10 item scale to reassess for two emotion regulation strategies: cognitive reappraisal and expressive suppression. Participants rate each item on a 7-point Likert scale, ranging from 1 (strongly disagree) to 7 (strongly agree). Scores for each subscale range from 1-7 (after dividing by the number of items), with higher scores indicating a greater tendency to use that particular emotion regulation strategy.

  6. Emotion Regulation Questionnaire

    Time frame: Post 1 week

    A 10 item scale to reassess for two emotion regulation strategies: cognitive reappraisal and expressive suppression. Participants rate each item on a 7-point Likert scale, ranging from 1 (strongly disagree) to 7 (strongly agree). Scores for each subscale range from 1-7 (after dividing by the number of items), with higher scores indicating a greater tendency to use that particular emotion regulation strategy.

  7. Insomnia Severity Index

    Time frame: Baseline

    A 7-item measure to evaluate severity of insomnia symptoms. Each item is evaluated on a scale from 0-4. Scores range from 0-28, with higher scores indicating greater severity of insomnia symptoms.

  8. Insomnia Severity Index

    Time frame: Post 1 week

    A 7-item measure to evaluate severity of insomnia symptoms. Each item is evaluated on a scale from 0-4. Scores range from 0-28, with higher scores indicating greater severity of insomnia symptoms.

  9. Patient Health Questionnaire-8

    Time frame: Baseline

    8 item scale that measures depression symptoms on a continuous scale. Scores range from 0-24, with a higher score indicating greater severity of symptoms of depression.

  10. Patient Health Questionnaire-8

    Time frame: Post 1 week

    8 item scale that measures depression symptoms on a continuous scale. Scores range from 0-24, with a higher score indicating greater severity of symptoms of depression.

  11. Generalized Anxiety Disorder-7

    Time frame: Baseline

    7 item scale that measures anxiety symptoms on a continuous scale. Scores range from 0-21, with a higher score indicating greater severity of symptoms of anxiety.

  12. Generalized Anxiety Disorder-7

    Time frame: Post 1 week

    7 item scale that measures anxiety symptoms on a continuous scale. Scores range from 0-21, with a higher score indicating greater severity of symptoms of anxiety.

Other outcomes

  1. Qualitative Interview

    Time frame: Post 1 week

    Remote interview to assess for participant feedback on usability, obstacles to use, and suggestions for improvement.

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 8, 2025
Registry last updated
May 4, 2026

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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