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

August 10, 2026 updated by: Philip Chow, Ph.D., University of Virginia
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22904
        • University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Savoring
Participants are asked to think of a positive and personally meaningful memory to meditate on. They are led through steps to enter their memory, which is then summarized and turned into a meditation practice.
Behavioral: Digital Micro-Interventions
Digital Micro-Interventions are brief interventions that target specific behavioral and cognitive mechanisms of mental health, designed for brief periods of engagement.
Experimental: Gratitude
Participants are asked to generate a list of things they are grateful for. They are led through an automated process of selecting a source of gratitude and reflecting on it.
Behavioral: Digital Micro-Interventions
Digital Micro-Interventions are brief interventions that target specific behavioral and cognitive mechanisms of mental health, designed for brief periods of engagement.
Experimental: Challenging UnhelpfulThoughts
Participants are taught how to identify unhelpful thoughts, challenge them, and generate more balanced, helpful thoughts through an automated process that leads them step-by-step.
Behavioral: Digital Micro-Interventions
Digital Micro-Interventions are brief interventions that target specific behavioral and cognitive mechanisms of mental health, designed for brief periods of engagement.
Experimental: Psychoeducation
Participants receive access to psychoeducation content on mental health, distress, and well-being. They are provided tidbits of information every day to learn from.
Behavioral: Digital Micro-Interventions
Digital Micro-Interventions are brief interventions that target specific behavioral and cognitive mechanisms of mental health, designed for brief periods of engagement.
Experimental: Behavioral Activation
Participants are led through an automated process of identifying tasks they can accomplish in their daily lives.
Behavioral: Digital Micro-Interventions
Digital Micro-Interventions are brief interventions that target specific behavioral and cognitive mechanisms of mental health, designed for brief periods of engagement.
Experimental: Acceptance
Participants are led through an automated process of accepting, rather than actively trying to push away, their distressing emotions or thoughts.
Behavioral: Digital Micro-Interventions
Digital Micro-Interventions are brief interventions that target specific behavioral and cognitive mechanisms of mental health, designed for brief periods of engagement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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. Note, this measure could only be administered at post because it requires that participants used the intervention they were assigned, which was provided after they completed the baseline questionnaire battery.
Post 1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
Baseline
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.
Baseline
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.
Post 1 week
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.
Baseline
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.
Post 1 week
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.
Baseline
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.
Post 1 week
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.
Post 1 week
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.
Post 1 week
PROMIS-29 Profile
Time Frame: Baseline
24 items that measure various physical and mental health subdomains. Each question is scored on a 1-5 scale. The total raw score for Mental Health is composed of the 2 subdomains of Anxiety and Depression range from 8-40, where higher scores indicate worse overall mental health. The total raw score for Physical Health is composed of the 4 subdomains of Physical Function, Fatigue, Sleep Disturbance, and Ability to Participate in Social Activities, range from 16-80, where higher scores indicate worse overall physical health. The 4-item Pain Interference subscale and an item that assesses pain from 1-10 were omitted from the original PROMIS-29 Profile to limit redundancy with another pain measure.
Baseline
PROMIS-29 Profile
Time Frame: Post 1 week
24 items that measure various physical and mental health subdomains. Each question is scored on a 1-5 scale. The total raw score for Mental Health is composed of the 2 subdomains of Anxiety and Depression range from 8-40, where higher scores indicate worse overall mental health. The total raw score for Physical Health is composed of the 4 subdomains of Physical Function, Fatigue, Sleep Disturbance, and Ability to Participate in Social Activities, range from 16-80, where higher scores indicate worse overall physical health. The 4-item Pain Interference subscale and an item that assesses pain from 1-10 were omitted from the original PROMIS-29 Profile to limit redundancy with another pain measure.
Post 1 week

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative Interview
Time Frame: Post 1 week
Remote interview to assess for participant feedback on usability, obstacles to use, and suggestions for improvement. The count of participants in each group that endorsed each theme is provided.
Post 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 12, 2025

Primary Completion (Actual)

March 31, 2026

Study Completion (Actual)

March 31, 2026

Study Registration Dates

First Submitted

August 29, 2025

First Submitted That Met QC Criteria

August 29, 2025

First Posted (Actual)

September 8, 2025

Study Record Updates

Last Update Posted (Actual)

August 13, 2026

Last Update Submitted That Met QC Criteria

August 10, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6002
  • 4R37CA248434-05 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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