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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Mental Health Issue
• Intervention / Treatment: Behavioral: Digital Micro-Interventions

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

6

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	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.	Post 1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire-8	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	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
PROMIS-29 Profile	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.	Baseline
PROMIS-29 Profile	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.	Post 1 week
Pain, Enjoyment of Life and General Activity (PEG) Scale	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	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	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	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	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	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	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	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative Interview	Remote interview to assess for participant feedback on usability, obstacles to use, and suggestions for improvement.	Post 1 week

Collaborators and Investigators

• Sponsor: University of Virginia
• Collaborators: National Cancer Institute (NCI)

Study record dates

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): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Well-Being
• Additional Relevant MeSH Terms: Mental Disorders; Neoplasms by Site; Neoplasms; Behavioral Symptoms; Skin Diseases; Breast Diseases; Behavior; Skin and Connective Tissue Diseases; Anxiety Disorders; Depression; Breast Neoplasms
• 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