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

NCT07160439 | Completed

• 2 other identifiers: 60024R37CA248434-05
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mental Health Issue; Breast Cancer

Keywords

Depression; Anxiety; Well-Being

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• PROMIS-29 Profile

  Baseline

• PROMIS-29 Profile

  Post 1 week

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

  Baseline

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

  Post 1 week

• Emotion Regulation Questionnaire

  Baseline

Other Outcomes (1)

• Qualitative Interview

  Post 1 week

Study Arms (6)

Savoring

EXPERIMENTAL

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

Gratitude

EXPERIMENTAL

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

Challenging UnhelpfulThoughts

EXPERIMENTAL

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

Psychoeducation

EXPERIMENTAL

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

Behavioral Activation

EXPERIMENTAL

Participants are led through an automated process of identifying tasks they can accomplish in their daily lives.

Behavioral: Digital Micro-Interventions

Acceptance

EXPERIMENTAL

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

Interventions

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.

Acceptance; Behavioral Activation; Challenging UnhelpfulThoughts; Gratitude; Psychoeducation; Savoring

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age = 18 years.
• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Virginia: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22904, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavioral Symptoms; Behavior; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Pilot study to test early stage digital micro-interventions (n=20 per micro-intervention)

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: September 8, 2025
• Study Start: August 12, 2025
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)