Digital Interventions for Breast Cancer

Overseen By Philip Chow, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Virginia

Disqualifiers: Suicidal ideation, No compatible phone, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for breast cancer survivors who might benefit from digital interventions to improve their mental health and coping skills. Specific eligibility criteria are not provided, so it's best to contact the study organizers for details on who can participate.

Inclusion Criteria

I am 18 years old or older.

I was diagnosed with Stage I-III breast cancer within the last 5 years.

I have moderate to severe symptoms of depression or anxiety.

Exclusion Criteria

Active suicidal ideation during the enrollment/screening call

Do not have an app-compatible phone (iOS 10.3 or later or Android 4.0.3 or later)

I am currently in one-on-one therapy for depression or anxiety without recent changes in my medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in digital micro-interventions such as savoring, gratitude, challenging unhelpful thoughts, psychoeducation, behavioral activation, and acceptance

1 week

Remote participation

Follow-up

Participants are monitored for satisfaction and acceptability of the digital interventions

1 week

Remote interview

What Are the Treatments Tested in This Trial?

Interventions

• Digital Micro-Interventions

Trial Overview The study is testing digital micro-interventions (DMIs) designed to be easily integrated into daily life with minimal burden. These DMIs aim to help breast cancer survivors by providing personalized support for a range of psychosocial needs.

How Is the Trial Designed?

Group I: Savoring Experimental Treatment 1 Intervention

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.

Group II: Psychoeducation Experimental Treatment 1 Intervention

Participants receive access to psychoeducation content on mental health, distress, and well-being. They are provided tidbits of information every day to learn from.

Group III: Gratitude Experimental Treatment 1 Intervention

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.

Group IV: Challenging UnhelpfulThoughts Experimental Treatment 1 Intervention

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.

Group V: Behavioral Activation Experimental Treatment 1 Intervention

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

Group VI: Acceptance Experimental Treatment 1 Intervention

Participants are led through an automated process of accepting, rather than actively trying to push away, their distressing emotions or thoughts.

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+