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

University of Virginia

Status

Enrolling

Conditions

Breast Cancer

Mental Health Issue

Treatments

Behavioral: Digital Micro-Interventions

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT07160439

6002

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

Details and patient eligibility

About

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.

Enrollment

120 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 6 patient groups

Savoring

Experimental group

Description:

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.

Treatment:

Behavioral: Digital Micro-Interventions

Gratitude

Experimental group

Description:

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.

Treatment:

Behavioral: Digital Micro-Interventions

Challenging UnhelpfulThoughts

Experimental group

Description:

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.

Treatment:

Behavioral: Digital Micro-Interventions

Psychoeducation

Experimental group

Description:

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

Treatment:

Behavioral: Digital Micro-Interventions

Behavioral Activation

Experimental group

Description:

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

Treatment:

Behavioral: Digital Micro-Interventions

Acceptance

Experimental group

Description:

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