120 Participants Needed

Digital Interventions for Breast Cancer

PC
Overseen ByPhilip Chow, PhD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: University of Virginia
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores digital tools designed to support the mental and emotional well-being of breast cancer survivors. It tests small, focused digital activities such as meditating on happy memories, listing things to be grateful for, and managing unhelpful thoughts. These digital micro-interventions aim to integrate easily into daily life, offering personalized support without requiring active mental health symptoms. Women recently diagnosed with Stage I-III breast cancer who experience symptoms like anxiety or depression may benefit from this trial. Participants need a smartphone and must be comfortable using apps in English. As an unphased trial, this study provides a unique opportunity to explore innovative digital support tools tailored to individual needs.

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current medications, as long as you are not receiving individual therapy for depression or anxiety. You can still participate if you are on antidepressant medication, provided you haven't changed the dosage in the past two weeks.

What prior data suggests that these digital micro-interventions are safe for breast cancer survivors?

Research has shown that digital programs like those in this study are generally safe and well-received by breast cancer survivors.

For the "Savoring" and "Challenging Unhelpful Thoughts" programs, studies have found that these digital tools can improve health outcomes with few side effects. Participants in similar digital programs usually find them helpful and acceptable.

The "Gratitude" program has been tested with breast cancer patients and improved their well-being, with very few negative effects reported.

The "Psychoeducation" approach, which provides information about mental health, is commonly used and has safely reduced distress in these patients.

"Behavioral Activation" and "Acceptance" programs have been used to lower depression and anxiety. Research suggests these digital methods are effective and safe for breast cancer survivors. They are designed to be easy to use, making them suitable for everyday life.

Overall, these digital programs have a good safety record in similar groups. They aim to improve mental health without causing significant problems or side effects.12345

Why are researchers excited about this trial?

Researchers are excited about the digital micro-interventions for breast cancer because they offer a novel approach to emotional and psychological support. Unlike traditional therapies that often require in-person sessions, these digital interventions can be accessed remotely, providing flexibility and accessibility for patients. Each intervention focuses on unique psychological strategies, such as savoring positive memories, fostering gratitude, and challenging negative thoughts, potentially enhancing mental well-being during treatment. The integration of technology allows for personalized and automated guidance, making these interventions distinct from conventional support methods. By exploring these innovative techniques, researchers hope to improve the overall quality of life for breast cancer patients.

What evidence suggests that this trial's digital micro-interventions could be effective for breast cancer survivors?

Research has shown that digital tools can improve mental health for breast cancer survivors. This trial will explore various digital micro-interventions, each as a separate treatment arm. Participants in the "Savoring" arm will engage in activities like remembering happy moments, which studies have found can lower stress and improve well-being. The "Gratitude" arm involves keeping a gratitude journal, an activity shown to enhance emotional health. In the "Challenging Unhelpful Thoughts" arm, participants will learn to challenge negative thoughts, while the "Psychoeducation" arm focuses on understanding mental health better. The "Behavioral Activation" arm encourages setting small, daily goals to increase motivation and improve mood. Finally, the "Acceptance" arm teaches participants to accept difficult emotions rather than fighting them, which has been shown to reduce symptoms. Overall, these small digital activities could provide important support for breast cancer survivors seeking to improve their mental health.16789

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.
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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?
6Treatment groups
Experimental Treatment
Group I: SavoringExperimental Treatment1 Intervention
Group II: PsychoeducationExperimental Treatment1 Intervention
Group III: GratitudeExperimental Treatment1 Intervention
Group IV: Challenging UnhelpfulThoughtsExperimental Treatment1 Intervention
Group V: Behavioral ActivationExperimental Treatment1 Intervention
Group VI: AcceptanceExperimental Treatment1 Intervention

Find a Clinic Near You

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+

Citations

The effectiveness of internet-based acceptance and ...Online ACT over time reduces the difficulty in emotion regulation and reduces the severity of symptoms in breast cancer patients.
Evaluating Digital Micro-Interventions to Reduce Distress ...Digital mental and behavioral health interventions have potential to significantly improve accessibility for the large number of breast ...
Evidence-based digital health interventions for breast ...We conducted an umbrella review to summarize the evidence on digital health interventions aimed at improving health-related outcomes for BCS.
Digital Approaches Improved Mental Health Outcomes in ...A meta-analysis of studies demonstrated that internet-based interventions could reduce anxiety and depression in patients with breast ...
Evaluating Digital Micro-Interventions to Reduce Distress ...Digital mental and behavioral health interventions have potential to significantly improve accessibility for the large number of breast cancer survivors who ...
Acceptability of the RecoverEsupport Digital Health ...Evidence suggests that intervention use is optimized when DHIs are considered acceptable to end users. RecoverEsupport is a DHI designed to ...
The Acceptance and Use of Digital Technologies for Self ...We aim to assess oncology patients' perceptions of medication and communication safety during care transitions and their willingness to use digital technologies ...
ENABLE—App-Based Digital Capture and Intervention of ...The ENABLE study was designed to systematically evaluate HRQoL and AEs in patients with invasive breast cancer using digital questionnaires ...
The effectiveness of internet-based acceptance and ...This study contributes to the growing body of literature on the potential benefits of internet-based ACT for breast cancer patients. The ...
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