Living Well Program for Anxiety in Breast Cancer

Overseen By Angelica Angelica

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Scott A. Irwin, MD, PhD

Disqualifiers: Different cancer, Serious mental illness, Suicidal ideation, Active addiction

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

Compensation: Varies

Number of Visits: 8

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the Living Well Program, a digital therapy app with telecoaching, can reduce healthcare costs and ease anxiety in breast cancer patients. Participants will use the app and join telecoaching sessions to address anxiety over a 6-month period, followed by a follow-up phase. It suits individuals with stage II to IV breast cancer who experience moderate to severe anxiety and are beginning cancer treatment. As an unphased trial, this study provides a unique opportunity to explore innovative digital therapy solutions for managing anxiety.

What prior data suggests that the Living Well Program is safe for breast cancer patients with anxiety?

A previous study of the Living Well Program showed very few potential risks. The main concern was that some participants might feel upset when answering questions about their health. However, the study reported no serious side effects, suggesting that the program is generally safe for users. The program employs online support and phone coaching to help manage anxiety in breast cancer patients, aiming to improve mental health without significant risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Living Well Program because it offers a fresh approach to managing anxiety in breast cancer patients. Unlike traditional treatments such as medication and therapy sessions, this program utilizes a digital app combined with telecoaching sessions, making it more accessible and flexible for patients. This method empowers individuals to engage with their mental health management on their own schedule, potentially improving adherence and outcomes. The innovative use of technology in this program could redefine how supportive care is delivered to breast cancer patients, providing personalized support that fits into their daily lives.

What evidence suggests that the Living Well Program is effective for anxiety in breast cancer patients?

Research shows that the Living Well Program, which participants in this trial will engage with, can significantly reduce anxiety in breast cancer patients. Previous studies have shown promising results, with improvements in anxiety, fatigue, and sleep issues. For example, using apps like the Living Well Program led to noticeable decreases in anxiety symptoms for breast cancer patients. Additionally, participants reported high satisfaction with the program, finding it both helpful and enjoyable. These results suggest that using the Living Well app with support from a coach could effectively manage anxiety in breast cancer patients. ^{1 2 6 7 8}

Who Is on the Research Team?

Scott Irwin, MD

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

This trial is for breast cancer patients with moderate-to-severe anxiety. Participants must be diagnosed with stage II to IV breast cancer and experiencing mental health challenges like depression or anxiety disorders.

Inclusion Criteria

Prognosis of greater than 1 year

I am under the care of a Cedars-Sinai oncologist and about to start or have just started therapy before or after surgery.

I am 18 years old or older.

Exclusion Criteria

Current active addiction (drugs, alcohol, etc.) evidenced by Opioid Risk Tool, chart review and/or diagnosis codes

Serious mental illness evidenced by patient self-report, chart review and/or diagnosis codes

Presence of suicidal ideation as measured by the Ask Suicide-Screening Questions (ASQ) or a history of suicide attempts as evidenced by self-report or chart review

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Active Intervention

Participants use the Living Well app and complete 21 mental health modules and 5 telecoaching sessions over 3 months

3 months

5 telecoaching sessions (virtual)

Extended Monitoring

Participants complete any outstanding modules and telecoaching sessions while being monitored

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, with access to the app for continued use

6 months

Follow-up assessments at 3-, 6-, and 12-months post-baseline

What Are the Treatments Tested in This Trial?

Interventions

• Living Well Program

Trial Overview The study tests the Living Well Program, a digital app combined with telecoaching support, designed to improve mental health in breast cancer patients. It evaluates if this approach can reduce healthcare costs over a period of 9 months.

How Is the Trial Designed?

Group I: Intervention Arm Experimental Treatment 1 Intervention

The intervention arm will participate in the Living Well app modules and telecoaching sessions.

Who Is Running the Clinical Trial?

Scott A. Irwin, MD, PhD

Lead Sponsor

Trials

1

Recruited

4+

Cedars-Sinai Medical Center

Collaborator

Trials

523

Recruited

165,000+

Prosoma

Collaborator

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07236437

Living Well Program: Impact on Healthcare Costs and ... There have been promising preliminary results from previous studies of this intervention in reducing anxiety and depression in cancer patients.

2. accc-cancer.org accc-cancer.org/docs/documents/oncology-issues/articles/2024/v39-n2/v39-n2-the-impact-of-the-living-well-after-cancer-program-on-multiple-indicators-of-wellness-and-quality-of-life.pdf

The Impact of the Living Well After Cancer Program on ... Results of this study indicated statistically significant improvement in anxiety, fatigue, pain interference, physical functioning, sleep disturbance, social ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12057781/

Effects of using app-based interventions on quality of life ... The present study found that app-based interventions significantly improved anxiety symptoms in breast cancer patients, but the improvement in ...

4. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(25)00305-0/fulltext

Efficacy of an online mindfulness program (MindOnLine) to ... The study demonstrated significant reductions in FCR, anxiety, and depression at both 9 weeks and 9 months, suggesting durable psychological benefits. These ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2772696724000036

Interim results and program satisfaction of the EXCEL study Participants reported high satisfaction with program staff (average ​= ​4.5/5) and that the program was beneficial and enjoyable (average ​= ​4.6/5). Conclusion.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11064693/

App-based support for breast cancer patients to reduce ... The negative impact of unmanaged psychological distress on quality of life and outcome in breast cancer survivors has been demonstrated.

7. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-016-2858-0

Living well after breast cancer randomized controlled trial ... The Living Well after Breast Cancer randomized controlled trial aims to evaluate a 12-month telephone-delivered weight loss intervention (versus usual care) on ...

8. nature.com nature.com/articles/s41598-024-52574-7

Feasibility of online managing cancer and living ... CALM therapy can reduce depression, distress, attachment avoidance while improving quality of life in Chinese metastatic breast cancer patients.