Resilience Reminders for Mental Health in Cancer Survivors

Overseen By Andrea Pires, MS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Legal incapacity, Non-English speakers

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

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called Mindset Moments™ (also known as Resilience Reminders) to help young cancer survivors manage stress and build resilience. Participants will join online group sessions and complete daily activities focused on relaxation and positive thinking. The goal is to determine if this program is both feasible and effective in easing emotional distress. The trial seeks young adults aged 19-25 who have completed their main cancer treatments and are experiencing significant stress. As an unphased trial, this study offers a unique opportunity for participants to contribute to innovative research that could enhance emotional well-being for future cancer survivors.

Do I need to stop taking my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Mindset Moments™ program is safe for managing psychological distress in cancer survivors?

Research shows that resilience programs, like the one under study, are generally safe for improving mental health. Resilience involves bouncing back from tough times, and studies indicate it can help maintain or quickly recover mental health during difficult periods.

These programs often aim for positive outcomes, such as improved quality of life and well-being. Sources report no serious side effects, suggesting low risks. The treatment includes activities like guided imagery and check-ins using cognitive behavioral therapy (CBT). These practices are widely used and known to be safe and well-tolerated.

While specific data on the safety of the Mindset Moments™ program is not available, similar programs have not shown significant safety concerns. As this program is non-invasive, it is likely safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Resilience Reminders is unique because it focuses on enhancing mental health in cancer survivors through a blend of online group sessions and app-based daily activities. Unlike traditional treatments, which may focus primarily on medication or one-on-one therapy, this approach combines cognitive behavioral therapy (CBT) with guided imagery in a digital format. Researchers are excited about this method because it offers a flexible, accessible way for survivors to build resilience and support mental well-being, potentially filling gaps left by conventional therapies.

What evidence suggests that the Resilience Reminders program is effective for managing psychological distress in cancer survivors?

Research has shown that resilience programs can greatly improve the mental health and quality of life for cancer patients. One study found that these programs help patients become more resilient and improve their mental well-being, making it easier for them to cope with stress. Another study found that online mental health tools can help manage the common emotional distress experienced by cancer patients. Resilience, the ability to bounce back from challenges, is important for improving life quality and reducing symptoms of depression and PTSD (post-traumatic stress disorder). Overall, evidence suggests that resilience-building programs can effectively support the mental health of cancer survivors. Participants in this trial will engage in the "Resilience Reminders" program, which involves attending eight weekly, one-hour, live online group sessions and completing daily 5-minute activities such as guided imageries and CBT (cognitive behavioral therapy) check-ins within the app. ^{6 7 8 9 10}

Who Is on the Research Team?

Sophia K Smith, PhD, MSW

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for young adults aged 19-25 who have survived adolescent or young adult cancer and finished their main treatment. They must be experiencing some psychological distress, indicated by a score of 3+ on the Distress Thermometer. Participants need to be fluent in English and able to consent.

Inclusion Criteria

Score of 3 or above on the Distress Thermometer at the time of recruitment

Prior AYA cancer diagnosis

I am between 19 and 25 years old.

Exclusion Criteria

I am unable to legally consent for myself.

I am not fluent in English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants attend 8 weekly, one-hour, live online group sessions and complete daily 5-minute activities such as guided imageries and CBT check-ins within the app

8 weeks

8 visits (virtual)

Follow-up

Participants are monitored for psychological outcomes such as anxiety, depression, PTSD symptoms, and distress

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Resilience Reminders

Trial Overview

The study tests the Resilience Reminders program's ability to help manage stress and build resilience in young cancer survivors. It includes weekly online group sessions for two months, daily activities via an app, and surveys at the start, halfway point, and end.

How Is the Trial Designed?

Group I: Interventional arm Experimental Treatment 1 Intervention

Study participation will involve attending 8 weekly, one hour, live online group sessions and completing daily 5 minute activities such as guided imageries and CBT (cognitive behavioral therapy) check-in within the app.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Published Research Related to This Trial

The CanCope Mind (CM) intervention is a web-based program designed to improve emotion regulation and mental health in cancer survivors, and it is being compared to a healthy lifestyle intervention (CanCope Lifestyle) in a randomized controlled trial with 224 participants.

This study is significant as it is one of the first to specifically target emotion regulation in cancer survivors through an internet-delivered format, with assessments planned at multiple time points to evaluate its efficacy in reducing anxiety and depression symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing an Internet-Delivered, Emotion-Focused Intervention Compared With a Healthy Lifestyle Active Control Intervention in Improving Mental Health in Cancer Survivors: Protocol for a Randomized Controlled Trial. Smith, IS., Wallace, R., Wellecke, C., et al.[2022]

A systematic review of 11 randomized trials involving 2249 breast cancer survivors found that psychological mobile health interventions, primarily based on cognitive behavioral therapy, showed limited effectiveness in improving mental health outcomes, with only a few studies reporting significant short-term benefits for psychological distress.

Despite some short-term improvements in specific areas like distress and anxiety, there was no evidence of long-term benefits beyond three months, and a notable percentage of participants either did not start or discontinued the interventions, highlighting the need for better-designed studies in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review on the effectiveness of mobile health applications on mental health of breast cancer survivors. Horn, A., Jírů-Hillmann, S., Widmann, J., et al.[2023]

The Finding My Way (FMW) online intervention for cancer survivors showed significant improvements in emotional functioning at 3 months and reduced health service utilization immediately after the intervention, indicating potential short-term benefits for participants.

However, while both the FMW and control groups experienced reductions in cancer-related distress, there were no significant differences between the groups over time, suggesting that the FMW intervention may not provide long-term advantages beyond its active use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Finding My Way: results of a multicentre RCT evaluating a web-based self-guided psychosocial intervention for newly diagnosed cancer survivors. Beatty, L., Kemp, E., Coll, JR., et al.[2020]

In a study involving 82 breast cancer survivors, both memory training and speed of processing training showed significant improvements in cognitive function, with speed of processing training leading to immediate and lasting enhancements in processing speed and verbal memory.

Participants reported high satisfaction and acceptability for both interventions, indicating that these cognitive training programs could be beneficial and well-received by breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advanced cognitive training for breast cancer survivors: a randomized controlled trial. Von Ah, D., Carpenter, JS., Saykin, A., et al.[2022]

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