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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the feasibility and acceptability of the Mindset Moments™ (MM™) program in managing psychological distress and resiliency in adolescent and young adult cancer survivors. 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 check in within the app. Participants will also be asked to complete an online survey at the time of enrollment and at 4 and 8 weeks.

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 data supports the effectiveness of the treatment Resilience Reminders for mental health in cancer survivors?

The study on advanced cognitive training for breast cancer survivors showed that interventions like memory and speed of processing training improved cognitive function, mood, and quality of life, suggesting that similar treatments could help cancer survivors with mental health challenges. ^{1 2 3 4 5}

Is Resilience Reminders safe for cancer survivors?

The research articles provided do not contain specific safety data for Resilience Reminders or similar interventions. However, studies on related interventions for cancer survivors, such as cognitive training, reported high satisfaction and acceptability, suggesting they are generally well-tolerated. ^{2 5 6 7 8}

How is the Resilience Reminders treatment different from other mental health treatments for cancer survivors?

Resilience Reminders is unique because it likely focuses on providing ongoing psychological support through reminders, which may be delivered via mobile health applications, to help cancer survivors manage mental health challenges. This approach is different from traditional in-person therapy or medication, as it offers continuous, accessible support tailored to the needs of cancer survivors. ^{1 4 5 9 10}

Research Team

Sophia K Smith, PhD, MSW

Principal Investigator

Duke University

Eligibility Criteria

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

I am between 19 and 25 years old.

Prior AYA cancer diagnosis

Exclusion Criteria

I am unable to legally consent for myself.

I am not fluent in English.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

National estimates of mental health service use and unmet needs among adult cancer survivors. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Advanced cognitive training for breast cancer survivors: a randomized controlled trial. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

"Is My Brain Ever Going to Work Fully Again?": Challenges and Needs of Cancer Survivors with Persistent Cancer-Related Cognitive Impairment. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Systematic review on the effectiveness of mobile health applications on mental health of breast cancer survivors. [2023]

5. Germany 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. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Policies and Practices to Address Cancer's Long-Term Adverse Consequences. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

Anxiety, depression, and concentration in cancer survivors: National Health and Nutrition Examination Survey results. [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

Australian oncology health professionals' knowledge, perceptions, and clinical practice related to cancer-related cognitive impairment and utility of a factsheet. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Physical and mental health among cancer survivors: considerations for long-term care and quality of life. [2023]

10. Canada 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. [2022]