Stress Management Program for Depression and Anxiety in Young Adults With Cancer

(PRISM Trial)

Recruiting at 1 trial location

Overseen By Samantha Bento, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Pregnancy, Prisoners, Suicidality, others

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

Compensation: Varies

Number of Visits: 9

Duration: 6-12 weeks

15 Participants Needed

Trial Summary

What is the purpose of this trial?

This research study is being done to test the feasibility of an existing supportive program (PRISM) to address psychological symptoms (i.e., depressive and anxiety symptoms) that young adult participants diagnosed with cancer or desmoid tumor may experience. The name of the intervention used in this research study is: -Promoting Resilience in Stress Management (PRISM) Program

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the treatment Promoting Resilience in Stress Management Program (PRISM) for depression and anxiety in young adults with cancer?

Research shows that the PRISM program, which helps young people with cancer build resilience (the ability to recover from difficulties), has been effective in improving their quality of life and reducing distress. It has also been shown to enhance coping skills like hopeful thinking and finding benefits in challenging situations. ^{1 2 3 4 5}

Is the Stress Management Program for Depression and Anxiety in Young Adults With Cancer safe?

Research on similar stress management programs, like the SMART program for breast cancer survivors and a virtual resiliency program for lymphoma survivors, suggests they are generally safe and can improve stress coping, anxiety, and quality of life without reported safety concerns. ^{6 7 8 9 10}

How is the PRISM treatment different from other treatments for depression and anxiety in young adults with cancer?

The PRISM treatment is unique because it focuses on building resilience and coping skills, such as hopeful thinking and goal setting, specifically for young adults with cancer, which is not commonly addressed by other treatments. It is a skills-based program that has shown effectiveness in improving quality of life and reducing distress in this group. ^{1 2 4 11 12}

Research Team

Samantha Bento, PhD

Principal Investigator

Dana-Farber Cancer Institute

Greta Jankauskaite, PhD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

This trial is for young adults with cancer who are experiencing symptoms of depression and anxiety. The study aims to see if a program called PRISM can help manage these psychological symptoms.

Inclusion Criteria

Support persons must be a friend or family member invited by the study participant to join the 6th PRISM session

I was diagnosed with cancer that has not spread more than 6 weeks ago.

I am currently undergoing cancer treatment or finished it within the last 6 months.

Exclusion Criteria

Patients who score >14 on PHQ-9 and/or GAD-7

Individuals who report any suicidality (ideation, plan, and/or intent) at the time of the eligibility screening

Individuals who score <10 on both PHQ-9 and GAD-7

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person or virtual)

Baseline Assessment

Participants complete baseline questionnaires and a diagnostic assessment of depressive and anxiety symptoms

1 week

1 visit (in-person or virtual)

Treatment

Participants undergo the PRISM intervention, consisting of 6 weekly or bi-weekly psychotherapy sessions

6-12 weeks

6 visits (remote or in-clinic)

Post-Intervention Assessment

Participants complete final questionnaires and a post-study exit interview

1 week

1 visit (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Promoting Resilience in Stress Management Program

Trial Overview The intervention being tested is the Promoting Resilience in Stress Management (PRISM) Program, which is designed to support young adults with cancer by addressing their depressive and anxiety symptoms.

Participant Groups

Group I: PRISM Program Experimental Treatment 1 Intervention

Participants will be enrolled and will complete study procedures as follows: * Baseline visit with questionnaires. * 6 weekly or bi-weekly remote or in-clinic, psychotherapy sessions with psychologist. * Final questionnaires and post-study exit interview

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Findings from Research

The PRISM intervention significantly improved coping skills related to benefit finding and hopeful thinking in adolescents and young adults with cancer, with moderate-to-large effect sizes observed in a study of 92 participants.

Despite the positive effects on benefit finding and hope, PRISM did not show a significant impact on goal setting, suggesting that while it enhances certain coping strategies, further development may be needed to address goal-setting skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hope and benefit finding: Results from the PRISM randomized controlled trial. Rosenberg, AR., Bradford, MC., Barton, KS., et al.[2020]

The PRISM intervention, a skills-based coaching program for adolescents and young adults with cancer, led to significant improvements in quality of life, hope, and resilience, with these benefits sustained for up to 24 months after the program ended.

Among participants who showed initial improvement after 6 months, those in the PRISM group were more likely to maintain their positive outcomes in quality of life and psychological well-being compared to those receiving usual care, indicating the long-term efficacy of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of the Promoting Resilience in Stress Management Intervention for Adolescent and Young Adult Survivors of Cancer at 2 Years: Secondary Analysis of a Randomized Clinical Trial. Rosenberg, AR., Zhou, C., Bradford, MC., et al.[2022]

The PRISM intervention, which includes four skills-based training sessions, significantly improved health-related quality of life (HRQOL) in adolescents and young adults with cancer compared to usual care, particularly in psychosocial areas.

Participants in the PRISM group showed more positive changes in specific HRQOL subdomains, such as treatment anxiety and cognitive function, indicating that PRISM effectively enhances resilience and overall wellbeing in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Psychosocial Intervention's Impact on Quality of Life in AYAs with Cancer: A Post Hoc Analysis from the Promoting Resilience in Stress Management (PRISM) Randomized Controlled Trial. Steineck, A., Bradford, MC., Lau, N., et al.[2022]

The PRISM-AC trial aims to evaluate the effectiveness of a new resilience training program for adolescents and young adults (AYAs) with advanced cancer, involving 144 participants across multiple sites, focusing on improving their health-related quality of life and reducing distress.

This intervention includes skills-based training in stress management and goal-setting, along with a family meeting and a smartphone app, potentially offering a comprehensive approach to support AYAs and their caregivers during a challenging time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for the promoting resilience in stress management (PRISM) intervention: a multi-site randomized controlled trial for adolescents and young adults with advanced cancer. O'Daffer, A., Comiskey, L., Scott, SR., et al.[2023]

The PRISM-AC trial aims to evaluate the effectiveness of a new intervention designed to improve psychosocial outcomes for adolescents and young adults (AYAs) with advanced cancer, involving 144 participants across multiple sites.

This intervention includes skills-based training in resilience resources and aims to enhance health-related quality of life, reduce anxiety and depression, and support family involvement, potentially offering a valuable resource for this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for The Promoting Resilience in Stress Management (PRISM) Intervention: a multi-site randomized controlled trial for adolescents and young adults with advanced cancer. O'Daffer, A., Comiskey, L., Scott, SR., et al.[2023]

An 8-week resiliency group program for posttreatment lymphoma survivors showed promising feasibility, with 76.9% of participants completing at least 6 out of 8 sessions, indicating strong acceptability among survivors.

Participants demonstrated significant improvements in stress coping, uncertainty tolerance, and anxiety, suggesting that the program effectively addresses emotional and social challenges faced by survivors after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A virtual resiliency program for lymphoma survivors: helping survivors cope with post-treatment challenges. Perez, GK., Walsh, EA., Quain, K., et al.[2022]

In a study of over 1,200 cancer patients, nearly 50% reported clinically significant levels of distress, highlighting the need for effective screening and psychosocial support.

Younger patients, single individuals, and females were more likely to experience higher distress levels, suggesting that these demographic factors can help identify those who may benefit from early interventions and support services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Distress and Psychosocial Needs: Demographic Predictors of Clinical Distress After a Diagnosis of Cancer. Hamilton, J., Kruse, H., Holcomb, L., et al.[2019]

The SMART (Stress Management and Resiliency Training) program significantly improved resilience, reduced perceived stress and anxiety, and enhanced quality of life in 25 women with breast cancer over a 12-week period, compared to a control group.

The intervention, which included group training sessions and follow-up calls, was found to be feasible and effective, indicating that brief resilience training can be beneficial for breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stress Management and Resilience Training (SMART) program to decrease stress and enhance resilience among breast cancer survivors: a pilot randomized clinical trial. Loprinzi, CE., Prasad, K., Schroeder, DR., et al.[2022]

Cancer patients experience significant stress that can negatively impact their quality of life and may even promote tumor growth and metastasis, highlighting the importance of effective stress management.

Randomized controlled trials have shown that stress management interventions can improve psychological and physiological adaptation, potentially leading to better health outcomes for cancer patients and survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stress Management Interventions to Facilitate Psychological and Physiological Adaptation and Optimal Health Outcomes in Cancer Patients and Survivors. Antoni, MH., Moreno, PI., Penedo, FJ.[2023]

The STREAM intervention, a web-based stress management program for newly diagnosed cancer patients, aims to improve quality of life and reduce anxiety and depression through eight modules with minimal psychologist contact, involving 120 participants in a controlled trial.

This study is significant as it explores the feasibility and efficacy of online psychological support for cancer patients, potentially offering a cost-effective and accessible alternative to traditional face-to-face therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-based stress management for newly diagnosed cancer patients (STREAM-1): a randomized, wait-list controlled intervention study. Grossert, A., Urech, C., Alder, J., et al.[2018]

The 'Promoting Resilience in Stress Management' intervention showed positive effects on resilience, hope, quality of life, and distress in adolescents and young adults with cancer, based on a study of 92 participants.

However, the intervention was less effective for those living in disadvantaged neighborhoods, suggesting that socioeconomic factors may influence the efficacy of this palliative care approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining key sociodemographic characteristics of adolescents and young adults with cancer: A post hoc analysis of the Promoting Resilience in Stress Management randomized clinical trial. Lau, N., Bradford, MC., Steineck, A., et al.[2022]

The ongoing randomized-controlled trial aims to evaluate the efficacy of the PRISM resilience-coaching program in reducing depression and anxiety among adolescents and young adults (AYAs) receiving hematopoietic cell transplantation (HCT) for cancer, with a target enrollment of 90 participants across four US centers.

The PRISM intervention includes four coaching sessions focused on stress management and cognitive restructuring, and it is hypothesized that AYAs receiving PRISM will report lower levels of psychological distress compared to those receiving standard psychosocial care, with outcomes assessed at 3 and 6 months post-enrollment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Promoting Resilience in Stress Management (PRISM) intervention for adolescents and young adults receiving hematopoietic cell transplantation: a randomized controlled trial protocol. Fladeboe, KM., Scott, S., Comiskey, L., et al.[2022]

References

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

Hope and benefit finding: Results from the PRISM randomized controlled trial. [2020]

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

Assessment of the Promoting Resilience in Stress Management Intervention for Adolescent and Young Adult Survivors of Cancer at 2 Years: Secondary Analysis of a Randomized Clinical Trial. [2022]

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

A Psychosocial Intervention's Impact on Quality of Life in AYAs with Cancer: A Post Hoc Analysis from the Promoting Resilience in Stress Management (PRISM) Randomized Controlled Trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Protocol for the promoting resilience in stress management (PRISM) intervention: a multi-site randomized controlled trial for adolescents and young adults with advanced cancer. [2023]

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

Protocol for The Promoting Resilience in Stress Management (PRISM) Intervention: a multi-site randomized controlled trial for adolescents and young adults with advanced cancer. [2023]

6. England pubmed.ncbi.nlm.nih.gov

A virtual resiliency program for lymphoma survivors: helping survivors cope with post-treatment challenges. [2022]

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

Distress and Psychosocial Needs: Demographic Predictors of Clinical Distress After a Diagnosis of Cancer. [2019]

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

Stress Management and Resilience Training (SMART) program to decrease stress and enhance resilience among breast cancer survivors: a pilot randomized clinical trial. [2022]

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

Stress Management Interventions to Facilitate Psychological and Physiological Adaptation and Optimal Health Outcomes in Cancer Patients and Survivors. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Web-based stress management for newly diagnosed cancer patients (STREAM-1): a randomized, wait-list controlled intervention study. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Examining key sociodemographic characteristics of adolescents and young adults with cancer: A post hoc analysis of the Promoting Resilience in Stress Management randomized clinical trial. [2022]

12. England pubmed.ncbi.nlm.nih.gov

The Promoting Resilience in Stress Management (PRISM) intervention for adolescents and young adults receiving hematopoietic cell transplantation: a randomized controlled trial protocol. [2022]