Stress Management Program for Depression and Anxiety in Young Adults With Cancer
(PRISM Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Dana-Farber Cancer Institute
Disqualifiers: Pregnancy, Prisoners, Suicidality, others
No Placebo Group
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.
12345Is 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.
678910How 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.
1241112Eligibility 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 between 18 and 25 years old.
+4 more
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
+2 more
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: PRISM ProgramExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Dana-Farber Cancer InstituteBrighton, MA
Dana-Farber Cancer InstituteBoston, MA
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Who Is Running the Clinical Trial?
Dana-Farber Cancer InstituteLead Sponsor
References
Hope and benefit finding: Results from the PRISM randomized controlled trial. [2020]Adolescents and young adults (AYAs) with cancer are at risk for poor psychosocial outcomes, perhaps because they have not acquired skills to navigate the adversities of illness. In a recent phase II randomized controlled trial (RCT), the "Promoting Resilience in Stress Management" (PRISM) intervention was associated with improved patient-reported resilience, quality of life, and distress. In this planned analysis of secondary aims, we hypothesized PRISM would also improve targeted coping skills of hopeful thinking, benefit finding, and goal setting.
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]Adolescents and young adults (AYAs) with cancer have a high risk of poor psychosocial outcomes. The Promoting Resilience in Stress Management (PRISM) intervention is one of few psychosocial interventions targeting younger people with cancer that has demonstrated efficacy in a randomized clinical trial.
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]Promoting Resilience in Stress Management (PRISM), a psychosocial intervention for adolescents and young adults (AYAs) with serious illness, enhances resilience resources via four skills-based training sessions. A recent randomized controlled trial showed PRISM improved health-related quality of life (HRQOL) compared to usual care (UC). This post hoc exploratory analysis aimed to better understand the effect of PRISM on HRQOL by describing changes in HRQOL subdomain scores. English-speaking AYAs (12-25 years) with cancer were randomized to PRISM or UC. At enrollment and six months later, HRQOL was assessed using the Pediatric Quality of Life Inventory (PedsQL) Generic Short Form (SF-15) and Cancer Module. Scores at each time point were summarized descriptively and individual HRQOL trajectories were categorized (
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]Adolescents and young adults (AYAs) with cancer are at high risk of poor psychosocial outcomes, and evidence-based interventions designed to meet their psychosocial and communication needs are lacking. The main objective of this project is to test the efficacy of a new adaptation of the Promoting Resilience in Stress Management intervention for AYAs with Advanced Cancer (PRISM-AC).
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]Background Adolescents and young adults (AYAs) with cancer are at high risk of poor psychosocial outcomes, and evidence-based interventions designed to meet their psychosocial and communication needs are lacking. The main objective of this project is to test the efficacy of a new adaptation of the Promoting Resilience in Stress Management intervention for AYAs with Advanced Cancer (PRISM-AC). Methods/design: The PRISM-AC trial is a 2-arm, parallel, non-blinded, multisite, randomized controlled trial. 144 participants with advanced cancer will be enrolled and randomized to either usual, non-directive, supportive care without PRISM-AC ("control" arm) or with PRISM-AC ("experimental" arm). PRISM is a manualized, skills-based training program comprised of four 30-60 minute, one-on-one sessions targeting AYA-endorsed resilience resources (stress-management, goal-setting, cognitive-reframing, and meaning-making). It also includes a facilitated family meeting and a fully equipped smartphone app. The current adaptation includes an embedded advance care planning module. English- or Spanish-speaking individuals 12-24 years old with advanced cancer (defined as progressive, recurrent, or refractory disease, or any diagnosis associated with
A virtual resiliency program for lymphoma survivors: helping survivors cope with post-treatment challenges. [2022]Objectives To adapt and test the feasibility, acceptability, and preliminary efficacy of an 8-week resiliency group program for posttreatment lymphoma survivors.Design and outcomes. This is an exploratory mixed methods study. Phase 1: We conducted qualitative interviews to inform program adaptation. Phase 2: Using a single-arm pilot design, we assessed program feasibility, acceptability, and preliminary efficacy (exploratory outcomes: stress coping, uncertainty intolerance, distress). We also examined the feasibility of collecting hair cortisol samples.Results. Phase 1: Survivors reported feeling socially isolated as they grappled with lingering symptoms that interfered with their return to normalcy. Fears about recurrence triggered bodily hypervigilance. Survivors desired wellness programs that 1) target their whole-body experience, 2) promote social connectedness, and 3) manage fear of recurrence. Phase 2: Thirty-seven survivors enrolled. Participants completed a median of 7/8 sessions, and 76.9% completed ≥6/8 sessions; 65% provided a hair sample. Survivors demonstrated improvements in stress coping (d = .67), uncertainty tolerance (d = .71), and anxiety (d = .41) at program completion.Conclusions. Findings suggest promising feasibility and efficacy of this program in addressing posttreatment survivorship challenges, particularly fears of uncertainty. A cancer care model that adopts early integration of this program posttreatment has the potential to improve survivors' emotional, social and physical well-being.
Distress and Psychosocial Needs: Demographic Predictors of Clinical Distress After a Diagnosis of Cancer. [2019]Patients with cancer have increased rates of clinical distress compared to healthy individuals. Programs are needed to screen patients for distress and make appropriate psychosocial referrals.
Stress Management and Resilience Training (SMART) program to decrease stress and enhance resilience among breast cancer survivors: a pilot randomized clinical trial. [2022]This randomized controlled trial assessed the effect of a SMART (Stress Management and Resiliency Training) program among 25 women diagnosed with breast cancer. Resilience, perceived stress, anxiety, and quality of life improved at 12 weeks in the active but not the control arm. A brief training in the SMART program can enhance resilience and quality of life and decrease stress and anxiety.
Stress Management Interventions to Facilitate Psychological and Physiological Adaptation and Optimal Health Outcomes in Cancer Patients and Survivors. [2023]Cancer diagnosis and treatment constitute profoundly stressful experiences involving unique and common challenges that generate uncertainty, fear, and emotional distress. Individuals with cancer must cope with multiple stressors, from the point of diagnosis through surgical and adjuvant treatments and into survivorship, that require substantial psychological and physiological adaptation. This can take a toll on quality of life and well-being and may also promote cellular and molecular changes that can exacerbate physical symptoms and facilitate tumor growth and metastasis, thereby contributing to negative long-term health outcomes. Since modifying responses tostressors might improve psychological and physiological adaptation, quality of life, and clinical health outcomes, several randomized controlled trials have tested interventions that aim to facilitate stress management. We review evidence for the effects of stress management interventions on psychological and physiological adaptation and health outcomes in cancer patients and survivors and summarize emerging research in the field to address unanswered questions.
Web-based stress management for newly diagnosed cancer patients (STREAM-1): a randomized, wait-list controlled intervention study. [2018]Being diagnosed with cancer causes major psychological distress, yet the majority of newly diagnosed cancer patients lack psychological support. Internet interventions overcome many barriers for seeking face-to-face support and allow for independence in time and place. We assess efficacy and feasibility of the first web-based stress management intervention (STREAM: STREss-Aktiv-Mindern) for newly diagnosed, German-speaking cancer patients.
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]The "Promoting Resilience in Stress Management" intervention is a skills-based, early palliative care intervention with demonstrated efficacy in adolescents and young adults with cancer.
The Promoting Resilience in Stress Management (PRISM) intervention for adolescents and young adults receiving hematopoietic cell transplantation: a randomized controlled trial protocol. [2022]Psychological distress is prevalent among adolescents and young adults (AYAs) receiving hematopoietic cell transplantation (HCT). The Promoting Resilience in Stress Management (PRISM) intervention is a resilience-coaching program that has been shown to mitigate distress and improve quality of life among AYAs receiving chemotherapy for newly diagnosed or advanced cancer. This article describes the protocol of an ongoing randomized-controlled trial (RCT) examining the efficacy of PRISM among AYAs receiving HCT for cancer and/or blood disorders.