R01CA269574

Promoting resilience in early survivorship among adolescents and young adults with cancer - project summary.

Adolescents and early young adults (AYAs, 12-25 years-old) with cancer are at high risk of poor psychosocial outcomes because their distinct developmental challenges add to the burden of cancer. This is particularly true when AYAs transition from active treatment to cancer-surveillance ("early survivorship") because this time demands increasing autonomy, re-integration into social, educational/vocational networks, and re-evaluation of self-identity.

We created "Promoting Resilience in Stress Management" (PRISM): a novel, brief, skills-based program promoting AYA-endorsed "resilience resources" (stress-management, goal-setting, positive-reframing, and meaning-making). PRISM involves 4, 30-60 minute telehealth sessions between AYAs and certified PRISM coaches, plus an award-winning smartphone app.

In a phase 2 randomized trial of 92 AYAs receiving cancer-treatment, PRISM improved patient-reported resilience, quality of life, hope, benefit-finding, and psychological distress early after its delivery, compared to usual care. While these findings were promising, they were tempered by 3 key threats to PRISM's scalability: (1) PRISM's delivery demands scarce human resources that might be replaced by digital media; (2) PRISM's durability was limited after the study ended; and, (3) we lacked tools to recognize real-time changes in AYA distress that warranted additional support.

Thus, we now propose a multi-center, sequential, multiple assignment, randomized trial (SMART) to address these 3 barriers among AYA survivors of cancer. Specifically, we aim to: (1) evaluate the efficacy of video- and text-PRISM coaching vs. the self-guided MPRISM app; (2) determine the optimal method for maintenance of PRISM-response; and (3) explore correlations between patient-reported resilience, distress, hope, quality of life, anxiety, and depression with validated instruments and: (a) in-app resilience and stress ratings, and (b) digital phenotype (passive smart-phone data including phone/text logs and accelerometer data).

With SMART design, N=325 English or Spanish speaking AYAs from 3 diverse U.S. regions (Northwest/Alaska/Hawaii, Midwest, and South) who completed cancer-directed therapy within the past 2 years will be randomized 1:2:2 first to receive app-only, video, or text-based PRISM lay-coaching. Responders in the video- and text- arms will be randomized 1:1 second to app-only (low) maintenance or text-based (high) maintenance. Because non-response suggests a demand for more in-person engagement, text non-responders will be non-randomly assigned to video, and video non-responders will receive referrals to specialty care.

Exploratory analyses will evaluate the role of in-app and digital phenotypic data in detecting real-time AYA distress. This proposal is significant because early survivorship is highly stressful for AYAs with cancer, and we propose a scalable, evidence-based program to support AYA resilience. Findings will facilitate an accessible, sustainable, evidence-based program designed to target and meet the needs of thousands of AYAs, in turn alleviating the burdens of cancer survivorship and improving their quality of life.

Dana-Farber Cancer Institute

TO IDENTIFY CANCER RISKS AND RISK REDUCTION STRATEGIES, TO IDENTIFY FACTORS THAT CAUSE CANCER IN HUMANS, AND TO DISCOVER AND DEVELOP MECHANISMS FOR CANCER PREVENTION AND PREVENTIVE INTERVENTIONS IN HUMANS. RESEARCH PROGRAMS INCLUDE: (1) CHEMICAL, PHYSICAL AND MOLECULAR CARCINOGENESIS, (2) SCREENING, EARLY DETECTION AND RISK ASSESSMENT, INCLUDING BIOMARKER DISCOVERY, DEVELOPMENT AND VALIDATION, (3) EPIDEMIOLOGY, (4) NUTRITION AND BIOACTIVE FOOD COMPONENTS, (5) IMMUNOLOGY AND VACCINES, (6) FIELD STUDIES AND STATISTICS, (7) CANCER CHEMOPREVENTION AND INTERCEPTION, (8) PRE-CLINICAL AND CLINICAL AGENT DEVELOPMENT, (9) ORGAN SITE STUDIES AND CLINICAL TRIALS, (10) HEALTH-RELATED QUALITY OF LIFE AND PATIENT-CENTERED OUTCOMES, AND (11) SUPPORTIVE CARE AND MANAGEMENT OF SYMPTOMS AND TOXICITIES. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO EXPAND AND IMPROVE THE SBIR PROGRAM, TO STIMULATE TECHNICAL INNOVATION, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT FUNDING, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION IN INNOVATION AND ENTREPRENEURSHIP BY WOMEN AND SOCIALLY/ECONOMICALLY DISADVANTAGED PERSONS. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT FUNDING, AND FOSTER PARTICIPATION IN INNOVATION AND ENTREPRENEURSHIP BY WOMEN AND SOCIALLY/ECONOMICALLY DISADVANTAGED PERSONS.

93.393 - Cancer Cause and Prevention Research

National Cancer Institute (NCI) [HHS - NIH]

Boston, Massachusetts 022155418 United States

Single Zip Code

Cancer Prevention and Control Clinical Trials Grant Program (R01 Clinical Trial Required) (PAR-21-035)

Amendment Since initial award the total obligations have increased 284% from $930,291 to $3,572,750.