Supportive Care for Young Adult Cancer Survivors

Not currently recruiting at 4 trial locations

Overseen By Study Intake

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Fred Hutchinson Cancer Center

Disqualifiers: Subsequent malignancy, Stem cell transplant, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if an interactive program can help young adults who have survived cancer access better healthcare resources and manage their health more effectively. Participants will either use a mobile app called INSPIRE, which includes telehealth support, or access a website with helpful links. This trial suits young adults who completed treatment for certain cancers, such as leukemia or breast cancer, at least six months ago and are within five years of their diagnosis. Participants should be comfortable using a smartphone or the internet. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance healthcare access and management for young cancer survivors.

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

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 prior data suggests that this interactive survivorship program is safe for young adult cancer survivors?

Research has shown that programs like the INSPIRE program, which assist young cancer survivors, are generally safe. Studies have not reported any safety issues or negative effects. This program helps survivors manage their health better using digital tools and resources, aiming to improve access to healthcare information and support.

Although no specific studies have shown negative effects, the program is not a drug or medical procedure. It uses mobile apps and online resources for health management, making physical side effects less likely compared to traditional medical treatments.

Overall, participants have well-received these interactive programs. They are designed to be supportive and informative, providing young cancer survivors with tools to help them thrive after treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Interactive Survivorship Program because it provides a personalized approach to support young adult cancer survivors. Unlike traditional care, which often focuses more on clinical follow-ups, this program offers a mobile application called INSPIRE that tailors support to each individual's needs, enhancing their survivorship journey. Additionally, the program includes the option for telehealth stepped care, ensuring users receive timely and personalized support beyond just information access. This digital and interactive approach could transform how young survivors manage their health and well-being post-treatment.

What evidence suggests that the Interactive Survivorship Program is effective for young adult cancer survivors?

Studies have shown that the Interactive Survivorship Program, or INSPIRE, helps young adult cancer survivors by improving their access to healthcare resources. In this trial, participants in one arm will use the INSPIRE mobile app and may receive telehealth care for personalized support. This approach encourages adherence to healthcare guidelines and reduces anxiety about cancer. By enhancing understanding of health information and self-care skills, INSPIRE enables young survivors to take better care of themselves. ^{1 2 3 4 6}

Who Is on the Research Team?

K. Scott Baker, MD

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

This trial is for young adult cancer survivors aged 18 or older who were diagnosed with leukemia, lymphoma, melanoma, sarcoma, breast, thyroid, or colorectal cancer between ages 15-39. They must be within 1-5 years of diagnosis and have finished active treatment at least 6 months ago. Participants need to understand English and have access to email and a smartphone or internet.

Inclusion Criteria

I finished my active cancer treatment more than 6 months ago.

English proficiency adequate to complete assessments

I have undergone treatment for my advanced disease, including surgery, chemotherapy, targeted therapy, or radiation.

Exclusion Criteria

Does not complete baseline patient reported outcome (PRO) assessment items required to determine stratification or whether the survivor meets inclusion and exclusion criteria

I have been diagnosed with a new cancer that is not non-melanoma skin cancer.

Health issues prohibiting computer use or ability to comply with study procedures

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a personalized Survivorship Care Plan and use the INSPIRE mobile application. Telehealth stepped care may be provided after 1 month.

12 months

Monthly virtual check-ins

Control

Participants receive access to a control website with resources. After 12 months, they receive a personalized SCP and access to the digital INSPIRE program.

12 months

Access to online resources

Follow-up

Participants are monitored for healthcare adherence and distress levels after the intervention.

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Interactive Survivorship Program

Trial Overview The INSPIRE-AYA study tests an interactive program designed to help adolescent and young adult cancer survivors by improving their access to healthcare resources. The goal is to enhance health literacy, self-management skills, adherence to care guidelines and reduce distress related to their past cancer experience.

How Is the Trial Designed?

Group I: Arm I (INSPIRE, telehealth care) Experimental Treatment 4 Interventions

Patients receive a personalized SCP and use the INSPIRE mobile application. Patients may receive telehealth stepped care after 1 month.

Group II: Arm II (control website) Active Control 2 Interventions

Patients receive access to a study-specific control website that has annotated links to existing resources for AYA survivors. After 12 months, patients receive a personalized SCP and have access to the digital INSPIRE intervention program without telehealth calls.

Who Is Running the Clinical Trial?

Fred Hutchinson Cancer Center

Lead Sponsor

Trials

583

Recruited

1,341,000+

Fred Hutchinson Cancer Research Center

Lead Sponsor

Trials

444

Recruited

148,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Young adult cancer survivors (YAS) show high satisfaction with Internet-based survivorship care plans (SCPs), with 93% reporting content satisfaction and 71% sharing their plans with healthcare providers.

Despite experiencing significant late effects like fatigue and neurocognitive concerns, YAS reported fewer late effects overall compared to older adult survivors, suggesting that SCPs may effectively address their specific needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survivorship Care Planning for Young Adults After Cancer Treatment: Understanding Care Patterns and Patient-Reported Outcomes. Szalda, D., Schapira, MM., Jacobs, LA., et al.[2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39561920/

INteractive survivorship program to improve health care ... The INteractive Survivorship Program to Improve Health care REsources [INSPIRE] is designed to improve adherence to AYA health care guidelines and reduce ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04593277

Study Details | NCT04593277 | Interactive Survivorship ... This trial studies how well an interactive survivorship program works in improving healthcare resources in adolescent and young adult cancer survivors.

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2020-04792

Interactive Survivorship Program for the Improvement of ... This trial studies how well an interactive survivorship program works in improving healthcare resources in adolescent and young adult cancer survivors.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714424003288

INteractive survivorship program to improve health care ... Adolescents and young adults with cancer (AYAs, ages 15–39 at the time of diagnosis) experience significant adverse health and psychosocial outcomes.

5. withpower.com withpower.com/trial/phase-3-skin-neoplasms-2022-125c7

Supportive Care for Young Adult Cancer Survivors This trial studies how well an interactive survivorship program works in improving healthcare resources in adolescent and young adult cancer survivors.

6. researchprotocols.org researchprotocols.org/2024/1/e59222

Digitizing Survivorship Care Plans Through the POST ... Conclusions: This study is among the first to digitize the SCP in a mobile app and test the effects of a mobile health–delivered behavioral ...