Supportive Care for Young Adult Cancer Survivors

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

549 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Interactive Survivorship Program for young adult cancer survivors?

A study on cancer survivorship care for young adults showed that a self-management intervention improved symptoms like distress, insomnia, fatigue, pain, and depression compared to usual care, suggesting that supportive care programs can be beneficial for young adult cancer survivors. ^{1 2 3 4 5}

What makes the Interactive Survivorship Program unique for young adult cancer survivors?

The Interactive Survivorship Program is unique because it focuses on providing personalized support and education to young adult cancer survivors, helping them manage the long-term effects of cancer treatment and improve their quality of life. Unlike standard treatments, it emphasizes self-advocacy and building a supportive community among survivors. ^{1 3 6 7 8}

What is the purpose of this trial?

This trial studies how well an interactive survivorship program works in improving healthcare resources in adolescent and young adult cancer survivors. By improving access to survivorship resources, health literacy, self-management skills, and support, an interactive survivorship program may help to improve adherence to adolescent and young adult healthcare guidelines and reduce cancer-related distress.

Research Team

K. Scott Baker, MD

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Scotland pubmed.ncbi.nlm.nih.gov

Cancer-specific distress, supportive care needs and satisfaction with psychosocial care in young adult cancer survivors. [2020]

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

Cancer survivorship care for young adults: a risk-stratified, multicenter randomized controlled trial to improve symptoms. [2022]

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

Engagement and experience with cancer-related follow-up care among young adult survivors of childhood cancer after transfer to adult care. [2018]

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

Systematic Review of the Impact of Cancer Survivorship Care Plans on Health Outcomes and Health Care Delivery. [2022]

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

"You're too young for this": adolescent and young adults' perspectives on cancer survivorship. [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

Advocacy skills training for young adult cancer survivors: the Young Adult Survivors Conference at Camp Māk-a-Dream. [2018]

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

Survivorship Care Planning for Young Adults After Cancer Treatment: Understanding Care Patterns and Patient-Reported Outcomes. [2019]

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

"There Should Have Been a More Holistic Approach"-A Qualitative Study of Young Adult Cancer Survivors' Experiences of Follow-up After Cancer Treatment. [2022]