Healthy Lifestyle Program for Young Cancer Survivors

(HEALTHY-AYA Trial)

Overseen By Caroline S Dorfman, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Pregnancy, Non-ambulatory, Major mental illness, others

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

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help young adult cancer survivors manage weight and improve heart health through a healthy lifestyle program called HEALTHY AYA. It targets those who have survived cancer but struggle with obesity and related symptoms like pain and fatigue. Participants will either join a group learning strategies for better diet and activity or receive general health information. Ideal candidates are young adults diagnosed with cancer between ages 18 and 39, with a BMI over 30, and who can exercise at home. As an unphased trial, this study offers a unique opportunity to contribute to research that could improve health outcomes for young adult cancer survivors.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this protocol is safe for young cancer survivors?

Research shows that healthy lifestyle programs can be safe and helpful for young cancer survivors. The "HEALTHY AYA" program assists with managing weight and symptoms through diet and exercise. This gentle approach teaches participants to handle symptoms like pain and tiredness while improving their diet and reducing sedentary time.

Specific data from past studies on the safety of this exact program is not available. However, similar programs are generally considered low-risk because they focus on improving daily habits, which typically do not cause harm. This program does not involve medications or surgery, reducing the chance of side effects.

In summary, although direct safety data for this program is lacking, its approach suggests it is well-tolerated. Participants learn to manage their health safely compared to more invasive treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the HEALTHY AYA program because it offers a fresh approach for young cancer survivors by focusing on lifestyle changes rather than traditional medical treatments. Unlike standard care, which might focus on medication or follow-up screenings, this program emphasizes cognitive and behavioral strategies to help manage symptoms and improve overall health. It uniquely combines improving diet and reducing sedentary behavior with mental health techniques, aiming to enhance long-term health outcomes for young survivors. By addressing these lifestyle factors, HEALTHY AYA could offer sustainable benefits that traditional treatments may not provide.

What evidence suggests that this program is effective for young cancer survivors?

Research has shown that young cancer survivors often face long-term health issues such as heart disease, high blood pressure, and diabetes. Weight gain and unhealthy habits can worsen these problems. Studies indicate that a healthy lifestyle, including a balanced diet and regular exercise, can help manage weight and reduce the risk of heart disease. In this trial, participants in the HEALTHY AYA program will undergo an 8-session intervention designed to teach young survivors effective ways to manage symptoms and improve habits to protect their heart health. This approach is based on the idea that changing daily habits can greatly enhance overall health and well-being. ^{2 4 6 7 8}

Who Is on the Research Team?

Caroline S Dorfman, PhD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for young adults aged 18-39 who had cancer and are within 2 years of completing treatment. Participants should have a BMI over 30, be healthy enough to do home-based exercise, and must understand English well enough to give informed consent.

Inclusion Criteria

I have had cancer in the past.

I finished my cancer treatments within the last 2 years.

I was diagnosed with cancer between 18 and 39 years old.

Exclusion Criteria

Current pregnancy

I cannot walk by myself.

Major mental illness (i.e., schizophrenia)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an 8-session intervention providing instruction in cognitive and behavioral symptom coping strategies as well as behavioral strategies to improve diet and decrease sedentary time

8 weeks

8 sessions (virtual)

Follow-up

Participants are monitored for changes in weight, diet, physical activity, and cardiovascular risk factors

up to 3 months

What Are the Treatments Tested in This Trial?

Interventions

• HEALTHY AYA

Trial Overview The study tests 'HEALTHY AYA', a program designed to help these survivors manage their weight and reduce cardiovascular risk through better eating habits and physical activity. It's compared with an education control group in a pilot randomized controlled trial.

How Is the Trial Designed?

Group I: HEALTHY AYA Experimental Treatment 1 Intervention

Participants randomized to the intervention arm will receive an 8 session intervention providing instruction in cognitive and behavioral symptom coping strategies as well as behavioral strategies to improve diet and decrease sedentary time.

Group II: Education Control Experimental Treatment 1 Intervention

Participants randomized to the education control arm will receive information about topics of relevance to adolescent and young adult cancer survivors including sleep, cognitive problems, finances, sexual health, and return to work/school.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Published Research Related to This Trial

A systematic review identified four studies focused on dietary interventions for adolescent and young adult (AYA) cancer survivors, all of which showed significant improvements in dietary quality or body composition despite the heterogeneity in participant age, cancer type, and intervention duration.

The review highlights the importance of tailored dietary interventions that consider the unique physiological and psychosocial needs of AYA cancer survivors, suggesting that future programs should incorporate social support and various delivery methods to enhance effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary Interventions for Adult Survivors of Adolescent and Young Adult Cancers: A Systematic Review and Narrative Synthesis. Skiba, MB., McElfresh, JJ., Howe, CL., et al.[2021]

This systematic review analyzed 17 studies involving 2314 adolescents and young adults (AYA) who are cancer survivors, highlighting that while there are positive outcomes from health promotion and psychological interventions, the overall quality of the studies is variable and often shows risk of bias.

Psychological and physical activity interventions were found to be more effective than general health promotion strategies, suggesting that targeted approaches may better support the health and well-being of AYA cancer survivors, although no specific interventions were conclusively favored.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health promotion and psychological interventions for adolescent and young adult cancer survivors: A systematic literature review. Bradford, NK., Chan, RJ.[2022]

There are over 600,000 adolescent and young adult cancer survivors at high risk for late effects from their treatments, highlighting the need for effective survivorship care plans (SCPs).

Current guidelines for AYA cancer survivorship care show significant disagreements on key aspects such as treatment exposure links to late effects and screening protocols, which can complicate follow-up care and impact the quality of life for survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is the Adolescent and Young Adult Cancer Survivor at Risk for Late Effects? It Depends on Where You Look. Barthel, EM., Spencer, K., Banco, D., et al.[2018]

Adolescent and young adult (AYA) cancer survivors showed better health behaviors than the general Australian population, with higher fruit and vegetable consumption and lower rates of obesity and smoking.

Despite these positive health behaviors, AYA cancer survivors experienced increased fatigue and lower health-related quality of life (HR-QoL), particularly among those not meeting physical activity guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health-related quality of life, fatigue and health behaviours in Australian adolescent and young adult cancer survivors. Murnane, A., Kiss, N., Fraser, SF., et al.[2022]

The ACCESS AYA program effectively increased health literacy and communication between adolescent and young adult cancer survivors and healthcare providers, as indicated by a high mean effectiveness rating of 4 out of 5 from participants.

The evaluation identified key themes such as survivor wellbeing and the importance of professional education, highlighting the need for ongoing resources to support AYA cancer survivors in managing their long-term health after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adolescent and Young Adult Cancer Survivorship Educational Programming: A Qualitative Evaluation. Vollmer Dahlke, D., Fair, K., Hong, YA., et al.[2020]

Adolescents and young adults (AYA) cancer survivors engage in risky health behaviors, such as smoking and drug use, at rates comparable to their peers, but they binge drink significantly less than the general population (61.0% vs. 76.6%).

Factors such as time since treatment, fear of health issues, and body mass index were identified as significant predictors of binge drinking among AYA cancer survivors, highlighting the need for further research into the influences on their health behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations Among Health Behaviors and Psychosocial Outcomes in Adolescent and Young Adult Cancer Survivors. Deleemans, JM., Zwicker, HM., Reynolds, KA., et al.[2021]

There is a growing population of long-term adolescent and young adult cancer survivors who face significant cancer-related health risks, highlighting the urgent need for effective health promotion programs.

Current research on lifestyle interventions for these survivors is limited, indicating a need for increased prioritization and funding to integrate health education into pediatric oncology care, similar to the focus on disease control in cancer trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Education and health promotion in adolescent and young adult cancer survivors. Hudson, MM., Patte, C.[2016]

Healthy lifestyle interventions (HLSIs) that combine exercise and education significantly improve health-related quality of life (HR-QoL) in childhood and adolescent cancer survivors, especially when these interventions last at least 6 months and are conducted in groups.

While HLSIs focused solely on health education also enhance self-efficacy, the physical outcomes such as exercise capacity and body mass index did not show significant improvements, indicating a need for further research in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthy lifestyle interventions for childhood and adolescent cancer survivors: a systematic review and meta-analysis. Kang, KA., Han, SJ., Chun, J., et al.[2023]

Teenage and young adult cancer survivors express a strong desire for age-appropriate lifestyle information on topics like physical activity, diet, and sun safety, indicating a need for tailored health interventions.

Social support plays a crucial role in helping these survivors change their health behaviors and build self-efficacy, suggesting that health professionals should incorporate support systems into lifestyle interventions throughout the cancer care process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Lifestyle Information and Intervention Preferences of Teenage and Young Adult Cancer Survivors: A Qualitative Study. Pugh, G., Hough, R., Gravestock, H., et al.[2022]

Adolescent and young adult (AYA) cancer survivors face specific long-term challenges and risks related to their treatment and disease, which can significantly impact their quality of life.

An interprofessional survivorship clinic has been developed to address the unique needs of AYA cancer survivors aged 18-39, aiming to provide tailored support and care for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adolescent and Young Adult Cancer Survivors: Development of an Interprofessional Survivorship Clinic. Colabroy, D.[2021]

Adolescent and young adult (AYA) cancer survivors, particularly those aged 20 to 29 and female survivors, are more likely to forgo necessary health care due to cost compared to their peers without a cancer history, with a relative risk of 1.67.

Despite similar rates of being uninsured between survivors and controls, the study highlights that AYA cancer survivors face significant cost barriers that may prevent them from accessing health care, which could hinder early detection of late effects from their cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Limitations in health care access and utilization among long-term survivors of adolescent and young adult cancer. Kirchhoff, AC., Lyles, CR., Fluchel, M., et al.[2018]

A systematic review of 14 studies involving 1519 lung cancer survivors found that healthy lifestyle-based interventions significantly improved quality of life, reduced psychological distress, and alleviated cancer-related symptoms compared to control groups.

The interventions varied widely in their components and implementation, but overall, they demonstrated a beneficial effect on the well-being of lung cancer patients, although the optimal timing for these interventions remains unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of healthy lifestyle-based interventions in lung cancer survivors: a systematic review and meta-analysis. Heredia-Ciuró, A., Martín-Núñez, J., López-López, JA., et al.[2022]

A survey of 73 adolescent and young adult cancer survivors revealed that 93.2% reported facing multiple cancer-specific barriers to maintaining healthy behaviors, with an average of 5 barriers per family.

There were significant correlations between barriers to physical activity, nutrition, and sleep, indicating that addressing these areas together in wellness interventions could be beneficial for AYA survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer-Related Barriers to Health Behaviors Among Adolescent and Young Adult Survivors of Pediatric Cancer and Their Families. Marchak, JG., Kegler, MC., Meacham, LR., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5292773/

Health Status of Adolescent and Young Adult Cancer ... A significantly greater proportion of AYA cancer survivors reported having cardiovascular disease, hypertension, asthma, and diabetes compared with respondents ...

2. healthcaredelivery.cancer.gov healthcaredelivery.cancer.gov/aya/

Adolescent & Young Adult Health Outcomes & Patient ... The adolescent and young adult (AYA) population between the ages of 15 and 39 years has seen little or no improvement in cancer survival rates for decades.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0305737225001148

Long-term surveillance recommendations for young adult ... Advancements in cancer treatment have led to increased survival rates among young adult cancer survivors (YACS). However, these individuals face unique ...

4. link.springer.com link.springer.com/article/10.1007/s11764-024-01597-0

Health-related conditions among long-term cancer ... Health-related conditions among long-term cancer survivors diagnosed in adolescence and young adulthood (AYA): results of the SURVAYA study.

5. ascopubs.org ascopubs.org/doi/abs/10.1200/JCO.23.01465

Psychological Outcomes in Adolescent and Young Adult ... Overall, AYA survivors appear to be at elevated risk of emotional distress symptoms, mood and anxiety disorders, suicide, and mental health care ...

6. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.3322/caac.70030

Talking with adolescent and young adult cancer survivors ... AYA survivors are a heterogeneous group that includes people between the ages of 15 and 39 years who were treated for cancer during their ...

7. massgeneral.org massgeneral.org/cancer-center/patient-and-family-resources/supportive-care/adolescent-and-young-adult-program

Adolescent and Young Adult (AYA) Cancer Program The Adolescent and Young Adult (AYA) Cancer Program was created to optimize the care, outcomes, and experiences of adolescent and young adult patients (ages 15 ...

8. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.e24048

Healthy lifestyle behaviors among a diverse population of ... Background: Adolescent and young adults (AYA) cancer survivors have worse long-term physical health than survivors of adult cancers.