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

36 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment HEALTHY AYA for young cancer survivors?

Research shows that dietary interventions can improve dietary quality and body composition in young cancer survivors, suggesting that lifestyle changes like those in the HEALTHY AYA program may be effective. Additionally, healthy lifestyle interventions have been shown to enhance the quality of life in childhood and adolescent cancer survivors, indicating potential benefits for young cancer survivors. ^{1 2 3 4 5}

Is the Healthy Lifestyle Program for Young Cancer Survivors safe for participants?

The research does not provide specific safety data for the Healthy Lifestyle Program or its variations like HEALTHY AYA, but it suggests that health behavior interventions for young cancer survivors are generally focused on improving lifestyle factors such as diet and physical activity, which are typically safe. However, specific safety evaluations for this program are not detailed in the available studies. ^{1 6 7 8 9}

How is the Healthy Lifestyle Program for Young Cancer Survivors different from other treatments for young cancer survivors?

The Healthy Lifestyle Program for Young Cancer Survivors is unique because it focuses on promoting health behaviors and improving quality of life through lifestyle changes, rather than traditional medical treatments. This approach addresses the long-term well-being and psychosocial needs of young cancer survivors, which are often overlooked in standard cancer care. ^{7 10 11 12 13}

What is the purpose of this trial?

There are close to 700,000 survivors of adolescent and young adult (AYA) cancer (aged 15 to 39 at diagnosis) in the US. Survivorship for AYAs is often complicated by long-term and late-effects. Cardiovascular disease (CVD), in particular, is a leading cause of death for cancer survivors and is a growing public health concern for survivors diagnosed as AYAs. Risk of CVD may be associated with treatment exposures and may be potentiated by weight gain and poor health behaviors. Healthy eating and physical activity are key behaviors for weight loss and maintenance and may be protective against CVD risk, yet few AYA cancer survivors adhere to guidelines for healthy eating or activity. AYA survivors' abilities to engage in health behaviors (i.e., healthy eating, physical activity) necessary to manage weight may also be challenged by persistent cancer-related symptoms (i.e., pain, fatigue, psychological distress). Thus, weight gain is common. Using input from AYA cancer survivors, the investigators have adapted a behavioral weight and symptom management protocol for AYA cancer survivors with obesity to create an intervention that is responsive to AYAs' unique needs. A pilot randomized controlled trial will be conducted to examine intervention feasibility and acceptability and to examine patterns of change in outcomes including weight, body mass index, symptoms (e.g., pain, fatigue, distress) as well as other CVD risk factors, including blood pressure, cholesterol (total, HDL, LDL), HbA1c, and atherosclerotic cardiovascular disease (ASCVD) risk score.

Research Team

Caroline S Dorfman, PhD

Principal Investigator

Duke University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

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 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]

References

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

Dietary Interventions for Adult Survivors of Adolescent and Young Adult Cancers: A Systematic Review and Narrative Synthesis. [2021]

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

The Lifestyle Information and Intervention Preferences of Teenage and Young Adult Cancer Survivors: A Qualitative Study. [2022]

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

Education and health promotion in adolescent and young adult cancer survivors. [2016]

4. Germany pubmed.ncbi.nlm.nih.gov

Effectiveness of healthy lifestyle-based interventions in lung cancer survivors: a systematic review and meta-analysis. [2022]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Healthy lifestyle interventions for childhood and adolescent cancer survivors: a systematic review and meta-analysis. [2023]

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

Associations Among Health Behaviors and Psychosocial Outcomes in Adolescent and Young Adult Cancer Survivors. [2021]

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

Health-related quality of life, fatigue and health behaviours in Australian adolescent and young adult cancer survivors. [2022]

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

Limitations in health care access and utilization among long-term survivors of adolescent and young adult cancer. [2018]

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

Cancer-Related Barriers to Health Behaviors Among Adolescent and Young Adult Survivors of Pediatric Cancer and Their Families. [2023]

10. Canada pubmed.ncbi.nlm.nih.gov

Adolescent and Young Adult Cancer Survivorship Educational Programming: A Qualitative Evaluation. [2020]

11. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

Is the Adolescent and Young Adult Cancer Survivor at Risk for Late Effects? It Depends on Where You Look. [2018]

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

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