36 Participants Needed

Healthy Lifestyle Program for Young Cancer Survivors

(HEALTHY-AYA Trial)

CS
Overseen ByCaroline S Dorfman, PhD
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Duke University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.16789

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.710111213

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

CS

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.
See 4 more

Exclusion Criteria

Current pregnancy
I cannot walk by myself.
Major mental illness (i.e., schizophrenia)
See 1 more

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
2Treatment groups
Experimental Treatment
Group I: HEALTHY AYAExperimental Treatment1 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 ControlExperimental Treatment1 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.

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

References

Dietary Interventions for Adult Survivors of Adolescent and Young Adult Cancers: A Systematic Review and Narrative Synthesis. [2021]
The Lifestyle Information and Intervention Preferences of Teenage and Young Adult Cancer Survivors: A Qualitative Study. [2022]
Education and health promotion in adolescent and young adult cancer survivors. [2016]
Effectiveness of healthy lifestyle-based interventions in lung cancer survivors: a systematic review and meta-analysis. [2022]
Healthy lifestyle interventions for childhood and adolescent cancer survivors: a systematic review and meta-analysis. [2023]
Associations Among Health Behaviors and Psychosocial Outcomes in Adolescent and Young Adult Cancer Survivors. [2021]
Health-related quality of life, fatigue and health behaviours in Australian adolescent and young adult cancer survivors. [2022]
Limitations in health care access and utilization among long-term survivors of adolescent and young adult cancer. [2018]
Cancer-Related Barriers to Health Behaviors Among Adolescent and Young Adult Survivors of Pediatric Cancer and Their Families. [2023]
Adolescent and Young Adult Cancer Survivorship Educational Programming: A Qualitative Evaluation. [2020]
Health promotion and psychological interventions for adolescent and young adult cancer survivors: A systematic literature review. [2022]
12.United Statespubmed.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 Statespubmed.ncbi.nlm.nih.gov
Adolescent and Young Adult Cancer Survivors: Development of an Interprofessional Survivorship Clinic. [2021]
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