Healthy Lifestyle Program for Young Cancer Survivors

(HEALTHY-AYA Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Caroline S Dorfman, PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Duke University

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

No Placebo Group

Trial Summary

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.

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}

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)

Trial 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 (Behavioural Intervention)

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Duke University Durham, NC

Who Is Running the Clinical Trial?

Duke University Lead Sponsor

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] Adolescent and young adult (AYA) cancer survivors, here defined as individuals diagnosed with cancer between 15 and 39 years of age, are at high risk for adverse late-term metabolic effects of treatment through adulthood. Diet is a modifiable lifestyle behavior that may improve metabolic health outcomes in AYA cancer survivors. However, the details of dietary interventions for this unique population remain largely undescribed. In this systematic review, we aim to synthesize the results of dietary interventions for adult AYA cancer survivors. Seven databases and clinical trial registries were searched in March 2019 for interventions targeting dietary behaviors in AYA cancer survivors (PROPSERO systematic review number: CRD42019126376). Descriptive statistics and a narrative synthesis were completed to detail intervention participants and components. After full text review of 233 studies, four studies met all inclusion criteria. All studies were heterogeneous for participant age, cancer type, and duration, and were designed for feasibility and preliminary efficacy. Included studies followed different dietary guidance; however, each resulted in a significant change on a primary outcome of either dietary quality or body composition. Three of the four studies included a theoretical framework, where self-efficacy was a central construct. Counseling, in person, telephone, or electronic, provided behavioral support. Results of this systematic review suggest high potential to change dietary behaviors in AYA, but interventions remain limited. AYA cancer survivors demonstrate unique physiological and psychosocial needs, and future interventions designed to address this care gap should be targeted for this population with consideration of social support, delivery mode, and individual tailoring.

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] Little is currently known about how best to promote healthy lifestyle choices among teenage and young adult (TYA) cancer survivors. Such data gathered from a patient-centered perspective are instrumental for the development of health behavior change interventions for young people with cancer.

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

Education and health promotion in adolescent and young adult cancer survivors. [2016] The increasing numbers of long-term adolescent and young adult cancer survivors and their well-established risk of cancer-related morbidity strongly support the need for effective health promotion programs that motivate and sustain positive lifestyle changes. To date, the priority of these initiatives has been relatively low as only a handful of studies have been organized that prospectively evaluate lifestyle interventions and health education curricula with these aims. To effectively integrate lifestyle interventions into pediatric oncology care, prioritization and funding of health promotion research efforts must be comparable to that of disease control in frontline cancer trials.

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

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

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

Healthy lifestyle interventions for childhood and adolescent cancer survivors: a systematic review and meta-analysis. [2023] This study investigated the effects of healthy lifestyle interventions (HLSIs) on health-related quality of life (HR-QoL) in childhood and adolescent cancer survivors (CACS).

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

Associations Among Health Behaviors and Psychosocial Outcomes in Adolescent and Young Adult Cancer Survivors. [2021] Purpose: Adolescents and young adults (AYA) experience challenges both during and after their cancer treatment. Health behaviors are important contributors to health, yet little research examines health behaviors in AYA cancer survivors. We examined frequencies of health behaviors and associations between health behaviors, psychosocial, and clinical factors in AYA cancer survivors. Methods: Participants were survivors of AYA cancer (n = 60; 38.3% male; mean age = 25.3 years [standard deviation, SD = 4.6]; mean years since therapy completion = 9.0 [SD = 4.2]) from the Alberta Children's Hospital (ACH). Survivors were 13-21 years old at the time of diagnosis. Measures included demographic and clinical data, and the ACH Long-Term Survivor's Questionnaire. Health behaviors were compared with a control group (n = 600) using data from the 2017 Canadian Community Health Survey. Frequencies, conditional logistic regression, and logistic regression analyses were conducted. Results: Compared with controls, survivors reported engaging in physical activity (91.5% vs. 87.5%; odds ratio [OR] = 0.87, 95% confidence interval [CI] = 0.34-2.24; p = 0.77), smoking tobacco (15.3% vs. 19.7%; OR = 1.85, 95% CI = 0.89-3.85; p = 0.10), and street drug use (27.6% vs. 36.5%; OR = 1.60, 95% CI = 0.88-2.91; p = 0.12) at the same rate. Survivors reported binge drinking significantly less (61.0% vs. 76.6%; OR = 0.53, 95% CI = 0.30-0.92; p = 0.024) than controls. Logistic regression analyses revealed a significant model predicting binge drinking [χ2(5, 58) = 23.17, p < 0.001] with greater time off treatment, fear of another health condition, and higher mean body mass index emerging as significant predictors. Conclusion: AYA cancer survivors engage in risky health behaviors at rates similar to their peers. Further research is needed to understand factors mediating survivors' decision to participate in risky health behaviors.

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] Current knowledge of the long-term health behaviours and well-being of adolescent and yong adult (AYA) cancer survivors is limited. The aim of this study was to evaluate the health behaviours of AYA cancer survivors compared to Australian normative data and describe their health-related quality of life (HR-QoL) and levels of fatigue.

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] Health care outcomes for long-term survivors of adolescent and young adult (AYA) cancer were compared with young adults without a cancer history, using the 2009 Behavioral Risk Factor Surveillance System data.

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] Adolescent and young adult (AYA) survivors of pediatric cancer and their caregivers frequently do not meet national guidelines for physical activity (PA), nutrition, or sleep. Respondents from N = 73 AYA-aged (mean [M] = 19.0 years, range = 11-30 years) survivor families completed a survey on cancer-related barriers to health behaviors. Almost all respondents (68/73, 93.2%) endorsed ≥1 cancer-specific barrier(s) to current health behaviors (median = 5, standard deviation = 3.42, range = 0-16) in their family. Cancer-related barriers to PA, nutrition, and sleep were positively correlated (PA-nutrition: r = 0.39, p = 0.001; PA-sleep: r = 0.41, p < 0.001; nutrition-sleep: r = 0.52, p < 0.001). Wellness interventions are needed to address the unique needs of AYA-aged survivors and support multiple health behaviors simultaneously.

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

Adolescent and Young Adult Cancer Survivorship Educational Programming: A Qualitative Evaluation. [2020] This program evaluation considers the need for increased professional and patient education for adolescent and young adult (AYA) cancer survivorship. Due to the high incidence of late effects of cancer treatment among AYA cancer survivors, knowledge sharing and communications are needed throughout the transition from cancer care into community care. AYA survivors are likely to need developmentally appropriate psychosocial care as well as extensive follow-on surveillance by physicians who are educated and aware of the likely chronic conditions and late effects that may occur in these patients.

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

Health promotion and psychological interventions for adolescent and young adult cancer survivors: A systematic literature review. [2022] The effects of cancer and treatment have severe and long lasting negative impacts on quality of life. Adolescents and Young Adults (AYA) have high survival rates but may not reach their full life potential because of these consequences. This review aims to identify, appraise and synthesise the effects of health promotion and psychological interventions for AYA after cancer treatment.

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] The adolescent and young adult (AYA) population is a growing group of survivors, exceeding more than 600,000, at high risk for late effects of cancer-directed therapy. While many guidelines exist for cancer survivorship care, choosing which to use for an AYA cancer survivor is challenging, yet vital, to ensure comprehensive follow-up care.

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

Adolescent and Young Adult Cancer Survivors: Development of an Interprofessional Survivorship Clinic. [2021] Adolescent and young adult (AYA) cancer survivors experience unique needs and challenges, including the long-term risk of adverse treatment and disease effects. In addition, consequences of the cancer experience may profoundly affect their quality of life. This article describes the development of an interprofessional survivorship clinic established to meet the unique needs of AYA cancer survivors aged 18-39 years.