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Trial Title:
Healthy Lifestyles After Cancer for Adolescents and Young Adults: A Program to Reduce Cardiovascular Risk Factors
NCT ID:
NCT05869604
Condition:
Cancer
Cardiovascular Diseases
Weight Management
Pain
Fatigue
Distress, Emotional
Physical Inactivity
Conditions: Official terms:
Cardiovascular Diseases
Conditions: Keywords:
AYA Cancer Survivors
Symptom management
Health Behavior Change
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
HEALTHY AYA
Description:
8-session health lifestyle behavior intervention combining behavioral symptom management
strategies with strategies to improve diet and increase physical activity.
Arm group label:
HEALTHY AYA
Intervention type:
Other
Intervention name:
Education Control
Description:
Participants will receive paper materials on topics of relevance to adolescent and young
adult cancer survivors.
Arm group label:
Education Control
Summary:
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.
Detailed description:
There are close to 700,000 survivors of adolescent and young adult (AYA) cancer (aged 15
to 39 at diagnosis) in the US. Advances in treatment have yielded five year survival
rates of >80% suggesting that the majority of AYAs will become long-term cancer
survivors. While trends in survival are encouraging, the survivorship trajectories for
AYAs are 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. AYA cancer survivors have more than a
two-fold risk of CVD when compared to age-matched peers and are at significantly greater
risk of cardiac mortality. 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. Adolescence and young adulthood are important developmental periods for the
establishment of lifelong healthy behaviors, yet few AYA cancer survivors adhere to
recommended guidelines for healthy eating or activity. Moreover, they report struggling
to identify and maintain strategies to manage diet, improve nutrition, and increase
activity. AYA survivors' efforts to engage in positive health behaviors (i.e., adhere to
exercise and nutrition recommendations) necessary to manage weight may also be challenged
by persistent cancer-related symptoms (i.e., pain, fatigue, psychological distress).
Thus, weight gain is common, with >50% of AYA survivors classified as overweight or
obese. Interventions for AYAs with obesity that aim to lower CVD risk through weight
management, however, are rare and do not address symptoms that challenge healthy eating
and activity despite recognition of the importance of improving health behaviors and
symptom management in AYAs' transition to survivorship. The PI recently developed and
evaluated a 12-session, in-person behavioral weight and symptom management intervention
for breast cancer survivors with obesity and their intimate partners. Based on input from
AYA cancer survivors, this intervention was adapted for AYA cancer survivors with obesity
to produce an intervention responsive to AYAs' unique needs. A pilot RCT will be
conducted to examine intervention feasibility and acceptability as well as patterns of
change in outcomes. N=36 AYAs will be randomized to the intervention or education control
arms. The protocol will be delivered via videoconferencing over 8 sessions. Assessments
will be completed at baseline and post-treatment. AYAs will be weighed, have their blood
pressure taken, complete a blood draw, and respond to self-report measures (e.g.,
symptoms, symptom interference, diet, activity). Weight and body mass index (BMI) will be
assessed. Other CVD risk factors to be assessed include blood pressure, cholesterol
(total, HDL, LDL), HbA1c, and atherosclerotic cardiovascular disease (ASCVD) risk score.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- History of cancer
- Diagnosed with cancer between the ages of 18 and 39
- Within 5 years of completing cancer treatments
- BMI >30
- Healthy enough to participate in home-based physical activity
- Able to speak and read English
- Able to provide informed consent
Exclusion Criteria:
- Current pregnancy
- Non-ambulatory
- Major mental illness (i.e., schizophrenia)
- untreated /uncontrolled mental illness (i.e., bipolar disorder)
Gender:
All
Minimum age:
18 Years
Maximum age:
39 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Duke University
Address:
City:
Durham
Zip:
27705
Country:
United States
Status:
Recruiting
Contact:
Last name:
Caroline Dorfman, PhD
Phone:
919-416-3473
Email:
caroline.dorfman@duke.edu
Contact backup:
Last name:
Smrithi Divakaran, MPH
Phone:
919-681-7695
Email:
smrithi.divakaran@duke.edu
Start date:
December 1, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Duke University
Agency class:
Other
Source:
Duke University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05869604
