Symptoms and General Pathology

All Conditions

Rare Diseases

Chronic Pain

Pain

Chronic Graft Versus Host Disease

AYACS will participate in a 16-week physical activity program. AYACS will be instructed to start with a session duration of \<15-min, three days per week at low intensity (e.g., activities expending \>1.5 to 3 METs or intensity \<5 on a scale of 0 to 10). Any type of physical activity will be acceptable. The program will be individualized, and activity increased according to patients' health status, results from the physical function assessment, and most recent week's achieved physical activities. The program will include support calls and texts from research staff (exercise physiologist). The program will be modified and adapted during support calls or texts, including frequency, intensity, time and type to maximize AYACS' success. AYACS will receive a Fitbit at the beginning of the intervention.

Physical activity intervention coupled with standard post-cancer directed treatment care

AYACS in the control group will not participate in a 16-week physical activity program and will not receive support calls or texts. Physical activity advice according to the Exercise Guidelines for Cancer Survivors will be offered to AYACS following completion of 16-week follow-up. Moreover, AYACS will receive a Fitbit following completion of 16-week follow-up

Standard post-cancer directed treatment care control

Maxime Caru, PhD, PhD

Smita Dandekar, MD

The purpose of this study is to demonstrate that integration of exercise intervention into standard post-cancer directed treatment care will improve patient reported pain, decrease the need for medications to manage chronic pain and improve functional and psychosocial outcomes in survivors of cancers in adolescents and young adults (AYA). Our central hypothesis is that integration of exercise interventions into standard post-cancer directed treatment care will be acceptable and feasible while improving patients' pain, decreasing the cumulative dose of pain medication and improving patients' functional and psychosocial outcomes as compared to patients who only receive standard post-cancer directed treatment care.

Exercise and Pain in AYACS

Exercise Intervention Coupled With Standard Post-cancer Directed Treatment Care to Reduce Chronic Pain in Adolescents and Young Adult Cancer Survivors Who Have Completed Cancer-directed Therapy Less Than One Year

The number of participants approached who agree to participate in the study

The number of participants randomized to the physical activity program intervention coupled with standard post-cancer directed treatment care who complete at least 50% of the physical activity intervention

Self-reported chronic pain questionnaire using the Brief Pain Inventory Range 0 to 10, Higher scores indicate more pain and greater interference

Chart review: number of pain medications prescribed, total dosage and length of time prescribed.

Self-reported pain medication: usage of prescription medication and information about the use of non-prescription pain medications (e.g., over the counter oral and topical pain medications).

The Prescription Drug Monitoring Program will be accessed to gather information on all filled prescriptions for controlled substances within the state of Pennsylvania.

Morphine equivalent dose will be calculated for each patient after looking at the total daily amount of each opioid the patient is taking. Using the standard conversion factors developed by the CDC, the Morphine milligram equivalent equates the many different opioids into a standard value that is based on morphine and its potency providing an easily interpretable metric for representing opioid utilization

Psychosocial questionnaires using the NIH developed PROMIS questionnaires, including self-reported physical function mobility, anxiety, depressive symptoms, fatigue, social isolation, pain interference, pain intensity, sleep disturbance, sleep-related impairment and cognitive function PROMIS questionnaires assessing patient-reported outcomes on 5-point Likert scale (min value: 1 to max value: 5) responses

Self-reported physical activity questionnaire using the Godin-Shephard leisure-time physical activity questionnaire.

* Less than 14 units: Insufficiently active
* 14 to 23 units: Moderately active
* 24 units or more: Active

Self-reported physical activity questionnaire using the International Physical Activity Questionnaire-Short Form

* Self-reports physical activity frequency
* Self-reports physical activity intensity
* Self-reports physical activity time
* Self-reports physical activity type

Validated physical function tests, including the 6-min walking test Further distances indicate greater physical function

Validated physical function tests, including the 30-second chair stand test Greater amounts of sit/stands indicate greater physical function

Validated physical function tests, including the "Timed Up and Go" test Shorter durations indicate greater physical function

Validated physical function tests, including the grip strength test Greater grip strength indicate greater physical function

Milton S. Hershey Medical Center

Principal Investigator

Nutritional and Metabolic Diseases

Fatigue

Obesity

Body Weight

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.

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.

8-session health lifestyle behavior intervention combining behavioral symptom management strategies with strategies to improve diet and increase physical activity.

HEALTHY AYA

Participants will receive paper materials on topics of relevance to adolescent and young adult cancer survivors.

Education Control

Caroline S Dorfman, PhD

Caroline Dorfman, PhD

Smrithi Divakaran, MPH

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.

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.

Healthy Lifestyles After Cancer for Adolescents and Young Adults: A Program to Reduce Cardiovascular Risk Factors

Improving Cardiovascular Disease Risk Factors in Survivors of Adolescent and Young Adult Cancer With Obesity: Adaptation and Pilot Testing of a Behavioral Weight and Symptom Management Intervention

The Self-Efficacy for Managing Chronic Disease Scale is a 6-item scale. Participants rate their confidence in keeping pain, fatigue, emotional distress, and other symptoms from interfering with things they want to do on a scale from 1 "not at all confident" to 10 "totally confident."

The Weight Efficacy Lifestyle Questionnaire is an 8-item measure of eating self-efficacy. Participants are asked to provide information about how certain they are that they can resist overeating in difficult situation (e.g., over the weekend, when tired, etc.). Response choices range from 0= "not at all confident" to 10= "very confident."

Both systolic and dyastolic blood pressure will be assessed at the baseline and follow-up assessment.

Cholesterol will be assessed through peripheral blood at the baseline and follow-up assessment.

LDL will be assessed through peripheral blood at the baseline and follow-up assessment

HDL will be assessed through peripheral blood at the baseline and follow-up assessments.

Triglycerides will be assessed through peripheral blood at the baseline and follow-up assessments.

HbA1c will be assessed through peripheral blood at the baseline and follow-up assessments.

The 10 year risk for ASCVD is calculated using a patient's age, sex, race, systolic blood pressure, diastolic blood pressure, total cholesterol, HDL, LDL, history of diabetes, smoking status, whether or not they're on hypertension treatment, and whether or not they're on statin.

Number of participants recruited over the course of 12 months.

Treatment feasibility will be assessed by measuring the session attendance rate for each participant.

Participant attrition will be assessed by measuring the number of participants who drop out of the study

The Treatment Acceptability Questionnaire is a six-item scale assessing participants' views of an intervention as acceptable, ethical, and effective.

Items are rated on a 7-point Likert scale (e.g., 1 "very unacceptable" to 7 "very acceptable).

Intervention satisfaction will be assessed using the SSTS-R, a 13-item measure with the first 12-items on a five-point scale ranging from 1 "strongly disagree" to 5 "strongly disagree." The 13th item asks, "How much did the program help with the specific concern that led you to participate?" with 5 answer choices ranging from "made things a lot better" to made things a lot worse."

Intervention will be evaluated using 3 open-ended questions, including the following: "1) What was the most helpful part of the program?," "2) What was the least helpful part of the program?", and "3) What suggestions do you have for us to help improve the program?"

Eating behaviors will be assessed using the Three Factor Eating Questionnaire (TFEQ). The 21-item short-form will be used for the present study. The TFEQ measures three domains of eating behavior: 1) cognitive restraint, 2) uncontrolled eating, and 3) emotional eating.

Participants will be weighed at each assessment.

The Dietary Screener Questionnaire is a 25-item measure asking participants to rate on the frequency of eating/drinking certain foods in the last week.

The L-Cat is a measure of physical activity. Individuals identify which descriptive category best describes their level of activity during leisure time in the last month. Descriptive categories range from inactive to very active.

The BPI is a 9-item self-report measure assessing pain severity. Participants rate their pain on a scale from 0 to 10 where 0 represents "no pain" and 10 represents "pain as bad as you can imagine." Participants also rate their level of interference from pain.

The Promis Fatigue Scale is a 8-item self-report measure of fatigue in the last week. Participants are asked to respond to items (e.g., "I felt fatigued", "I have troubled starting things because I am tired") using scales ranging from 1 to 5.

Depressive Symptoms will be assessed using the PROMIS Depression Short Form, an 8-item measure assessing symptoms of depression in the last week. Participants are asked to respond to items (e.g., "I felt sad," "I felt helpless") using a five-point scale ranging from 1 "never" to 5 "always."

Symptoms of Anxiety will be assessed using the PROMIS Anxiety Short Form, an 8-item measure assessing symptoms of anxiety in the last week. Participants are asked to respond to items (e.g., "I felt nervous," "I felt tense") using a five-point scale ranging from 1 "never" to 5 "always".

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Exercise and Pain in AYACS	NCT05562570	AYA Cancer Surv...	Physical activi... Standard post-c...	18 Years -	Milton S. Hershey Medical Center
Healthy Lifestyles After Cancer for Adolescents and Young Adults: A Program to Reduce Cardiovascular Risk Factors	NCT05869604	Cancer Cardiovascular ... Weight Manageme... Pain Fatigue Distress, Emoti... Physical Inacti...	HEALTHY AYA Education Contr...	18 Years - 39 Years	Duke University
Exercise and Pain in AYACS	NCT05562570	AYA Cancer Surv...	Physical activi... Standard post-c...	18 Years -	Milton S. Hershey Medical Center
Healthy Lifestyles After Cancer for Adolescents and Young Adults: A Program to Reduce Cardiovascular Risk Factors	NCT05869604	Cancer Cardiovascular ... Weight Manageme... Pain Fatigue Distress, Emoti... Physical Inacti...	HEALTHY AYA Education Contr...	18 Years - 39 Years	Duke University

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