The intervention arm will receive a 12 month mobile health (mHealth) physical activity intervention with a goal of increasing their moderate-vigorous intensity physical activity levels by 90 minutes per week above baseline

Controls will receive general health education materials

The intervention includes a physical activity prescription, a Polar activity tracker watch, access to a private AYA cancer survivor community through the Polar Flow community platform, mHealth nudges and surveys via text messaging, and regular phone or email contact from study staff.

Physical Activity

Leanne Dickau

Pamela Round

Miranda Fidler-Benaoudia

Christine Friedenreich

In this randomized controlled trial the investigators will determine whether a mobile health intervention can increase physical activity levels in AYA cancer survivors over a one year period. The investigators will recruit 320 cancer survivors in Alberta who were diagnosed with a first cancer between the ages of 15 to 39 years and are within one year of treatment completion. Participants will be randomized into either the control group (educational information) or the intervention group (educational information; personalized physical activity plan; activity tracker watch; access to a private, online survivor community; motivational text messages and check-in calls/e-mails). All participants will complete fitness testing and questionnaires at baseline, 6 months and 12 months. A final measurement at 24 months will test long-term effectiveness.

Background:

There is a need for adolescent and young adult (AYA) cancer research because the number of new cancers in young people is increasing and the survivor population is growing. Interventions that try to reduce problems that affect people after cancer are particularly important since its treatments can have negative effects on survivors' physical and mental health even decades after diagnosis.

Aim:

Given the many positive effects of physical activity (e.g. improved fitness and quality of life), the study aims to encourage AYA cancer survivors to be more physically active as they shift from treatment to survivorship care. The main goal of this study is to see if a home-based, mobile health (mHealth) physical activity intervention can increase physical activity levels by at least 90 minutes/week compared to baseline in AYA cancer survivors.

Methods:

The investigators will conduct a two-center randomized controlled trial of 320 AYA cancer survivors. Participants (N=320) will be Albertan residents, diagnosed with a first cancer between the ages of 15 and 39 years, and within one year of cancer treatment completion. At the start of the study, participants will complete fitness testing and questionnaires. Participants will then be randomly put into either a control or intervention group. The control group will receive educational information only. The intervention group will also receive a personalized physical activity plan, an activity tracker watch, access to a private, online survivor community, motivational text messages and check-in calls/e-mails. Fitness testing and questionnaires will be repeated at 6 and 12 months to see if the intervention increased physical activity levels and improved health outcomes among the participants in the intervention group compared to controls. A final measurement at 24 months will test long-term use.

The study team, with the exception of the study coordinator, will be blinded to reduce bias.

mHealth Physical Activity Intervention for Young Cancer Survivors

Adolescents and Young Adults Becoming Physically Active After Cancer Trial

Global score range is 0 to 23 where higher scores indicate worse sleep quality

Measured by combining height (meters) and weight (kilograms) and reported in kg/m2

Measured by peak oxygen consumption in relative (ml/kg/min) values using the incremental Balke and Ware treadmill test with direct measures of gas exchange and ventilation

Measured by peak oxygen consumption in absolute (L/min) values using the incremental Balke and Ware treadmill test with direct measures of gas exchange and ventilation

Measured in kilograms using a hand dynamometer

Measured in kilograms using an 8-10 repetition maximum (RM) chest press test used to predict 1-RM

Measured in kilograms using the maximum number of chest press repetitions completed at 50-70% of estimated 1-RM

Measured in kilograms using an 8-10 repetition maximum (RM) leg press test used to predict 1-RM

Measured in kilograms using the maximum number of leg press repetitions completed at 50-70% of estimated 1-RM

Defined according to the Fried phenotype which takes into account low lean muscle mass, exhaustion, low energy expenditure, walking limitations, and weakness

Score range is from 0 to 100 where higher scores indicate better mental health

Score range is from 0 to 100 where higher scores indicate better physical health

Score range is from 0 to 100 where higher scores indicate higher functioning

Score range is from 0 to 100 where higher scores indicate less pain

Score range is from 0 to 100 where higher scores indicate better health

Score range is from 0 to 100 where higher scores indicate higher vitality

Scores range from 0 to 100 where higher scores indicate more distress

Score range is from 0 to 80. Higher scores indicate poorer quality of life.

Score range is from 0 to 16 where higher scores indicate poorer cognition

Score range is from 0 to 36 where higher scores indicate poorer cognition

Score range is from 0 to 52 where higher scores indicate less fatigue

Score range is from 0 to 44 where higher scores indicate better financial wellbeing

University of Calgary

AHS Cancer Control Alberta

The intervention group will follow a physical exercise and lifestyle counselling program.

the intervention group will follow a physical exercise and health counselling intervention--see below.

The exercise program will be performed in the hospital gymnasium (3 supervised sessions/week of aerobic and muscle strength exercises) or in the patients' room (during phases of treatment-induced immunodepression, where isolation is needed to prevent infections). It will also include specific training of the respiratory ('inspiratory') muscles (e.g., diaphragm) on 5 days/week. The counselling program will include psychological (once weekly), nutritional (twice monthly), support (with survivors of adolescent cancer, twice/month) and educational (for relatives/caregivers, once monthly) sessions.

lifestyle and physical exercise

Alejandro Lucia

The investigators will study the effects of an inhospital exercise intervention combined with lifestyle--including diet--counselling along the duration of treatment (neoadjuvant \[solid tumours\]/intense chemotherapy \[leukemias\], expected median duration 5-6 months) on several health-related variables. Participants will be recruited from 3 hospitals in Madrid (Spain). Inclusion criteria: male/female aged 12-19 years, newly diagnosed with a malignant extracranial tumour; not having received any type of therapy--except surgery--at the time of diagnosis; adequate health status (Karnofsky/Eastern Cooperative Oncology Group scale score ≥50/2); to understand Spanish language and to provide written informed consent. The investigators will recruit ≥136 participants and conduct a randomised controlled trial. In addition to usual care, the control group will be informed of the benefits of a healthy lifestyle. The intervention group will follow a physical exercise and lifestyle counselling program. The exercise intervention will be performed in the hospital gymnasium, except for neutropenic phases--during which time sessions will be performed in the patients' ward--and will also include inspiratory muscle training). Health counselling will include a psychological intervention based on motivational interviewing techniques, guidance by a nutritionist, and support sessions with survivors who will share their experiences with the study participants. The following outcomes will be assessed at baseline (diagnosis), end of treatment, and at 3-month follow-up in all participants: echocardiography-determined left ventricular function (primary outcome); and blood pressure, blood lipids, body composition, physical activity levels, energy intake, cardiorespiratory fitness, muscle strength, functional mobility, health-related quality of life, cancer-related fatigue, stress coping, anxiety, depression, clinical variables, and potential biological underpinnings of exercise multisystemic benefits (metabolic and inflammatory \[cytokine panel\] markers, plasma proteome, gut microbiome, and immune function).

Background. Health promotion interventions are needed during adolescent cancer treatment to facilitate the acquisition of good health practices as patients transition to survivorship. Although meta-analytical evidence supports the health benefits of exercise in the context of childhood cancer, there is scant data focusing solely on adolescents.

Hypothesis and objectives. The investigators hypothesise that an inhospital exercise intervention combined with lifestyle counselling during treatment for adolescent cancer will provide several health benefits, particularly related to the cardiometabolic profile. Thus, the investigators will study the effects of an inhospital exercise intervention combined with lifestyle--including diet--counselling along the duration of treatment (neoadjuvant \[solid tumours\]/intense chemotherapy \[leukaemias\], expected median duration 5-6 months) on several health-related variables.

Setting and Methods. Participants will be recruited from 3 hospitals in Madrid (Spain). Inclusion criteria: male/female aged 12-19 years, newly diagnosed with a malignant extracranial tumour; not having received any type of therapy--except surgery--at the time of diagnosis; adequate health status (Karnofsky/Eastern Cooperative Oncology Group scale score ≥50/2); to understand Spanish language and to provide written informed consent. The investigators will recruit ≥136 participants and conduct a randomised controlled trial (1:1 ratio randomisation with a block on gender and tumour type \[leukaemias/lymphomas\]). In addition to usual care, the control group will be informed of the benefits of a healthy lifestyle. The intervention group will follow a physical exercise and lifestyle counselling program. The exercise intervention will be performed in the hospital gymnasium (3 sessions/week of aerobic and resistance exercises), except for neutropenic phases--during which time sessions will be performed in the patients' ward--and will also include inspiratory muscle training (5 days/week). Health counselling will include a psychological intervention (1 session/week) based on motivational interviewing techniques, guidance by a nutritionist (2 sessions/month), and support sessions (1/month) with survivors (≥5-year survivorship) who will share their experiences with the study participants. The following outcomes will be assessed at baseline (diagnosis), end of treatment, and at 3-month follow-up in all participants: echocardiographydetermined left ventricular function (primary outcome); and blood pressure, blood lipids, dual-energy X-ray absorptiometry-determined body composition (fat \[including visceral adipose tissue\]/lean mass, bone mineral content/density), accelerometry-determined physical activity, dietary recall determined energy intake, cardiorespiratory fitness, muscle strength, functional mobility, health-related quality of life, cancer-related fatigue, stress coping, anxiety, depression, clinical variables (survival, treatment tolerability, hospitalisation length, infections), and potential biological underpinnings of exercise multisystemic benefits (metabolic \[glucose homeostasis indicators, high-sensitivity C-reactive protein\] and inflammatory \[cytokine panel\] markers, plasma proteome, gut microbiome, and immune function \[lymphocyte subpopulations, natural killer cell cytotoxicity\]) (secondary outcomes).

The investigators will apply a two-arm RCT design, following the Consolidated Standards of Reporting Trials recommendations (1:1 randomisation ratio using a computer-generated random allocation sequence with a block on gender and main tumour type \[leukaemias/solid tumours\])

Assessment staff will be blinded to participant randomisation assignment. Yet, because of the nature of the study, it will not be possible to conceal the group assignment from the staff (i.e., fitness specialists, psycho-oncologists and nutritionists) involved in the different intervention (physical exercise and health counselling) sessions. Participants will be explicitly informed on the group to which they will be assigned as well as on the study hypotheses and will be reminded not to discuss their randomisation assignments with assessment staff and/or other patient.

Exercise and Lifestyle in Adolescent Cancer (HEALTHYADOL)

Exercise and Lifestyle Intervention for Patients With Adolescent Cancer: a Randomised Controlled Trial (HEALTHY ADOL)

Echocardiography-determined LV ejection fraction (unit = %)

Echocardiography-determined LV fractional shortening (unit = %)

Arterial blood pressure (BP) (ausculatory method) (units = mmHg)

Total/HDL/LDL-cholesterol will be quantified with an automated chemistry analyser (units = mg/dL).

Tiglycerides will be quantified with an automated chemistry analyser (units = mg/dL).

DXA-determined total lean and fat mass (grams)

DXA-determined bone mineral density (unit = g/m2)

PA levels (moderate/vigorous PA) determined using triaxial accelerometry (units =minutes/week)

PA levels (moderate/vigorous PA) determined using triaxial accelerometry (units = minutes/week)

3-day 24 h-dietary recalls to record the participants' energy intake by either themselves or parents/caregivers.

3-day, 24 h-dietary recalls will be used to record the participants' energy intake by either themselves or parents/caregivers. The investigators will provide participants with instructions on how to obtain a correct food record. Dietary recall data will be analysed using Dietsource 3.0 (Novartis) to determine total energy intake (kcal)

3-day 24 h-dietary recalls to record the participants' energy intake by either themselves or parents/caregivers.

3-day, 24 h-dietary recalls will be used to record the participants' energy intake by either themselves or parents/caregivers. The participants will provide participants with instructions on how to obtain a correct food record. Dietary recall data will be analysed using Dietsource 3.0 (Novartis) to determine protein, fat, carbohydrate, and fiber intake (g/day)

VO2peak will be determined with 'breath-by breath' analysis of expired gases on a metabolic cart using a ramp-like treadmill--or arm-crank ergometer--test (units = mL/kg/min)

The 5-repetition maximum (commonly abbreviated as 5RM), which is the maximum strength capacity to perform 5 repetitions until momentary muscular exhaustion, will be measured for leg press and bench press (units = kg).

PImax (units = cmH20) will be determined using a mouth pressure meter with the best result from 3 attempts (interspersed with rest periods of ≥1 min-duration) taken.

Health-related QoL (HRQoL) (Paediatric Quality of Life Inventory \[PedsQL\] 3.0 Cancer Module, designed to measure paediatric/adolescent cancer specific HRQoL) (0 to 100 scale, with higher scores indicating better HRQoL)

Health-related QoL (HRQoL) (Paediatric Quality of Life Inventory \[abbreviated as PedsQL\] 3.0 Cancer Module, designed to measure paediatric/adolescent cancer specific HRQoL) (0 to 100 scale, with higher scores indicating better HRQoL)

Cancer-related fatigue (Paediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale) (0 to 100 score, higher scores meaning higher fatigue)

Cancer-related fatigue (Paediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale) (0 to 100 score, higher scores meaning higher fatigue

Stress coping (General form of the Adolescent Coping Scale) (0 to 20 scale, with higher scores indicating higher resilience to stress)

Anxiety (six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory \[abbbreviated as STAI\]) (0 to 100 score, with higher scores reflecting higher anxiety levels)

Anxiety (six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory \[abbreviated as STAI\]) (0 to 100 score, with higher scores reflecting higher anxiety levels)

Depression (Child Depression Scale) (0 to 52 scale, with higher scores reflecting more depression)

Survival (numebr of days from diagnosis to the end of the study or death)

Survival (number of days from diagnosis to the end of the study or death)

Treatment tolerability (number of days of treatment interruption/delay

Total hospitalisation length (number of days)

Common Toxicity Criteria for Adverse Events \[CTCAE, global score, 1 (low toxicity) to 5 (highest\])

Homeostasis model assessment-insulin resistance index (HOMA-IR) (molar units)

Panel of 21 cytokines/chemokines measured in serum using Luminex® (all assessed in the same units, micrograms/dL)

The investigators will use liquid chromatography coupled to tandem-mass spectrometry (LC-MS/MS) to measure levels in blood of thousands of proteins

Universidad Europea de Madrid

Will not receive the exercise intervention

Exercise

The main goal of this clinical trial is to use a novel exercise intervention to improve cardiometabolic and biopsychosocial health outcomes in overweight/obese sedentary survivors of AYA cancers at risk for chronic comorbid conditions. The investigator's hypothesis is that an exercise intervention will improve: cardiometabolic health; body composition; physical fitness and biopsychosocial outcomes when compared to the attention control group.

A Supervised Clinic-to-Community Exercise Intervention to Improve Cardiometabolic Health in Survivors of AYA Cancer

A Supervised Clinic-to-Community Exercise Intervention to Improve Cardiometabolic Health in Survivors of Adolescent and Young Adult Cancer: The ACSEND Trial

insulin resistance estimated by HOMA from a fasting blood sample

markers of metabolic syndrome, waist circumference via measuring tape (cm)

markers of metabolic syndrome, blood pressure via Omron cuff (mmHg)

fat mass and lean mass via DEXA (reported in lbs)

cardiorespiratory fitness via submaximal VO2 max (reported via ml/kg/min)

muscle strength through multiple repetition maximum (lbs)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
mHealth Physical Activity Intervention for Young Cancer Survivors	NCT04765241	Cancer	Physical Activi...	15 Years - 39 Years	AHS Cancer Control Alberta
Exercise and Lifestyle in Adolescent Cancer (HEALTHYADOL)	NCT05539794	Adolescent Canc...	lifestyle and p...	12 Years - 19 Years	Universidad Europea de Madrid
A Supervised Clinic-to-Community Exercise Intervention to Improve Cardiometabolic Health in Survivors of AYA Cancer	NCT04021446	Cardiometabolic... Young Adult Can... Adolescent Canc... Body Compositio...	Exercise	18 Years - 39 Years	University of Southern California
mHealth Physical Activity Intervention for Young Cancer Survivors	NCT04765241	Cancer	Physical Activi...	15 Years - 39 Years	AHS Cancer Control Alberta

Spots Global Cancer Trial Database for adolescent cancer