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

Behaviors and Mental Disorders

All Conditions

Quality of Life

Group will receive physical activity information targeted to young adult cancer survivors

Group will receive the Canadian Public Health Guidelines

Stride to Survive:An Exercise Guide for Young Adult Cancer Survivors

Canadian Physical Activity Guidelines

Young adult cancer survivors (YACS) are an understudied group in cancer survivorship research that have unique psychosocial, medical and survivorship issues. Physical activity (PA) has important effects on health-related outcomes in middle-aged and older cancer survivors and preliminary research suggests similar benefits in YACS (18-39 years). Unfortunately, only about half of YACS report meeting public health PA guidelines and there are no interventions or resources available to help YACS increase their PA. The purpose of this study is to test a physical activity guidebook that was developed for YACS based on the theory of planned behavior (TPB). The PA guidebook will be evaluated in a randomized controlled trial. Specifically, 300 YACS will be randomly assigned to (a) Canada's PA guidelines for adults or (b) the YACS PA guidebook. YACS will complete assessments of PA, quality of life, and psychosocial variables at baseline (prior to randomization), 1 month, and 3 months. The primary endpoint in the trial will be change in self-reported PA minutes from baseline to 3 months. Secondary endpoints will include changes in TPB constructs and quality of life. It is hypothesized that the group receiving the YACS PA guidebook (TARG) will report a greater increase in PA minutes compared to the group receiving Canada's PA guidelines (CPAG).

Targeted Vs Generic Print Materials on Physical Activity and Quality of Life in Young Adult Cancer Survivors

Effects of Targeted Versus Generic Print Materials on Physical Activity and Quality of Life in Young Adult Cancer Survivors: A Randomized Control Trial

University of Alberta

All Drugs and Chemicals

Nicotine

Participants receive online, group-based yoga classes 2 times/week for 60 minutes/class over 12 weeks.

Participants receive the yoga program, which is delivered by a trained yoga instructor (completed at least a 200-hour yoga teacher training, Yoga Thrive Teacher Training Certification (or similar), and/or practical experience working with individuals affected by cancer). The first class of the week is comprised of 45 minutes of gentle, progressive, hatha-based yoga sequencing and postures with the last 15 minutes focused on guided behaviour change and mindfulness techniques that varies week-to-week, based on the participants in the class. The second class of the week is 60 minutes of gentle, yin-based yoga sequencing and postures with an element of opening and relaxing.

Yoga

S. Nicole Culos-Reed, PhD

Amanda Wurz, PhD

Wellness Lab

Yoga may enhance physical and psychological outcomes among young adults affected by cancer. Yet, yoga has rarely been studied in this population. We developed and piloted a yoga program, which is now ready for implementation and evaluation. This single-group, mixed-methods project will explore effectiveness and implementation of the yoga program.

Yoga for Young Adults Affected by Cancer

Yoga for Young Adults Affected by Cancer: Exploring Implementation and Effectiveness of an Online Program

The number of people who participate, and reasons why or why not.

Number of classes attended out of the number of classes offered by study staff.

Percentage of missing data on quantitative measures and completion of qualitative interviews.

Change in Barrier Self-Efficacy Scale (1). Scale range 0-100; higher scores indicates less barriers to participation.

Changes in Godin Leisure Time Scale (2). Individuals indicate how many times per week and how long per session they exercise at certain intensity (mild, moderate, high). Higher scores indicate higher levels of physical activity.

Change in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (3). Scale range 0-4; selected items are reverse scored; higher score indicate less fatigue.

Changes in Functional Assessment of Cancer Therapy - Cognitive Scale (4). Scale range 1-4; some items are reversed scored; higher scores indicate less cognitive impairment.

Change in Edmonton Symptom Assessment Scale (5). Scale range 0-10; lower scores indicate fewer/less severe symptoms.

Change in EuroQual - 5Dimensions (EQ-5D) Scale (6). Scale range 1-5 with lower scores indicating greater quality of life; visual analogue scale range 0-100 with higher scores indicating greater quality of life.

Change in Functional Assessment of Cancer Therapy - General Scale (7). Scale range 0-4; selected items are reversed scored; higher scores indicate greater quality of life.

Change in Mindful Attention Awareness Scale (8). Scale range 1-6; higher scores indicate higher levels of dispositional mindfulness.

Change in Self-Compassion Scale (9). Scale range 1-5; higher scores indicate greater self-compassion.

Change in Perceived Stress Scale (10). Scale range 0-4; some items are reverse scored; higher scores indicate more perceived stress.

Change in Group Identification Scale (11). Scale range 1-7; higher scores indicate greater identification with the group.

Change in one legged stance test (seconds) (see 12).

Change in active shoulder flexion range of motion (degrees) (see 12).

Change in sit-and-reach test (cm) (see 12).

Change in sit-to-stand (number of repetitions in 30 seconds) (see 12).

Change in 2 minute step test (steps) results (see 12).

Adverse events will be defined as any negative effect caused (or suspected to be caused by) the yoga program.

Time and expertise to deliver the intervention and physical assessments will be tracked.

Fidelity of the physical activity program implementation will be assessed via randomly video-auditing a subset of classes.

Canadian Cancer Society (CCS)

Canadian Institutes of Health Research (CIHR)

Caregiver Burden

Stress, Psychological

Behavioral Symptoms

Young adults with cancer and their partner-caregivers will attend dyadic virtual psychotherapy sessions lasting 45-60 minutes on a weekly basis for eight weeks.

This intervention is based on cognitive-behavioral therapy and couples' therapy. It aims to improve cancer and caregiving-related self-efficacy and coping, as well as promote relationship maintenance in context of cancer. The intervention will be delivered by a trained mental health practitioner and include didactics, experiential exercises, and home practice.

Young Adults Coping with Cancer Together Intervention

Jamie M Jacobs, Ph.D.

Zeba N Ahmad, Ph.D.

Jamie M Jacobs, PhD

Giselle K Perez, Ph.D.

The purpose of this pilot study is to examine the feasibility and acceptability of a brief psychotherapy intervention to improve psychosocial coping and maintain couple relationships among young adults (aged 25-39) with cancer and their caregiving partners.

Young adults (YA) with cancer have unique challenges in coping, and their primary partners may experience burden and low self-efficacy related to caregiving. In this single-arm pilot trial, the investigators shall deliver an eight-session intervention to YAs with cancer and their self-identified partners who provide caregiving. The intervention is founded on principles from cognitive-behavioral therapy and couples-focused interventions, tailored for YA. The aim of the study is to assess the feasibility and acceptability of the intervention, which will inform refinements prior to a larger-scale clinical trial. This study will include 10 YAs and their partner-caregivers (N=20). Participants will complete surveys at baseline and after the intervention, and will be invited to complete optional semi-structured exit interviews.

A Dyadic Intervention for Young Adult Patients With Cancer and Their Partner Caregivers

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: jjacobs@mgh.harvard.edu. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Feasibility will be measured by measured by participant rates of enrollment (≥50% of those eligible), participant retention (≥70% of those enrolled), and intervention attendance (≥70% attending at least 6 of 8 sessions).

Acceptability with be measured by satisfaction with the intervention as rated on the Client Satisfaction Questionnaire. The intervention will be deemed acceptable if ≥75% of participants report average satisfaction that exceeds the CSQ's midpoint.

Massachusetts General Hospital

Assistant Professor, Harvard Medical School Department of Psychiatry

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
Targeted Vs Generic Print Materials on Physical Activity and Quality of Life in Young Adult Cancer Survivors	NCT05450315	Behaviour Chang...	Stride to Survi... Canadian Physic...	18 Years - 39 Years	University of Alberta
Yoga for Young Adults Affected by Cancer	NCT05314803	Young Adult Can... Young Adult Onc...	Yoga	18 Years -	University of Calgary
Yoga for Young Adults Affected by Cancer	NCT05314803	Young Adult Can... Young Adult Onc...	Yoga	18 Years -	University of Calgary
A Dyadic Intervention for Young Adult Patients With Cancer and Their Partner Caregivers	NCT06172907	Cancer Survivorship Caregiver Burde... Psychological D... Coping Skills Couples	Young Adults Co...	25 Years - 39 Years	Massachusetts General Hospital
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 young adult cancer