(1) 12 weekly interactive sessions with a health coach to help them set goals and make changes toward becoming physically active and consuming the recommended number of fruits and vegetables.

This arm will receive personalized health coaching (behaviour change counseling)

interactive sessions

Participating in regular physical activity and consuming a diet high in fruits and vegetables can aid in the management of various acute and chronic side effects of cancer treatment; however, few rural-dwelling young adult cancer survivors are active enough and consume enough fruits and vegetables to accrue benefits. Telehealth interventions show promise for helping these young adults increase their motivation to participate in these behaviours by addressing barriers associated with accessing face-to-face behaviour counselling services (e.g., time commitment, travel distance). Yet, few researchers have examined the feasibility and acceptability of a telehealth intervention that provides motivational support grounded in self-determination theory for these health behaviours in rural-dwelling young adult cancer survivors. Based on previous research, the researchers reasoned that rural-dwelling young adult cancer survivors' physical activity and fruit and vegetable consumption would be more likely to increase if they participated in a telehealth intervention therefore, the researchers aim to test the feasibility, acceptability, and preliminary efficacy of the intervention. The researchers also aim to assess if changes in perceived basic psychological need satisfaction, behaviour regulation, and perceived autonomy support are associated with changes in physical activity and fruit and vegetable consumption.

Making Healthy Choices: Does Having an Online Health Coach Help?

Helping Rural-living Young Adult Cancer Survivors Make Healthy Lifestyle Choices: Does Having a Telehealth Personal Health Coach Help?

Change in self-reported physical activity (over the past 7 days) from baseline to post-intervention, with higher scores representing a better outcome.

Change in self-reported fruit and vegetable intake (over the past 7 days) from baseline to post-intervention, with higher scores representing a better outcome.

Change in basic psychological need satisfaction for physical activity from baseline to post-intervention, using a 1 (false) to 6 (true) scale with higher scores representing a better outcome.

Change in basic psychological need satisfaction for fruit and vegetable consumption from baseline to post-intervention, using a 1 (strongly disagree) to 7 (strongly agree) scale with higher scores representing a better outcome.

Change in motivational regulations for physical activity from baseline to post-intervention, using a 1 (not at all true) to 7 (very true) scale with higher scores representing a better outcome.

Change in motivational regulations for fruit and vegetable consumption from baseline to post-intervention, using a 1 (not at all true) to 7 (very true) scale with higher scores representing a better outcome.

Level of perceived autonomy support for health behaviours post-intervention, using a 1 (strongly disagree) to 7 (strongly agree) scale with higher scores representing a better outcome.

The number of eligible participants who enrol in the study out of the number assessed for eligibility

The number of participants completing the 12-week intervention.

The number of eligible participants completing ≥ 70% of the intervention sessions (i.e., 8/12)

Participants will be asked what they liked, disliked, and experienced during the intervention

University of Ottawa

Associate Professor

The patient will be asked to come in to the Counseling Center at MSKCC (641 Lexington Avenue, 7th Floor) and participate in an individual interview at their convenience.

The patient will be asked to come in to the Counseling Center at MSKCC (641 Lexington Avenue, 7th Floor) and participate in a focus group at their convenience.

The patient will be asked to participate in three 60-90 minute telephone interviews scheduled at their convenience.

The doctor and/or one of her trained research study staff will ask the patient about their experience as an adolescent/young adult cancer survivor, their health and quality of life. It should take (approximately 1-1 ½ hours)to complete. Interviews will be audiotaped and transcribed by a professional transcription service.

interview

The patient will participate with 6-8 other adolescent/young adult cancer survivors. The doctor and/or her trained research study staff will ask about their experience as an adolescent/young adult cancer survivor, their health and quality of life. It should take about one-and-a-half hour to complete. Focus groups will be audio taped and transcribed by a professional transcription service.

Focus groups

The patient will be asked to participate in three 60-90 minute telephone interviews conducted by the doctor and/or her trained research study staff scheduled at the patient's convenience, the second interview approximately 6-8 months after the first and the last interview approximately 12-16 months after the first. The questionnaire will ask about their experience as an adolescent/young adult cancer survivor, their health and quality of life.

Questionnaire

Marie Barnett, PhD

The purpose of this study is to better understand how the illness has affected the identity and what needs the survivor may have. We hope that this information will help us provide better care to future adolescent and young adult cancer survivors.

Adolescent and Young Adult Cancer Survivors: Identity Development

Memorial Sloan Kettering Cancer Center

-All eligible providers will be sent questionnaires electronically to their email at baseline and follow-up. Providers will be invited to attend a training session to educate them on the PREVENT tool at baseline. The providers will be delivering the PREVENT tool.

* Complete questionnaires and accelerometry at baseline (administered electronically or by mail; accelerometers administered by mail). Following baseline measurement, patients will be randomized and attend their clinic visit. Follow-up measures will be administered 3-months and 6-months after the clinic visit electronically and by mail
* A PREVENT action plan (behavior change prescription, community resources, and education) will be provided to the patient via email after the completion of the follow-up measurement.

* Complete questionnaires and accelerometry at baseline (administered electronically or by mail; accelerometers administered by mail). Following baseline measurement, patients will be randomized and attend their clinic visit. Follow-up measures will be administered 3-months and 6-months after the clinic visit electronically and by mail
* At the clinic visit, the provider will use PREVENT tool to discuss risk and deliver a tailored behavioral change plan inclusive of patient-centered community resources. PREVENT will calculate patient's overall risk for developing cardiovascular disease. Physical activity and food intake recommendations are tailored to current weight status and health behaviors using evidence-based recommendations.

-Will receive routine clinical care. After completion of follow-up measures, control participants will receive a behavior change prescription via the PREVENT tool

Wait-List Control

-PREVENT is a novel Health Information Technology tool designed to promote physical activity and healthy food intake among overweight/obese patients at the point of care. PREVENT automates the delivery of personalized, evidence-based behavior change recommendations and provides an interactive map of community resources to help providers link patients to resources in their community.

PREVENT tool

Maura Kepper, Ph.D.

Health information technology (HIT) has the potential to improve the quality, efficiency, consistency, and availability of cancer survivor care. PREVENT is a novel HIT tool designed by our team for adolescents (12-19 years). PREVENT aggregates and displays the American Heart Association's (AHA) Life Simple 7 cardiovascular health (CVH) risk factors and provides tailored, evidence-based, behavior change recommendations inclusive of community resources that are delivered to overweight/obese adolescents at the point-of-care to improve CVH. The investigators seek to expand this tool for patients beyond 19 years of age to increase this tool's reach to the entire adolescent and young adult (AYA) age range and then evaluate its effectiveness among AYA cancer survivors.

Using Health Information Technology to Improve Health Behaviors and Promote Cardiovascular Health Among Adolescent and Young Adult Cancer Survivors

Physical activity will be measured using a triaxial accelerometer (Actigraph GT3X+, Actigraph of Ft. Walton Beach, FL). The participant will be instructed to wear the accelerometer on an elasticized belt, on the left mid-axillary line. The Actigraph is one of the most common accelerometers used for scientific purposes. Participants will be encouraged to wear the accelerometer 24-hours per day for at least 7-days, including 2 weekend days.

Patient-reported food intake behaviors (fruit and vegetable intake, whole grains, sugar-sweetened beverages and snacking behaviors) are collected using a brief Health Behavior \& Attitudes Survey.

A survey (6-question) administered to patients will assess attitudes toward and readiness for behavior change. Questions are asked using a 5-point Likert scale (range: 0-30) with a higher score indicating more positive attitudes.

A survey (15-questions) will assess provider's satisfaction with five aspects of health information technology: content, accuracy, format, ease of use and timeliness. Questions are asked on a 5-point Likert scale (range: 15-75) with a higher score indicating greater satisfaction

-A survey (12-questions) will assess provider's intent to change their behavior and continue using PREVENT were adapted from Legare's CPD Reaction Questionnaire. Questions are asked using a 7-point Likert scale (range: 12-84) with a higher score indicating greater motivation for sustained use.

-Fidelity will be measured using direct observation of patient-provider interactions while using the PREVENT tool. A direct observation checklist will be used by the observer to determine the number of interactions with the PREVENT tool that were implemented as intended.

American Cancer Society, Inc.

Washington University School of Medicine

Participants allocated to group A will receive a behavioural support intervention via real-time videoconferencing.

Participants allocated to group B will receive usual care and will be advised to continue with their regular activities of daily living.

Participants in Group A will receive six real-time, 1-on-1 60-minute sessions led by a physical activity counsellor over a 12-week period. Sessions will be delivered via videoconferencing and will aim to provide young adult cancer survivors with support as well as the knowledge, skills, and confidence to identify and overcome challenges to engaging in physical activity in order to increase physical activity behaviour and enhance patient-reported outcomes.

12-week videoconferencing behavioural support intervention to promote physical activity behaviour

Survival rates for cancer are increasing, resulting in more young adult cancer survivors living with lingering side effects. Physical activity has been shown to improve the quality and length of life in young adult cancer survivors; yet, few are active enough, and little is currently being done to promote physical activity in this population. The investigators developed a novel behaviour support intervention to promote physical activity in young adult cancer survivors. In this two-arm pilot randomized controlled trial, the investigators aim to: (1) assess trial and intervention feasibility, (2) assess trial and intervention acceptability, and (3) generate data on physical activity behaviour. Young adult cancer survivors will be randomized to receive either a 12-week behaviour support intervention delivered via videoconferencing or will be allocated to usual care.

Background: Young adults commonly experience persistent side effects following cancer treatment that impair quality of life. Physical activity (PA) holds promise as an intervention to mitigate persistent side effects and improve quality of life. Yet, few young adults are active enough to incur these benefits and efforts to promote PA following cancer treatment are lacking. Therefore, the investigators developed a novel behaviour support intervention to promote PA in young adults following cancer treatment, and have undertaken a pilot randomized controlled trial (RCT) to determine whether the intervention delivered via videoconferencing is both feasible and acceptable. Specifically, the aims of this ongoing parallel group two-arm pilot RCT are to: (1) assess trial and intervention feasibility and acceptability, and (2) generate data on PA behaviour.

Methods: Young adults who have completed cancer treatment are recruited from across Canada. Recruits are randomized to the intervention group (IG; i.e., a 12-week behaviour support intervention delivered via videoconferencing) or usual care (UC; no intervention). Drawing on the CONSORT 2010 statement and flow diagram, several feasibility outcomes pertaining to enrolment, allocation, follow-up, and analysis are tracked by study staff. Acceptability is assessed through interviews exploring IG and UC participants' experiences, thoughts, and perspectives of the trial, IG participants' views of the intervention and its mode of delivery, and PA counsellors' experiences delivering the intervention. PA is measured using accelerometers. Assessments take place at baseline (pre-randomization), post-intervention period, and at follow-up (24 weeks post-baseline).

Discussion: Feasibility and acceptability data will help determine if/what changes/modifications are needed to improve the trial protocol and/or intervention, and will inform the timeline for a definitive RCT. The PA behaviour data collected will inform sample size calculation for a future RCT that aims to test the effects of this intervention in young adults following cancer treatment.

Physical Activity Counselling for Young Adult Cancer Survivors

Self-reported socio-demographic and medical information (e.g., age, gender, civil and educational status, ethnicity) will be collected and used to describe the sample. Participants will be provided with a range of response options for each item.

The number of eligible participants who enrol in the trial out of the number who are referred

The number of intervention sessions attended out of the total recommended as part of the intervention

Participants will be asked to share their experiences, thoughts, and perspectives of the trial, the physical activity counsellor and the intervention by responding to open and close-ended questions during a semi-structured interview. Responses to close-ended questions will range from 1 ('poor' or 'not satisfied at all') to 10 ('excellent' or 'extremely satisfied').

The number of participants completing all three scheduled assessments.

The percentage of missing data on quantitative measures.

The number of participants completing the acceptability interview following the intervention.

Change in participants' objective levels of physical activity as measured by accelerometers (ActiGraph GT3X+), which will be worn for a 7-day period across baseline (week 0), post-intervention (week 12), and follow-up (week 24).

Change in participants' self-reported health-related quality of life across baseline (week 0), post-intervention (week 12) and post-intervention follow-up (week 24). The SF-36 measures eight dimensions: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. Each item is scored on a 0 to 100 scale, with higher scores representing a more favourable health state.

Change in participants' self-reported positive and negative affect across baseline (week 0), post-intervention (week 12) and post-intervention follow-up (week 24). Each item is scored on a scale from 1 ('Very slightly or not at all') to 5 ('Extremely'). Items in the positive scale are averaged together to create a Positive Affect Score, and items in the negative scale are averaged together to create a Negative Affect Score. Higher positive and negative scores represent higher positive and negative affect, respectively.

Change in participants self-reported depressive symptoms across baseline (week 0), post-intervention (week 12) and post-intervention follow-up (week 24). Each item is scored on a 0 ('Not at all') to 3 ('Nearly every day') scale with higher scores representing greater severity of depressive symptoms.

Change in participants self-reported anxiety symptoms across baseline (week 0), post-intervention (week 12) and post-intervention follow-up (week 24). Each item is scored on a 0 ('Not at all') to 3 ('Nearly every day') scale, with higher scores representing greater severity of anxiety symptoms.

Change in participants' self-reported perceptions of cancer impact from baseline (week 0), post-intervention (week 12) and post-intervention follow-up (week 24). Each item is scored on a scale from 0 ('Strongly disagree') to 4 ('Strongly agree'), with higher scores representing greater impact of cancer.

Change in participants' self-reported motivation for physical activity across baseline (week 0), post-intervention (week 12) and post-intervention follow-up (week 24). This measure taps six behavioural regulations in the physical activity context: amotivation, external, introjected, identified, integrated, and intrinsic motivation. Each item is scored on a scale from 0 ('Not true for me') to 4 ('Very true for me'), with higher scores reflecting greater amotivation, external, introjected, identified, integrated, and intrinsic motivation for physical activity.

Change in participants self-reported psychological need satisfaction in relation to physical activity across baseline (week 0), post-intervention (week 12) and post-intervention follow-up (week 24). The PNSE measures perceptions of competence, autonomy and relatedness in relation to physical activity. Each item is scored on a scale from 1 ('False') to 6 ('True'), with higher scores representing greater perceived competence, autonomy and relatedness.

Participants perceived sense of autonomy support, structure and interpersonal involvement for physical activity post-intervention (week 12). Each item is scored on a scale from 1 ('Strongly disagree') to 7 ('Strongly agree'), with higher scores representing greater perceived autonomy support, structure and interpersonal involvement for physical activity.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Making Healthy Choices: Does Having an Online Health Coach Help?	NCT03691545	Physical Activi... Dietary Modific...	interactive ses...	20 Years - 39 Years	University of Ottawa
Adolescent and Young Adult Cancer Survivors: Identity Development	NCT00832325	Cancer	interview Focus groups Questionnaire	15 Years - 25 Years	Memorial Sloan Kettering Cancer Center
Adolescent and Young Adult Cancer Survivors: Identity Development	NCT00832325	Cancer	interview Focus groups Questionnaire	15 Years - 25 Years	Memorial Sloan Kettering Cancer Center
Using Health Information Technology to Improve Health Behaviors and Promote Cardiovascular Health Among Adolescent and Young Adult Cancer Survivors	NCT04623190	Cardiovascular ... Young Adult Can...	Wait-List Contr... PREVENT tool	20 Years - 39 Years	Washington University School of Medicine
Physical Activity Counselling for Young Adult Cancer Survivors	NCT04163042	Survivorship Cancer	12-week videoco...	18 Years - 39 Years	University of Ottawa
Adolescent and Young Adult Cancer Survivors: Identity Development	NCT00832325	Cancer	interview Focus groups Questionnaire	15 Years - 25 Years	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for young adult cancer survivors