Mobile Health & Mindfulness for Young Adult Cancer Survivors

Not currently recruiting at 1 trial location

Overseen By Siobhan M Phillips, PhD, MPH

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Non-melanoma skin cancer, Metastatic disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different mobile health and mindfulness strategies can help young adult cancer survivors improve their quality of life. The focus is on testing four components: e-coaching, buddy support, general mindfulness, and mindfulness for physical activity, to assess their impact on exercise habits and overall health. Participants are young adults diagnosed with cancer between ages 18-39, who have completed primary treatments like surgery or chemotherapy, and currently engage in less than 60 minutes of moderate to vigorous physical activity per week. As an unphased trial, this study provides a unique opportunity to explore innovative strategies that could enhance well-being.

Do I need to stop my current medications to join the trial?

The trial does not specify whether you need to stop taking your current medications. However, it mentions that participants may still be undergoing endocrine or hormone therapies.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the trial components have undergone safety testing in earlier studies. Mindfulness training is a safe, non-toxic method for cancer survivors, reducing stress, anxiety, and fatigue, making it a well-accepted option for many patients.

The e-coaching component, which offers digital support to encourage healthy habits, has proven effective and acceptable for cancer survivors. Studies indicate that remote coaching can be integrated effectively without risk.

The "buddy" system provides peer support, positively reviewed for enhancing the emotional well-being of cancer survivors. It fosters a network of social support, crucial for a good quality of life.

The trial's main component involves physical activity, generally safe and beneficial for young adult cancer survivors. Exercise plays a key role in recovery and maintaining health for this group.

Overall, previous research has shown these treatments to be safe and well-accepted, making them promising options for those considering joining this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how mobile health tools and mindfulness practices can help young adult cancer survivors. Unlike traditional treatments that mainly focus on medical and physical recovery, this trial investigates the impact of mental and emotional wellness on overall health outcomes. The trial incorporates unique elements like an E-Coach, Buddy support, and both general and MVPA-specific mindfulness training. These components aim to improve survivors' quality of life by reducing stress and promoting mental well-being, potentially offering a more holistic approach to recovery.

What evidence suggests that this trial's treatments could be effective for young adult cancer survivors?

Research has shown that mindfulness activities can reduce stress and anxiety in cancer survivors. These activities improve quality of life and lessen symptoms like depression and anxiety. In this trial, participants may receive General Mindfulness Training or MVPA-Specific Mindfulness Training as part of their treatment arm. The buddy system, involving peer support, is another component tested in this trial and has helped people feel more confident in their ability to succeed, proving more effective than standard care in past studies. E-coaching, also evaluated in this trial, may help young adult cancer survivors improve their lifestyle and health. The main goal of the intervention is to increase physical activity using a mobile app, although past studies did not find a significant increase in activity levels with similar programs. Participants in this trial will receive different combinations of these interventions to assess their effectiveness. ^{3 6 7 8 9}

Who Is on the Research Team?

David E Victorson, PhD

Principal Investigator

Northwestern University

Siobhan M Phillips, PhD, MPH

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for young adult cancer survivors aged 18-39, who are at least three months post-primary treatment but may still be on hormone therapies. They should engage in less than 60 minutes of moderate to vigorous physical activity weekly, own a smartphone with internet access, and speak English fluently. Participants need a 'Buddy' willing to support them and share Fitbit data. Pregnant individuals or those in other trials cannot join.

Inclusion Criteria

For Buddies: Ownership of a smartphone (iPhone version 5 or greater, or Android version 5.0 or greater)

For Buddies: Score of 0 on Exercise Preparticipation Health Screening Questionnaire or willingness to obtain medical clearance

I was diagnosed with cancer, other than non-melanoma skin cancer, within the last 5 years.

Exclusion Criteria

For YACS: Current enrollment in another dietary or physical activity trial

I have been diagnosed with a type of skin cancer that is not melanoma.

For YACS: Currently pregnant or plans to become pregnant in the next 12 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (online, phone, or in-person)

Baseline Assessment and Randomization

Participants complete baseline assessments and are randomized into intervention groups

1 week

1 visit (online)

Intervention

Participants engage in a 12-week mHealth physical activity intervention with various components such as e-coaching, buddy system, and mindfulness training

12 weeks

Weekly virtual check-ins

Follow-up

Participants maintain their MVPA during the 12-week follow-up period with access to all materials

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Buddy
• Core Intervention
• E-Coach
• General Mindfulness Training
• MVPA-Specific Mindfulness Training

Trial Overview The OPT2MOVE study tests four components: e-coaching, buddy support, general mindfulness training, and MVPA-specific mindfulness training within a mobile health program aimed at increasing physical activity over 12 weeks among young adult cancer survivors to improve their quality of life.

How Is the Trial Designed?

Group I: Exp Condition 1 Experimental Treatment 5 Interventions

Research participant receives the Core Intervention + E-Coach + General Mindfulness Training + MVPA Specific Mindfulness Training + Buddy

Group II: Exp Condition 10 Active Control 2 Interventions

Research participant receives the Core Intervention + General Mindfulness Training

Group III: Exp Condition 11 Active Control 3 Interventions

Research participant receives the Core Intervention + MVPA Specific Mindfulness Training + Buddy

Group IV: Exp Condition 2 Active Control 4 Interventions

Research participant receives the Core Intervention + E-Coach + General Mindfulness Training + MVPA Specific Mindfulness Training

Group V: Exp Condition 4 Active Control 2 Interventions

Research participant receives the Core Intervention + E-Coach

Group VI: Exp Condition 6 Active Control 3 Interventions

Research participant receives the Core Intervention + E-Coach + General Mindfulness Training

Group VII: Exp Condition 7 Active Control 4 Interventions

Research participant receives the Core Intervention + E-Coach + MVPA Specific Mindfulness Training + Buddy

Group VIII: Exp Condition 9 Active Control 3 Interventions

Research participant receives the Core Intervention + General Mindfulness Training + Buddy

Group IX: Exp Condition 12 Active Control 2 Interventions

Research participant receives the Core Intervention + MVPA Specific Mindfulness Training

Group X: Exp Condition 14 Active Control 3 Interventions

Research participant receives the Core Intervention + General Mindfulness Training + MVPA Specific Mindfulness Training

Group XI: Exp Condition 15 Active Control 2 Interventions

Research participant receives the Core Intervention + Buddy

Group XII: Exp Condition 16 Active Control 1 Intervention

Research participant receives the Core Intervention

Group XIII: Exp Condition 13 Active Control 4 Interventions

Research participant receives the Core Intervention + General Mindfulness Training + MVPA Specific Mindfulness Training + Buddy

Group XIV: Exp Condition 3 Active Control 3 Interventions

Research participant receives the Core Intervention + E-Coach + Buddy

Group XV: Exp Condition 5 Active Control 4 Interventions

Research participant receives the Core Intervention + E-Coach + General Mindfulness Training + Buddy

Group XVI: Exp Condition 8 Active Control 3 Interventions

Research participant receives the Core Intervention + E-Coach + MVPA Specific Mindfulness Training

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Wake Forest University Health Sciences

Collaborator

Trials

1,432

Recruited

2,506,000+

Published Research Related to This Trial

The study involving 68 cancer survivors showed that a distance-based intervention using wearable technology significantly increased moderate-to-vigorous physical activity (MVPA) levels, which were maintained 12 weeks after the intervention ended.

At 24 weeks, the intervention group continued to engage in higher levels of MVPA compared to the control group, indicating that such interventions can have lasting effects on physical activity in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The wearable activity technology and action-planning trial in cancer survivors: Physical activity maintenance post-intervention. Hardcastle, SJ., Maxwell-Smith, C., Hince, D., et al.[2021]

Mindful awareness practices (MAPs) significantly reduced intrusive thoughts and worry in younger breast cancer survivors, and increased positive affect and a sense of meaning in life, with effects lasting up to 3 months after the intervention.

Compared to a wait-list control group, MAPs also showed a decrease in proinflammatory gene expression, suggesting potential immune benefits, while survivorship education (SE) also improved psychological outcomes but did not affect inflammation as significantly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving biobehavioral health in younger breast cancer survivors: Pathways to Wellness trial secondary outcomes. Bower, JE., Partridge, AH., Wolff, AC., et al.[2023]

The mHealth physical activity intervention did not significantly increase accelerometer-measured total physical activity compared to a self-help group over 12 months, but it did lead to greater self-reported physical activity in participants.

At the 12-month mark, a higher percentage of participants in the intervention group reported meeting national physical activity guidelines compared to the self-help group (47.9% vs. 33.1%), indicating potential benefits of digital approaches for promoting sustained physical activity in young adult cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity maintenance among young adult cancer survivors in an mHealth intervention: Twelve-month outcomes from the IMPACT randomized controlled trial. Valle, CG., Diamond, MA., Heiling, HM., et al.[2023]

A 12-week intervention using wearable activity trackers and HAPA-based support for 68 colorectal and gynecologic cancer survivors aims to increase physical activity and improve cardiovascular health.

The study will assess changes in physical activity, blood pressure, and BMI, indicating that structured interventions can potentially enhance health outcomes for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable Activity Technology And Action-Planning (WATAAP) to promote physical activity in cancer survivors: Randomised controlled trial protocol. Maxwell-Smith, C., Cohen, PA., Platell, C., et al.[2023]

A pilot trial involving 20 cancer survivors and their partners tested a couple-based physical activity intervention, showing that it was generally acceptable and feasible, with 78% of participants completing all sessions.

Participants in the intervention reported greater improvements in physical activity, partner support, and physical well-being compared to those in the control group, suggesting potential benefits for future larger-scale studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot randomized trial of a couple-based physical activity videoconference intervention for sedentary cancer survivors. Porter, LS., Gao, X., Lyna, P., et al.[2023]

A trial involving 226 cancer survivors will assess the impact of peer support on maintaining moderate-to-vigorous physical activity (MVPA) and health markers over 12 months after a 4-week supervised high-intensity interval training (HIIT) program.

If effective, peer support could be a valuable strategy to help cancer survivors sustain exercise habits, potentially leading to improved physical and mental health outcomes and reduced disease burden.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer support for the maintenance of physical activity and health in cancer survivors: the PEER trial - a study protocol of a randomised controlled trial. Adlard, KN., Jenkins, DG., Salisbury, CE., et al.[2022]

The pilot randomized controlled trial successfully recruited 50 young adult cancer survivors and demonstrated feasibility, with participants wearing the Fitbit device on 82.9% of intervention days and high follow-up questionnaire completion rates (93.9%).

The intervention significantly reduced sedentary time by an average of 52.4 minutes per day compared to controls, although it did not lead to an increase in moderate-to-vigorous physical activity or improvements in quality of life measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Randomized Controlled Trial of a Fitbit- and Facebook-Based Physical Activity Intervention for Young Adult Cancer Survivors. Johnson, AM., Baker, KS., Haviland, MJ., et al.[2023]

A peer-led physical activity intervention for breast cancer survivors significantly improved both self-reported and objectively measured physical activity levels over 12 weeks, highlighting its efficacy as a supportive treatment approach.

The intervention increased participants' self-efficacy and social support while reducing perceived disadvantages of exercise, suggesting that enhancing confidence and addressing barriers can effectively promote physical activity among cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mediators of physical activity outcomes in a peer-led intervention for breast cancer survivors. Pinto, BM., Dunsiger, SI., DeScenza, VR., et al.[2023]

Active video games (AVGs) combined with videoconferencing may help improve quality of life and reduce fatigue in adolescent and young adult (AYA) cancer survivors, based on a review of six studies.

However, the evidence for significant improvements in physical function is limited, indicating a need for more rigorous interventions specifically targeting AYA cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of active video games with or without videoconferencing on health outcomes in adolescent and young adult cancer survivors: a systematic review. Christopherson, U., Wells, SJ., Parker, N., et al.[2022]

A study involving 87 breast and colorectal cancer survivors showed that using a Fitbit and receiving health coaching significantly increased their moderate-to-vigorous physical activity (MVPA) by nearly 50 minutes per week compared to those who only received printed materials.

This research is the first to demonstrate that combining wearable technology with remote health coaching can effectively enhance physical activity levels in cancer survivors living in remote areas, suggesting a promising approach for improving health outcomes in underserved populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of Promoting Physical Activity in Regional and Remote Cancer Survivors (PPARCS). Hardcastle, SJ., Maxwell-Smith, C., Cavalheri, V., et al.[2023]

Citations

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