Mobile Health & Mindfulness for Young Adult Cancer Survivors

Recruiting in Chicago (>99 mi)

+1 other location

Overseen by David E Victorson, PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Northwestern University

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

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests a mobile health program using a Fitbit and an app to help young adult cancer survivors stay active. The program includes coaching, support from a buddy, and mindfulness exercises. It aims to improve their quality of life by increasing physical activity and reducing symptoms like fatigue and anxiety.

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.

What data supports the effectiveness of the treatment Mobile Health & Mindfulness for Young Adult Cancer Survivors?

Research shows that peer support and physical activity interventions can help cancer survivors maintain physical activity, which is important for health. Mindfulness practices have also been shown to improve stress and psychological outcomes in cancer survivors. ^{1 2 3 4 5}

Is the Mobile Health & Mindfulness intervention safe for young adult cancer survivors?

The studies reviewed did not report any safety concerns related to the use of wearable activity technology and digital coaching interventions for cancer survivors, suggesting they are generally safe for human use. ^{2 6 7 8 9}

How is the 'Mobile Health & Mindfulness for Young Adult Cancer Survivors' treatment different from other treatments for young adult cancer survivors?

This treatment is unique because it combines mobile health technology with mindfulness training and peer support to promote physical activity and well-being among young adult cancer survivors. It integrates digital coaching and social support components, which are not typically part of standard cancer survivor care, making it a novel approach to improving quality of life and physical activity maintenance. ^{1 2 5 9 10}

Research Team

Siobhan M Phillips, PhD, MPH

Principal Investigator

Northwestern University

David E Victorson, PhD

Principal Investigator

Northwestern University

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

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

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.

Participant Groups

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+

Dr. Jeffrey Sherman

Northwestern University

Chief Medical Officer

MD from Northwestern University

Dr. Alicia Löffler

Northwestern University

Chief Executive Officer since 2010

PhD from the University of Massachusetts at Amherst, post-doctoral training at Caltech

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Wake Forest University Health Sciences

Collaborator

Trials

1,432

Recruited

2,506,000+

Dr. L. Ebony Boulware

Wake Forest University Health Sciences

Chief Medical Officer since 2022

MD from Duke University School of Medicine, MPH from Johns Hopkins Bloomberg School of Public Health

Dr. Julie Ann Freischlag

Wake Forest University Health Sciences

Chief Executive Officer since 2020

BS from University of Illinois, MD from Rush University

Findings from Research

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Mediators of physical activity outcomes in a peer-led intervention for breast cancer survivors. [2023]

2. Australia pubmed.ncbi.nlm.nih.gov

The wearable activity technology and action-planning trial in cancer survivors: Physical activity maintenance post-intervention. [2021]

3. England 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. [2022]

4. United States 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. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Improving biobehavioral health in younger breast cancer survivors: Pathways to Wellness trial secondary outcomes. [2023]

6. Spain pubmed.ncbi.nlm.nih.gov

Wearable Activity Technology And Action-Planning (WATAAP) to promote physical activity in cancer survivors: Randomised controlled trial protocol. [2023]

7. China pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of Promoting Physical Activity in Regional and Remote Cancer Survivors (PPARCS). [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Pilot randomized trial of a couple-based physical activity videoconference intervention for sedentary cancer survivors. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

A Pilot Randomized Controlled Trial of a Fitbit- and Facebook-Based Physical Activity Intervention for Young Adult Cancer Survivors. [2023]

10. United States 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. [2023]