Mobile Health + Social Media for Cancer Survivors

Not currently recruiting at 129 trial locations

Age: < 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Children's Oncology Group

Disqualifiers: Pregnancy, Previous HSCT, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a mobile health app and social media can encourage adolescent and young adult cancer survivors to be more active compared to using only a fitness tracker. Physical activity can help maintain a healthy weight and improve energy and overall health, which is crucial for those who have completed cancer treatment, as they often face challenges like weight gain and health issues. Participants will either use a fitness tracker with additional support from a mobile app and social media or just the tracker alone. Those who have completed cancer treatment with chemotherapy or radiation in the last 3 to 36 months and are currently not very active might be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in post-cancer care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

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

Research has shown that mobile health tools and social media are generally safe for cancer survivors. In past studies, participants used fitness trackers, apps, and social media without serious problems. These studies aimed to increase activity and improve health management, and they found no major safety issues. Most participants found these tools easy to use and helpful for staying active. As this treatment is part of a Phase 3 trial, earlier stages have already tested its safety, indicating it is usually well-tolerated by most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the mobile health and social media approach for cancer survivors because it offers a fresh way to boost physical activity, which is crucial for recovery and long-term health. Unlike traditional methods that rely solely on educational materials or in-person sessions, this intervention leverages technology like Fitbits and social media to engage participants more interactively and continuously. By setting goals and tracking progress in real-time, it aims to motivate survivors to stay active in a more personal and connected manner, potentially leading to better adherence and outcomes. This innovative blend of technology and social interaction could redefine how we support cancer survivors in their journey post-treatment.

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

Research has shown that mobile health tools and social media can help cancer survivors become more active. In this trial, participants in the intervention group will receive a multi-component mobile health and social media physical activity intervention, including educational materials, goal setting, and a Fitbit. One study found that survivors using similar tools walked more and increased their physical activity after three months. Another study discovered that personalized exercise plans, combined with social media support, encouraged survivors to exercise more regularly. Although some studies did not find a significant increase in overall activity, mobile apps and social media support still offer potential benefits. These tools aim to simplify staying active for survivors, helping them maintain a healthy weight and improve overall health. Participants in the control group will receive educational materials and wear a Fitbit daily for 48 weeks. ^{1 2 3 6 7}

Who Is on the Research Team?

Nina S Kadan-Lottick

Principal Investigator

Children's Oncology Group

Are You a Good Fit for This Trial?

This trial is for adolescent and young adult childhood cancer survivors who've had chemotherapy or radiation, are expected to live more than a year, can walk, and have no medical issues preventing increased physical activity. They must be in remission, finished treatment within the last 3-36 months, do less than 420 minutes of exercise per week, and be able to use devices like Fitbits and smartphones.

Inclusion Criteria

No known significant physical or cognitive impairment that would prevent use of the electronic devices used for the protocol intervention (e.g. Fitbit, smartphone, tablet, or computer)

I can walk and have no health issues preventing me from being more active.

You can find the Godin-Shephard Leisure Time Physical Activity Questionnaire on the COG Study Web Page or through an online calculator.

Exclusion Criteria

I am not pregnant nor planning to become pregnant in the next year.

Note: Pregnancy status can be established by clinical history with patient. Post-menarchal female patients are eligible as long as they agree to use an effective contraceptive method (including abstinence) during study participation

Patients with previous hematopoietic stem cell transplant (HSCT) are excluded

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intensive Phase

Participants wear a physical activity tracker (Fitbit) daily, receive weekly reminders, goal setting sessions, and participate in a social media peer support group.

24 weeks

Weekly virtual check-ins

Maintenance Phase

Participants continue to wear a Fitbit daily, set their own step count goals, and have monthly check-ins with study staff. They also post content on the Instagram account moderated by study staff.

24 weeks

Monthly virtual check-ins

Follow-up

Participants are monitored for changes in physical activity levels, health, and quality of life.

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Multi-component mobile health and social media physical activity intervention
• Wearing a physical activity tracker alone

Trial Overview The StepByStep Study compares two programs: one that combines mobile health tools with social media to encourage physical activity versus just wearing an activity tracker. The goal is to see which method better increases physical activity levels over time and how this affects overall health and quality of life.

How Is the Trial Designed?

Group I: Intervention group (educational materials, goal set, Fitbit) Experimental Treatment 6 Interventions

See outline

Group II: Control Group (educational materials, Fitbit) Active Control 2 Interventions

Participants receive educational materials about physical activity and wear a Fitbit daily for 48 weeks.

Who Is Running the Clinical Trial?

Children's Oncology Group

Lead Sponsor

Trials

467

Recruited

241,000+

MedStar Georgetown University Hospital

Collaborator

Trials

6

Recruited

22,900+

Yale University

Collaborator

Trials

1,963

Recruited

3,046,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Adding behavioral counseling to a 4-week supervised physical activity program for kidney cancer survivors showed feasibility and a potential increase in physical activity levels, although the increase was not statistically significant.

Participants receiving behavioral counseling improved their 6-minute walk distance significantly more than those receiving standard exercise counseling, suggesting that behavioral strategies may enhance fitness outcomes in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and preliminary efficacy of adding behavioral counseling to supervised physical activity in kidney cancer survivors: a randomized controlled trial. Trinh, L., Plotnikoff, RC., Rhodes, RE., et al.[2014]

A multi-component mobile health intervention significantly improved daily physical activity and physical health in cancer survivors compared to a control group, with participants increasing their daily steps and overall well-being over a 6-month period.

The social media component of the intervention enhanced perceived social support among cancer survivors, indicating that social interaction can play a beneficial role in their recovery and health management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of personalized exercise prescriptions and social media delivered through mobile health on cancer survivors' physical activity and quality of life. Gao, Z., Ryu, S., Zhou, W., et al.[2023]

Out of 341 physical activity apps reviewed, only 67 were deemed appropriate for cancer survivors, with 46% offering a mix of aerobic and strength/stretching exercises.

The apps generally scored well in objective quality (average score of 4.11 out of 5) but were less effective in promoting knowledge and awareness about physical activity, indicating a need for better content tailored to cancer survivors' needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prescribing fitness apps for people with cancer: a preliminary assessment of content and quality of commercially available apps. Martín Payo, R., Harris, J., Armes, J.[2020]

The CHAT intervention, a 4-week mobile health program for African American breast cancer survivors, demonstrated high participant engagement and acceptability, with 85% of participants reporting positive behavior changes.

Participants in the intervention group significantly reduced their sedentary time by 4.37 hours per day and decreased fast food intake by 1.5 servings, indicating the potential effectiveness of mobile technology in improving health behaviors among this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot and Feasibility Mobile Health Intervention to Support Healthy Behaviors in African American Breast Cancer Survivors. Allicock, M., Kendzor, D., Sedory, A., et al.[2022]

Young adult cancer survivors showed similar levels of engagement on Facebook in both a physical activity intervention group and a self-help group, with no significant differences in the number of comments or participation over 12 weeks.

Participant-initiated posts received more interaction than those initiated by moderators, and engagement on Facebook was linked to increased light physical activity, suggesting that social media can play a role in promoting physical activity among this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engagement of young adult cancer survivors within a Facebook-based physical activity intervention. Valle, CG., Tate, DF.[2023]

Mobile health (mHealth) interventions, especially those including personal contact, have strong evidence for effectively increasing moderate-to-vigorous physical activity among cancer survivors, based on a review of 31 studies.

However, the evidence for mHealth interventions in increasing total activity levels and reducing sedentary behavior remains inconclusive, highlighting the need for further research in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

mHealth Interventions to Address Physical Activity and Sedentary Behavior in Cancer Survivors: A Systematic Review. Khoo, S., Mohbin, N., Ansari, P., et al.[2021]

In a pilot study involving 30 cancer patients, the use of a wearable activity tracker combined with personalized text message feedback led to 39% of participants increasing their daily steps by at least 20% over 3 months.

The intervention was well-received, with 72% of participants continuing to use the activity tracker at least 4 days a week after 6 months, suggesting it may effectively promote physical activity among cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing physical activity in Cancer Survivors through a Text-messaging Exercise motivation Program (ICanSTEP). Koontz, BF., Levine, E., McSherry, F., et al.[2022]

A 10-week pilot study with 10 breast cancer survivors showed that using the MapMyFitness app and a Facebook-based health education intervention significantly increased physical activity levels, with participants averaging an additional 2.6 minutes of moderate-to-vigorous activity and 1,657 more steps per day.

Participants also experienced notable health improvements, including a decrease in weight by 2.4 kg and body fat percentage by 2.3%, along with enhanced social support and quality of life, indicating that technology-based interventions can be effective for promoting health in breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of smartphone application and social media intervention on breast cancer survivors' health outcomes. Pope, Z., Lee, JE., Zeng, N., et al.[2019]

Breast cancer survivors (N = 96, average age 55.8) showed a strong preference for social support features in technology-supported physical activity interventions, with 77.1% interested in having a coach and 66.7% in team support.

While survivors valued social connectedness and sharing activity data, there was mixed feedback on competitive features, indicating a need for tailored approaches in designing these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast cancer survivors' preferences for social support features in technology-supported physical activity interventions: findings from a mixed methods evaluation. Lloyd, GR., Hoffman, SA., Welch, WA., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8578050/

Mobile Health Applications, Cancer Survivors and Lifestyle ... This review examined the evidence surrounding cancer survivors' use of mHealth interventions for lifestyle modification. Of the studies reviewed, 10 reported on ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10658306/

Effects of personalized exercise prescriptions and social ... This study aimed to examine the effects of a multi-component mobile health intervention (wearable, apps, and social media) on cancer survivors' (CS') physical ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04089358?rank=1&term=ALTE2031

Mobile Health and Social Media Physical Activity ... This phase III trial compares a multi-component mobile health and social media physical activity intervention versus wearing a physical activity tracker alone ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2352013224000802

Effectiveness of a theory-based tailored mHealth physical ... Compared to the baseline data, breast cancer patients in the intervention group had significant improvements in walking and overall PA after three months (P < ...

5. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.34556

Effect of an mHealth intervention on physical activity outcomes ... Young adult cancer survivors participating in a mobile health intervention did not significantly increase accelerometer-measured total ...

6. ascopubs.org ascopubs.org/doi/10.1200/CCI.24.00014

Mapping the Evidence on the Impact of mHealth ... All studies contained multiple interventions, including physical activity, tailored information for self-management of the disease, and symptom tracker.

7. cancer.jmir.org cancer.jmir.org/2016/1/e7/

Assessment of Cancer Survivors' Experiences of Using a ... This study aims to (1) assess recruitment, study uptake, and engagement for a publicly available PA mobile app (GAINFitness) intervention in cancer survivors.