Overseen BySiobhan M Phillips, PhD, MPH
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.
12345Is 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.
26789How 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.
125910Eligibility 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.
+13 more
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
+4 more
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
Participant Groups
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.
16Treatment groups
Experimental Treatment
Active Control
Group I: Exp Condition 1Experimental Treatment5 Interventions
Research participant receives the Core Intervention + E-Coach + General Mindfulness Training + MVPA Specific Mindfulness Training + Buddy
Group II: Exp Condition 10Active Control2 Interventions
Research participant receives the Core Intervention + General Mindfulness Training
Group III: Exp Condition 11Active Control3 Interventions
Research participant receives the Core Intervention + MVPA Specific Mindfulness Training + Buddy
Group IV: Exp Condition 2Active Control4 Interventions
Research participant receives the Core Intervention + E-Coach + General Mindfulness Training + MVPA Specific Mindfulness Training
Group V: Exp Condition 4Active Control2 Interventions
Research participant receives the Core Intervention + E-Coach
Group VI: Exp Condition 6Active Control3 Interventions
Research participant receives the Core Intervention + E-Coach + General Mindfulness Training
Group VII: Exp Condition 7Active Control4 Interventions
Research participant receives the Core Intervention + E-Coach + MVPA Specific Mindfulness Training + Buddy
Group VIII: Exp Condition 9Active Control3 Interventions
Research participant receives the Core Intervention + General Mindfulness Training + Buddy
Group IX: Exp Condition 12Active Control2 Interventions
Research participant receives the Core Intervention + MVPA Specific Mindfulness Training
Group X: Exp Condition 14Active Control3 Interventions
Research participant receives the Core Intervention + General Mindfulness Training + MVPA Specific Mindfulness Training
Group XI: Exp Condition 15Active Control2 Interventions
Research participant receives the Core Intervention + Buddy
Group XII: Exp Condition 16Active Control1 Intervention
Research participant receives the Core Intervention
Group XIII: Exp Condition 13Active Control4 Interventions
Research participant receives the Core Intervention + General Mindfulness Training + MVPA Specific Mindfulness Training + Buddy
Group XIV: Exp Condition 3Active Control3 Interventions
Research participant receives the Core Intervention + E-Coach + Buddy
Group XV: Exp Condition 5Active Control4 Interventions
Research participant receives the Core Intervention + E-Coach + General Mindfulness Training + Buddy
Group XVI: Exp Condition 8Active Control3 Interventions
Research participant receives the Core Intervention + E-Coach + MVPA Specific Mindfulness Training
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Wake Forest School of MedicineWinston-Salem, NC
Northwestern UniversityChicago, IL
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Who Is Running the Clinical Trial?
Northwestern UniversityLead Sponsor
National Cancer Institute (NCI)Collaborator
Wake Forest University Health SciencesCollaborator
References
Mediators of physical activity outcomes in a peer-led intervention for breast cancer survivors. [2023]Physical activity (PA) adoption can reduce treatment-related sequelae of breast cancer. Peer-led PA interventions are a promising and relatively inexpensive approach to scaling up interventions. The current study seeks to identify mediators of PA change amongst cancer survivors enrolled in a peer-led behavior change intervention. The study team partnered with the American Cancer Society's Reach to Recovery program (RTR) whose volunteers' provided information and support to breast cancer survivors.
The wearable activity technology and action-planning trial in cancer survivors: Physical activity maintenance post-intervention. [2021]The study objective was to assess whether moderate-to-vigorous intensity physical activity (MVPA) change in cancer survivors (n = 68, mean age = 64 years) was maintained 12-weeks following the Wearable Activity Technology and Action Planning (WATAAP) intervention. Secondary aims were to assess the effects of the intervention on blood pressure (BP) and body mass index (BMI), and to explore group differences between baseline and 24-weeks.
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]Despite an overwhelming body of evidence showing the benefits of physical activity (PA) and exercise for cancer survivors, few survivors meet the exercise oncology guidelines. Moreover, initiating, let alone maintaining exercise programs with cancer survivors continues to have limited success. The aim of this trial is to evaluate the influence of peer support on moderate-to-vigorous PA (MVPA) and various markers of health 12 months following a brief supervised exercise intervention in cancer survivors.
Use of active video games with or without videoconferencing on health outcomes in adolescent and young adult cancer survivors: a systematic review. [2022]Adolescent and young adult (AYA) cancer survivors experience greater functional deficits compared to non-cancer peers or older survivors with a similar diagnosis. Physical activity (PA) is a key strategy for mitigating functional decline, and motivation and peer support are critical PA facilitators in AYA cancer survivors. Active video games (AVGs) may be a "gateway" method to promote PA. Further, integrating AVGs into group videoconferencing, a medium used by AYAs to socialize, can capitalize on peer support needed for PA motivation. Thus, we examined the use of AVGs and/or videoconferencing in PA interventions that included AYA survivors and the effect on physical function and health outcomes.
Improving biobehavioral health in younger breast cancer survivors: Pathways to Wellness trial secondary outcomes. [2023]The Pathways to Wellness trial tested the efficacy of 2 interventions for younger breast cancer survivors: mindful awareness practices (MAPs) and survivorship education (SE). This planned secondary analysis examines intervention effects on stress, positive psychological outcomes, and inflammation (Clincaltrials.gov NCT03025139).
Wearable Activity Technology And Action-Planning (WATAAP) to promote physical activity in cancer survivors: Randomised controlled trial protocol. [2023]Background/Objective: Colorectal and gynecologic cancer survivors are at cardiovascular risk due to comorbidities and sedentary behaviour, warranting a feasible intervention to increase physical activity. The Health Action Process Approach (HAPA) is a promising theoretical framework for health behaviour change, and wearable physical activity trackers offer a novel means of self-monitoring physical activity for cancer survivors. Method: Sixty-eight survivors of colorectal and gynecologic cancer will be randomised into 12-week intervention and control groups. Intervention group participants will receive: a Fitbit Alta™ to monitor physical activity, HAPA-based group sessions, booklet, and support phone-call. Participants in the control group will only receive the HAPA-based booklet. Physical activity (using accelerometers), blood pressure, BMI, and HAPA constructs will be assessed at baseline, 12-weeks (post-intervention) and 24-weeks (follow-up). Data analysis will use the Group x Time interaction from a General Linear Mixed Model analysis. Conclusions: Physical activity interventions that are acceptable and have robust theoretical underpinnings show promise for improving the health of cancer survivors.
A randomized controlled trial of Promoting Physical Activity in Regional and Remote Cancer Survivors (PPARCS). [2023]Physical activity (PA) is important for cancer survivors. Trials of remotely delivered interventions are needed to assist in reaching under-served non-metropolitan cancer survivors. The objective of this study was to ascertain whether wearable technology, coupled with health coaching was effective in increasing PA in breast and colorectal cancer survivors living in regional and remote areas in Australia.
Pilot randomized trial of a couple-based physical activity videoconference intervention for sedentary cancer survivors. [2023]Including partners in interventions to increase physical activity (PA) could promote better adherence and longer-term effects. In preparation for a future large-scale randomized controlled trial (RCT), this randomized pilot trial tested the acceptability of a novel couple-based PA intervention for breast and prostate cancer survivors and the feasibility of conducting an RCT testing the intervention.
A Pilot Randomized Controlled Trial of a Fitbit- and Facebook-Based Physical Activity Intervention for Young Adult Cancer Survivors. [2023]Purpose: Most young adult cancer survivors (YACS) do not meet physical activity (PA) guidelines. Although PA can improve health and quality of life (QOL), few randomized controlled trials (RCTs) of PA interventions for YACS exist. We conducted a pilot RCT to test feasibility of a PA intervention among YACS. Methods: We recruited 18-39-year-olds (≥1 and <5 years postcancer therapy) from Seattle Cancer Care Alliance. The 12-week intervention involved a wrist-worn PA-tracking device (Fitbit), a peer-based Facebook support group, step count goal setting, and a self-selected support "buddy." Controls received Fitbit only. Baseline assessments occurred before randomization; follow-up assessments occurred during intervention weeks 10-12. Feasibility criteria are listed below. Exploratory outcomes included PA, sedentary time (ST), QOL measures (e.g., fatigue), and self-determination theory (SDT) construct measures. Results: All feasibility criteria were met: We recruited 50 YACS, intervention participants wore the Fitbit on the majority of intervention days (82.9%), ≥75% of participants completed questionnaires at baseline (100%) and follow-up (93.9%). Exploratory analyses, adjusted for wave, accelerometer wear time, race, and income, showed significant group differences for change in ST (-52.4 vs. 2.5 minutes/day; p = 0.002) but no change in moderate-to-vigorous intensity PA (0.0 vs. -0.2 minutes/day; p = 0.40), comparing intervention participants to controls. The intervention (vs. control) group had a greater increase in fatigue interference (p = 0.03). No other significant differences in SDT or QOL measures were found. Conclusion: This Fitbit and Facebook-based PA intervention was feasible to YACS, with promising effects on reducing ST, and warrants a fully powered RCT. Clinical Trial Registration no.: NCT03233581.
Physical activity maintenance among young adult cancer survivors in an mHealth intervention: Twelve-month outcomes from the IMPACT randomized controlled trial. [2023]Most physical activity (PA) interventions in young adult cancer survivors (YACS) have focused on short-term outcomes without evaluating longer-term outcomes and PA maintenance. This study examined the effects of an mHealth PA intervention at 12 months, after 6 months of tapered contacts, relative to a self-help group among 280 YACS.