Exercise Coaching and Digital App for Cancer Survivors
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Complement Theory Inc.
Disqualifiers: Recent surgery, Medically unfit, ECOG 3-5
No Placebo Group
Trial Summary
What is the purpose of this trial?A Decentralized, Double-blinded, Randomized, 18 month, Parallel-group, Superiority Study to evaluate the impact of Complement Theory's Live 1:1 Exercise Coaching and Personalized Digital Application on Cancer Survivors' Cost of 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's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Complement Theory's Live 1:1 Exercise Coaching and Personalised Digital Application for cancer survivors?
Research shows that exercise can improve outcomes for cancer survivors, such as better physical fitness and quality of life. Supervised exercise and personalized interventions, like those offered by Complement Theory, have been found to be effective in increasing physical activity and improving health in cancer survivors.
12345Is exercise coaching and digital app use safe for cancer survivors?
Exercise programs for cancer patients, including those using digital apps, are generally safe with few serious adverse events (unwanted effects). Most reported issues are minor, like muscle soreness or mild discomfort, and serious problems are rare.
36789How is the treatment 'Complement Theory's Live 1:1 Exercise Coaching and Personalised Digital Application' unique for cancer survivors?
This treatment is unique because it combines live, one-on-one exercise coaching with a personalized digital app, offering a tailored approach to increase physical activity among cancer survivors. Unlike other treatments, it provides real-time coaching and personalized feedback, which may enhance motivation and adherence to exercise routines.
1011121314Eligibility Criteria
This trial is for cancer survivors aged 21-64 who have had breast, prostate, colorectal, lung or other cancers at any stage from 1 to 4. Participants must have completed some form of cancer treatment in the past year, own a smartphone or tablet and allow access to their digital health records from the last year.Inclusion Criteria
My cancer is one of the following types: breast, prostate, colorectal, lung, or another specified type.
My cancer is between stage 1 and 4.
I have had cancer treatment in the past year.
+3 more
Exclusion Criteria
I have not had surgery in the last 4 weeks and do not plan to have any in the next 4 weeks.
Participants declared medically unfit by their physicians to do physical exercise
I have limited self-care abilities and spend most of my time in bed or a chair.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either the live 1:1 coaching program or access to the digital application for 24 weeks
24 weeks
Decentralized visits via mobile app
Follow-up
Participants are monitored for healthcare expenditure, quality of life, and other health outcomes
18 months
Participant Groups
The study compares two approaches: one group receives Complement Theory's Live 1:1 Exercise Coaching with a personalized digital app; another gets just the app with lifestyle modification advice. It's an 18-month test to see if these methods can lower healthcare costs for cancer survivors.
2Treatment groups
Experimental Treatment
Active Control
Group I: Test GroupExperimental Treatment1 Intervention
Live 1:1 Coaching program, focusing on Exercise and Meditation, along with app-guided evidence-based information on Diet, Sleep, and other lifestyle practices for 24 weeks
Group II: Control GroupActive Control1 Intervention
24 weeks access to Digital application with expert guidelines on lifestyle modification focusing on exercise, meditation, as well as information on diet, sleep and other lifestyle practices. Does not include live coaching and personalization.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Complement Theory Inc.Dover, DE
Loading ...
Who Is Running the Clinical Trial?
Complement Theory Inc.Lead Sponsor
References
Bootcamp during neoadjuvant chemotherapy for breast cancer: a randomized pilot trial. [2021]Exercise may improve cancer outcomes. Neoadjuvant chemotherapy (NC) for breast cancer provides a unique setting to evaluate intervention effects. Treatments leading to decreased post-neoadjuvant Ki-67 levels, smaller tumor size, and higher pathologic response are associated with improved survival and lower recurrence. This randomized, prospective pilot trial evaluates the feasibility of supervised exercise during NC for breast cancer.
Effect of Group Dynamics-Based Exercise Versus Personal Training in Breast Cancer Survivors. [2022]To determine the feasibility and preliminary effectiveness of a group dynamics-based exercise intervention versus a personal training intervention for increasing physical activity (PA), physical fitness, and quality of life (QOL) in post-treatment breast cancer survivors.
Effects of Theory-Based Behavioral Interventions on Physical Activity Among Overweight and Obese Female Cancer Survivors: A Systematic Review of Randomized Controlled Trials. [2019]To determine whether theory-based physical activity (PA) interventions for overweight and obese female cancer survivors lead to increased PA and improved health.
Feasibility and preliminary efficacy of an exercise telephone counseling intervention for hematologic cancer survivors: a phase II randomized controlled trial. [2022]Supervised exercise interventions produce the largest improvements in patient-reported outcomes in cancer survivors but their scalability has been questioned. Telephone counseling has been proposed as a more feasible alternative but its impact on exercise behavior and health outcomes have been modest. Basing telephone counseling exercise (TCE) interventions on the theoretical advances described in the multi-process action control framework (M-PAC) may improve these outcomes.
Self-efficacy, motivation, and habits: psychological correlates of exercise among women with breast cancer. [2023]The purpose of this analysis was to explore associations between exercise behaviour among breast cancer survivors and three behavioural constructs from distinct theories: self-efficacy from social cognitive theory, motivation from self-determination theory, and habits from habit theory.
Efficacy of Exercise Therapy on Cardiorespiratory Fitness in Patients With Cancer: A Systematic Review and Meta-Analysis. [2022]Purpose To evaluate the effects of exercise therapy on cardiorespiratory fitness (CRF) in randomized controlled trials (RCTs) among patients with adult-onset cancer. Secondary objectives were to evaluate treatment effect modifiers, safety, and fidelity. Methods A systematic search of PubMed, Embase, Cumulative Index to Nursing and Allied Health Literature, and the Cochrane Library was conducted to identify RCTs that compared exercise therapy to a nonexercise control group. The primary end point was change in CRF as evaluated by peak oxygen consumption (VO2peak; in mL O2 × kg-1 × min-1) from baseline to postintervention. Subgroup analyses evaluated whether treatment effects differed as a function of exercise prescription (ie, modality, schedule, length, supervision), study characteristics (ie, intervention timing, primary cancer site), and publication year. Safety was defined as report of any adverse event (AE); fidelity was evaluated by rates of attendance, adherence, and loss to follow-up. Results Forty-eight unique RCTs that represented 3,632 patients (mean standard deviation age, 55 ± 7.5 years; 68% women); 1,990 (55%) and 1,642 (45%) allocated to exercise therapy and control/usual care groups, respectively, were evaluated. Exercise therapy was associated with a significant increase in CRF (+2.80 mL O2 × kg-1 × min-1) compared with no change (+0.02 mL O2 × kg-1 × min-1) in the control group (weighted mean differences, +2.13 mL O2 × kg-1 × min-1; 95% CI, 1.58 to 2.67; I2, 20.6; P < .001). No statistical significant differences were observed on the basis of any treatment effect modifiers. Thirty trials (63%) monitored AEs; a total of 44 AEs were reported. The mean standard deviation loss to follow-up, attendance, and adherence rates were 11% ± 13%, 84% ± 12%, and 88% ± 32%, respectively. Conclusion Exercise therapy is an effective adjunctive therapy to improve CRF in patients with cancer. Our findings support the recommendation of exercise therapy for patients with adult-onset cancer.
[Evidence and recommendations for oncologic clinical exercise - a personalized treatment concept for cancer patients]. [2015]Oncological treatments can lead to acute and chronic cancer related toxicities. In recent years, a large number of clinical studies have reported positive effects of exercise to the bio-psycho-social regeneration of cancer patients. However, very few evidence-based programs have been implemented into practice with little opportunity for cancer patients to engage in such programs. Reviews and RCT studies on exercise and cancer are showing that specific exercise programs have a positive impact on fatigue syndrome, urinary incontinence, lymphedema, polyneuropathy, arthralgia, and androgen deprivation related toxicities. With the increasing evidence for exercise oncology interventions, recommendations arising from clinical trials should be translated into clinical practice and this should be viewed as an important next step in this fast moving field of exercise oncology. For that the personalized treatment concept "Oncologic clinical exercise" (OTT) was developed.
Adverse Events During Supervised Exercise Interventions in Pediatric Oncology-A Nationwide Survey. [2021]Objectives: Exercise interventions during and after treatment for pediatric cancer are associated with beneficial physical, psychological, and social effects. However, valid data about adverse events (AEs) of such interventions have rarely been evaluated. This retrospective study evaluates AEs that occurred during supervised oncological exercise programs for pediatric cancer patients and survivors. Methods: This Germany-wide study used a self-administered online survey focusing on general program characteristics and AEs retrospectively for 2019. The questionnaire included (a) basic data on the offered exercise program, (b) AEs with consequences (Grade 2-5) that occurred in 2019 during an exercise intervention, (c) number of Grade 1 AEs, (d) safety procedures as part of the exercise programs, and (e) possibility to give feedback and describe experience with AEs in free text. Results: Out of 26 eligible exercise programs, response rate of program leaders was 92.3% (n = 24). Representatives working for Universities (n = 6), rehabilitation clinics (n = 3), acute cancer clinics (n = 12), and activity camps (n = 3) participated. In total, 35,110 exercise interventions with varying duration were recorded for 2019. Six AEs with consequences (Grade 2-3) occurred during exercise interventions after cancer treatment resulting in an incidence of 17 per 100,000 exercise interventions (0.017%). No life-threatening consequences or death were reported and no serious AE occurred during acute cancer treatment. Grade 1 AE occurred with a frequency of 983, corresponding to an incidence of 2,800 per 100,000 interventions (2.8%). Most frequent Grade 1 AE were muscle soreness, circulatory problems, and abdominal pain. The most frequent preventive safety procedures at the institutions were regular breaks, consultations with the medical treatment team, and material selection with low injury potential. Conclusions: Supervised exercise interventions for pediatric cancer patients and survivors seem to be safe and AEs with consequences comparatively rare when compared to general childhood population data. Occurrence of grade 1 AEs was common, however, causality was probably not evident between AEs and the exercise intervention. Future research should standardize assessment of AEs in clinical practice and research, and prospectively register and evaluate AEs that occur in the context of exercise interventions in pediatric cancer patients and survivors.
Rising to the challenge: designing, implementing and reporting exercise oncology trials in understudied populations. [2021]Exercise can improve cancer-related fatigue, quality of life and physical fitness, but is understudied in less common cancers such as multiple myeloma. Studying less common cancers and the adoption of novel study designs and open-science practices would improve the generalisability, transparency, rigour, credibility and reproducibility of exercise oncology research.
Does Health Coaching Grow Capacity in Cancer Survivors? A Systematic Review. [2018]Interventions that grow patient capacity to do the work of health care and life are needed to support the health of cancer survivors. Health coaching may grow capacity. This systematic review of health coaching interventions explored coaching's ability to grow capacity of cancer survivors. The authors included randomized trials or quasi-experimental studies comparing coaching to alternative interventions, and adhered to PRISMA reporting guidelines. Data were analyzed using the Theory of Patient Capacity (BREWS: Capacity is affected by factors that influence ability to reframe Biography ["B"], mobilize or recruit Resources ["R"], interact with the Environment of care ["E"], accomplish Work ["W"]), and function Socially ["S"]). The authors reviewed 2210 references and selected 12 studies (6 randomized trials and 6 pre-post). These studies included 1038 cancer survivors, mean age 57.2 years, with various type of cancers: breast, colorectal, prostate, and lung. Health coaching was associated with improved quality of life, mood, and physical activity but not self-efficacy. Classified by potential to support growth in patient capacity, 67% of included studies reported statistically significant outcomes that support "B" (quality of life, acceptance, spirituality), 75% "R" (decreased fatigue, pain), 67% "W" (increased physical activity), and 33% "S" (social deprivation index). None addressed changing the patient's environment of care. In cancer survivors, health coaching improved quality of life and supported patient capacity by several mechanisms, suggesting an important role for "Capacity Coaching." Future interventions that improve self-efficacy and patients' environments of care are needed. Capacity Coaching may improve health and quality of life of cancer survivors.
A Practical Approach to Using Integrated Knowledge Translation to Inform a Community-Based Exercise Study. [2021]Our aim was to understand cancer survivor needs prior to, and following the Alberta Cancer Exercise (ACE) pilot randomized trial as a means to inform implementation of a province-wide cancer-specific, community-based exercise program.
Efficacy of a Mobile-Enabled Web App (iCanFit) in Promoting Physical Activity Among Older Cancer Survivors: A Pilot Study. [2022]The benefits of physical activity for cancer survivors are well documented. However, few older cancer survivors are engaged in regular physical activity. Mobile technologies may be an effective method to deliver physical activity promotion programs for older cancer survivors. iCanFit, a mobile-enabled Web-based app, was developed based on formative research and usability testing. This app includes interactive features of physical activity, goal setting and tracking, and receiving personalized visual feedback.
Evaluation of a Mobile Health Intervention to Improve Wellness Outcomes for Breast Cancer Survivors. [2022]Breast cancer survivors are at increased risk of cancer recurrence, second malignancies, and other comorbid conditions. This study examined if use of a convenient, commercially available, $65 per month app that gives breast cancer survivors access to a health and wellness coach is more effective than a self-guided toolkit and one-time health education session at achieving the following goals: 1) improving adherence to a plant-based diet, 2) increasing physical activity, 3) assisting with weight loss and reduction in body mass index, 4) reducing elevated depression and fatigue scores, and 5) leading to sustained adherence to lifestyle and wellness plan at and beyond 6 months.
Efficacy of health coaching and a web-based program on physical activity, weight, and distress management among cancer survivors: A multi-centered randomised controlled trial. [2020]To investigate the efficacy of health coaching and a web-based program on survivor physical activity (PA), weight, and distress management among stomach, colon, lung and breast cancer patients.