Exercise Coaching and Digital App for Cancer Survivors

Overseen By Trupti Mukker, MBA

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Complement Theory Inc.

Disqualifiers: Recent surgery, Medically unfit, ECOG 3-5

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

146 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if personalized exercise coaching and a digital app can help cancer survivors reduce healthcare costs. Participants will receive either live one-on-one coaching with lifestyle tips via an app or just the app with general advice. The trial seeks individuals who have had breast, prostate, colorectal, lung, or other cancers and received treatment in the past year. Access to a smartphone or tablet is necessary, as the program uses a digital app. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance 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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Complement Theory's Live 1:1 Exercise Coaching and Personalized Digital Application is safe for cancer survivors?

Research shows that exercise programs and digital health apps are generally safe and user-friendly. Studies on Complement Theory's Live 1:1 Exercise Coaching and Personalized Digital Application for cancer survivors have not identified any serious safety issues. This program includes exercise, meditation, diet, and sleep, which are typically safe activities for most individuals.

Although specific safety data for this program is limited, exercise and lifestyle improvements are known to carry a low risk of adverse effects. Participants in similar programs usually experience no major negative effects, making this type of treatment a safe choice for many. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the impact of personalized exercise and lifestyle coaching specifically tailored for cancer survivors, using a combination of live 1:1 coaching and a digital app. Unlike typical post-cancer treatment care that often lacks individualized attention, this approach offers personalized exercise plans and guidance on meditation, diet, and sleep, all tailored to each individual's needs. By integrating real-time coaching with an evidence-based digital platform, the trial aims to enhance the overall well-being and recovery of cancer survivors in a more comprehensive and supportive manner.

What evidence suggests that Complement Theory's Live 1:1 Exercise Coaching and Personalized Digital Application is effective for cancer survivors?

Research shows that exercise and lifestyle changes can help cancer survivors feel better. Studies have found that personalized exercise coaching can improve overall well-being and reduce tiredness. In this trial, participants in the test group will receive Complement Theory's program, which offers live coaching and a digital app providing personalized advice on exercise, diet, and sleep. Although specific data on this program is limited, it aligns with existing evidence suggesting that personalized exercise and lifestyle support can be beneficial. Early results from similar programs have shown improvements in both physical and mental health for cancer survivors. Participants in the control group will access the digital application with expert guidelines on lifestyle modification, focusing on exercise, meditation, diet, sleep, and other lifestyle practices, but without live coaching and personalization. ^{1 2 3 4 5}

Who Is on the Research Team?

Claudio L. Battaglini, PhD

Principal Investigator

University of North Carolina

Erik Hanson, PhD

Principal Investigator

University of North Carolina

Are You a Good Fit for This Trial?

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

I am between 21 and 64 years old.

Permission to access to last 1 year digital health records

Access to smartphone or a tablet

Exclusion Criteria

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.

I have not had surgery in the last 4 weeks and do not plan to have any in the next 4 weeks.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Complement Theory's Live 1:1 Exercise Coaching and Personalised Digital Application

Trial Overview 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.

How Is the Trial Designed?

Group I: Test Group Experimental Treatment 1 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 Group Active Control 1 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.

Who Is Running the Clinical Trial?

Complement Theory Inc.

Lead Sponsor

Trials

1

Recruited

150+

Published Research Related to This Trial

Exercise has been shown to enhance cancer-related fatigue, quality of life, and physical fitness, but its effects on less common cancers like multiple myeloma are not well-researched.

Incorporating novel study designs and open-science practices in exercise oncology research could lead to more reliable and generalizable findings, particularly for less common cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rising to the challenge: designing, implementing and reporting exercise oncology trials in understudied populations. Lahart, IM., Weller, SK., Kirkham, AA.[2021]

Health coaching interventions for cancer survivors showed significant improvements in quality of life, mood, and physical activity among 1038 participants across 12 studies, indicating its efficacy in enhancing patient capacity.

While health coaching positively impacted various aspects of patient capacity, it did not significantly improve self-efficacy, highlighting the need for future interventions to focus on enhancing self-efficacy and the patient's environment of care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Health Coaching Grow Capacity in Cancer Survivors? A Systematic Review. Barakat, S., Boehmer, K., Abdelrahim, M., et al.[2018]

The iCanFit app was pilot tested with 30 older cancer survivors, showing significant improvements in both physical activity levels and quality of life after 2-3 months of use.

Participants particularly liked the goal-setting feature of iCanFit, which motivated them to stay active, indicating that mobile technology can effectively promote physical activity among older cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a Mobile-Enabled Web App (iCanFit) in Promoting Physical Activity Among Older Cancer Survivors: A Pilot Study. Hong, YA., Goldberg, D., Ory, MG., et al.[2022]

A 1-year randomized controlled trial involving cancer survivors showed that both a web-based program and a combination of health coaching with the web program significantly improved physical activity, weight management, and psychological distress compared to a control group.

The combination of health coaching and the web program led to a notable improvement in psychological well-being, as measured by the Post Traumatic Growth Inventory, indicating its effectiveness in reducing distress among cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Yun, YH., Lim, CI., Lee, ES., et al.[2020]

Theory-based physical activity interventions for overweight and obese female cancer survivors are safe and feasible, with high adherence and retention rates, and they can lead to moderate to large improvements in physical activity, especially when including a center-based component.

Health-related outcomes showed positive effects, such as improvements in aerobic fitness and significant reductions in waist circumference, while only one serious adverse event was reported, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Theory-Based Behavioral Interventions on Physical Activity Among Overweight and Obese Female Cancer Survivors: A Systematic Review of Randomized Controlled Trials. Rossi, A., Friel, C., Carter, L., et al.[2019]

In a pilot trial involving 10 breast cancer patients undergoing neoadjuvant chemotherapy, adding a supervised exercise program resulted in a significant decrease in body mass index (BMI) compared to those receiving chemotherapy alone (28.0 vs. 35.8, P = 0.03).

While the exercise group showed a trend towards lower Ki-67 levels (7% vs. 29%, P = 0.14), indicating potential benefits in tumor proliferation rates, the difference was not statistically significant, suggesting further research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bootcamp during neoadjuvant chemotherapy for breast cancer: a randomized pilot trial. Rao, R., Cruz, V., Peng, Y., et al.[2021]

Exercise has been shown to positively impact various cancer-related toxicities, including fatigue, urinary incontinence, and lymphedema, based on recent reviews and randomized controlled trials.

Despite the evidence supporting exercise as beneficial for cancer patients, there is a lack of implementation of evidence-based exercise programs in clinical practice, highlighting the need for personalized treatment approaches like 'Oncologic clinical exercise' (OTT).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evidence and recommendations for oncologic clinical exercise - a personalized treatment concept for cancer patients]. Baumann, FT., Hallek, M., Meyer, J., et al.[2015]

Breast cancer survivors using a health and wellness coaching app showed significant weight loss and a greater reduction in body mass index compared to those using a self-guided toolkit, indicating the app's effectiveness in promoting healthier lifestyles.

The app users also reported improvements in physical activity and dietary patterns, suggesting that access to live coaching can enhance adherence to wellness plans, although long-term app usage declined after 12 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a Mobile Health Intervention to Improve Wellness Outcomes for Breast Cancer Survivors. Cairo, J., Williams, L., Bray, L., et al.[2022]

Exercise therapy significantly improves cardiorespiratory fitness (CRF) in patients with adult-onset cancer, with an average increase of 2.80 mL O2 × kg-1 × min-1 compared to no change in control groups, based on a review of 48 randomized controlled trials involving 3,632 patients.

The study found that exercise therapy is safe, with only 44 adverse events reported across 30 trials, and high adherence rates (88%) suggest that patients are likely to stick with the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Exercise Therapy on Cardiorespiratory Fitness in Patients With Cancer: A Systematic Review and Meta-Analysis. Scott, JM., Zabor, EC., Schwitzer, E., et al.[2022]

In a study of 35,110 exercise interventions for pediatric cancer patients and survivors, serious adverse events (AEs) were rare, with only six Grade 2-3 AEs reported, resulting in an incidence of 17 per 100,000 interventions, indicating that supervised exercise programs are generally safe.

While Grade 1 AEs, such as muscle soreness and circulatory problems, were more common (2,800 per 100,000 interventions), these were typically mild and likely not directly caused by the exercise, suggesting that exercise can be safely integrated into cancer care for children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events During Supervised Exercise Interventions in Pediatric Oncology-A Nationwide Survey. Gauß, G., Beller, R., Boos, J., et al.[2021]

Cancer survivors prefer exercise programs supervised by specialists who understand cancer, and they value support from healthcare providers and accessible community locations, as identified in a study with 13 survivors and 5 caregivers before the ACE trial.

After participating in the ACE trial, survivors expressed a need for better exercise counseling from healthcare providers and suggested that exercise should be introduced earlier in their care, highlighting gaps in support that could improve their recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Practical Approach to Using Integrated Knowledge Translation to Inform a Community-Based Exercise Study. Suderman, K., Dolgoy, N., Yurick, J., et al.[2021]

In a study involving 26 post-treatment breast cancer survivors, both a group dynamics-based exercise intervention and a personal training intervention led to significant improvements in physical activity and fitness over an eight-week period.

The group dynamics-based exercise intervention was particularly effective, resulting in greater enhancements in overall quality of life compared to the personal training approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Group Dynamics-Based Exercise Versus Personal Training in Breast Cancer Survivors. Leach, HJ., Covington, KR., Voss, C., et al.[2022]

A 12-week telephone counseling exercise (TCE) intervention based on the multi-process action control framework significantly increased weekly aerobic exercise by 218 minutes in hematologic cancer survivors, compared to just 93 minutes in a self-directed exercise group.

Participants in the TCE group also showed clinically meaningful improvements in quality of life, particularly in mental health, suggesting that this intervention could enhance both physical activity and overall well-being for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and preliminary efficacy of an exercise telephone counseling intervention for hematologic cancer survivors: a phase II randomized controlled trial. Vallerand, JR., Rhodes, RE., Walker, GJ., et al.[2022]

A study of 204 breast cancer survivors found that higher levels of identified motivation and established exercise habits were significantly linked to increased overall physical activity, while coping self-efficacy was associated with resistance training participation.

The findings suggest that interventions aimed at enhancing motivation, habits, and self-efficacy could effectively encourage more exercise among breast cancer survivors, highlighting the importance of psychological factors in physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-efficacy, motivation, and habits: psychological correlates of exercise among women with breast cancer. Jones, TL., Edbrooke, L., Rawstorn, JC., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06397651

Study Details | NCT06397651 | A Randomised Controlled ... A Randomised Controlled Trial to Evaluate the Impact of Complement Theory's Live 1:1 Exercise Coaching and Personalised Digital Application on Cancer Survivors' ...

2. ctv.veeva.com ctv.veeva.com/study/a-randomised-controlled-trial-to-evaluate-the-impact-of-complement-theorys-live-1-1-exercise-coachi

Complement Theory Inc. - ClinicalTrials.Veeva A randomised controlled trial to evaluate the impact of Complement Theory's Live 1:1 Exercise Coaching and Personalised Digital Application on Cancer Survivors ...

3. trial.medpath.com trial.medpath.com/clinical-trial/769e86b26bb54cd8/nct06397651-decentralized-double-blinded-randomized-study-complement-theory

A Randomised Controlled Trial to Evaluate the Impact of ... A Randomised Controlled Trial to Evaluate the Impact of Complement Theory's Live 1:1 Exercise Coaching and Personalised Digital Application on Cancer Survivors' ...

4. withpower.com withpower.com/trial/exercise-coaching-and-digital-app-for-cancer-survivors-54095

Exercise Coaching and Digital App for Cancer Survivors What data supports the effectiveness of the treatment Complement Theory's Live 1:1 Exercise Coaching and Personalised Digital Application for cancer survivors?

5. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/51/NCT06397651/Prot_SAP_000.pdf

CT Cancer Study Protocol_vF Participants will get access to Complement Theory's 24-week Live. 1:1 Coaching program, focusing on Exercise and Meditation and supplemented ...