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?

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.

Is 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. ^{1 2 3 4 5}

How 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. ^{6 7 8 9 10}

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. ^{4 11 12 13 14}

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

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.

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.

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

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

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

Bootcamp during neoadjuvant chemotherapy for breast cancer: a randomized pilot trial. [2021]

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

Effect of Group Dynamics-Based Exercise Versus Personal Training in Breast Cancer Survivors. [2022]

3. United States 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. [2019]

4. United States 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. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Self-efficacy, motivation, and habits: psychological correlates of exercise among women with breast cancer. [2023]

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

Efficacy of Exercise Therapy on Cardiorespiratory Fitness in Patients With Cancer: A Systematic Review and Meta-Analysis. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

[Evidence and recommendations for oncologic clinical exercise - a personalized treatment concept for cancer patients]. [2015]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Adverse Events During Supervised Exercise Interventions in Pediatric Oncology-A Nationwide Survey. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Rising to the challenge: designing, implementing and reporting exercise oncology trials in understudied populations. [2021]

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

Does Health Coaching Grow Capacity in Cancer Survivors? A Systematic Review. [2018]

11. Switzerland pubmed.ncbi.nlm.nih.gov

A Practical Approach to Using Integrated Knowledge Translation to Inform a Community-Based Exercise Study. [2021]

12. Canada pubmed.ncbi.nlm.nih.gov

Efficacy of a Mobile-Enabled Web App (iCanFit) in Promoting Physical Activity Among Older Cancer Survivors: A Pilot Study. [2022]

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

Evaluation of a Mobile Health Intervention to Improve Wellness Outcomes for Breast Cancer Survivors. [2022]

14. England 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. [2020]