Breast CancerNCT06397651
A Randomised Controlled Trial to Evaluate the Impact of Complement Theory's Live CoActive Exercise Coaching and Personalized Digital Application on Cancer Survivors' Quality of Life
A study testing Complement Theory's Live CoActive Exercise Coaching and Personalized Digital Application and Digital application with expert guidelines on lifestyle modification in people with Breast Cancer and Lung Cancer, run by Complement Theory Inc. at 1 site in United States.
Trial summary
A Decentralized, Double-blinded, Randomized, 18 month, Parallel-group, Superiority Study to evaluate the impact of Complement Theory's Live Coactive Exercise Coaching and Personalized Digital Application on Cancer Survivors' Quality of Life Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Breast Cancer, Lung Cancer, Prostate Cancer
- What is being tested?
- Complement Theory's Live CoActive Exercise Coaching and Personalized Digital Application and Digital application with expert guidelines on lifestyle modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2024to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cancer Type: Breast, Prostate, Colorectal, Lung and Other Cancer
- Cancer Stage: Stage 1 to 4
- Treatment Status: Has undergone any cancer-related treatment in last 12 months
- Age: Above 21 years
- Permission to access to last 1 year digital health records
- Access to smartphone or a tablet
Who cannot join
- Excludes individuals who have undergone surgery within the last 4 weeks or will undergo surgery in the next 4 weeks
- Participants declared medically unfit by their physicians to do physical exercise
- ECOG Score 3,4 or 5
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Decentralized, Double-blinded, Randomized, 18 Month, Parallel-group, Superiority Study to Evaluate the Impact of Complement Theory's Live Coactive Exercise Coaching and Personalized Digital Application on Cancer Survivors' Quality of Life
A Decentralized, Double-blinded, Randomized, 18 month, Parallel-group, Superiority Study to evaluate the impact of Complement Theory's Live Coactive Exercise Coaching and Personalized Digital Application on Cancer Survivors' Quality of Life
Read the detailed description
The randomized controlled trial (RCT) aims to evaluate the efficacy of Complement Theory's (CT) personalized and interactive, evidence-backed lifestyle program in improving Cancer Survivors' Quality of Life across all major cancer types.
Distinct from conventional interventions, CT's program offers live CoActive coaching through a mobile app, concentrating on Exercise and Meditation, and is enriched with evidence-based advice on Diet. This trial is pivotal in assessing the program's effectiveness against an active comparator - expert-recommended lifestyle modification resources suitable for cancer survivors -- to isolate the impact of coaching and personalization.
The primary objective is to investigate whether CT's novel approach can significantly improve Quality of Life for survivors. Furthermore, the trial seeks to measure absenteeism and presenteeism at work to provide a holistic evaluation of the program's impact on patient care and well-being. As an exploratory effort, the trial will also measure changes in healthcare expenditure across all survivors along with assessing cancer progression, recurrence in Prostate, Lung and Colorectal cancer survivors.
- Conditions
- Breast Cancer, Lung Cancer, Prostate Cancer, Colorectal Cancer, Other Cancer
- Being tested
- Complement Theory's Live CoActive Exercise Coaching and Personalized Digital Application, Digital application with expert guidelines on lifestyle modification
- Keywords
- Other cancer here refers to all cancers apart from Breast, Lung, Prostate and Colorectal Cancer
- Medical subject headings
- Breast Neoplasms, Lung Neoplasms, Prostatic Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complement Theory's Live CoActive Exercise Coaching and Personalized Digital ApplicationBehavioural
Participants will get access for 18 months to Complement Theory's Live CoActive Coaching program, focusing on Exercise and Meditation and supplemented with evidence-based information on Diet, adjunct to the core treatment.
- Each week, up to five sessions of 45 minutes each will be offered, with a recommendation for participants to engage in a minimum of three sessions to ensure adequate program exposure and benefits.
- Each session will consist of 30 Minutes of Physical Exercise and 7 minutes of meditation. Each session will be a combination session focused on Aerobic and Strength, with flexibility and balance exercises included as supplements.
Digital application with expert guidelines on lifestyle modificationBehavioural
18 months 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.
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Live CoActive Coaching program, focusing on Exercise and Meditation, along with evidence-based information on Diet, for 18 months Receives: Behavioral: Complement Theory's Live CoActive Exercise Coaching and Personalized Digital Application |
| Control Group | Active comparator | 18 months 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. Receives: Behavioral: Digital application with expert guidelines on lifestyle modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of the program cancer survivors' Quality of Life Scores (QoLS), measured by the FACT-G instrument.
To quantify the impact of Complement Theory's Program on cancer survivors' Quality of Life, as measured by the change in FACT-G scores over the course of the trial.
Measured: 18 months
Secondary outcomes (2)
Effect on Employee Absenteeism
Quantify the effect of CT's program on employee absenteeism by tracking changes in the number of sick days taken by participants.
Measured: 18 Months
Impact on Employee Presenteeism
Determine the program's impact on employee presenteeism by assessing changes in work motivation and employee performance review scores.
Measured: 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start12 May 2024
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Treatment Group * Participants will get access to Complement Theory's Live Coaching program, focusing on Exercise and Meditation and supplemented with evidence-based information on Diet, Sleep, and other lifestyle practices, adjunct to the core treatment. * Each week, up to five sessions of 45 minutes each will be offered, with a recommendation for participants to engage in a minimum of 3 sessions. * Each session will consist of 30 Minutes of Physical Exercise and 7 minutes of meditation. Each session will be a combination session focused on Aerobic and Strength, with flexibility and balance exercises included as supplements. Active Comparator (Control) Group * Participants in this group will receive access to a curated collection of publicly available guidelines for lifestyle modification. These resources, presented through a digital application, will focus on exercise, meditation, diet, and sleep, but without the live coaching or program personalization.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Complement Theory Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Claudio L. Battaglini, PhD, Principal investigator, University of North CarolinaErik Hanson, PhD, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06397651
- Sponsor's protocol ID
- Pro00077693
- Status last verified
- Dec 2025
- First submitted
- 25 Apr 2024
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data shall be shared. This includes both primary and secondary outcomes related data points.
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Decentralized, Double-blinded, Randomized, 18 Month, Parallel-group, Superiority Study to Evaluate the Impact of Complement Theory's Live Coactive Exercise Coaching and Personalized Digital Application on Cancer Survivors' Quality of Life
- ClinicalTrials.gov ID
- NCT06397651
- Acronym / sponsor ID
- Pro00077693
- Conditions
- Breast Cancer, Lung Cancer, Prostate Cancer, Colorectal Cancer, Other Cancer
- Keywords
- Other cancer here refers to all cancers apart from Breast, Lung, Prostate and Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Complement Theory Inc.Industry (pharma, biotech, devices)
- Study start
- 12 May 2024 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 3 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Decentralized, Double-blinded, Randomized, 18 month, Parallel-group, Superiority Study to evaluate the impact of Complement Theory's Live Coactive Exercise Coaching and Personalized Digital Application on Cancer Survivors' Quality of Life
Detailed description
The randomized controlled trial (RCT) aims to evaluate the efficacy of Complement Theory's (CT) personalized and interactive, evidence-backed lifestyle program in improving Cancer Survivors' Quality of Life across all major cancer types.
Distinct from conventional interventions, CT's program offers live CoActive coaching through a mobile app, concentrating on Exercise and Meditation, and is enriched with evidence-based advice on Diet. This trial is pivotal in assessing the program's effectiveness against an active comparator - expert-recommended lifestyle modification resources suitable for cancer survivors -- to isolate the impact of coaching and personalization.
The primary objective is to investigate whether CT's novel approach can significantly improve Quality of Life for survivors. Furthermore, the trial seeks to measure absenteeism and presenteeism at work to provide a holistic evaluation of the program's impact on patient care and well-being. As an exploratory effort, the trial will also measure changes in healthcare expenditure across all survivors along with assessing cancer progression, recurrence in Prostate, Lung and Colorectal cancer survivors.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Treatment Group * Participants will get access to Complement Theory's Live Coaching program, focusing on Exercise and Meditation and supplemented with evidence-based information on Diet, Sleep, and other lifestyle practices, adjunct to the core treatment. * Each week, up to five sessions of 45 minutes each will be offered, with a recommendation for participants to engage in a minimum of 3 sessions. * Each session will consist of 30 Minutes of Physical Exercise and 7 minutes of meditation. Each session will be a combination session focused on Aerobic and Strength, with flexibility and balance exercises included as supplements. Active Comparator (Control) Group * Participants in this group will receive access to a curated collection of publicly available guidelines for lifestyle modification. These resources, presented through a digital application, will focus on exercise, meditation, diet, and sleep, but without the live coaching or program personalization.
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Behavioral: Complement Theory's Live CoActive Exercise Coaching and Personalized Digital ApplicationLive CoActive Coaching program, focusing on Exercise and Meditation, along with evidence-based information on Diet, for 18 months |
| Control Group | Active comparator | Behavioral: Digital application with expert guidelines on lifestyle modification18 months 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 may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Cancer Type: Breast, Prostate, Colorectal, Lung and Other Cancer
- Cancer Stage: Stage 1 to 4
- Treatment Status: Has undergone any cancer-related treatment in last 12 months
- Age: Above 21 years
- Permission to access to last 1 year digital health records
Key exclusion criteria (3 listed)
- Excludes individuals who have undergone surgery within the last 4 weeks or will undergo surgery in the next 4 weeks
- Participants declared medically unfit by their physicians to do physical exercise
- ECOG Score 3,4 or 5
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Complement Theory's Live CoActive Exercise Coaching and Personalized Digital ApplicationParticipants will get access for 18 months to Complement Theory's Live CoActive Coaching program, focusing on Exercise and Meditation and supplemented with evidence-based information on Diet, adjunct to the core treatment. * Each week, up to five sessions of 45 minutes each will be offered, with a recommendation for participants to engage in a minimum of three sessions to ensure adequate program exposure and benefits. * Each session will consist of 30 Minutes of Physical Exercise and 7 minutes of meditation. Each session will be a combination session focused on Aerobic and Strength, with flexibility and balance exercises included as supplements. | Behavioural | Test Group |
| Digital application with expert guidelines on lifestyle modification18 months 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. | Behavioural | Control Group |
Primary outcome
Impact of the program cancer survivors' Quality of Life Scores (QoLS), measured by the FACT-G instrument.
Time frame: 18 months
To quantify the impact of Complement Theory's Program on cancer survivors' Quality of Life, as measured by the change in FACT-G scores over the course of the trial.
2 secondary outcomes
Effect on Employee Absenteeism
Time frame: 18 Months
Impact on Employee Presenteeism
Time frame: 18 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: Yes. De-identified data shall be shared. This includes both primary and secondary outcomes related data points.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudio L. Battaglini, PhD principal investigator
University of North Carolina
Erik Hanson, PhD principal investigator
University of North Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complement Theory's Live CoActive Exercise Coaching and Personalized Digital Application and Digital application with expert guidelines on lifestyle modification in people with Breast Cancer and Lung Cancer, run by Complement Theory Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of the program cancer survivors' Quality of Life Scores (QoLS), measured by the FACT-G instrument. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.