ExerciseSTEP-RNCT06668402
Study of Daily Step Count and Treatment Response in Rectal Cancer (STEP-R)
An observational study of Exercise and Total Neoadjuvant Treatment, run by Gazi University at 3 sites in Turkey (Türkiye).
Trial summary
This study aims to examine the impact of daily physical activity, specifically step count, on treatment outcomes and side effects in patients with locally advanced rectal cancer receiving total neoadjuvant therapy (chemotherapy and radiotherapy before surgery). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Exercise, Total Neoadjuvant Treatment, Rectal Tumors
- What is being tested?
- Utilizing a smartwatch to gather data on individuals receiving treatment for rectal neoplasm.
- Type of treatment
- Medical device
- How many people
- 160 participants
- Where
- 3 sitesTurkey (Türkiye)
- Study dates
- 30 Oct 2024to 5 Sep 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will involve adult patients diagnosed with locally advanced rectal cancer (stages II and III) who are scheduled to receive total neoadjuvant therapy (TNT), which includes chemotherapy and radiotherapy prior to surgery. Participants are required to have sufficient physical capacity for regular activity monitoring via a wearable smartwatch, which will collect data on physical activity, heart rate, and sleep quality. Stage I and metastatic (stage IV) rectal cancer patients are excluded, as they are not candidates for TNT. The study population represents individuals who are eligible for this preoperative treatment and can benefit from objective monitoring of activity as part of their treatment response assessment.
Who may be able to join
- Patients aged 18 years and older.
- Diagnosed with locally advanced rectal cancer (stage II or III) and eligible for total neoadjuvant therapy (TNT).
- Planned to undergo chemotherapy and radiotherapy as part of neoadjuvant treatment before surgery.
- Capable of providing informed consent.
- Able to wear and operate the Huawei Watch Fit 2 smartwatch throughout the treatment period.
- Sufficient mobility to engage in physical activity, including walking, as per study requirements.
- Willing to complete weekly monitoring visits and complete the EORTC QLQ-C30 and Pittsburgh Sleep Quality Index questionnaires at baseline and study end
Who cannot join
- Stage I or metastatic (stage IV) rectal cancer.
- Contraindications to physical activity, including but not limited to severe cardiovascular or respiratory conditions that limit mobility.
- Prior treatment for rectal cancer with chemotherapy or radiotherapy.
- Use of a pacemaker or other implanted medical devices that might interfere with smartwatch functionality.
- Known allergic reaction to materials in the Huawei Watch Fit 2 smartwatch.
- Severe cognitive or psychological disorders that would hinder participation in the study or completion of questionnaires.
- Any medical or psychiatric condition that, in the opinion of the investigator, may compromise patient safety or interfere with study adherence.
Trial locations and contacts
3 sites in 1 country.
Turkey (Türkiye)3 sites
Etlik City Hospital
Ankara, Yenimahalle, 06170
Gazi University
Ankara, Yenimahalle, 06560
Ankara University
Ankara
About this study
Official title: Prospective Observational Study of the Association Between Daily Step Count and Treatment Response in Patients With Locally Advanced Rectal Cancer Undergoing Total Neoadjuvant Therapy: STEP-R Trial
This study aims to examine the impact of daily physical activity, specifically step count, on treatment outcomes and side effects in patients with locally advanced rectal cancer receiving total neoadjuvant therapy (chemotherapy and radiotherapy before surgery). Using Huawei Watch Fit 2 smartwatches, we will track participants' daily step counts, heart rate, and sleep quality.
The primary hypothesis is that higher step counts and physical activity levels correlate with higher rates of complete pathological response at surgery. A secondary hypothesis is that increased physical activity may be associated with fewer or less severe side effects during treatment.
Read more
Participants will wear a smartwatch and complete the EORTC QLQ-C30 Quality of Life Questionnaire and the Pittsburgh Sleep Quality Index at the beginning and end of treatment. Data from the smartwatch, including step count, heart rate changes, and sleep duration, will be reviewed weekly during routine visits.
Approximately 200 patients with rectal cancer will participate, and each will be followed from the start of therapy until surgery (around 4-6 months). Total data collection is expected to take 12-15 months.
This study could improve cancer care by identifying links between physical activity and treatment outcomes, supporting future exercise guidelines for oncology patients.
Read the detailed description
Background and Rationale Rectal cancer treatment includes a multimodal approach, often involving total neoadjuvant therapy (TNT), which combines chemotherapy and radiotherapy before surgical intervention. While physical activity, particularly walking, has shown general health benefits for cancer patients, the specific effects of objectively measured daily activity on treatment outcomes, such as response rates and side effect incidence, remain insufficient. Current methods for assessing physical activity largely rely on self-reported data, which can be less accurate. This study uses wearable technology (Huawei Watch Fit 2 smartwatches) to gather objective, real-time data on patients' physical activity, offering a novel approach to tracking exercise and health metrics throughout cancer treatment.
Study Objectives Primary Objective: To determine whether higher physical activity levels, specifically daily step counts, are associated with increased complete pathological response rates in rectal cancer patients undergoing TNT.
Secondary Objectives:
To evaluate the relationship between physical activity (step count) and the frequency and severity of treatment-related side effects.
To assess changes in sleep quality and heart rate as additional metrics of physical well-being and their potential influence on treatment tolerance and outcomes.
Methodology Participants: This study will include approximately 200 patients diagnosed with locally advanced rectal cancer and scheduled to begin TNT. Eligibility criteria focus on patients who can safely undergo physical activity monitoring and do not have contraindications for wearable device use.
Data Collection with Smartwatches:
Physical Activity: The smartwatch will track daily step counts and duration of physical activity that elevates the heart rate by at least 20% above the basal level.
Heart Rate Monitoring: Continuous heart rate data will be recorded to observe variability and detect any correlations with activity and side effect tolerance.
Sleep Quality: Sleep patterns and quality will be recorded to assess rest as a potential factor affecting treatment response.
Questionnaires: Two validated questionnaires will be administered:
EORTC QLQ-C30 (to assess cancer-related quality of life) and Pittsburgh Sleep Quality Index (to assess sleep quality and disturbances). Intervention and Monitoring Plan Weekly Monitoring: Patients will be seen weekly as part of their standard treatment schedule. During these visits, data from the smartwatch app (step count, heart rate, and sleep quality) will be reviewed alongside any updates on treatment side effects.
Duration and Follow-Up: Each participant will be followed from the initiation of TNT until surgical intervention (approximately 4-6 months). Data collection and follow-up are expected to span a total of 12-15 months for comprehensive data gathering across all enrolled patients.
Anticipated Outcomes and Significance This study aims to enhance understanding of physical activity's role in cancer treatment. By leveraging wearable technology to gather objective data, the study seeks to establish whether physical activity metrics correlate with treatment efficacy and side effect profiles. If successful, the findings could support integrating exercise recommendations into routine oncology care, tailored to individual patient metrics.
Future Directions Pending study outcomes, further research could focus on expanded trials in diverse cancer types, potentially using smartwatches to guide individualized exercise protocols, adjust treatment regimens, and support patient education on activity benefits during cancer therapy.
- Being tested
- Utilizing a smartwatch to gather data on individuals receiving treatment for rectal neoplasm.
- Medical subject headings
- Motor Activity, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Utilizing a smartwatch to gather data on individuals receiving treatment for rectal neoplasm.Device
Employing a smartwatch to monitor steps, sleep quality, intense physical activity, and vital signs in persons undergoing treatment for rectal carcinoma.
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of pathological complete response in rectal cancer patients receiving neoadjuvant therapy
This outcome measure assesses the relationship between daily physical activity levels, specifically step count, and the rate of pathological complete response (pCR) in rectal cancer patients undergoing neoadjuvant therapy. By tracking patients' step counts throughout the treatment period, we aim to investigate whether higher physical activity levels correlate with a higher likelihood of achieving a pCR, defined as no residual tumor in resected tissue at the time of surgery.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start30 Oct 2024
- Primary completion15 May 2026
- Study completion5 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Orhun Akdoğan, Gazi University
- Investigators
- Ozan Yazici, Prof. Dr., Study chair, Gazi UniversityOsman Sutcuoglu, Associate Professor, Study director, Gazi UniversityOrhun Akdogan, MD, Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06668402
- Sponsor's protocol ID
- AESH-BADEK-2024-725
- Acronym
- STEP-R
- Status last verified
- Feb 2025
- First submitted
- 30 Oct 2024
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to privacy concerns and in alignment with ethical guidelines protecting participant confidentiality. Data sharing is restricted to maintain compliance with institutional and national regulations governing patient privacy. Currently, no plans exist to provide IPD access beyond the research team responsible for the study.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study of the Association Between Daily Step Count and Treatment Response in Patients With Locally Advanced Rectal Cancer Undergoing Total Neoadjuvant Therapy: STEP-R Trial
- ClinicalTrials.gov ID
- NCT06668402
- Acronym / sponsor ID
- STEP-R / AESH-BADEK-2024-725
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 30 Oct 2024 (actual)
- Primary completion
- 15 May 2026 (actual)
- Study completion
- 5 Sep 2026 (actual)
- First posted
- 31 Oct 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.
This study aims to examine the impact of daily physical activity, specifically step count, on treatment outcomes and side effects in patients with locally advanced rectal cancer receiving total neoadjuvant therapy (chemotherapy and radiotherapy before surgery). Using Huawei Watch Fit 2 smartwatches, we will track participants' daily step counts, heart rate, and sleep quality.
The primary hypothesis is that higher step counts and physical activity levels correlate with higher rates of complete pathological response at surgery. A secondary hypothesis is that increased physical activity may be associated with fewer or less severe side effects during treatment.
Participants will wear a smartwatch and complete the EORTC QLQ-C30 Quality of Life Questionnaire and the Pittsburgh Sleep Quality Index at the beginning and end of treatment. Data from the smartwatch, including step count, heart rate changes, and sleep duration, will be reviewed weekly during routine visits.
Approximately 200 patients with rectal cancer will participate, and each will be followed from the start of therapy until surgery (around 4-6 months). Total data collection is expected to take 12-15 months.
This study could improve cancer care by identifying links between physical activity and treatment outcomes, supporting future exercise guidelines for oncology patients.
Detailed description
Background and Rationale Rectal cancer treatment includes a multimodal approach, often involving total neoadjuvant therapy (TNT), which combines chemotherapy and radiotherapy before surgical intervention. While physical activity, particularly walking, has shown general health benefits for cancer patients, the specific effects of objectively measured daily activity on treatment outcomes, such as response rates and side effect incidence, remain insufficient. Current methods for assessing physical activity largely rely on self-reported data, which can be less accurate. This study uses wearable technology (Huawei Watch Fit 2 smartwatches) to gather objective, real-time data on patients' physical activity, offering a novel approach to tracking exercise and health metrics throughout cancer treatment.
Study Objectives Primary Objective: To determine whether higher physical activity levels, specifically daily step counts, are associated with increased complete pathological response rates in rectal cancer patients undergoing TNT.
Secondary Objectives:
To evaluate the relationship between physical activity (step count) and the frequency and severity of treatment-related side effects.
To assess changes in sleep quality and heart rate as additional metrics of physical well-being and their potential influence on treatment tolerance and outcomes.
Methodology Participants: This study will include approximately 200 patients diagnosed with locally advanced rectal cancer and scheduled to begin TNT. Eligibility criteria focus on patients who can safely undergo physical activity monitoring and do not have contraindications for wearable device use.
Data Collection with Smartwatches:
Physical Activity: The smartwatch will track daily step counts and duration of physical activity that elevates the heart rate by at least 20% above the basal level.
Heart Rate Monitoring: Continuous heart rate data will be recorded to observe variability and detect any correlations with activity and side effect tolerance.
Sleep Quality: Sleep patterns and quality will be recorded to assess rest as a potential factor affecting treatment response.
Questionnaires: Two validated questionnaires will be administered:
EORTC QLQ-C30 (to assess cancer-related quality of life) and Pittsburgh Sleep Quality Index (to assess sleep quality and disturbances). Intervention and Monitoring Plan Weekly Monitoring: Patients will be seen weekly as part of their standard treatment schedule. During these visits, data from the smartwatch app (step count, heart rate, and sleep quality) will be reviewed alongside any updates on treatment side effects.
Duration and Follow-Up: Each participant will be followed from the initiation of TNT until surgical intervention (approximately 4-6 months). Data collection and follow-up are expected to span a total of 12-15 months for comprehensive data gathering across all enrolled patients.
Anticipated Outcomes and Significance This study aims to enhance understanding of physical activity's role in cancer treatment. By leveraging wearable technology to gather objective data, the study seeks to establish whether physical activity metrics correlate with treatment efficacy and side effect profiles. If successful, the findings could support integrating exercise recommendations into routine oncology care, tailored to individual patient metrics.
Future Directions Pending study outcomes, further research could focus on expanded trials in diverse cancer types, potentially using smartwatches to guide individualized exercise protocols, adjust treatment regimens, and support patient education on activity benefits during cancer therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will involve adult patients diagnosed with locally advanced rectal cancer (stages II and III) who are scheduled to receive total neoadjuvant therapy (TNT), which includes chemotherapy and radiotherapy prior to surgery. Participants are required to have sufficient physical capacity for regular activity monitoring via a wearable smartwatch, which will collect data on physical activity, heart rate, and sleep quality. Stage I and metastatic (stage IV) rectal cancer patients are excluded, as they are not candidates for TNT. The study population represents individuals who are eligible for this preoperative treatment and can benefit from objective monitoring of activity as part of their treatment response assessment.
Key inclusion criteria (7 listed)
- Patients aged 18 years and older.
- Diagnosed with locally advanced rectal cancer (stage II or III) and eligible for total neoadjuvant therapy (TNT).
- Planned to undergo chemotherapy and radiotherapy as part of neoadjuvant treatment before surgery.
- Capable of providing informed consent.
- Able to wear and operate the Huawei Watch Fit 2 smartwatch throughout the treatment period.
Key exclusion criteria (7 listed)
- Stage I or metastatic (stage IV) rectal cancer.
- Contraindications to physical activity, including but not limited to severe cardiovascular or respiratory conditions that limit mobility.
- Prior treatment for rectal cancer with chemotherapy or radiotherapy.
- Use of a pacemaker or other implanted medical devices that might interfere with smartwatch functionality.
- Known allergic reaction to materials in the Huawei Watch Fit 2 smartwatch.
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 |
|---|---|---|
| Utilizing a smartwatch to gather data on individuals receiving treatment for rectal neoplasm.Employing a smartwatch to monitor steps, sleep quality, intense physical activity, and vital signs in persons undergoing treatment for rectal carcinoma. | Device | – |
Primary outcome
The rate of pathological complete response in rectal cancer patients receiving neoadjuvant therapy
Time frame: 9 months
This outcome measure assesses the relationship between daily physical activity levels, specifically step count, and the rate of pathological complete response (pCR) in rectal cancer patients undergoing neoadjuvant therapy. By tracking patients' step counts throughout the treatment period, we aim to investigate whether higher physical activity levels correlate with a higher likelihood of achieving a pCR, defined as no residual tumor in resected tissue at the time of surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to privacy concerns and in alignment with ethical guidelines protecting participant confidentiality. Data sharing is restricted to maintain compliance with institutional and national regulations governing patient privacy. Currently, no plans exist to provide IPD access beyond the research team responsible for the study.
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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.
Ozan Yazici, Prof. Dr. study chair
Gazi University
Osman Sutcuoglu, Associate Professor study director
Gazi University
Orhun Akdogan, MD principal investigator
Gazi University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exercise and Total Neoadjuvant Treatment, run by Gazi University at 3 sites in Turkey (Türkiye).
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 7 inclusion and 7 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: finished, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The rate of pathological complete response in rectal cancer patients receiving neoadjuvant therapy (time frame: 9 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 29 Sep 2026.