Breast CancerNCT07227077
Dosing Physical Activity Among Older Cancer Survivors Who Experience Chronic Pain: a Micro-randomized Trial
A study testing Physical Activity Promotion Intervention in people with Breast Cancer and Cervical Cancer, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
The purpose of this study is to assess the best time to deliver a message to increase physical activity and how often participants will experience a pain episode in the 24 hours following their receipt of a message to increase physical activity. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Breast Cancer, Cervical Cancer, Bladder Cancer
- What is being tested?
- Physical Activity Promotion Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2026to 1 May 2027
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age greater than or equal to 65 years.
- Patients with a history of bladder, breast, cervical, colorectal, endometrial, lung, and prostate cancer diagnosis and treatment.
- Fluent in spoken and written English.
- Patient has access to smartphone
- Ability to understand a written informed consent document, and the willingness to sign it.
Who cannot join
- Patient has metastatic disease.
- Patient has cancer recurrence.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Whitney Morelli, PhD contact
United States1 site, 1 recruiting
- Recruiting
Froedtert Hospital
Milwaukee, Wisconsin, 53226
Kelly Clohesey Clinical Research Coordinator, MOT, 414-801-6710, kclohesey@mcw.edu
Whitney Morelli, Assistant Professor, PhD
About this study
Official title: An Adaptive Design for Dosing Physical Activity Among Older Cancer Survivors Who Experience Chronic Pain: a Micro-randomized Trial
The purpose of this study is to assess the best time to deliver a message to increase physical activity and how often participants will experience a pain episode in the 24 hours following their receipt of a message to increase physical activity.
Read the detailed description
The primary objective of this study is to test a theory-based, micro-randomized trial to determine the optimal state to deliver a message to increase physical activity by determining the probability older cancer survivors will be physically active in the one hour following a messaging prompt. The secondary, exploratory objective is to determine the probability older cancer survivors will experience a pain episode in the 24 hours following their receipt of a message to increase physical activity.
Eligibility criteria is deliberately incomplete to preserve the scientific integrity of the study.
- Conditions
- Breast Cancer, Cervical Cancer, Bladder Cancer, Colorectal Cancer, Endometrial Cancer, Lung Cancer
- Being tested
- Physical Activity Promotion Intervention
- Keywords
- Physical Activity, Exercise, Survivorship, Supportive Care, Pain, Symptom Management
- Medical subject headings
- Breast Neoplasms, Uterine Cervical Neoplasms, Urinary Bladder Neoplasms, Colorectal Neoplasms, Endometrial Neoplasms, Lung Neoplasms, Prostatic Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity Promotion InterventionBehavioural
This physical activity promotion intervention is a micro-randomized trial designed to determine the most effective time to send a message to promote physical activity among cancer survivors who experience chronic pain symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Micro-randomized trial study arm | Experimental | In this one-armed, 4-week trial, participants will receive prompts to report their pain symptoms 4 times throughout the day. Participants may receive up to 4 reminders to move messages throughout the day to promote participants to engage in physical activity. The receipt of messages is randomized each day. Participants will wear a research-grade activity monitor throughout the duration of their participation in the intervention to measure physical activity behaviors. Receives: Behavioral: Physical Activity Promotion Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
ActiGraph accelerometer measured physical activity behaviors (sedentary, light, moderate, vigorous intensity).
Physical activity will be measured using an ActiGraph accelerometer. Data will be aggregated into physical activity estimations (sedentary, light, moderate, vigorous, steps, etc.) using standard methods. Outcome of interest will be probability older cancer survivors are physically active in the 30 minutes following the receipt of a messaging prompt to promote physical activity.
Measured: 4 weeks
11-point box scale to assess pain on a scale of 0 (no pain) to 10 (worst possible pain).
Pain state will be assessed by response to the pain rating measured by the 11-Point Box Scale in the study app. Participants will receive a smart phone prompt to rate their pain 4 times per day. Outcome of interest will be probability older cancer survivors experience a pain episode in the 24 hours following the receipt of a messaging prompt to increase physical activity.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2025
- Study start7 Feb 2026
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (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.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Micro-Randomized Trial (MRT)
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Whitney Morelli, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07227077
- Sponsor's protocol ID
- PRO00055140
- Other IDs
- K01CA255414
- Status last verified
- Aug 2026
- First submitted
- 7 Nov 2025
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Adaptive Design for Dosing Physical Activity Among Older Cancer Survivors Who Experience Chronic Pain: a Micro-randomized Trial
- ClinicalTrials.gov ID
- NCT07227077
- Acronym / sponsor ID
- PRO00055140
- Conditions
- Breast Cancer, Cervical Cancer, Bladder Cancer, Colorectal Cancer, Endometrial Cancer, Lung Cancer
- Keywords
- Physical Activity, Exercise, Survivorship, Supportive Care, Pain, Symptom Management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 Feb 2026 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 12 Nov 2025 (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.
The purpose of this study is to assess the best time to deliver a message to increase physical activity and how often participants will experience a pain episode in the 24 hours following their receipt of a message to increase physical activity.
Detailed description
The primary objective of this study is to test a theory-based, micro-randomized trial to determine the optimal state to deliver a message to increase physical activity by determining the probability older cancer survivors will be physically active in the one hour following a messaging prompt. The secondary, exploratory objective is to determine the probability older cancer survivors will experience a pain episode in the 24 hours following their receipt of a message to increase physical activity.
Eligibility criteria is deliberately incomplete to preserve the scientific integrity of the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Micro-Randomized Trial (MRT)
| Arm | Type | Receives |
|---|---|---|
| Micro-randomized trial study arm | Experimental | Behavioral: Physical Activity Promotion InterventionIn this one-armed, 4-week trial, participants will receive prompts to report their pain symptoms 4 times throughout the day. Participants may receive up to 4 reminders to move messages throughout the day to promote participants to engage in physical activity. The receipt of messages is randomized each day. Participants will wear a research-grade activity monitor throughout the duration of their participation in the intervention to measure physical activity behaviors. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Age greater than or equal to 65 years.
- Patients with a history of bladder, breast, cervical, colorectal, endometrial, lung, and prostate cancer diagnosis and treatment.
- Fluent in spoken and written English.
- Patient has access to smartphone
- Ability to understand a written informed consent document, and the willingness to sign it.
Key exclusion criteria (2 listed)
- Patient has metastatic disease.
- Patient has cancer recurrence.
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 |
|---|---|---|
| Physical Activity Promotion InterventionThis physical activity promotion intervention is a micro-randomized trial designed to determine the most effective time to send a message to promote physical activity among cancer survivors who experience chronic pain symptoms. | Behavioural | Micro-randomized trial study arm |
Primary outcome
ActiGraph accelerometer measured physical activity behaviors (sedentary, light, moderate, vigorous intensity).
Time frame: 4 weeks
Physical activity will be measured using an ActiGraph accelerometer. Data will be aggregated into physical activity estimations (sedentary, light, moderate, vigorous, steps, etc.) using standard methods. Outcome of interest will be probability older cancer survivors are physically active in the 30 minutes following the receipt of a messaging prompt to promote physical activity.
11-point box scale to assess pain on a scale of 0 (no pain) to 10 (worst possible pain).
Time frame: 4 weeks
Pain state will be assessed by response to the pain rating measured by the 11-Point Box Scale in the study app. Participants will receive a smart phone prompt to rate their pain 4 times per day. Outcome of interest will be probability older cancer survivors experience a pain episode in the 24 hours following the receipt of a messaging prompt to increase physical activity.
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 20 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Whitney Morelli, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity Promotion Intervention in people with Breast Cancer and Cervical Cancer, run by Medical College of Wisconsin 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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 20 Aug 2026. 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?
Contact Kelly Clohesey Clinical Research Coordinator, MOT (4149554099, kclohesey@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ActiGraph accelerometer measured physical activity behaviors (sedentary, light, moderate, vigorous intensity). (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 20 Aug 2026.