CancerNCT07215091
Testing a Brief Motivational Intervention to Increase Physical Activity for Cancer Survivors
A study testing Brief Motivational Intervention in people with Cancer, run by Stony Brook University at 1 site in United States.
Trial summary
The goal of this study is to test a brief motivational intervention to increase physical activity in a group of cancer survivors who are participants in the World Trade Center Health Program. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer
- What is being tested?
- Brief Motivational Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2025to 1 Jul 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participation in the World Trade Center Health Program
- History of cancer, completed treatment
- Ability to be physically active (at minimum be able to walk slowly)
Who cannot join
- Participants receiving active cancer treatment (excluding hormonal therapy);
- Late-stage cancer (metastatic);
- Inability to follow the scheduled visits;
- Women who are pregnant
- Patients who would not be safe exercising without medical supervision (ECOG score of 3, significant comorbidities, unable to even walk slowly)
- Inability to speak and read English.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stony Brook University
Stony Brook, New York, 11794-8240
Pamela Ginex, EdD, MPH, RN, 631 444 6269, pamela.ginex@stonybrookmedicine.edu
Pamela K Ginex, EdD, MPH, RN
About this study
Official title: Effectiveness and Implementation of a Brief Motivational Intervention to Increase Physical Activity for World Trade Center Health Program Cancer Survivors
The goal of this study is to test a brief motivational intervention to increase physical activity in a group of cancer survivors who are participants in the World Trade Center Health Program.
Read the detailed description
The World Trade Center Health Program (WTCHP) tracks the ongoing health and well-being of over 91,000 first responders and people who lived and worked near the World Trade Center. Research has established that WTCHP members are at higher risk for a constellation of health conditions, including cancer. Cancer survivors, the focus of this study, are at risk for physical and functional impairment. As WTCHP members with cancer age, developing pragmatic interventions to mitigate physical decline is an important next step in a coordinated program of care and research in this vulnerable population. Physical activity (PA) interventions are strong candidates for investigation, given that physical inactivity in WTCHP members has been correlated with respiratory illness, poor sleep, and PTSD. PA has many health benefits, yet interventions to support PA are not routinely incorporated into clinical practice. Evidence-based guidelines recommend PA counseling in clinical care and health professionals believe they should be doing this. However, a gap remains in implementing PA interventions at the point of care. This study will test an evidence-based motivational intervention to initiate and maintain PA among WTCHP particpatants with cancer.
- Conditions
- Cancer
- Being tested
- Brief Motivational Intervention
- Keywords
- World Trade Center Health Program
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Motivational InterventionBehavioural
The study includes a 3-component motivational intervention based on the Theory of Planned Behavior. The components include motivational interviewing (MI); mobile health monitoring; and action planning.
MI is used to build a positive attitude towards physical activity (PA). Mobile health monitoring will be conducted with a Fitbit to monitor steps per day. The last component of the intervention includes action planning to design a PA program that fits their abilities and lifestyle. The research team will develop a PA grid that includes aerobic, strength, and flexibility PA options. The PA grid provides an opportunity to personalize the action plan by choosing from a 'menu' to match interests. Following the in-person baseline visit, participants will be called approximately every 2 weeks (4-5 phone contacts) during the 3-month intervention period to review and update their action plan.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Motivational Intervention:
The intervention group will receive a 3-component motivational intervention based on the Theory of Planned Behavior in addition to an enhanced standard of care. The components of the intervention include motivational interviewing (MI); mobile health monitoring; and action planning.
At the initial visit, following baseline data collection, the clinician will use MI to build a positive attitude towards physical activity (PA). Next, they will discuss why and how to use Fitbit to monitor steps per day. The last component of the intervention includes action planning to design a PA program that fits their abilities and lifestyle. Following the in-person baseline visit, participants will be called approximately every 2 weeks during the 3-month intervention period. During these calls, the action plan will be reviewed and updated, and their step count reviewed. Receives: Behavioral: Brief Motivational Intervention |
| Wait List Control | Active comparator | Wait List Control:
The control group will receive a Fitbit and advice to continue their normal physical activity. At the end of 3 months, the wait-list control group will be seen in the clinic for the motivational intervention which will be the same as the intervention group. They will return to the clinic at the end of the study (6 months) for final data collection. Participants in the wait list control group will use the Fitbit for the full 6 months of the study, during the 3 month waiting period and the 3 month intervention. Receives: Behavioral: Brief Motivational Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Moderate to Vigorous Physical Activity
The primary outcomes will be measured with Fitbit data. Fitbit software allows classification of each minute as being in sedentary, light, moderate, or vigorous activity, and provides metabolic equivalents (METs) for each minute. Positive changes in levels of physical activity will be determined by a 25% increase in MVPA from baseline to end of intervention. This estimation is based on a systematic review of motivational physical activity interventions in cancer survivors (Takemura, 2024). This change in outcome measure is well justified and sensitive to small changes in activity.
Measured: Baseline to end of study (6 months)
Secondary outcomes (5)
Quality of Life (SF-20)
SF-20 includes 20 quality-of-life statements that are well validated and reliable. The survey measures health across 6 domains: physical functioning (6 questions), role functioning (2 questions), social functioning (1 question), mental health (5 questions), health perceptions (5 questions), and pain (1 question). The total score will be used to measure quality of life and the physical functioning domain score will be used to subjectively measure physical functioning. Higher scores indicate better health.
Measured: Baseline to end of study (6 months)
Sleep (PROMIS Sleep SF)
Sleep will be measured with the PROMIS Sleep Disturbance short form, a 6-item scale that assesses sleep quality and satisfaction with sleep on a five-point Likert scale. The scale is reliable and valid and correlates strongly with longer forms. Higher scores indicate more sleep disturbance.
Measured: Baseline to end of study (6 months)
Fatigue (PROMIS Fatigue SF)
Fatigue will be measured with the PROMIS Fatigue short form. This scale includes 8 items related to fatigue and the impact of fatigue on day-to-day life. The form has good reliability (0.88) and validity (.60 -.85) across different groups and has been used across diverse clinical populations. Higher scores indicate more fatigue.
Measured: Baseline to end of study (6 months)
Physical Functioning (Short Physical Performance Battery)
Physical function will be derived from performance on the Short Physical Performance Battery (SPPB). The SPPB consists of 3 components: balance (side-by-side, semi-tandem, and tandem positions held for 10 seconds unassisted), gait speed (amount of time to walk a four-meter course at a typical pace), and repetitive chair stand (amount of time to rise from a chair unassisted 5 consecutive times). Each component is rated on a 4-point scale based on the ability and amount of time necessary to complete each task. SPPB ≥10 indicated scores in the normal range, whereas a score of ≤9 indicated functional impairment (further stratified into mild (7-9) vs moderate (4-6) to severe (≤3)). Grip strength will be measured by using a standard dynamometer and assessed from a single 3-s maximal grip effort of the right- and left-side arms. Decreased grip strength has been strongly associated with a range of adverse health outcomes.
Measured: Baseline to end of study (6 months)
Post traumatic stress disorder (PCL-5)
The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report questionnaire that assesses Post-Traumatic Stress Disorder (PTSD) symptoms on a 5-point Likert scale, with total scores ranging from 0 to 80. Symptoms are grouped into four clusters corresponding to DSM-5 PTSD criteria, and scoring involves summing item responses to calculate a total score or to identify minimum symptom endorsement for a provisional diagnosis. Higher scores indicate more severe PTSD symptoms, with scores of 31-33 or above generally considered clinically significant and potentially indicative of PTSD
Measured: Baseline to end of study (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2025
- Study start4 Jan 2025
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pamela Ginex, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07215091
- Sponsor's protocol ID
- IRB2024-00344
- Other IDs
- 5R21OH012630-02
- Status last verified
- Oct 2025
- First submitted
- 8 Oct 2025
- Last updated
- 14 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Implementation of a Brief Motivational Intervention to Increase Physical Activity for World Trade Center Health Program Cancer Survivors
- ClinicalTrials.gov ID
- NCT07215091
- Acronym / sponsor ID
- IRB2024-00344
- Conditions
- Cancer
- Keywords
- World Trade Center Health Program
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- 4 Jan 2025 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 10 Oct 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 goal of this study is to test a brief motivational intervention to increase physical activity in a group of cancer survivors who are participants in the World Trade Center Health Program.
Detailed description
The World Trade Center Health Program (WTCHP) tracks the ongoing health and well-being of over 91,000 first responders and people who lived and worked near the World Trade Center. Research has established that WTCHP members are at higher risk for a constellation of health conditions, including cancer. Cancer survivors, the focus of this study, are at risk for physical and functional impairment. As WTCHP members with cancer age, developing pragmatic interventions to mitigate physical decline is an important next step in a coordinated program of care and research in this vulnerable population. Physical activity (PA) interventions are strong candidates for investigation, given that physical inactivity in WTCHP members has been correlated with respiratory illness, poor sleep, and PTSD. PA has many health benefits, yet interventions to support PA are not routinely incorporated into clinical practice. Evidence-based guidelines recommend PA counseling in clinical care and health professionals believe they should be doing this. However, a gap remains in implementing PA interventions at the point of care. This study will test an evidence-based motivational intervention to initiate and maintain PA among WTCHP particpatants with cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Brief Motivational InterventionMotivational Intervention: The intervention group will receive a 3-component motivational intervention based on the Theory of Planned Behavior in addition to an enhanced standard of care. The components of the intervention include motivational interviewing (MI); mobile health monitoring; and action planning. At the initial visit, following baseline data collection, the clinician will use MI to build a positive attitude towards physical activity (PA). Next, they will discuss why and how to use Fitbit to monitor steps per day. The last component of the intervention includes action planning to design a PA program that fits their abilities and lifestyle. Following the in-person baseline visit, participants will be called approximately every 2 weeks during the 3-month intervention period. During these calls, the action plan will be reviewed and updated, and their step count reviewed. |
| Wait List Control | Active comparator | Behavioral: Brief Motivational InterventionWait List Control: The control group will receive a Fitbit and advice to continue their normal physical activity. At the end of 3 months, the wait-list control group will be seen in the clinic for the motivational intervention which will be the same as the intervention group. They will return to the clinic at the end of the study (6 months) for final data collection. Participants in the wait list control group will use the Fitbit for the full 6 months of the study, during the 3 month waiting period and the 3 month intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Participation in the World Trade Center Health Program
- History of cancer, completed treatment
- Ability to be physically active (at minimum be able to walk slowly)
Key exclusion criteria (6 listed)
- Participants receiving active cancer treatment (excluding hormonal therapy);
- Late-stage cancer (metastatic);
- Inability to follow the scheduled visits;
- Women who are pregnant
- Patients who would not be safe exercising without medical supervision (ECOG score of 3, significant comorbidities, unable to even walk slowly)
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 |
|---|---|---|
| Brief Motivational InterventionThe study includes a 3-component motivational intervention based on the Theory of Planned Behavior. The components include motivational interviewing (MI); mobile health monitoring; and action planning. MI is used to build a positive attitude towards physical activity (PA). Mobile health monitoring will be conducted with a Fitbit to monitor steps per day. The last component of the intervention includes action planning to design a PA program that fits their abilities and lifestyle. The research team will develop a PA grid that includes aerobic, strength, and flexibility PA options. The PA grid provides an opportunity to personalize the action plan by choosing from a 'menu' to match interests. Following the in-person baseline visit, participants will be called approximately every 2 weeks (4-5 phone contacts) during the 3-month intervention period to review and update their action plan. | Behavioural | Intervention, Wait List Control |
Primary outcome
Change in Moderate to Vigorous Physical Activity
Time frame: Baseline to end of study (6 months)
The primary outcomes will be measured with Fitbit data. Fitbit software allows classification of each minute as being in sedentary, light, moderate, or vigorous activity, and provides metabolic equivalents (METs) for each minute. Positive changes in levels of physical activity will be determined by a 25% increase in MVPA from baseline to end of intervention. This estimation is based on a systematic review of motivational physical activity interventions in cancer survivors (Takemura, 2024). This change in outcome measure is well justified and sensitive to small changes in activity.
5 secondary outcomes
Quality of Life (SF-20)
Time frame: Baseline to end of study (6 months)
Sleep (PROMIS Sleep SF)
Time frame: Baseline to end of study (6 months)
Fatigue (PROMIS Fatigue SF)
Time frame: Baseline to end of study (6 months)
Physical Functioning (Short Physical Performance Battery)
Time frame: Baseline to end of study (6 months)
Post traumatic stress disorder (PCL-5)
Time frame: Baseline to end of study (6 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 14 Oct 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Motivational Intervention in people with Cancer, run by Stony Brook University 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 3 inclusion and 6 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 14 Oct 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?
Contact Pamela K Ginex, EdD. MPH, RN (631 444 6269, pamela.ginex@stonybrookmedicine.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Moderate to Vigorous Physical Activity (time frame: Baseline to end of study (6 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 14 Oct 2025.