Radiation TherapyACTIVATENCT06746428
Activity Coaching During Pelvic Radiation Therapy
A study testing Exercise Coaching in people with Radiation Therapy and Gynecologic Cancer, run by Inova Health Care Services at 4 sites in United States.
Trial summary
Research has shown that for women who are undergoing pelvic radiation therapy, fatigue is a common side effect. Fatigue that occurs during radiation therapy can make it harder to perform daily living activities. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Radiation Therapy, Gynecologic Cancer, Exercise Therapy
- What is being tested?
- Exercise Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 4 sitesUnited States
- Study dates
- 27 Jan 2025to 1 Mar 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Pathologic diagnosis of endometrial cancer (any histology, Stage I-IVA)
- Has undergone modified radical or radical hysterectomy
- Plan to receive adjuvant treatment with pelvic external beam radiation therapy at ISCI
- ECOG performance status of 0-1
- Patient has a computer, smart phone, or tablet virtual access to the web-based platform and email
Show all 12Show fewer
- Able to read, understand and provide written informed consent
- Deemed appropriate for unmonitored exercise by treating physician based on the following evidence-based criteria (1)
- Walk without any assistance or assistance device
- Absence of significant cognitive impairment
- Absence of high risk for falls
- Participant does not need to refrain from any activity
Who cannot join
- Unable to schedule and attend coaching visits
- Participation in a regular exercise program of ≥150 minutes of moderate intensity exercise a week at baseline
- Unable to perform the five-times stand test
- Medical comorbidities including:
- Unstable angina
- Uncontrolled dysrhythmias
- Acute pulmonary embolus
- Active pulmonary infection
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Inova Schar Cancer Institute - Alexandria
Alexandria, Virginia, 22311
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
Inova Schar Cancer Institute - Fair Oaks
Fairfax, Virginia, 22033
Inova Schar Cancer Institute - Loudoun
Leesburg, Virginia, 20176
About this study
Official title: ACTIVATE: A Pilot Randomized Activity Coaching Trial to Increase Vitality and Energy During Post-operative Pelvic Radiation Therapy for Endometrial Cancer
Research has shown that for women who are undergoing pelvic radiation therapy, fatigue is a common side effect. Fatigue that occurs during radiation therapy can make it harder to perform daily living activities. While there are studies that recommend exercise as a treatment for fatigue in cancer patients and survivors, there are currently no studies that focus on the role of exercise for women undergoing pelvic radiation therapy. The purpose of this study is to see if incorporating an activity coaching program is helpful in improving treatment-related fatigue for women undergoing pelvic radiation therapy for endometrial cancer.
Read the detailed description
The exercise coaching program is a program in which Participants will have ten weekly check-ins with a certified exercise coach. During check-ins, Participants and the exercise coach will set weekly goals. Participants will try to incorporate activities that are easy and enjoyable for them. These visits can be scheduled at their convenience and choose whether these check-ins will be in-person, or virtually.
All Participants who agree to join this study will be asked to:
- Participate in a program with an exercise coach to set weekly goals for activity. The timing of when the program will start will be based on the group Participants are assigned to.
- Receive a Fitbit to track how active they are, their heart rate and how many steps they've have taken.
- Complete 4 surveys which will be given throughout the course of the study.
- Complete a short 6-minute walking test to see how their heart and lungs respond to exercise. This test will be completed 4 times throughout the study.
- Participate in an interview with the principal investigator at the end of the study for feedback on how the study can be improved.
The study team expects to enroll 16 patients in this study. Participants will either be placed in the Immediate Start Activity Coaching Program or the Delayed Start Activity Coaching Program. 8 patients will be assigned to the Immediate Start Group, and 8 will be assigned to the Delayed Start Group. Participants will spend about 6 months in this study.
- Conditions
- Radiation Therapy, Gynecologic Cancer, Exercise Therapy
- Being tested
- Exercise Coaching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise CoachingBehavioural
An exercise coaching program tailored for women with Stage I-IVA endometrial cancer who have undergone total or modified radical hysterectomy with surgical staging. The intervention targets a total of 8 participants who are planned to complete pelvic external beam radiation therapy as part of their adjuvant treatment.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Start Group | Experimental | Participants in this group will start the intervention during the first week of radiation therapy and continue through and post-completion of radiation Receives: Behavioral: Exercise Coaching |
| Delayed Start Group | Experimental | Participants in this group will start 6-8 weeks post - radiation and continue 16-19 weeks post-radiation. Receives: Behavioral: Exercise Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of a Randomized Trial: Participant Adherence to Exercise Coaching Sessions
Participant adherence to coaching sessions will be defined as complete adherence when engaging in 10 of the 10 planned exercise coaching sessions and high adherence as engaging in at least 7 of the planned 10 exercise coach check-ins. Participant adherence will be considered feasible if 70% of participants adhere to the coaching sessions.
Measured: Enrollment to end of follow up, up to 24 months
Secondary outcomes (7)
Change in patient-reported fatigue
Measurement of changes in the level of fatigue as reported by patients, using a Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue. FACIT-F fatigue subscale consists of 13 items. Patients rate the intensity of their fatigue symptoms on a scale of 0 to 4 (0=not at all and 4=very much). Total FACIT-F fatigue subscale score ranges from 0 to 52 with higher scores less fatigue and lower scores more fatigue
Measured: Enrollment to end of follow up, up to 24 months
Change in patient-reported bowel/urinary toxicity
Assessment of changes in the severity of bowel and urinary toxicity symptoms, as reported by patients, using Expanded Prostate Cancer Index Composite (EPIC) bowel and urinary short form assessments. The EPIC-15 is a short-form version that includes 15 items across two domains: Urinary Function and Bowel Habits. Each item in the EPIC-15 is scored on a Likert scale, and the scores are transformed to a 0-100 scale, with higher scores indicating better quality of life.
Measured: Enrollment to end of follow up, up to 24 months
Change in patient-reported Quality of Life (QOL)
Measurement of changes in the quality of life based on patient-reported outcomes, using Patient-Reported Outcomes Measurement Information System (PROMIS-29) Profile v2.1. It includes 29 items that assess seven key areas: Physical Function, Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles/Activities and Pain Interference. Each question usually has five response options ranging in value from one to five. The scores are then converted to T-scores using a scoring table. Higher T-Scores for Physical Function indicate better physical functioning, Higher T-Scores for Anxiety and Depression indicate more severe symptoms. Higher T-Scores for Fatigue and Sleep Disturbance indicate more fatigue or sleep problems. Higher T-Scores in ability to participate in social roles/activities indicate better ability to participate in social roles and activities. Higher T-Scores for Pain Interference means more interference from pain in daily activities and intense pain
Measured: Enrollment to end of follow up, up to 24 months
Change in patient-reported cognitive function
Evaluation of cognitive function changes reported by patients, measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function Short Form 4a. This form contains 4 items. Each item is scored on a Likert scale from 1 (Never) to 5 (Very often). Raw scores are converted to T-scores using a scoring table. Higher T-scores indicate better cognitive function.
Measured: Enrollment to end of follow up, up to 24 months
Change in patient-reported sexual function and satisfaction
Changes in sexual function and satisfaction, as reported by patients, using a Patient-Reported Outcomes Measurement Information System (PROMIS) Brief Profile Sexual Function and Satisfaction. Each item is scored on a Likert scale, and then converted into a T-Score. Higher T-scores indicate better sexual function and satisfaction.
Measured: Enrollment to end of follow up, up to 24 months
Change in patient-reported self-efficacy
Measurement of changes in patients' perceived self-efficacy, using Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Chronic Conditions. Each item is scored on a Likert scale, and then converted into a T-Score. Higher T-scores indicate greater self-efficacy.
Measured: Enrollment to end of follow up, up to 24 months
Change in distance walked during the 6-Minute Walk Test (6MWT)
Measurement of the change in distance walked by patients during the 6-Minute Walk Test, a standardized test used to assess physical function.
Measured: Enrollment to end of follow up, up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start27 Jan 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation TherapyStudies 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
- Parallel groups
- Model description
- Participants will either be randomized to the Immediate Start Group or to the Delayed Start Group. Participants in the: * Immediate Start Group: Sessions with the exercise coach will start during the first week of participants' radiation therapy, concurrently with radiation treatment and continue post-radiation. * Delayed Start Group: Sessions with the exercise coach will start 6-8 weeks after participants have completed radiation and continue 16-19 weeks post-radiation.
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inova Health Care Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Avani Rao, MD, Principal investigator, Inova Health Care Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06746428
- Sponsor's protocol ID
- INOVA-2024-91
- Acronym
- ACTIVATE
- Status last verified
- Aug 2026
- First submitted
- 17 Dec 2024
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACTIVATE: A Pilot Randomized Activity Coaching Trial to Increase Vitality and Energy During Post-operative Pelvic Radiation Therapy for Endometrial Cancer
- ClinicalTrials.gov ID
- NCT06746428
- Acronym / sponsor ID
- ACTIVATE / INOVA-2024-91
- Conditions
- Radiation Therapy, Gynecologic Cancer, Exercise Therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Inova Health Care ServicesUniversity, hospital or other
- Study start
- 27 Jan 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 24 Dec 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.
Research has shown that for women who are undergoing pelvic radiation therapy, fatigue is a common side effect. Fatigue that occurs during radiation therapy can make it harder to perform daily living activities. While there are studies that recommend exercise as a treatment for fatigue in cancer patients and survivors, there are currently no studies that focus on the role of exercise for women undergoing pelvic radiation therapy. The purpose of this study is to see if incorporating an activity coaching program is helpful in improving treatment-related fatigue for women undergoing pelvic radiation therapy for endometrial cancer.
Detailed description
The exercise coaching program is a program in which Participants will have ten weekly check-ins with a certified exercise coach. During check-ins, Participants and the exercise coach will set weekly goals. Participants will try to incorporate activities that are easy and enjoyable for them. These visits can be scheduled at their convenience and choose whether these check-ins will be in-person, or virtually.
All Participants who agree to join this study will be asked to:
- Participate in a program with an exercise coach to set weekly goals for activity. The timing of when the program will start will be based on the group Participants are assigned to.
- Receive a Fitbit to track how active they are, their heart rate and how many steps they've have taken.
- Complete 4 surveys which will be given throughout the course of the study.
- Complete a short 6-minute walking test to see how their heart and lungs respond to exercise. This test will be completed 4 times throughout the study.
- Participate in an interview with the principal investigator at the end of the study for feedback on how the study can be improved.
The study team expects to enroll 16 patients in this study. Participants will either be placed in the Immediate Start Activity Coaching Program or the Delayed Start Activity Coaching Program. 8 patients will be assigned to the Immediate Start Group, and 8 will be assigned to the Delayed Start Group. Participants will spend about 6 months in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will either be randomized to the Immediate Start Group or to the Delayed Start Group. Participants in the: * Immediate Start Group: Sessions with the exercise coach will start during the first week of participants' radiation therapy, concurrently with radiation treatment and continue post-radiation. * Delayed Start Group: Sessions with the exercise coach will start 6-8 weeks after participants have completed radiation and continue 16-19 weeks post-radiation.
| Arm | Type | Receives |
|---|---|---|
| Immediate Start Group | Experimental | Behavioral: Exercise CoachingParticipants in this group will start the intervention during the first week of radiation therapy and continue through and post-completion of radiation |
| Delayed Start Group | Experimental | Behavioral: Exercise CoachingParticipants in this group will start 6-8 weeks post - radiation and continue 16-19 weeks post-radiation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- At least 18 years of age
- Pathologic diagnosis of endometrial cancer (any histology, Stage I-IVA)
- Has undergone modified radical or radical hysterectomy
- Plan to receive adjuvant treatment with pelvic external beam radiation therapy at ISCI
- ECOG performance status of 0-1
Key exclusion criteria (8 listed)
- Unable to schedule and attend coaching visits
- Participation in a regular exercise program of ≥150 minutes of moderate intensity exercise a week at baseline
- Unable to perform the five-times stand test
- Medical comorbidities including:
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 |
|---|---|---|
| Exercise CoachingAn exercise coaching program tailored for women with Stage I-IVA endometrial cancer who have undergone total or modified radical hysterectomy with surgical staging. The intervention targets a total of 8 participants who are planned to complete pelvic external beam radiation therapy as part of their adjuvant treatment. | Behavioural | Delayed Start Group, Immediate Start Group |
Primary outcome
Feasibility of a Randomized Trial: Participant Adherence to Exercise Coaching Sessions
Time frame: Enrollment to end of follow up, up to 24 months
Participant adherence to coaching sessions will be defined as complete adherence when engaging in 10 of the 10 planned exercise coaching sessions and high adherence as engaging in at least 7 of the planned 10 exercise coach check-ins. Participant adherence will be considered feasible if 70% of participants adhere to the coaching sessions.
7 secondary outcomes
Change in patient-reported fatigue
Time frame: Enrollment to end of follow up, up to 24 months
Change in patient-reported bowel/urinary toxicity
Time frame: Enrollment to end of follow up, up to 24 months
Change in patient-reported Quality of Life (QOL)
Time frame: Enrollment to end of follow up, up to 24 months
Change in patient-reported cognitive function
Time frame: Enrollment to end of follow up, up to 24 months
Change in patient-reported sexual function and satisfaction
Time frame: Enrollment to end of follow up, up to 24 months
Change in patient-reported self-efficacy
Time frame: Enrollment to end of follow up, up to 24 months
Change in distance walked during the 6-Minute Walk Test (6MWT)
Time frame: Enrollment to end of follow up, up to 24 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 1 Sep 2026.
- Individual participant dataSharing planned: Yes
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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.
Avani Rao, MD principal investigator
Inova Health Care Services
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Coaching in people with Radiation Therapy and Gynecologic Cancer, run by Inova Health Care Services at 4 sites 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 12 inclusion and 8 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 1 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 4 sites 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?
Feasibility of a Randomized Trial: Participant Adherence to Exercise Coaching Sessions (time frame: Enrollment to end of follow up, up to 24 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 1 Sep 2026.