Clinical trial NCT06746428: Activity Coaching During Pelvic Radiation Therapy
Official title: ACTIVATE: A Pilot Randomized Activity Coaching Trial to Increase Vitality and Energy During Post-operative Pelvic Radiation Therapy for Endometrial Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Radiation Therapy
Gynecologic Cancer
Exercise Therapy
Lead sponsor: Inova Health Care Services
Sponsor class: OTHER
First posted: 2024-12-24
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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
* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Feasibility of a Randomized Trial: Participant Adherence to Exercise Coaching Sessions
timeFrame: Enrollment to end of follow up, up to 24 months
Secondary outcomes:
measure: Change in patient-reported fatigue
timeFrame: Enrollment to end of follow up, up to 24 months
measure: Change in patient-reported bowel/urinary toxicity
timeFrame: Enrollment to end of follow up, up to 24 months
measure: Change in patient-reported Quality of Life (QOL)
timeFrame: Enrollment to end of follow up, up to 24 months
measure: Change in patient-reported cognitive function
timeFrame: Enrollment to end of follow up, up to 24 months
measure: Change in patient-reported sexual function and satisfaction
timeFrame: Enrollment to end of follow up, up to 24 months
measure: Change in patient-reported self-efficacy
timeFrame: Enrollment to end of follow up, up to 24 months
measure: Change in distance walked during the 6-Minute Walk Test (6MWT)
timeFrame: Enrollment to end of follow up, up to 24 months
Other outcomes:
Locations:
city: Alexandria
country: United States
facility: Inova Schar Cancer Institute - Alexandria
state: Virginia
city: Fairfax
country: United States
facility: Inova Schar Cancer Institute
state: Virginia
city: Fairfax
country: United States
facility: Inova Schar Cancer Institute - Fair Oaks
state: Virginia
city: Leesburg
country: United States
facility: Inova Schar Cancer Institute - Loudoun
state: Virginia
Study officials:
affiliation: Inova Health Care Services
name: Avani Rao, MD
role: PRINCIPAL_INVESTIGATOR
References: