Physical Activity Intervention Among Older Women With Gynecologic Cancers (Fit4Treatment)

Patient-Tailored Physical Activity Intervention Among Older Women With Gynecologic Cancers Undergoing Chemotherapy (Fit4Treatment)

The primary purpose of the study is to determine which of four components (symptom-burden tailored app, exercise partner, oncology provider engagement, coaching) added to a core intervention of a wearable activity tracker and commercially available app, will improve physical activity. The findings will generate meaningful knowledge about how to best increase physical activity in older gynecologic cancer patients receiving systemic cancer therapies to improve quality of life and cancer-specific survival.

Study Overview

• Status: Recruiting
• Conditions: Cervical Cancer; Vulvar Cancer; Cervix Cancer; Endometrial Cancer; Vaginal Cancer; Ovary Cancer; Uterine Cancer
• Intervention / Treatment: Behavioral: Fit4Treatment

Detailed Description

Gynecologic cancers include ovarian, uterine and cervical cancers and represent 102,000 cases of cancer in the United States every year; 60% occur in women greater than age 60. Older patients with gynecologic cancers have higher rates of advanced stage at presentation, more aggressive histology and more commonly require adjuvant treatment with systemic therapies such as chemotherapy, immunotherapy or targeted therapies. This chemotherapy, as well as underlying cancer, cause accelerated aging and toxicity, leaving women vulnerable to functional decline, increased frailty, decreased health related quality of life, and ultimately, less systemic therapy completion and inferior cancer survival.

Physical activity has been shown to improve functional health, improve quality of life, slow aging, and decrease rates of frailty. In fact, physical activity, and the multi-system health benefits that result, is the most recommended frailty intervention. Physical activity interventions in cancer survivors reduce sedentary time, decrease functional decline, and lower mortality. Studies specific to patients on active cancer treatment are less common, however, several randomized trials have found less decline in cardiorespiratory fitness, less chemotherapy toxicity, and fewer chemotherapy dose reductions. Although older adults with gynecologic cancer have a high likelihood of benefit from physical activity, challenges exist in accessing current interventions. Traditional in-person strenuous physical activity interventions with static goals may not be appropriate for older women undergoing chemotherapy, where symptom burden is high and varied, and healthcare visits frequent.

Remotely delivered mobile health (mHealth) technology-based physical activity interventions increase physical activity in diverse populations including those with metastatic cancer. Four evidence-based strategies to increase physical activity have demonstrated efficacy in cancer patients and older adults, including, 1) symptom burden tailored goal setting 2) exercise partners 3) oncology provider engagement and 4) coaching. This study will determine which components of a physical activity intervention (Fit4Treatment) meaningfully contribute to improving physical activity (steps) among older women with gynecologic cancer receiving systemic treatment such as chemotherapy.

• Study Type: Interventional
• Enrollment (Estimated): 192
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne Grace, PhD; Phone Number: 312-503-4165; Email: anne@northwestern.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern University
      • Contact: Anne Grace, PhD; Phone Number: 312-503-4165; Email: anne@northwestern.edu
      • Contact: Brenda Vega; Email: brenda.vega@northwestern.edu
      • Principal Investigator: Emma Barber, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Female; > 60 years of age
• Diagnosis of endometrial/uterine, ovarian, cervical or vulvar/vaginal cancer
• Undergoing or planning to undergo any systemic treatment for a gynecologic malignancy (e.g., chemotherapy, immunotherapy, anti-angiogenic therapies, targeted therapies, etc.)
• Willing to try to identify an exercise partner to participate with them, if needed
• Fluent in English

Exclusion Criteria:

• Uncontrolled cardiovascular disease or other major contraindications to physical activity
• Active brain metastases
• Cognitive or functional limitations that preclude a patient's ability to participate in the physical activity intervention
• Pregnant women or prisoners

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Symptom burden-tailored goal setting app; The Fit4Treatment app is designed to encourage physical activity among older women with gynecologic cancer while they are undergoing cancer therapy. The app will contain the following features 1) education about safely increasing physical activity and steps; 2) tailored patient-specific push notifications to encourage physical activity 3) syncing of Fitbit steps and transmission of these data to study staff in real time; 4) daily, weekly and monthly step progress; and 5) goal setting that incorporates prior physical activity, patient desires, and daily symptom burden. The app will prompt patients to report their symptom burden on a scale of 1-5 each morning. Based on their symptom rating and the previous days step counts (measured directly by the Fitbit) patients will be provided with three different goal choices to select. Daily activity goals increase, decrease or stay the same depending on the previous day and the patient's own goals.	Behavioral: Fit4Treatment; This study will test the core intervention of an activity tracker and commercially available app (Fitbit) in addition to four components which are expected to improve physical activity. The intervention will be delivered over 12 weeks with a 12 week follow up period.
Experimental: Exercise Partner; Participants assigned to the exercise partner component will be encouraged to discuss their step progress with their selected partner who will in turn support the participant and encourage them to stay active.	Behavioral: Fit4Treatment; This study will test the core intervention of an activity tracker and commercially available app (Fitbit) in addition to four components which are expected to improve physical activity. The intervention will be delivered over 12 weeks with a 12 week follow up period.
Experimental: Provider/oncologist engagement; Participants assigned to the provider/oncologist engagement component will have their physical activity data recorded by the Fitbit shared with their oncology provider through the electronic medical record (EMR). For participants randomized to this condition, clinical staff will place an order into the EMR, allowing the patient to use the patient-facing portal MyChart to link their Fitbit to the health record. Prior to regularly scheduled clinic visits, the patient's oncology team will receive a message summarizing the participant's physical activity (average daily steps) for the prior three weeks.	Behavioral: Fit4Treatment; This study will test the core intervention of an activity tracker and commercially available app (Fitbit) in addition to four components which are expected to improve physical activity. The intervention will be delivered over 12 weeks with a 12 week follow up period.
Experimental: Coaching; Participants assigned to the coaching intervention will receive weekly coaching calls. The study team will call them at a previously specified and mutually agreed upon time once per week to review topics related to physical activity and cancer treatment. Coaching calls will have an educational component and cover topics such as reducing sedentary behavior, benefits of increased physical activity, managing cancer treatment symptoms, social support, stress management, etc. During these calls, the topics as well as strategies and recommendations will be discussed. Barriers and facilitators will be reflected on and planned for to increased self-efficacy. Participants will engage in direct problem solving with their coach. Discussing these topics will enhance outcome expectation and increase motivation.	Behavioral: Fit4Treatment; This study will test the core intervention of an activity tracker and commercially available app (Fitbit) in addition to four components which are expected to improve physical activity. The intervention will be delivered over 12 weeks with a 12 week follow up period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Physical Activity	The primary outcome of average steps per day over a 7 day period will be measured with Actigraph. Patients will wear an accelerometer for 7 days prior to study intervention, 7 days at the conclusion of the 12-week Fit4Treatment intervention, and 7 days at the conclusion of the 12 week follow up period.	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Functional Performance	Patients will complete the short performance physical battery (SPPB). This is a well validated physical performance measure specifically in an older patient population and consists of balance testing, a 4-meter walk test and timed standing from a chair.	24 weeks
Change in Frailty	Frailty will be assessed using the Fried's phenotype method.	24 weeks
Change in Anxiety	Patient Reported Outcomes Measurement Information System (PROMIS) for anxiety will be measured at baseline, after the 12-week intervention, and after 24 weeks using Patient Reported Outcomes Measurement Information System Item Bank v1.0 - Emotional Distress - Anxiety - Short Form 7a, using a scale of 1-5, where 1 is the best outcome. PROMIS measures are validated, reliable measures of health states that can be completed with minimal patient burden and have been used in myriad studies of both older adults and cancer patients.	24 weeks
Change in Fatigue	Patient Reported Outcomes Measurement Information System (PROMIS) for fatigue will be measured at baseline, after the 12-week intervention, and after 24 weeks using Patient Reported Outcomes Measurement Information System Item Bank v1.0 - Fatigue - Short Form 7a, using a scale of 1-5, where 1 is the best outcome. PROMIS measures are validated, reliable measures of health states that can be completed with minimal patient burden and have been used in myriad studies of both older adults and cancer patients.	24 weeks
Change in Physical Function	Patient Reported Outcomes Measurement Information System (PROMIS) for physical function will be measured at baseline, after the 12-week intervention, and after 24 weeks using Patient Reported Outcomes Measurement Information System Item Bank v1.0 - Physical Function - Short Form 10a, using a scale of 1-5, where 1 is the best outcome. PROMIS measures are validated, reliable measures of health states that can be completed with minimal patient burden and have been used in myriad studies of both older adults and cancer patients.	24 weeks
Change in Pain Interference	Patient Reported Outcomes Measurement Information System (PROMIS) for pain will be measured at baseline, after the 12-week intervention, and after 24 weeks using Patient Reported Outcomes Measurement Information System Item Bank v1.0 - Pain Interference - Short Form 6a, using a scale of 1-5, where 1 is the best outcome. PROMIS measures are validated, reliable measures of health states that can be completed with minimal patient burden and have been used in myriad studies of both older adults and cancer patients.	24 weeks
Change in Sleep Disturbance	Patient Reported Outcomes Measurement Information System (PROMIS) for sleep disturbance will be measured at baseline, after the 12-week intervention, and after 24 weeks using Patient Reported Outcomes Measurement Information System Item Bank v1.0 - Sleep Disturbance - Short Form 6a, using a scale of 1-5, where 1 or 5 is the best outcome, depending on the question. PROMIS measures are validated, reliable measures of health states that can be completed with minimal patient burden and have been used in myriad studies of both older adults and cancer patients.	24 weeks
Change in Global Quality of Life	Quality of Life will be measured at baseline, after the 12-week intervention, and after 24 weeks using the Global Quality of Life (QOL) scale of 1-5, where 5 is the best outcome.	24 weeks
Treatment Outcomes	Medical record review will be performed to examine treatment(s) administered and treatment delays.	3 years
Treatment Complications	Medical record review will be performed to monitor complications of systemic treatment.	3 years
Healthcare Utilization	Medical record review will be performed to monitor for hospitalizations, emergency room visits, and unscheduled clinic visits.	3 years
Survival Outcomes	Medical records will be reviewed for three years to monitor for cancer recurrence.	3 years
Adverse Events	The number of adverse events will be recorded and graded according to Common Terminology Criteria for Adverse Events, v5.0.	3 years

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Emma Barber, MD, MS, Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2029

Study Registration Dates

• First Submitted: January 31, 2023
• First Submitted That Met QC Criteria: February 21, 2023
• First Posted (Actual): February 24, 2023

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: physical activity; chemotherapy; behavioral intervention; quality of life; systemic therapy; cancer outcomes
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Vaginal Diseases; Vulvar Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Uterine Cervical Neoplasms; Ovarian Neoplasms; Endometrial Neoplasms; Vulvar Neoplasms; Vaginal Neoplasms; Uterine Neoplasms
• Other Study ID Numbers: STU00218257

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No