Clinical trial NCT05743517: Physical Activity Intervention Among Older Women With Gynecologic Cancers (Fit4Treatment)
Official title: Patient-Tailored Physical Activity Intervention Among Older Women With Gynecologic Cancers Undergoing Chemotherapy (Fit4Treatment)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ovary Cancer
Endometrial Cancer
Uterine Cancer
Cervical Cancer
Cervix Cancer
Vulvar Cancer
Vaginal Cancer
Keywords: behavioral intervention
physical activity
cancer outcomes
chemotherapy
systemic therapy
quality of life
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2023-02-24
Enrollment: 192
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: The researchers will use a MOST full factorial study design to optimize the Fit4Treatment physical activity intervention by testing the core intervention of an activity tracker and commercially available app (Fitbit) in addition to four components which are expected to improve physical activity: 1) symptom-burden tailored goal setting app, 2) exercise partner, 3) oncology provider engagement, and 4) coaching calls. Patients will be randomized to 16 groups formed by all possible combinations of these four components in a full factorial design.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Physical Activity
timeFrame: 24 weeks
Secondary outcomes:
measure: Change in Functional Performance
timeFrame: 24 weeks
measure: Change in Frailty
timeFrame: 24 weeks
measure: Change in Anxiety
timeFrame: 24 weeks
measure: Change in Fatigue
timeFrame: 24 weeks
measure: Change in Physical Function
timeFrame: 24 weeks
measure: Change in Pain Interference
timeFrame: 24 weeks
measure: Change in Sleep Disturbance
timeFrame: 24 weeks
measure: Change in Global Quality of Life
timeFrame: 24 weeks
measure: Treatment Outcomes
timeFrame: 3 years
measure: Treatment Complications
timeFrame: 3 years
measure: Healthcare Utilization
timeFrame: 3 years
measure: Survival Outcomes
timeFrame: 3 years
measure: Adverse Events
timeFrame: 3 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Emma Barber, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: