Physical Activity Intervention Among Older Women With Gynecologic Cancers (Fit4Treatment)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fit4Treatment.
- Who it may be relevant to
- Registry conditions: Ovary Cancer, Endometrial Cancer, Uterine Cancer, Cervical Cancer. Basic parameters: from 60 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Patient-Tailored Physical Activity Intervention Among Older Women With Gynecologic Cancers Undergoing Chemotherapy (Fit4Treatment)
Overview
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.
Interventions
- 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.
Primary outcome measures
- Change in Physical Activity [Time frame: 24 weeks]
Secondary outcome measures (12)
- Change in Functional Performance [Time frame: 24 weeks]
- Change in Frailty [Time frame: 24 weeks]
- Change in Anxiety [Time frame: 24 weeks]
- Change in Fatigue [Time frame: 24 weeks]
- Change in Physical Function [Time frame: 24 weeks]
- Change in Pain Interference [Time frame: 24 weeks]
- Change in Sleep Disturbance [Time frame: 24 weeks]
- Change in Global Quality of Life [Time frame: 24 weeks]
- Treatment Outcomes [Time frame: 3 years]
- Treatment Complications [Time frame: 3 years]
- Healthcare Utilization [Time frame: 3 years]
- Survival Outcomes [Time frame: 3 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Northwestern University — Chicago
Identifiers
NCT: NCT05743517 · STU00218257