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

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

NCT ID: NCT05743517

Condition: Ovary Cancer
Endometrial Cancer
Uterine Cancer
Cervical Cancer
Cervix Cancer
Vulvar Cancer
Vaginal Cancer

Conditions: Official terms:
Uterine Cervical Neoplasms
Endometrial Neoplasms
Vulvar Neoplasms
Vaginal Neoplasms
Uterine Neoplasms
Ovarian Neoplasms

Conditions: Keywords:
behavioral intervention
physical activity
cancer outcomes
chemotherapy
systemic therapy
quality of life

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Factorial Assignment

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

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: Fit4Treatment
Description: 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.
Arm group label: Coaching
Arm group label: Exercise Partner
Arm group label: Provider/oncologist engagement
Arm group label: Symptom burden-tailored goal setting app

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.

Criteria for 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

Gender: Female

Minimum age: 60 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Northwestern University

Address:
City: Chicago
Zip: 60611
Country: United States

Status: Recruiting

Contact:
Last name: Anne Grace, PhD

Phone: 312-503-4165
Email: anne@northwestern.edu

Contact backup:
Last name: Brenda Vega
Email: brenda.vega@northwestern.edu

Investigator:
Last name: Emma Barber, MD
Email: Principal Investigator

Start date: September 15, 2023

Completion date: August 1, 2029

Lead sponsor:
Agency: Northwestern University
Agency class: Other

Source: Northwestern University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05743517