Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05743517

Physical Activity Intervention Among Older Women With Gynecologic Cancers (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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Ovary Cancer Adnexal Diseases Behavior Cervical Cancer Cervix Cancer Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Motor Activity Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Cancer Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Vaginal Cancer Vaginal Diseases Vaginal Neoplasms Vulvar Cancer Vulvar Diseases Vulvar Neoplasms

Age range

60 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

Location status: Recruiting

Location contact

Anne Grace, PhD

CONTACT

[email protected]

3125034165

Brenda Vega

CONTACT

[email protected]

Emma Barber, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fit4Treatment

Behavioral

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 outcomes

  1. Change in Physical Activity

    Time frame: 24 weeks

    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.

Secondary outcomes

  1. Change in Functional Performance

    Time frame: 24 weeks

    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.

  2. Change in Frailty

    Time frame: 24 weeks

    Frailty will be assessed using the Fried's phenotype method.

  3. Change in Anxiety

    Time frame: 24 weeks

    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.

  4. Change in Fatigue

    Time frame: 24 weeks

    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.

  5. Change in Physical Function

    Time frame: 24 weeks

    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.

  6. Change in Pain Interference

    Time frame: 24 weeks

    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.

  7. Change in Sleep Disturbance

    Time frame: 24 weeks

    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.

  8. Change in Global Quality of Life

    Time frame: 24 weeks

    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.

  9. Treatment Outcomes

    Time frame: 3 years

    Medical record review will be performed to examine treatment(s) administered and treatment delays.

  10. Treatment Complications

    Time frame: 3 years

    Medical record review will be performed to monitor complications of systemic treatment.

  11. Healthcare Utilization

    Time frame: 3 years

    Medical record review will be performed to monitor for hospitalizations, emergency room visits, and unscheduled clinic visits.

  12. Survival Outcomes

    Time frame: 3 years

    Medical records will be reviewed for three years to monitor for cancer recurrence.

  13. Adverse Events

    Time frame: 3 years

    The number of adverse events will be recorded and graded according to Common Terminology Criteria for Adverse Events, v5.0.

Study contacts

Contact information is provided by the study sponsor or research team.

Anne Grace, PhD

CONTACT

[email protected]

312-503-4165

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2028
Study completion
2029
First posted
Feb 24, 2023
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.