Ignite Creation Date:
2024-05-06 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05743517
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2023-01-31
Brief Title:
Physical Activity Intervention Among Older Women With Gynecologic Cancers Fit4Treatment
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Patient-Tailored Physical Activity Intervention Among Older Women With Gynecologic Cancers Undergoing Chemotherapy Fit4Treatment
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 102000 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None