Ovarian Cancer Clinical Trial
— FIT4SURGERYOfficial title:
A Pilot Study of Prehabilitation During the Neoadjuvant Window of Opportunity in Older Women With Ovarian Cancer (FIT4SURGERY)
The purpose of this study is to test the effectiveness of a home-based, patient-tailored intervention, FIT4SURGERY, to promote physical activity among women with ovarian cancer undergoing neoadjuvant chemotherapy.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | August 31, 2024 |
Est. primary completion date | August 31, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 60 Years and older |
Eligibility | Inclusion Criteria: - Female; = 60 years of age - Diagnosed with ovarian, fallopian tube or primary peritoneal cancer and undergoing planned neoadjuvant chemotherapy and are expecting to undergo planned surgery - Fluent in spoken and written English - Own a smartphone - Have access to the internet to complete assessments Exclusion Criteria: - Patients receiving planned chemotherapy only - Patients with uncontrolled cardiovascular disease, who are non-ambulatory, or who have severe cognitive or functional limitations precluding their ability to participate in a physical activity intervention - Pregnant women or prisoners - Patients whose oncologist has not provided clearance for their participation |
Country | Name | City | State |
---|---|---|---|
United States | Northwestern University | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Northwestern University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients who are evaluable for both baseline and post-intervention assessments | Evaluability will be measured for all patients enrolled in the study regardless of intervention assignment. Patients will be considered evaluable if they complete both the pre-intervention baseline assessments (frailty, PROs) and the post-intervention pre-surgery assessments. The proportion of patients evaluable, according to the above definition, over all patients enrolled will be calculated. | Through study completion, average of 9-12 weeks | |
Primary | Proportion of patients who are adherent to the Fit4Surgery intervention measured among those in the Fit4Surgery arm. | Adherence will be measured in the Fit4Surgery arm. Patients will be considered adherent to the Fit4Surgery intervention if they wear their Fitbit for >70% of the days during the study period (i.e., ~44/63 days) and if they meet their physical activity goals (step count) on >70% of the days during the study period. The proportion of patients in the Fit4Surgery arm who are adherent to the intervention, according to the above definition, will be calculated. | Through study completion, average of 9-12 weeks | |
Secondary | Change in frailty | Frailty will be assessed at baseline and prior to surgery using the "Fried's phenotype method" in patients in both groups. According to this scale, patients will be categorized as non-frail, pre-frail or frail. | Baseline and once at 9-12 weeks | |
Secondary | Change in anxiety | Anxiety will be measured using "PROMIS anxiety short form 7a" measure. | Baseline and once at 9-12 weeks | |
Secondary | Change in physical function | Physical function will be measured using "PROMIS physical function short form 10a" measure. | Baseline and once at 9-12 weeks | |
Secondary | Change in fatigue | Fatigue will be measured using "PROMIS fatigue short form 7a" measure. | Baseline and once at 9-12 weeks | |
Secondary | Adverse Events | The number of adverse events will be recorded and graded according to CTCAE v5.0. | Once at 9-12 weeks | |
Secondary | Surgical Complications | Medical record review will be performed to examine postoperative complications which will be graded using the Clavien-Dindo scale. | 90 days post surgery | |
Secondary | Progression free survival | Medical records will be reviewed for up to three years to monitor for cancer recurrence. | three years post surgery | |
Secondary | Overall survival | Medical records will be reviewed for up to three years to monitor for overall survival. | three years post surgery |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
Withdrawn |
NCT05201001 -
APX005M in Patients With Recurrent Ovarian Cancer
|
Phase 2 | |
Completed |
NCT02963831 -
A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT06376253 -
A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers
|
Phase 1 | |
Recruiting |
NCT05489211 -
Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)
|
Phase 2 | |
Recruiting |
NCT03412877 -
Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer
|
Phase 2 | |
Active, not recruiting |
NCT03667716 -
COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors.
|
Phase 1 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT05156892 -
Tamoxifen and SUBA-Itraconzole Combination Testing in Ovarian Cancer
|
Phase 1 | |
Suspended |
NCT02432378 -
Intensive Locoregional Chemoimmunotherapy for Recurrent Ovarian Cancer Plus Intranodal DC Vaccines
|
Phase 1/Phase 2 | |
Recruiting |
NCT04533763 -
Living WELL: A Web-Based Program for Ovarian Cancer Survivors
|
N/A | |
Active, not recruiting |
NCT03371693 -
Cytoreductive Surgery(CRS) Plus Hyperthermic Intraperitoneal Chemotherapy(HIPEC) With Lobaplatin in Advanced and Recurrent Epithelial Ovarian Cancer
|
Phase 3 | |
Withdrawn |
NCT03032614 -
Combination of Carboplatin, Eribulin and Veliparib in Stage IV Cancer Patients
|
Phase 2 | |
Completed |
NCT01936363 -
Trial of Pimasertib With SAR245409 or Placebo in Ovarian Cancer
|
Phase 2 | |
Completed |
NCT02019524 -
Phase Ib Trial of Two Folate Binding Protein Peptide Vaccines (E39 and J65) in Breast and Ovarian Cancer Patients
|
Phase 1 | |
Terminated |
NCT00788125 -
Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT05059522 -
Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing
|
Phase 3 | |
Active, not recruiting |
NCT04383210 -
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
|
Phase 2 | |
Terminated |
NCT04586335 -
Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors.
|
Phase 1 | |
Terminated |
NCT03146663 -
NUC-1031 in Patients With Platinum-Resistant Ovarian Cancer
|
Phase 2 |