An Exercise Intervention Trial to Reduce Symptoms & Improve Clinical Outcomes of Platinum-Based Treatment in Ovarian Cancer Patients
Przegląd badań
Status
Warunki
Szczegółowy opis
PRIMARY OBJECTIVES:
I. To assess the feasibility of recruiting and enrolling newly diagnosed epithelial ovarian cancer patients who have undergone debulking surgery and will be starting platinum-based chemotherapy, to an exercise trial.
II. To evaluate adherence to the data collection and exercise trial protocol. It is necessary to determine the feasibility of collecting tablet-based questionnaire data and blood samples at multiple time points in one visit. It is also critical to determine whether the exercise intervention is feasible in this patient population.
SECONDARY OBJECTIVES:
I. To examine changes in DNA repair function before and after a single exercise session.
II. To examine changes in DNA repair function, body composition, quality of life, symptoms and patient satisfaction with care over the treatment time course.
III. To examine the effect of the exercise intervention on these measurements.
IV. To follow the patients an additional 12-months for clinical outcomes defined as death, cancer recurrence, or new primary cancer.
OUTLINE: Patients undergo supervised 1-on-1 exercise sessions for 60 minutes on day 1.Treatment repeats every 3 weeks for up to 18 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive a home-based exercise prescription including instructions for keeping patients' heart rate within 50-80% maximum.
After completion of study, patients are followed up for 12 months.
Typ studiów
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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-
California
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Duarte, California, Stany Zjednoczone, 91010
- City of Hope Medical Center
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Women who have been newly diagnosed with a first primary, epithelial ovarian cancer, have undergone surgical debulking and who will be treatment according to the Armstrong method
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately.
- Newly diagnosed, primary, epithelial ovarian cancer
- Have undergone surgical debulking
- Will be treated according to the Armstrong method
- Read and understand English
- All subjects must have the ability to understand and the willingness to sign a written informed consent
Exclusion Criteria:
- Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Arm I (exercise intervention)
Patients undergo supervised 1-on-1 exercise sessions for 60 minutes on day 1.Treatment repeats every 3 weeks for up to 18 weeks in the absence of disease progression or unacceptable toxicity.
Patients also receive a home-based exercise prescription including instructions for keeping patients' heart rate within 50-80% maximum.
|
Badania korelacyjne
Badania pomocnicze
Inne nazwy:
Badania pomocnicze
Undergo supervised 1-on-1 exercise sessions
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
|---|---|
|
Adherence to the data collection and exercise trial protocol, defined as the number of sessions attended, questionnaires completed, and blood samples completed
Ramy czasowe: 18 weeks
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18 weeks
|
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Feasibility of recruiting and enrolling patients to an exercise trial, defined as the number of people contacted, eligible consented and enrolled
Ramy czasowe: 12 months
|
12 months
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in body composition
Ramy czasowe: Baseline to 18 weeks
|
Will be analyzed using paired t-tests.
Data from women in course 1 will be compared to data in women in course 6.
|
Baseline to 18 weeks
|
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Change in DNA repair function, assessed by host reactivation assays
Ramy czasowe: Before single exercise session to after single exercise session, assessed up to 12 months
|
Will be analyzed using paired t-tests
|
Before single exercise session to after single exercise session, assessed up to 12 months
|
|
Change in DNA repair function, assessed by host reactivation assays
Ramy czasowe: Baseline to 18 weeks
|
Will be analyzed using paired t-tests.
Data from women in course 1 will be compared to data in women in course 6.
|
Baseline to 18 weeks
|
|
Change in quality of life, assessed by questionnaires
Ramy czasowe: Baseline to 18 weeks
|
Will be analyzed using paired t-tests.
Data from women in course 1 will be compared to data in women in course 6.
|
Baseline to 18 weeks
|
|
Change in symptoms, assessed by National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Ovarian Symptom Index-18 version 2
Ramy czasowe: Baseline to 18 weeks
|
Will be analyzed using paired t-tests.
Data from women in course 1 will be compared to data in women in course 6.
|
Baseline to 18 weeks
|
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Change in treatment satisfaction, assessed by Functional Assessment of Chronic Illness Therapy-Treatment Satisfaction-General
Ramy czasowe: Baseline to 18 weeks
|
Will be analyzed using paired t-tests.
Data from women in course 1 will be compared to data in women in course 6.
|
Baseline to 18 weeks
|
|
Clinical outcome follow-up defined as death, cancer recurrence, or new primary cancer
Ramy czasowe: Up to 12 months
|
Up to 12 months
|
Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Jessica Clague DeHart, PhD, City of Hope Medical Center
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Oczekiwany)
Ukończenie studiów (Oczekiwany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- 15388 (Inny identyfikator: City of Hope Medical Center)
- NCI-2016-01183 (Identyfikator rejestru: CTRP (Clinical Trial Reporting Program))
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