Emerging From the Haze for Gynecologic Cancer Survivors
Atslēgvārdi
Abstrakts
Datumi
| Pēdējoreiz pārbaudīts: | 12/31/2018 |
| Pirmais iesniegtais: | 09/20/2016 |
| Paredzētā reģistrācija iesniegta: | 09/27/2016 |
| Pirmais izlikts: | 09/28/2016 |
| Pēdējais atjauninājums iesniegts: | 01/01/2019 |
| Pēdējā atjaunināšana ievietota: | 01/03/2019 |
| Faktiskais studiju sākuma datums: | 01/09/2017 |
| Paredzamais primārās pabeigšanas datums: | 04/30/2017 |
| Paredzamais pētījuma pabeigšanas datums: | 10/31/2017 |
Stāvoklis vai slimība
Iejaukšanās / ārstēšana
Behavioral: Emerging from the Haze class
Fāze
Roku grupas
| Roka | Iejaukšanās / ārstēšana |
|---|---|
| Experimental: Emerging from the Haze class A 6-week psycho-educationally-based, cognitive behavioral program to help patients with subjective cognitive complaints after cancer treatment, titled Emerging from the Haze™ (Haze). Each series meets once a week for 2-2.5 hours for 6 weeks. | Behavioral: Emerging from the Haze class A 6-week class designed to combat chemotherapy-induced cognitive dysfunction. Patients will report symptoms at 6 months and 1 year after the end of their Haze class. |
Atbilstības kritēriji
| Vecums, kas piemērots studijām | 18 Years Uz 18 Years |
| Dzimumi, kas ir piemēroti studijām | Female |
| Pieņem veselīgus brīvprātīgos | Jā |
| Kritēriji | Inclusion Criteria: - Diagnosis of any stage gynecologic cancer including ovarian, uterine/endometrial, cervical, vulvar, and vaginal cancer - Treated with chemotherapy solely or in combination with surgery, radiation, and/or hormonal therapy - Female, age ≥ 18 years. - FACT-Cog score < 59 on the PCI sub scale - Eligible after 2 months (60 ±5 days) of completing all their active cancer treatment with the exception of long-term hormonal treatments - Subjective complaint of cognitive concerns at time of enrollment - Must be able to understand and communicate proficiently in English - Ability to understand and the willingness to sign a written informed consent. - Agree to complete study surveys Exclusion Criteria: - Patients who have significant personality disorders or unstable psychiatric disorders (including active major depression, substance abuse, psychosis or bipolar disorder) as assessed by the interviewing clinician - Patients with known brain metastases, history of brain metastases or radiation to the brain. - Patients with a history of stroke or other pre-existing neurological condition that may contribute to cognitive dysfunction. - Non-English speakers - Receiving treatment for another malignancy other than breast cancer - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, chronic anemia, uncontrolled hypothyroidism, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. |
Rezultāts
Primārie rezultāti
1. The Functional Assessment of Cancer Therapy- Cognition (FACT-Cog) Survey [First day of class (baseline), last day of class (6 weeks), 6 months and 1 year after class]
Sekundārie iznākuma mērījumi
1. Patient Reported Outcomes Measurement Information System (PROMIS) - Cognition and General Concerns Survey [First day of class (baseline), last day of class (6 weeks), 6 months and 1 year after class]
2. UCLA Loneliness Scale Survey [First day of class (baseline), last day of class (6 weeks), 6 months and 1 year after class]
Citi iznākuma pasākumi
1. Comparison of trainee-taught vs non-trainee taught class [First day of class (baseline), last day of class (6 weeks)]
