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Emerging From the Haze for Gynecologic Cancer Survivors

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Cedars-Sinai Medical Center

Raktažodžiai

Santrauka

At Cedars-Sinai Medical Center, the investigators have developed a novel curriculum for 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.
The objective of this study is to quantify the impact of a trainee-taught Emerging from the Haze course on gynecologic cancer survivors' self-report of cognitive changes based on the change of FACT-Cog score.

Datos

Paskutinį kartą patikrinta: 12/31/2018
Pirmasis pateikimas: 09/20/2016
Numatytas registravimas pateiktas: 09/27/2016
Pirmas paskelbtas: 09/28/2016
Paskutinis atnaujinimas pateiktas: 01/01/2019
Paskutinis atnaujinimas paskelbtas: 01/03/2019
Faktinė studijų pradžios data: 01/09/2017
Numatoma pirminio užbaigimo data: 04/30/2017
Numatoma studijų užbaigimo data: 10/31/2017

Būklė ar liga

Gynecologic Neoplasms
Cognition Disorders

Intervencija / gydymas

Behavioral: Emerging from the Haze class

Fazė

-

Rankų grupės

RankaIntervencija / gydymas
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.

Tinkamumo kriterijai

Amžius, tinkami studijuoti 18 Years Į 18 Years
Tinkamos studijoms lytysFemale
Priima sveikus savanoriusTaip
Kriterijai

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.

Rezultatas

Pirminės rezultatų priemonės

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]

Measure the change in score from baseline to each of three time points: last day of class (6 weeks), 6 months, and 1 year after class

Antrinės rezultatų priemonės

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]

Measure the change in score from baseline to each of three time points: 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]

Measure the change in score from baseline to each of three time points: last day of class (6 weeks), 6 months, and 1 year after class

Kitos rezultato priemonės

1. Comparison of trainee-taught vs non-trainee taught class [First day of class (baseline), last day of class (6 weeks)]

To compare the impact of a trainee-taught Emerging from the Haze course on gynecologic cancer survivors' self report of cognitive changes based on change of the FACT-Cog compared to the impact of an ongoing non-trainee-taught Emerging from the Haze course on breast cancer survivors' self report of cognitive changes based on the change in FACT-Cog score from first day of class (baseline) to last day of class (6 weeks) in these two groups

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