Gynecologic NeoplasmsNCT02918461
Emerging From the Haze for Gynecologic Cancer Survivors
A study testing Emerging from the Haze class in people with Gynecologic Neoplasms and Cognition Disorders, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Neoplasms, Cognition Disorders
- What is being tested?
- Emerging from the Haze class
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2017to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: A Pilot Study of Emerging From the Haze Evaluating a Trainee-taught Psycho-educational Program to Improve Cancer-related Cognitive Complaints in Gynecologic Cancer Survivors
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.
- Conditions
- Gynecologic Neoplasms, Cognition Disorders
- Being tested
- Emerging from the Haze class
- Medical subject headings
- Genital Neoplasms, Female, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emerging from the Haze classBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Emerging from the Haze class | Experimental | 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. Receives: Behavioral: Emerging from the Haze class |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Functional Assessment of Cancer Therapy- Cognition (FACT-Cog) Survey
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
Measured: First day of class (baseline), last day of class (6 weeks), 6 months and 1 year after class
Secondary outcomes (2)
Patient Reported Outcomes Measurement Information System (PROMIS) - Cognition and General Concerns Survey
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
Measured: First day of class (baseline), last day of class (6 weeks), 6 months and 1 year after class
UCLA Loneliness Scale Survey
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
Measured: First day of class (baseline), last day of class (6 weeks), 6 months and 1 year after class
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study start10 Jan 2017
- Primary completionMay 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arash Asher, MD, Cedars-Sinai Medical Center
- Investigators
- Arash Asher, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02918461
- Sponsor's protocol ID
- Pro00046105
- Status last verified
- Jan 2019
- First submitted
- 21 Sep 2016
- Last updated
- 4 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Emerging From the Haze Evaluating a Trainee-taught Psycho-educational Program to Improve Cancer-related Cognitive Complaints in Gynecologic Cancer Survivors
- ClinicalTrials.gov ID
- NCT02918461
- Acronym / sponsor ID
- Pro00046105
- Conditions
- Gynecologic Neoplasms, Cognition Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 10 Jan 2017 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 29 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Emerging from the Haze class | Experimental | Behavioral: Emerging from the Haze classA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emerging from the Haze classA 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. | Behavioural | Emerging from the Haze class |
Primary outcome
The Functional Assessment of Cancer Therapy- Cognition (FACT-Cog) Survey
Time frame: 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 secondary outcomes
Patient Reported Outcomes Measurement Information System (PROMIS) - Cognition and General Concerns Survey
Time frame: First day of class (baseline), last day of class (6 weeks), 6 months and 1 year after class
UCLA Loneliness Scale Survey
Time frame: First day of class (baseline), last day of class (6 weeks), 6 months and 1 year after class
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arash Asher, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emerging from the Haze class in people with Gynecologic Neoplasms and Cognition Disorders, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Functional Assessment of Cancer Therapy- Cognition (FACT-Cog) Survey (time frame: First day of class (baseline), last day of class (6 weeks), 6 months and 1 year after class). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2019.