- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03804164
Psycho-Educational Cognition Intervention in Patients With Blood and Lymph Cancer
A Study of the Feasibility and Acceptability of a Psycho-Educational Cognition Intervention in Adolescents and Young Adults (AYAs) With Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. Demonstrate feasibility and acceptability for young adult survivors of various cancers utilizing Emerging from the Haze program.
SECONDARY OBJECTIVES:
I. Describe, summarize study population. II. Characterize, compare the measure scores at pre-intervention assessment to the measure scores at post-intervention assessment.
OUTLINE:
Patients participate in the Emerging from the Haze psycho-educational program weekly over 2 hours for 6 weeks.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Duarte, California, United States, 91010
- City of Hope Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- A diagnosis of a hematological malignancy.
- Having received chemotherapy with or without radiation therapy.
- Physician approval.
- Functional Assessment of Cancer Therapy-Cognition (FACT-COG) score < 59 on the perceived cognitive impairments (PCI) subscale.
- Eligible after 2 months (60 +/- 5 days) of completing all their active cancer treatment with the exception of patients that are post-transplant.
- 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 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 speaking patients.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Supportive Care (psycho-educational sessions)
Patients participate in a psycho-educational program weekly over 2 hours for 6 weeks.
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Ancillary studies
Other Names:
Ancillary studies
Attend Emerging from the Haze psychoeducational sessions
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Enrollment of eligible participants (accrual)
Time Frame: Up to 30 days post the end of the six-week program
|
Feasibility will be assessed through enrollment of >= 60% of eligible participants (accrual) and completion of at least 5 out of 6 sessions for >= 80% of participants (adherence/engagement).
|
Up to 30 days post the end of the six-week program
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Completion of sessions (adherence/engagement)
Time Frame: Up to 30 days post the end of the six-week program
|
Feasibility will be assessed through enrollment of >= 60% of eligible participants (accrual) and completion of at least 5 out of 6 sessions for >= 80% of participants (adherence/engagement).
|
Up to 30 days post the end of the six-week program
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Functional Assessment of Cancer Therapy-Cognition scores
Time Frame: Baseline up to 30 days post the end of the six-week program
|
Functional Assessment of Cancer Therapy-Cognitive Function (version 3) (assesses cognitive functioning) The four subscales and associated ranges are as follows: Perceived Cognitive Impairments (range 0-72), Impact of Perceived Cognitive Impairments on Quality of Life (range 0-16), Comments from Others (range 0-16) and Perceived Cognitive Abilities (range 0-28). The higher the score, the better the outcome. There is no total score on this measure. |
Baseline up to 30 days post the end of the six-week program
|
Change in Patient Reported Outcomes Measurement Information System (PROMIS) scores
Time Frame: Baseline up to 30 days post the end of the six-week program
|
Will be used to characterize the change of the study population and evaluate patterns suggesting potential intervention efficacy on outcomes. Patient Reported Outcomes Measurement Information System: Cognitive Function- General Concerns version 1.0 and Cognitive Function-Abilities version 1.0 subscales (assess cognitive functioning).For each of these scales the raw score range is 8-40. These scores are then converted to T-scores (Mean = 50, SD = 10).For each of these scales the raw score range is 8-40. These scores are then converted to T-scores (Mean = 50, SD = 10). Subscales are not combined for these scales |
Baseline up to 30 days post the end of the six-week program
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Change in Global Self-Report of Cognition scores
Time Frame: Baseline up to 30 days post the end of the six-week program
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Will use two additional questions in an attempt to capture patient's perception of pre-treatment and current cognitive function and memory.
These questions will be scored on a Likert scale (0= best memory possible, 10= worst memory possible) and will be provided to patients at the first and last session.
Will be used to characterize the change of the study population and evaluate patterns suggesting potential intervention efficacy on outcomes.
|
Baseline up to 30 days post the end of the six-week program
|
Change in PROMIS-29 items (29) scores
Time Frame: Baseline up to 30 days post the end of the six-week program
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Each domain is scored separately. Will be used to characterize the change of the study population and evaluate patterns suggesting potential intervention efficacy on outcomes. Patient Reported Outcomes Measurement Information System-29 version 2.0 (assesses symptoms of depression, anxiety, physical function, pain interference, pain intensity, fatigue, sleep disturbance, and ability to participate in social and activities. Raw scores range from 4-20 for each subscale listed above except pain intensity which is a single item ranging from 0-10. The raw scores are then converted into T-scores (Mean = 50, SD = 10). For physical function, two sleep items and social activities subscales a higher T-score represents higher functioning. For anxiety, depression, fatigue, the other two sleep items and pain interference a higher T-score represents worse functioning. The subscales are not combined on this measure |
Baseline up to 30 days post the end of the six-week program
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Satisfaction Survey scores
Time Frame: Up to 30 days post the end of the six-week program
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Will use a survey to assess satisfaction with the class content and delivery. Will be used to characterize the change of the study population and evaluate patterns suggesting potential intervention efficacy on outcomes. Emerging From the Haze Course Survey (assesses satisfaction with the course and content). Total scores from responses range from 0-56. Higher values represent more satisfaction with the program. The scores are not combined for this survey. |
Up to 30 days post the end of the six-week program
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Natalie Kelly, PhD, City of Hope Medical Center
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18442 (City of Hope Medical Center)
- NCI-2018-03851 (REGISTRY: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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