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Psycho-Educational Cognition Intervention in Patients With Blood and Lymph Cancer

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ClinicalTrials.gov Identifier: NCT03804164
Recruitment Status : Withdrawn (Feasibility)
First Posted : January 15, 2019
Last Update Posted : December 17, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

Tracking Information
First Submitted Date  ICMJE January 11, 2019
First Posted Date  ICMJE January 15, 2019
Last Update Posted Date December 17, 2020
Actual Study Start Date  ICMJE February 10, 2020
Actual Primary Completion Date February 10, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 11, 2019)
  • 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).
  • 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2019)
  • 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.
  • 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
  • Change in Global Self-Report of Cognition scores [ Time Frame: Baseline up to 30 days post the end of the six-week program ]
    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.
  • Change in PROMIS-29 items (29) scores [ Time Frame: Baseline up to 30 days post the end of the six-week program ]
    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
  • Satisfaction Survey scores [ Time Frame: Up to 30 days post the end of the six-week program ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2019)
  • Change in Functional Assessment of Cancer Therapy-Cognition 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.
  • 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.
  • Change in Global Self-Report of Cognition scores [ Time Frame: Baseline up to 30 days post the end of the six-week program ]
    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.
  • Change in PROMIS-29 items (29) scores [ Time Frame: Baseline up to 30 days post the end of the six-week program ]
    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.
  • Change in Satisfaction Survey scores [ Time Frame: Baseline up to 30 days post the end of the six-week program ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Psycho-Educational Cognition Intervention in Patients With Blood and Lymph Cancer
Official Title  ICMJE A Study of the Feasibility and Acceptability of a Psycho-Educational Cognition Intervention in Adolescents and Young Adults (AYAs) With Cancer
Brief Summary This pilot trial studies how well a psycho-educational program called Emerging from the Haze works in helping patients with blood and lymph cancer. Sometimes, patients who have undergone treatment for cancer experience thinking or memory problems that make work, school, or everyday life activities, such as grocery shopping, difficult. The Emerging from the Haze program may provide resources to help deal with these types of challenges in patients with blood and lymph cancer.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Hematopoietic and Lymphoid Cell Neoplasm
Intervention  ICMJE
  • Other: Educational Intervention
    Attend Emerging from the Haze psychoeducational sessions
    Other Names:
    • Education for Intervention
    • Intervention by Education
    • Intervention through Education
    • Intervention, Educational
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Name: Quality of Life Assessment
  • Other: Survey Administration
    Ancillary studies
Study Arms  ICMJE Experimental: Supportive Care (psycho-educational sessions)
Patients participate in a psycho-educational program weekly over 2 hours for 6 weeks.
Interventions:
  • Other: Educational Intervention
  • Other: Quality-of-Life Assessment
  • Other: Survey Administration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: December 15, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: January 11, 2019)
10
Actual Study Completion Date  ICMJE February 10, 2020
Actual Primary Completion Date February 10, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 39 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03804164
Other Study ID Numbers  ICMJE 18442
NCI-2018-03851 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
18442 ( Other Identifier: City of Hope Medical Center )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party City of Hope Medical Center
Study Sponsor  ICMJE City of Hope Medical Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Natalie Kelly, PhD City of Hope Medical Center
PRS Account City of Hope Medical Center
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP