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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Recruitment Status : Withdrawn (Feasibility)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

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.

Condition or disease Intervention/treatment Phase
Hematopoietic and Lymphoid Cell Neoplasm Other: Educational Intervention Other: Quality-of-Life Assessment Other: Survey Administration Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Study of the Feasibility and Acceptability of a Psycho-Educational Cognition Intervention in Adolescents and Young Adults (AYAs) With Cancer
Actual Study Start Date : February 10, 2020
Actual Primary Completion Date : February 10, 2020
Actual Study Completion Date : February 10, 2020

Arm Intervention/treatment
Experimental: Supportive Care (psycho-educational sessions)
Patients participate in a psycho-educational program weekly over 2 hours for 6 weeks.
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




Primary Outcome Measures :
  1. 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).

  2. 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).


Secondary Outcome Measures :
  1. 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.


  2. 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


  3. 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.

  4. 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


  5. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03804164


Locations
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United States, California
City of Hope Medical Center
Duarte, California, United States, 91010
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Natalie Kelly, PhD City of Hope Medical Center
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Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT03804164    
Other Study ID Numbers: 18442
NCI-2018-03851 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
18442 ( Other Identifier: City of Hope Medical Center )
First Posted: January 15, 2019    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: December 2020

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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
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms by Site
Neoplasms
Hematologic Diseases