Back to resultsPsycho-Educational Cognition Intervention in Patients With Blood and Lymph Cancer
Primary Purpose
Hematopoietic and Lymphoid Cell Neoplasm
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational Intervention
Quality-of-Life Assessment
Survey Administration
Sponsored by
About this trial
This is an interventional supportive care trial for Hematopoietic and Lymphoid Cell Neoplasm
Eligibility 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.
Sites / Locations
- City of Hope Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Supportive Care (psycho-educational sessions)
Arm Description
Patients participate in a psycho-educational program weekly over 2 hours for 6 weeks.
Outcomes
Primary Outcome Measures
Enrollment of eligible participants (accrual)
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)
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
Change in Functional Assessment of Cancer Therapy-Cognition scores
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
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
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
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
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.
Full Information
NCT ID
NCT03804164
First Posted
January 11, 2019
Last Updated
December 15, 2020
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT03804164
Brief Title
Psycho-Educational Cognition Intervention in Patients With Blood and Lymph Cancer
Official Title
A Study of the Feasibility and Acceptability of a Psycho-Educational Cognition Intervention in Adolescents and Young Adults (AYAs) With Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Feasibility
Study Start Date
February 10, 2020 (Actual)
Primary Completion Date
February 10, 2020 (Actual)
Study Completion Date
February 10, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematopoietic and Lymphoid Cell Neoplasm
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Supportive Care (psycho-educational sessions)
Arm Type
Experimental
Arm Description
Patients participate in a psycho-educational program weekly over 2 hours for 6 weeks.
Intervention Type
Other
Intervention Name(s)
Educational Intervention
Other Intervention Name(s)
Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Intervention Description
Attend Emerging from the Haze psychoeducational sessions
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Survey Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Enrollment of eligible participants (accrual)
Description
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).
Time Frame
Up to 30 days post the end of the six-week program
Title
Completion of sessions (adherence/engagement)
Description
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).
Time Frame
Up to 30 days post the end of the six-week program
Secondary Outcome Measure Information:
Title
Change in Functional Assessment of Cancer Therapy-Cognition scores
Description
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.
Time Frame
Baseline up to 30 days post the end of the six-week program
Title
Change in Patient Reported Outcomes Measurement Information System (PROMIS) scores
Description
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
Time Frame
Baseline up to 30 days post the end of the six-week program
Title
Change in Global Self-Report of Cognition scores
Description
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.
Time Frame
Baseline up to 30 days post the end of the six-week program
Title
Change in PROMIS-29 items (29) scores
Description
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
Time Frame
Baseline up to 30 days post the end of the six-week program
Title
Satisfaction Survey scores
Description
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.
Time Frame
Up to 30 days post the end of the six-week program
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natalie Kelly, PhD
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Psycho-Educational Cognition Intervention in Patients With Blood and Lymph Cancer
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