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

Hematopoietic and Lymphoid Cell Neoplasm Clinical Trial

Official title:

A Study of the Feasibility and Acceptability of a Psycho-Educational Cognition Intervention in Adolescents and Young Adults (AYAs) With Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03804164
• Other study ID #: 18442
• Secondary ID: NCI-2018-0385118
• Status: Withdrawn
• Phase: N/A
• Start date: February 10, 2020
• Est. completion date: February 10, 2020

Study information

• Verified date: December 2020
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 10, 2020
• Est. primary completion date: February 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Hematopoietic and Lymphoid Cell Neoplasm

Intervention

Other:
• Educational Intervention
Attend Emerging from the Haze psychoeducational sessions
• Quality-of-Life Assessment
Ancillary studies
• Survey Administration
Ancillary studies

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Up to 30 days post the end of the six-week program
Primary	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).	Up to 30 days post the end of the six-week program
Secondary	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.	Baseline up to 30 days post the end of the six-week program
Secondary	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	Baseline up to 30 days post the end of the six-week program
Secondary	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.	Baseline up to 30 days post the end of the six-week program
Secondary	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	Baseline up to 30 days post the end of the six-week program
Secondary	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.	Up to 30 days post the end of the six-week program