Clinical trial NCT03804164: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Hematopoietic and Lymphoid Cell Neoplasm
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-01-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Enrollment of eligible participants (accrual)
timeFrame: Up to 30 days post the end of the six-week program
measure: Completion of sessions (adherence/engagement)
timeFrame: Up to 30 days post the end of the six-week program
Secondary outcomes:
measure: Change in Functional Assessment of Cancer Therapy-Cognition scores
timeFrame: Baseline up to 30 days post the end of the six-week program
measure: Change in Patient Reported Outcomes Measurement Information System (PROMIS) scores
timeFrame: Baseline up to 30 days post the end of the six-week program
measure: Change in Global Self-Report of Cognition scores
timeFrame: Baseline up to 30 days post the end of the six-week program
measure: Change in PROMIS-29 items (29) scores
timeFrame: Baseline up to 30 days post the end of the six-week program
measure: Satisfaction Survey scores
timeFrame: Up to 30 days post the end of the six-week program
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Natalie Kelly, PhD
role: PRINCIPAL_INVESTIGATOR
References: