A Study of the Feasibility and Acceptability of a Psycho-Educational Cognition Intervention in Adolescents and Young Adults (AYAs) With Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Locations
- 1
- Primary Endpoint
- Enrollment of eligible participants (accrual)
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 39 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Supportive Care (psycho-educational sessions)
Patients participate in a psycho-educational program weekly over 2 hours for 6 weeks.
Intervention: Educational Intervention (Other)
Supportive Care (psycho-educational sessions)
Patients participate in a psycho-educational program weekly over 2 hours for 6 weeks.
Intervention: Quality-of-Life Assessment (Other)
Supportive Care (psycho-educational sessions)
Patients participate in a psycho-educational program weekly over 2 hours for 6 weeks.
Intervention: Survey Administration (Other)
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- Change in Functional Assessment of Cancer Therapy-Cognition scores(Baseline up to 30 days post the end of the six-week program)
- Change in Patient Reported Outcomes Measurement Information System (PROMIS) scores(Baseline up to 30 days post the end of the six-week program)
- Change in Global Self-Report of Cognition scores(Baseline up to 30 days post the end of the six-week program)
- Satisfaction Survey scores(Up to 30 days post the end of the six-week program)
- Change in PROMIS-29 items (29) scores(Baseline up to 30 days post the end of the six-week program)