Hematopoietic and Lymphoid Cell Neoplasm
Conditions
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.
Interventions
OTHEREducational Intervention
Attend Emerging from the Haze psychoeducational sessions
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERSurvey Administration
Ancillary studies
Sponsors
National Cancer Institute (NCI)
City of Hope Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 39 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enrollment of eligible participants (accrual) | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Global Self-Report of Cognition scores | 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. |
| Change in Functional Assessment of Cancer Therapy-Cognition scores | 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. |
| Satisfaction Survey scores | 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. |
| Change in PROMIS-29 items (29) scores | 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 |
| Change in Patient Reported Outcomes Measurement Information System (PROMIS) scores | 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 |
Countries
United States
Outcome results
None listed