Hematopoietic and Lymphoid Cell NeoplasmNCT03804164
Psycho-Educational Cognition Intervention in Patients With Blood and Lymph Cancer
A study testing Educational Intervention, Quality-of-Life Assessment and Survey Administration in people with Hematopoietic and Lymphoid Cell Neoplasm, run by City of Hope Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Hematopoietic and Lymphoid Cell Neoplasm
- What is being tested?
- Educational Intervention, Quality-of-Life Assessment and Survey Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2020to 10 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
Official title: A Study of the Feasibility and Acceptability of a Psycho-Educational Cognition Intervention in Adolescents and Young Adults (AYAs) With Cancer
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.
Read the detailed description
PRIMARY OBJECTIVES:
- Demonstrate feasibility and acceptability for young adult survivors of various cancers utilizing Emerging from the Haze program.
SECONDARY OBJECTIVES:
- 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.
- Conditions
- Hematopoietic and Lymphoid Cell Neoplasm
- Being tested
- Educational Intervention, Quality-of-Life Assessment, Survey Administration
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Attend Emerging from the Haze psychoeducational sessions
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive Care (psycho-educational sessions) | Experimental | Patients participate in a psycho-educational program weekly over 2 hours for 6 weeks. Receives: Other: Educational Intervention; Other: Quality-of-Life Assessment; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 30 days post the end of the six-week program
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).
Measured: Up to 30 days post the end of the six-week program
Secondary outcomes (5)
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.
Measured: Baseline up to 30 days post the end of the six-week program
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
Measured: Baseline up to 30 days post the end of the six-week program
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.
Measured: Baseline up to 30 days post the end of the six-week program
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
Measured: Baseline up to 30 days post the end of the six-week program
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.
Measured: Up to 30 days post the end of the six-week program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start10 Feb 2020
- Primary completion10 Feb 2020
- Study completion10 Feb 2020
Why it stopped: Feasibility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphoid Cell NeoplasmStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Natalie Kelly, PhD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03804164
- Sponsor's protocol ID
- 18442
- Other IDs
- NCI-2018-03851, 18442
- Status last verified
- Dec 2020
- First submitted
- 11 Jan 2019
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Feasibility and Acceptability of a Psycho-Educational Cognition Intervention in Adolescents and Young Adults (AYAs) With Cancer
- ClinicalTrials.gov ID
- NCT03804164
- Acronym / sponsor ID
- 18442
- Conditions
- Hematopoietic and Lymphoid Cell Neoplasm
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Feasibility
- Enrolment
- 0 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 10 Feb 2020 (actual)
- First posted
- 15 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Demonstrate feasibility and acceptability for young adult survivors of various cancers utilizing Emerging from the Haze program.
SECONDARY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care (psycho-educational sessions) | Experimental | Other: Educational Intervention, Other: Quality-of-Life Assessment, Other: Survey AdministrationPatients participate in a psycho-educational program weekly over 2 hours for 6 weeks. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalAttend Emerging from the Haze psychoeducational sessions | Other | Supportive Care (psycho-educational sessions) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Supportive Care (psycho-educational sessions) |
| Survey AdministrationAncillary studies | Other | Supportive Care (psycho-educational sessions) |
Primary outcome
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).
5 secondary outcomes
Change in Functional Assessment of Cancer Therapy-Cognition scores
Time frame: Baseline up to 30 days post the end of the six-week program
Change in Patient Reported Outcomes Measurement Information System (PROMIS) scores
Time frame: Baseline up to 30 days post the end of the six-week program
Change in Global Self-Report of Cognition scores
Time frame: Baseline up to 30 days post the end of the six-week program
Change in PROMIS-29 items (29) scores
Time frame: Baseline up to 30 days post the end of the six-week program
Satisfaction Survey scores
Time frame: Up to 30 days post the end of the six-week program
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natalie Kelly, PhD principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention, Quality-of-Life Assessment and Survey Administration in people with Hematopoietic and Lymphoid Cell Neoplasm, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment of eligible participants (accrual) (time frame: Up to 30 days post the end of the six-week program). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.