Hematopoietic and Lymphoid Cell NeoplasmNCT04870320
Study of Attention and Memory Treatments for Cancer Survivors
A study testing Endeavor: Computer-Based Cognitive Stimulation Intervention, Words!: Computer-Based Cognitive Stimulation Intervention and Quality of Life (QOL) Questionnaires in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by University of California, San Francisco at 1 site in United States.
Trial summary
This clinical trial investigates if certain electronic games may be effective in improving attention and memory function in cancer survivors. Cancer related cognitive impairment (CRCI) is an issue experienced by many cancer patients/survivors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Endeavor: Computer-Based Cognitive Stimulation Intervention, Words!: Computer-Based Cognitive Stimulation Intervention and Quality of Life (QOL) Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 31 Jan 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Attention Function Index (AFI) score of < 7.5
- Are able to read, write, and understand English
- Ability to understand an electronic informed consent document, and the willingness to sign it
- Have a Karnofsky performance status (KPS) score of >= 50
- Have access to WiFi connection
Who cannot join
- Receiving active treatment for cancer recurrence
- Have significant cognitive impairment
- Have sensory or motor deficits that prevent them from doing the assessment and using the application
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94143
About this study
Official title: A Pilot Study of A Novel Cognitive Intervention for Cancer Survivors
This clinical trial investigates if certain electronic games may be effective in improving attention and memory function in cancer survivors. Cancer related cognitive impairment (CRCI) is an issue experienced by many cancer patients/survivors. CRCI includes perceived or objective problems with memory, executive function, and attention/concentration. CRCI has a negative impact on survivors' ability to work, carry out routine activities, and engage in social and family relationships. CRCI may result in significant distress and reduced quality of life. Certain electronic games may help improve attention and memory function in cancer survivors and reduce symptoms of CRCI.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the recruitment and retention rates for both arms of this study. II. Determine the effect size for changes in cognitive function (i.e., Test of Variables of Attention (TOVA) [i.e. attention], Adaptive Cognitive Evaluation (ACE) [i.e. working memory]) in the intervention group compared to the control group following the 4-week study.
III. Evaluate adherence rates for and satisfaction with the interventions. IV. Evaluate for treatment-related adverse events (e.g., nausea, motion sickness).
SECONDARY OBJECTIVE:
- To determine effect sizes for depression, fatigue, and sleep disturbance, by comparing changes in the intervention group to changes in the control group, following the 4-week study.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients play Endeavor over 25 minutes daily 5 days a week for 4 weeks.
ARM II: Patients play Words! over 25 minutes daily 5 days a week for 4 weeks.
- Being tested
- Endeavor: Computer-Based Cognitive Stimulation Intervention, Words!: Computer-Based Cognitive Stimulation Intervention, Quality of Life (QOL) Questionnaires
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endeavor: Computer-Based Cognitive Stimulation InterventionBehavioural
Also called Computer-Based Cognitive Stimulation Intervention, Computer-Based General Cognitive Stimulation Intervention
Endeavor application will be utilized by participant on iPad
Words!: Computer-Based Cognitive Stimulation InterventionBehavioural
Also called Computer-Based Cognitive Stimulation Intervention, Computer-Based General Cognitive Stimulation Intervention
Words! application will be utilized by participant on iPad
Quality of Life (QOL) QuestionnairesOther
Standardized QOL questionnaire will be administered at each study visit
| Study group | Role | What they receive |
|---|---|---|
| Arm I (Endeavor) | Experimental | Patients play Endeavor over 25 minutes daily 5 days a week for 4 weeks. Receives: Behavioral: Endeavor: Computer-Based Cognitive Stimulation Intervention; Other: Quality of Life (QOL) Questionnaires |
| Arm II (Words!) | Active comparator | Patients play Words! over 25 minutes daily 5 days a week for 4 weeks. Receives: Behavioral: Words!: Computer-Based Cognitive Stimulation Intervention; Other: Quality of Life (QOL) Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants who completed the study
Completion is defined as participants who completed all 4 weeks of intervention and final assessment.
Measured: Up to 6 weeks
Mean change in scores on the Test of Variables of Attention (TOVA) over time
The TOVA records responses to visual or auditory stimuli through the participants iPAD, with a unique, highly accurate +/1 millisecond (ms) microswitch. The TOVA (Copyright 1991- 2021 by The TOVA Company) automatically calculates response time variability (consistency), response time (speed), commissions (impulsivity), and omissions (focus and vigilance). Results are reported as standard scores (average = 100 with a standard deviation of 15) and are compared to a large normative sample stratified by gender and age. Scores above 85 are within normal limits, 80-85 are borderline, and below 80 are not within normal limits. The mean change in scores will be estimated as the norm-based standardized difference in means from enrollment (Week 1) to the last assessment (Week 4).
Measured: Up to 4 weeks
Percent change in scores on the TOVA over time
The TOVA records responses to visual or auditory stimuli through the participants iPAD, with a unique, highly accurate +/1 millisecond (ms) microswitch. The TOVA (Copyright 1991- 2021 by The TOVA Company) automatically calculates response time variability (consistency), response time (speed), commissions (impulsivity), and omissions (focus and vigilance). Results are reported as standard scores (average = 100 with a standard deviation of 15) and are compared to a large normative sample stratified by gender and age. Scores above 85 are within normal limits, 80-85 are borderline, and below 80 are not within normal limits. Will be estimated as the standardized difference between the groups in the percent score change from enrollment (Week 1) to the last assessment (Week 4).
Measured: Up to 4 weeks
Mean changes in Adaptive Cognitive Evaluation (ACE)
The ACE is a mobile cognitive control assessment battery containing standard tests that assess different aspects of cognitive control (attention, working memory, and goal management), modified by incorporating adaptive algorithms, immersive graphics, video tutorials, motivating feedback, and a user-friendly interface. The ACE is administered to all participants via iPad and the scores will be estimated as the standardized difference in means from enrollment (Week 1) to the last assessment (Week 4).
Measured: Up to 4 weeks
Percent change in scores on the ACE over time
The ACE is a mobile cognitive control assessment battery containing standard tests that assess different aspects of cognitive control (attention, working memory, and goal management), modified by incorporating adaptive algorithms, immersive graphics, video tutorials, motivating feedback, and a user-friendly interface. The ACE is administered to all participants via iPad and the scores will be estimated as the standardized difference between the groups in the percent score change from enrollment (Week 1) to the last assessment (Week 4).
Measured: Up to 4 weeks
Proportion of time using application
Adherence rate will be evaluated by comparing the amount of time the participant should have used the application to the actual amount of time the participant used the application.
Measured: Up to 4 weeks
Percentage of participants who experienced treatment-related adverse events
Safety analyses will involve examination of and comparison between groups for the percentage of participants by adverse event severity and type of treatment-related adverse events. Comparisons of the frequencies between groups will be conducted using Chi-square or Fisher's exact test.
Measured: Up to 6 weeks
Secondary outcomes (3)
Change in mean severity scores on the Center for Epidemiologic Studies - Depression Scale (CES-D)
The CES-D scale is a brief self-report scale designed to measure self-reported symptoms associated with depression experienced in the past week. Responses are rated on a 5 point Likert scale with response option ranging 0="Rarely or none of the time (less than 1 day )" to 4='Most or all of the time (5-7 days)". The scoring of positive items is reversed. Possible range of scores is 0 to 60, with the higher scores indicating the presence of more symptomatology and will be estimated as the standardized difference in means of each measure at the last assessment from enrollment to the last assessment.
Measured: Up to 4 weeks
Change in mean severity scores on the Lee Fatigue Scale
The Lee Fatigue Scale is used to measure the impact of fatigue on a participants quality of life. The scale consists of 18 items relating to the subjective experience of fatigue. Each item is rated on a 0 to 10 numeric rating scale (e.g., from "not at all tired" to "extremely tired"). Scores can range from 0 to 10. The instrument has two subscales: fatigue (items 1-5 and 11-18) and energy (items 6-10). The fatigue subscale score is calculated as the mean of the 13 fatigue items and the energy subscale score is the mean of the 5 energy items. Higher scores on the fatigue subscale represent greater fatigue severity, and higher scores on the energy subscale indicate higher levels of energy and will be estimated as the standardized difference in means of each measure at the last assessment from enrollment to the last assessment.
Measured: Up to 4 weeks
Change in severity scores on the General Sleep Disturbance Scale (GSDS)
The GSDS consists of 21 items related to frequency in the past month of difficulty getting to sleep when respondents were asked to think about the past month, and each response is on a 8-point Likert scale from 0 ("never") to 7 ("all the time"). Will be estimated as the standardized difference in means of each measure at the last assessment, and as the difference between the groups in the percent change from enrollment to the last assessment.
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start1 Mar 2021
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
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 University of California, San FranciscoThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Akili Interactive Labs, Inc.
- Responsible party
- Sponsor
- Investigators
- Christine Miaskowski, RN, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04870320
- Sponsor's protocol ID
- 19803
- Other IDs
- NCI-2021-02024
- Status last verified
- Mar 2022
- First submitted
- 28 Apr 2021
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of A Novel Cognitive Intervention for Cancer Survivors
- ClinicalTrials.gov ID
- NCT04870320
- Acronym / sponsor ID
- 19803
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Akili Interactive Labs, Inc.
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 3 May 2021 (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 clinical trial investigates if certain electronic games may be effective in improving attention and memory function in cancer survivors. Cancer related cognitive impairment (CRCI) is an issue experienced by many cancer patients/survivors. CRCI includes perceived or objective problems with memory, executive function, and attention/concentration. CRCI has a negative impact on survivors' ability to work, carry out routine activities, and engage in social and family relationships. CRCI may result in significant distress and reduced quality of life. Certain electronic games may help improve attention and memory function in cancer survivors and reduce symptoms of CRCI.
Detailed description
PRIMARY OBJECTIVES:
- Determine the recruitment and retention rates for both arms of this study. II. Determine the effect size for changes in cognitive function (i.e., Test of Variables of Attention (TOVA) [i.e. attention], Adaptive Cognitive Evaluation (ACE) [i.e. working memory]) in the intervention group compared to the control group following the 4-week study.
III. Evaluate adherence rates for and satisfaction with the interventions. IV. Evaluate for treatment-related adverse events (e.g., nausea, motion sickness).
SECONDARY OBJECTIVE:
- To determine effect sizes for depression, fatigue, and sleep disturbance, by comparing changes in the intervention group to changes in the control group, following the 4-week study.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients play Endeavor over 25 minutes daily 5 days a week for 4 weeks.
ARM II: Patients play Words! over 25 minutes daily 5 days a week for 4 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (Endeavor) | Experimental | Behavioral: Endeavor: Computer-Based Cognitive Stimulation Intervention, Other: Quality of Life (QOL) QuestionnairesPatients play Endeavor over 25 minutes daily 5 days a week for 4 weeks. |
| Arm II (Words!) | Active comparator | Behavioral: Words!: Computer-Based Cognitive Stimulation Intervention, Other: Quality of Life (QOL) QuestionnairesPatients play Words! over 25 minutes daily 5 days a week for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Attention Function Index (AFI) score of < 7.5
- Are able to read, write, and understand English
- Ability to understand an electronic informed consent document, and the willingness to sign it
- Have a Karnofsky performance status (KPS) score of >= 50
- Have access to WiFi connection
Key exclusion criteria (3 listed)
- Receiving active treatment for cancer recurrence
- Have significant cognitive impairment
- Have sensory or motor deficits that prevent them from doing the assessment and using the application
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 |
|---|---|---|
| Endeavor: Computer-Based Cognitive Stimulation InterventionAlso: Computer-Based Cognitive Stimulation Intervention, Computer-Based General Cognitive Stimulation InterventionEndeavor application will be utilized by participant on iPad | Behavioural | Arm I (Endeavor) |
| Words!: Computer-Based Cognitive Stimulation InterventionAlso: Computer-Based Cognitive Stimulation Intervention, Computer-Based General Cognitive Stimulation InterventionWords! application will be utilized by participant on iPad | Behavioural | Arm II (Words!) |
| Quality of Life (QOL) QuestionnairesStandardized QOL questionnaire will be administered at each study visit | Other | Arm I (Endeavor), Arm II (Words!) |
Primary outcome
Percentage of participants who completed the study
Time frame: Up to 6 weeks
Completion is defined as participants who completed all 4 weeks of intervention and final assessment.
Mean change in scores on the Test of Variables of Attention (TOVA) over time
Time frame: Up to 4 weeks
The TOVA records responses to visual or auditory stimuli through the participants iPAD, with a unique, highly accurate +/1 millisecond (ms) microswitch. The TOVA (Copyright 1991- 2021 by The TOVA Company) automatically calculates response time variability (consistency), response time (speed), commissions (impulsivity), and omissions (focus and vigilance). Results are reported as standard scores (average = 100 with a standard deviation of 15) and are compared to a large normative sample stratified by gender and age. Scores above 85 are within normal limits, 80-85 are borderline, and below 80 are not within normal limits. The mean change in scores will be estimated as the norm-based standardized difference in means from enrollment (Week 1) to the last assessment (Week 4).
Percent change in scores on the TOVA over time
Time frame: Up to 4 weeks
The TOVA records responses to visual or auditory stimuli through the participants iPAD, with a unique, highly accurate +/1 millisecond (ms) microswitch. The TOVA (Copyright 1991- 2021 by The TOVA Company) automatically calculates response time variability (consistency), response time (speed), commissions (impulsivity), and omissions (focus and vigilance). Results are reported as standard scores (average = 100 with a standard deviation of 15) and are compared to a large normative sample stratified by gender and age. Scores above 85 are within normal limits, 80-85 are borderline, and below 80 are not within normal limits. Will be estimated as the standardized difference between the groups in the percent score change from enrollment (Week 1) to the last assessment (Week 4).
Mean changes in Adaptive Cognitive Evaluation (ACE)
Time frame: Up to 4 weeks
The ACE is a mobile cognitive control assessment battery containing standard tests that assess different aspects of cognitive control (attention, working memory, and goal management), modified by incorporating adaptive algorithms, immersive graphics, video tutorials, motivating feedback, and a user-friendly interface. The ACE is administered to all participants via iPad and the scores will be estimated as the standardized difference in means from enrollment (Week 1) to the last assessment (Week 4).
Percent change in scores on the ACE over time
Time frame: Up to 4 weeks
The ACE is a mobile cognitive control assessment battery containing standard tests that assess different aspects of cognitive control (attention, working memory, and goal management), modified by incorporating adaptive algorithms, immersive graphics, video tutorials, motivating feedback, and a user-friendly interface. The ACE is administered to all participants via iPad and the scores will be estimated as the standardized difference between the groups in the percent score change from enrollment (Week 1) to the last assessment (Week 4).
Proportion of time using application
Time frame: Up to 4 weeks
Adherence rate will be evaluated by comparing the amount of time the participant should have used the application to the actual amount of time the participant used the application.
Percentage of participants who experienced treatment-related adverse events
Time frame: Up to 6 weeks
Safety analyses will involve examination of and comparison between groups for the percentage of participants by adverse event severity and type of treatment-related adverse events. Comparisons of the frequencies between groups will be conducted using Chi-square or Fisher's exact test.
3 secondary outcomes
Change in mean severity scores on the Center for Epidemiologic Studies - Depression Scale (CES-D)
Time frame: Up to 4 weeks
Change in mean severity scores on the Lee Fatigue Scale
Time frame: Up to 4 weeks
Change in severity scores on the General Sleep Disturbance Scale (GSDS)
Time frame: Up to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Christine Miaskowski, RN, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endeavor: Computer-Based Cognitive Stimulation Intervention, Words!: Computer-Based Cognitive Stimulation Intervention and Quality of Life (QOL) Questionnaires in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by University of California, San Francisco 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 8 Apr 2022. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of participants who completed the study (time frame: Up to 6 weeks). The study lists 7 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 8 Apr 2022.