Childhood Hematopoietic and Lymphatic System NeoplasmNCT06682039
Attention Bias Modification for the Improvement of Anxiety in Adolescent and Young Adult Cancer Survivors
A study testing Internet-Based Intervention, Interview and Questionnaire Administration in people with Childhood Hematopoietic and Lymphatic System Neoplasm and Childhood Malignant Solid Neoplasm, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
This clinical trial studies how well attention bias modification (ABM) improves anxiety in adolescent and young adult (AYA) cancer survivors. Cancer-related anxiety is the most prevalent mental health problem affecting AYA cancer survivors. Read more about this study
- Who is it for?
- Ages 15 to 29 years
- Conditions the study is for
- Childhood Hematopoietic and Lymphatic System Neoplasm, Childhood Malignant Solid Neoplasm
- What is being tested?
- Internet-Based Intervention, Interview and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2024to 12 Jan 2026
- 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 15 to 29 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 15-29 years
- Diagnosis of cancer malignancy
- Received active/curative cancer treatment OR received/actively receiving cancer survivorship care at Seattle Children's Hospital (SCH) or other study referring site (e.g. St. Jude)
- Currently off active/curative cancer treatment
- Patient able to understand/read/write English language
- Cognitively able to participate in ABM intervention and complete surveys
- Patient has access to smartphone able to send and receive text messages
- Patient has access to computer or smartphone for Inquisit program
Who cannot join
- Patients on active/curative cancer treatment
- Cognitively or physically unable to participate in ABM intervention and surveys
- Patients who cannot understand/read/write English will be excluded from the research because the ABM intervention is currently only available in English
- Furthermore, patients who do not have access to technology (smartphone/computer) will be excluded from the study as this technology is absolutely required to engage in the study intervention
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington/Seattle Children's Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: Anxiety and Negative Attentional Bias in Adolescent and Young Adult Cancer Survivors
This clinical trial studies how well attention bias modification (ABM) improves anxiety in adolescent and young adult (AYA) cancer survivors. Cancer-related anxiety is the most prevalent mental health problem affecting AYA cancer survivors. Cancer-related anxiety is associated with long-term negative outcomes such as poor quality of life, depression, distress, substance use, sleep problems, fatigue, and pain. ABM uses techniques to help patients change the way they react to environmental triggers that may cause a negative reaction. ABM uses brief self-guided smartphone applications. Patients complete repetitive association reaction-time tasks targeting automatic and unconscious negative attention biases to retrain attention away from perceived threat and towards a neutral or positive stimuli. Gratitude-finding and savoring activities are also provided to maintain and increase positive emotions. Using ABM plus gratitude-finding and savoring activities may improve anxiety in AYA cancer survivors.
Read the detailed description
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients engage in ABM over 10 minutes twice a week (BIW) and respond daily to text messaging prompts activity for 4 weeks.
ARM II: Patients engage in inert attention task sessions over 10 minutes BIW for 4 weeks. Patients also receive and respond to text messaging prompts QD for 4 weeks.
After completion of study intervention, patients are followed up at 4 weeks. After completion of this 4 week follow up survey, patients are given access to all components of ABM and texts on study.
- Being tested
- Internet-Based Intervention, Interview, Questionnaire Administration, Text Message-Based Navigation Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-Based InterventionOther
Engage in ABM + text messaging prompts
Internet-Based InterventionOther
Engage in inert attention task sessions
InterviewOther
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Text Message-Based Navigation InterventionOther
Also called Automated Text Message-Based Navigation, Text Message-Based Navigation
Participants will respond to daily messaging prompts.
| Study group | Role | What they receive |
|---|---|---|
| Arm I (ABM) | Experimental | Patients engage in ABM over 10 minutes BIW and respond daily to text messaging prompts for 4 weeks. Receives: Other: Internet-Based Intervention; Other: Interview; Other: Questionnaire Administration; Other: Text Message-Based Navigation Intervention |
| Arm II (inert attention task) | Active comparator | Patients engage in inert attention task sessions over 10 minutes BIW for 4 weeks. Patients also receive and respond to text messaging prompts QD for 4 weeks. After completion of the 4 week follow up survey, patients are given access to all components of ABM and texts on study. Receives: Other: Internet-Based Intervention; Other: Questionnaire Administration; Other: Text Message-Based Navigation Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinic recruitment rates
Feasibility will be assessed via clinic recruitment rates, defined as (number [#] of adolescent and young adults [AYAs] who enroll in the study) / (total # of AYAs screened as eligible). Attention bias modification (ABM) will be considered feasible with ≥ 50% enrollment.
Measured: Up to 4 weeks post-intervention
Retention rates
Uptake will be assessed via retention rates, defined as (# of AYAs who complete 4-week treatment duration of ABM) / (# of AYAs who enroll in the study). ABM will be considered feasible with ≥ 70% retention.
Measured: Up to 4 weeks post-intervention
Patient acceptability of ABM: Client Satisfaction Questionnaire (CSQ-8)
Will be assessed using the Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 is an 8-item questionnaire used to assess level of satisfaction with care. Items are scored on a Likert scale from 1 (low satisfaction) to 4 (high satisfaction) with different descriptors for each response point. Total scores range from 8 to 32, with higher scores indicating greater satisfaction(scores ≥26 indicate satisfaction).
Measured: At 4 weeks post intervention
Patient acceptability of ABM: System Usability Scale (SUS)
Will be assessed using the System Usability Scale (SUS). The SUS is a well-validated and widely used 10-item scale to evaluate the perceived usability of digital interventions. Items are rated on a 5-point Likert scale for a total score ranging from 0-100, and scores ≥ 70 considered adequate usability.
Measured: At 4 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start8 Nov 2024
- Primary completion12 Jan 2026
- Study completion12 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Childhood Hematopoietic and Lymphatic System NeoplasmStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Nancy Lau, PhD, Principal investigator, Fred Hutch/University of Washington/Seattle Children's Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06682039
- Sponsor's protocol ID
- RG1124389
- Other IDs
- NCI-2024-06745, P30CA015704, STUDY00004811
- Status last verified
- Jan 2026
- First submitted
- 7 Nov 2024
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lau N, Zhou C, Hong SJ, Aalfs H, Higgins S, Badillo I, McCauley E, Ketterl T, Chow EJ, Fann JR, Heathcote LC, Palermo TM. Digital Attention Bias in Cancer Survivors Intervention for Adolescent and Young Adult Cancer Survivors: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2026 Feb 25;15:e82665. doi: 10.2196/82665.
PubMed 41740148
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anxiety and Negative Attentional Bias in Adolescent and Young Adult Cancer Survivors
- ClinicalTrials.gov ID
- NCT06682039
- Acronym / sponsor ID
- RG1124389
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 8 Nov 2024 (actual)
- Primary completion
- 12 Jan 2026 (actual)
- Study completion
- 12 Jan 2026 (actual)
- First posted
- 12 Nov 2024 (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 studies how well attention bias modification (ABM) improves anxiety in adolescent and young adult (AYA) cancer survivors. Cancer-related anxiety is the most prevalent mental health problem affecting AYA cancer survivors. Cancer-related anxiety is associated with long-term negative outcomes such as poor quality of life, depression, distress, substance use, sleep problems, fatigue, and pain. ABM uses techniques to help patients change the way they react to environmental triggers that may cause a negative reaction. ABM uses brief self-guided smartphone applications. Patients complete repetitive association reaction-time tasks targeting automatic and unconscious negative attention biases to retrain attention away from perceived threat and towards a neutral or positive stimuli. Gratitude-finding and savoring activities are also provided to maintain and increase positive emotions. Using ABM plus gratitude-finding and savoring activities may improve anxiety in AYA cancer survivors.
Detailed description
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients engage in ABM over 10 minutes twice a week (BIW) and respond daily to text messaging prompts activity for 4 weeks.
ARM II: Patients engage in inert attention task sessions over 10 minutes BIW for 4 weeks. Patients also receive and respond to text messaging prompts QD for 4 weeks.
After completion of study intervention, patients are followed up at 4 weeks. After completion of this 4 week follow up survey, patients are given access to all components of ABM and texts on study.
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 (ABM) | Experimental | Other: Internet-Based Intervention, Other: Interview, Other: Questionnaire Administration, Other: Text Message-Based Navigation InterventionPatients engage in ABM over 10 minutes BIW and respond daily to text messaging prompts for 4 weeks. |
| Arm II (inert attention task) | Active comparator | Other: Internet-Based Intervention, Other: Questionnaire Administration, Other: Text Message-Based Navigation InterventionPatients engage in inert attention task sessions over 10 minutes BIW for 4 weeks. Patients also receive and respond to text messaging prompts QD for 4 weeks. After completion of the 4 week follow up survey, patients are given access to all components of ABM and texts on study. |
Who may qualify
- Ages
- 15 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Age 15-29 years
- Diagnosis of cancer malignancy
- Received active/curative cancer treatment OR received/actively receiving cancer survivorship care at Seattle Children's Hospital (SCH) or other study referring site (e.g. St. Jude)
- Currently off active/curative cancer treatment
- Patient able to understand/read/write English language
Key exclusion criteria (4 listed)
- Patients on active/curative cancer treatment
- Cognitively or physically unable to participate in ABM intervention and surveys
- Patients who cannot understand/read/write English will be excluded from the research because the ABM intervention is currently only available in English
- Furthermore, patients who do not have access to technology (smartphone/computer) will be excluded from the study as this technology is absolutely required to engage in the study intervention
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 |
|---|---|---|
| Internet-Based InterventionEngage in ABM + text messaging prompts | Other | Arm I (ABM) |
| Internet-Based InterventionEngage in inert attention task sessions | Other | Arm II (inert attention task) |
| InterviewAncillary studies | Other | Arm I (ABM) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (ABM), Arm II (inert attention task) |
| Text Message-Based Navigation InterventionAlso: Automated Text Message-Based Navigation, Text Message-Based NavigationParticipants will respond to daily messaging prompts. | Other | Arm I (ABM), Arm II (inert attention task) |
Primary outcome
Clinic recruitment rates
Time frame: Up to 4 weeks post-intervention
Feasibility will be assessed via clinic recruitment rates, defined as (number [#] of adolescent and young adults [AYAs] who enroll in the study) / (total # of AYAs screened as eligible). Attention bias modification (ABM) will be considered feasible with ≥ 50% enrollment.
Retention rates
Time frame: Up to 4 weeks post-intervention
Uptake will be assessed via retention rates, defined as (# of AYAs who complete 4-week treatment duration of ABM) / (# of AYAs who enroll in the study). ABM will be considered feasible with ≥ 70% retention.
Patient acceptability of ABM: Client Satisfaction Questionnaire (CSQ-8)
Time frame: At 4 weeks post intervention
Will be assessed using the Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 is an 8-item questionnaire used to assess level of satisfaction with care. Items are scored on a Likert scale from 1 (low satisfaction) to 4 (high satisfaction) with different descriptors for each response point. Total scores range from 8 to 32, with higher scores indicating greater satisfaction(scores ≥26 indicate satisfaction).
Patient acceptability of ABM: System Usability Scale (SUS)
Time frame: At 4 weeks post intervention
Will be assessed using the System Usability Scale (SUS). The SUS is a well-validated and widely used 10-item scale to evaluate the perceived usability of digital interventions. Items are rated on a 5-point Likert scale for a total score ranging from 0-100, and scores ≥ 70 considered adequate usability.
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 30 Jan 2026.
- Derived from this study: PubMed 41740148Lau N, Zhou C, Hong SJ, Aalfs H, Higgins S, Badillo I, McCauley E, Ketterl T, Chow EJ, Fann JR, Heathcote LC, Palermo TM. Digital Attention Bias in Cancer Survivors Intervention for Adolescent and Young Adult Cancer Survivors: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2026 Feb 25;15:e82665. doi: 10.2196/82665.
- 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.
Nancy Lau, PhD principal investigator
Fred Hutch/University of Washington/Seattle Children's Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-Based Intervention, Interview and Questionnaire Administration in people with Childhood Hematopoietic and Lymphatic System Neoplasm and Childhood Malignant Solid Neoplasm, run by Fred Hutchinson Cancer 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 8 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: finished, as of the sponsor's last update on 30 Jan 2026. 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?
Clinic recruitment rates (time frame: Up to 4 weeks post-intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06682039, which also lists 1 linked publication.
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 30 Jan 2026.