Survivors of Childhood CancerNCT07516301
Feasibility of Incorporating a Standardized Substance Use Measure With Linked-Brief Intervention Into Routine Psychosocial Care of Adult Childhood Cancer Survivors
A study testing WHO ASSIST v3.1 Screening with Feedback, ASSIST Linked Brief Intervention (10 Step Motivational interviewing (MI)/FRAMES) and WHO ASSIST v3.1 Screening (No Feedback) in people with Survivors of Childhood Cancer and Substance Use, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
The ASSIST Study is designed to explore whether a brief, evidence based substance use screening and counseling approach can be easily integrated into routine survivorship care at St. Jude Children's Research Hospital. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Survivors of Childhood Cancer, Substance Use
- What is being tested?
- WHO ASSIST v3.1 Screening with Feedback, ASSIST Linked Brief Intervention (10 Step Motivational interviewing (MI)/FRAMES) and WHO ASSIST v3.1 Screening (No Feedback)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Followed in the ACT Clinic at St. Jude Children's Research Hospital
- Greater than or equal to 15 years of age at time of evaluation
- Able to speak and read English
Who cannot join
- Significant mental or cognitive impairment that would impact ability to complete surveys or participate in the brief intervention
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Rachel Webster, PhD, 888-226-4343, referralinfo@stjude.org
About this study
Official title: Piloting the Feasibility of Incorporating a Standardized Substance Use Measure With Linked-Brief Intervention Into Routine Psychosocial Care of Adult Childhood Cancer Survivors
The ASSIST Study is designed to explore whether a brief, evidence based substance use screening and counseling approach can be easily integrated into routine survivorship care at St. Jude Children's Research Hospital.
During a regularly scheduled psychosocial visit, participants complete the World Health Organization's Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST). This short questionnaire helps identify patterns of use related to tobacco, alcohol, cannabis, prescription medications, and other substances. Survivors whose results show possible risk receive a brief, supportive counseling session during the same appointment. This session uses motivational interviewing techniques to help individuals reflect on their use and consider steps to reduce potential harm.
Read more
Primary Objective:
- Assess the feasibility and acceptability of integrating a standardized substance use screening and brief intervention protocol into routine psychosocial workflows within a survivorship clinic.
Secondary Objective:
- Evaluate the fidelity of delivering a brief substance use intervention to reduce substance use behaviors among survivors.
Read the detailed description
The ASSIST Study is a pilot study at St. Jude Children's Research Hospital designed to explore whether a brief, evidence-based approach to substance use screening and counseling can be integrated into routine survivorship care for adult survivors of childhood cancer. During a regular visit in the After Completion of Therapy (ACT) Clinic, participants will complete the World Health Organization's ASSIST questionnaire, which identifies potential risks related to alcohol, tobacco, and other substance use. Survivors who show moderate or high risk and are assigned to the intervention group receive a brief counseling session that uses motivational interviewing techniques to support healthy decision making.
This study will enroll 30 adult survivors to evaluate whether this screening and intervention approach is practical, acceptable, and delivered as intended within a busy clinic setting. Participants will also complete a follow up survey three months later to report whether they reduced their substance use. Results from this pilot will help determine whether a larger study should be conducted and may guide future efforts to enhance long term health outcomes for childhood cancer survivors.
- Conditions
- Survivors of Childhood Cancer, Substance Use
- Being tested
- WHO ASSIST v3.1 Screening with Feedback, ASSIST Linked Brief Intervention (10 Step Motivational interviewing (MI)/FRAMES), WHO ASSIST v3.1 Screening (No Feedback)
- Keywords
- Adult childhood cancer survivors (ACCS), Cancer Survivorship
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WHO ASSIST v3.1 Screening with FeedbackBehavioural
An 8 item clinician administered instrument assessing lifetime and recent (past 3 months) use across substance classes (tobacco, alcohol, cannabis, cocaine, amphetamine type stimulants, sedatives/sleeping pills, hallucinogens, inhalants, opioids, and other drugs).Risk scores wiil be produced to guide intervention level. The assessment will be administered orally during a routine psychosocial visit by an LCSW. In the experimental arm, risk feedback will be shared using a scorecard
ASSIST Linked Brief Intervention (10 Step Motivational interviewing (MI)/FRAMES)Behavioural
For participants screening moderate/high risk in the experimental arm, a same session, brief intervention consistent with motivational interviewing and FRAMES is delivered by an LCSW. Ten steps include: purpose of discussion, feedback on scores, information/advice, emphasize responsibility, express concern/support, explore "good things," explore "less good things," summarize, explore readiness/next steps with goal setting if ready, and provide self help materials. Sessions will be audio recorded for fidelity review.
WHO ASSIST v3.1 Screening (No Feedback)Behavioural
An 8 item clinician administered instrument assessing lifetime and recent (past 3 months) use across substance classes (tobacco, alcohol, cannabis, cocaine, amphetamine type stimulants, sedatives/sleeping pills, hallucinogens, inhalants, opioids, and other drugs).Risk scores wiil be produced to guide intervention level. The assessment will be administered orally during a routine psychosocial visit by an LCSW. In the control arm, no scorecard/feedback will be provided.
| Study group | Role | What they receive |
|---|---|---|
| ASSIST Screening with Feedback and Brief Intervention | Experimental | This arm is designed to integrate meaningful, patient centered conversations about substance use directly into routine survivorship care, making it easier for survivors to receive tailored support in real time Receives: Behavioral: WHO ASSIST v3.1 Screening with Feedback; Behavioral: ASSIST Linked Brief Intervention (10 Step Motivational interviewing (MI)/FRAMES) |
| ASSIST Screening Without Feedback | Active comparator | This comparison group will allow researchers to understand how the screening plus intervention approach differs from standard survivorship care, helping determine whether the added feedback and brief counseling are practical, acceptable, and potentially beneficial for adult survivors of childhood cancer. Receives: Behavioral: WHO ASSIST v3.1 Screening (No Feedback) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment Feasibility
Proportion of participants approached that enroll in the study
Measured: Through study completion, an average of 1 year
Screener Feasibility
Proportion of participants enrolled that completed the substance use screener with their social worker
Measured: Through study completion, an average of 1 year
Brief Intervention Feasibility
Proportion of participants that scored moderate-to-high risk on the substance use screener that received a brief intervention to reduce substance use
Measured: Through study completion, an average of 1 year
Care coordination Feasibility
Proportion of participants that received a referral for additional services received a coordination of care call from their social worker within 48 business hours of their social work visit
Measured: Through study completion, an average of 1 year
Screener Acceptability- Acceptability of Intervention Measure
A measure of intervention acceptability. Scores are summed and range from 4-20, with scores ≥12 indicative of intervention acceptability.
Measured: Time 1 (1-week post baseline assessment)
Intervention Acceptability - Acceptability of Intervention Measure
A measure of intervention acceptability. Scores are summed and range from 4-20, with scores ≥12 indicative of intervention acceptability.
Measured: Time 2 (3 months post baseline assessment)
Secondary outcomes (1)
Intervention Fidelity
Intervention fidelity will be evaluated through paneled audit of intervention session audio recordings by trained study fidelity coders who will assess adherence to the 10-step intervention protocol (Appendix V). Meeting fidelity thresholds will be defined as ≥80% protocol adherence. An abridged Motivational Interviewing Treatment Integrity Code (MITI 4) will also be used to assess adherence to key MI techniques used during delivery of the ASSIST linked brief intervention. Interrater reliability will be assessed by comparing percentages derived from the study-adapted MITI 4. Fidelity coders, who did not serve as interventionists, will be trained in all coding procedures. In addition to protocol adherence, behavior counts (e.g., information giving, eliciting change talk, reflections, affirmations, collaboration, autonomy support, and confrontation) will be summarized to characterize MI technique use. Fidelity will be monitored throughout the study and summarized at study completion.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Survivors of Childhood CancerStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel Webster, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07516301
- Sponsor's protocol ID
- ASSIST
- Other IDs
- NCI-2026-04535
- Status last verified
- Sep 2026
- First submitted
- 25 Mar 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piloting the Feasibility of Incorporating a Standardized Substance Use Measure With Linked-Brief Intervention Into Routine Psychosocial Care of Adult Childhood Cancer Survivors
- ClinicalTrials.gov ID
- NCT07516301
- Acronym / sponsor ID
- ASSIST
- Conditions
- Survivors of Childhood Cancer, Substance Use
- Keywords
- Adult childhood cancer survivors (ACCS), Cancer Survivorship
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 7 Apr 2026 (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.
The ASSIST Study is designed to explore whether a brief, evidence based substance use screening and counseling approach can be easily integrated into routine survivorship care at St. Jude Children's Research Hospital.
During a regularly scheduled psychosocial visit, participants complete the World Health Organization's Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST). This short questionnaire helps identify patterns of use related to tobacco, alcohol, cannabis, prescription medications, and other substances. Survivors whose results show possible risk receive a brief, supportive counseling session during the same appointment. This session uses motivational interviewing techniques to help individuals reflect on their use and consider steps to reduce potential harm.
Primary Objective:
- Assess the feasibility and acceptability of integrating a standardized substance use screening and brief intervention protocol into routine psychosocial workflows within a survivorship clinic.
Secondary Objective:
- Evaluate the fidelity of delivering a brief substance use intervention to reduce substance use behaviors among survivors.
Detailed description
The ASSIST Study is a pilot study at St. Jude Children's Research Hospital designed to explore whether a brief, evidence-based approach to substance use screening and counseling can be integrated into routine survivorship care for adult survivors of childhood cancer. During a regular visit in the After Completion of Therapy (ACT) Clinic, participants will complete the World Health Organization's ASSIST questionnaire, which identifies potential risks related to alcohol, tobacco, and other substance use. Survivors who show moderate or high risk and are assigned to the intervention group receive a brief counseling session that uses motivational interviewing techniques to support healthy decision making.
This study will enroll 30 adult survivors to evaluate whether this screening and intervention approach is practical, acceptable, and delivered as intended within a busy clinic setting. Participants will also complete a follow up survey three months later to report whether they reduced their substance use. Results from this pilot will help determine whether a larger study should be conducted and may guide future efforts to enhance long term health outcomes for childhood cancer survivors.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASSIST Screening with Feedback and Brief Intervention | Experimental | Behavioral: WHO ASSIST v3.1 Screening with Feedback, Behavioral: ASSIST Linked Brief Intervention (10 Step Motivational interviewing (MI)/FRAMES)This arm is designed to integrate meaningful, patient centered conversations about substance use directly into routine survivorship care, making it easier for survivors to receive tailored support in real time |
| ASSIST Screening Without Feedback | Active comparator | Behavioral: WHO ASSIST v3.1 Screening (No Feedback)This comparison group will allow researchers to understand how the screening plus intervention approach differs from standard survivorship care, helping determine whether the added feedback and brief counseling are practical, acceptable, and potentially beneficial for adult survivors of childhood cancer. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Followed in the ACT Clinic at St. Jude Children's Research Hospital
- Greater than or equal to 15 years of age at time of evaluation
- Able to speak and read English
Key exclusion criteria (1 listed)
- Significant mental or cognitive impairment that would impact ability to complete surveys or participate in the brief 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 |
|---|---|---|
| WHO ASSIST v3.1 Screening with FeedbackAn 8 item clinician administered instrument assessing lifetime and recent (past 3 months) use across substance classes (tobacco, alcohol, cannabis, cocaine, amphetamine type stimulants, sedatives/sleeping pills, hallucinogens, inhalants, opioids, and other drugs).Risk scores wiil be produced to guide intervention level. The assessment will be administered orally during a routine psychosocial visit by an LCSW. In the experimental arm, risk feedback will be shared using a scorecard | Behavioural | ASSIST Screening with Feedback and Brief Intervention |
| ASSIST Linked Brief Intervention (10 Step Motivational interviewing (MI)/FRAMES)For participants screening moderate/high risk in the experimental arm, a same session, brief intervention consistent with motivational interviewing and FRAMES is delivered by an LCSW. Ten steps include: purpose of discussion, feedback on scores, information/advice, emphasize responsibility, express concern/support, explore "good things," explore "less good things," summarize, explore readiness/next steps with goal setting if ready, and provide self help materials. Sessions will be audio recorded for fidelity review. | Behavioural | ASSIST Screening with Feedback and Brief Intervention |
| WHO ASSIST v3.1 Screening (No Feedback)An 8 item clinician administered instrument assessing lifetime and recent (past 3 months) use across substance classes (tobacco, alcohol, cannabis, cocaine, amphetamine type stimulants, sedatives/sleeping pills, hallucinogens, inhalants, opioids, and other drugs).Risk scores wiil be produced to guide intervention level. The assessment will be administered orally during a routine psychosocial visit by an LCSW. In the control arm, no scorecard/feedback will be provided. | Behavioural | ASSIST Screening Without Feedback |
Primary outcome
Enrollment Feasibility
Time frame: Through study completion, an average of 1 year
Proportion of participants approached that enroll in the study
Screener Feasibility
Time frame: Through study completion, an average of 1 year
Proportion of participants enrolled that completed the substance use screener with their social worker
Brief Intervention Feasibility
Time frame: Through study completion, an average of 1 year
Proportion of participants that scored moderate-to-high risk on the substance use screener that received a brief intervention to reduce substance use
Care coordination Feasibility
Time frame: Through study completion, an average of 1 year
Proportion of participants that received a referral for additional services received a coordination of care call from their social worker within 48 business hours of their social work visit
Screener Acceptability- Acceptability of Intervention Measure
Time frame: Time 1 (1-week post baseline assessment)
A measure of intervention acceptability. Scores are summed and range from 4-20, with scores ≥12 indicative of intervention acceptability.
Intervention Acceptability - Acceptability of Intervention Measure
Time frame: Time 2 (3 months post baseline assessment)
A measure of intervention acceptability. Scores are summed and range from 4-20, with scores ≥12 indicative of intervention acceptability.
1 secondary outcome
Intervention Fidelity
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
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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.
Rachel Webster, PhD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WHO ASSIST v3.1 Screening with Feedback, ASSIST Linked Brief Intervention (10 Step Motivational interviewing (MI)/FRAMES) and WHO ASSIST v3.1 Screening (No Feedback) in people with Survivors of Childhood Cancer and Substance Use, run by St. Jude Children's Research Hospital 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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 3 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Webster, PhD (888-226-4343, referralinfo@stjude.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment Feasibility (time frame: Through study completion, an average of 1 year). The study lists 6 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 3 Sep 2026.