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Feasibility of Incorporating a Standardized Substance Use Measure With Linked-Brief Intervention Into Routine Psychosocial Care of Adult Childhood Cancer Survivors

Piloting the Feasibility of Incorporating a Standardized Substance Use Measure With Linked-Brief Intervention Into Routine Psychosocial Care of Adult Childhood Cancer Survivors

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07516301
Enrollment
30
Registered
2026-04-07
Start date
2026-10-01
Completion date
2028-10-01
Last updated
2026-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Substance Use, Survivors of Childhood Cancer

Keywords

Adult childhood cancer survivors (ACCS), Cancer Survivorship

Brief 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. 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.

Interventions

BEHAVIORALWHO ASSIST v3.1 Screening with 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 experimental arm, risk feedback will be shared using a scorecard

BEHAVIORALASSIST 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.

BEHAVIORALWHO 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.

Sponsors

St. Jude Children's Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Significant mental or cognitive impairment that would impact ability to complete surveys or participate in the brief intervention

Design outcomes

Primary

MeasureTime frameDescription
Enrollment FeasibilityThrough study completion, an average of 1 yearProportion of participants approached that enroll in the study
Screener FeasibilityThrough study completion, an average of 1 yearProportion of participants enrolled that completed the substance use screener with their social worker
Brief Intervention FeasibilityThrough study completion, an average of 1 yearProportion of participants that scored moderate-to-high risk on the substance use screener that received a brief intervention to reduce substance use
Care coordination FeasibilityThrough study completion, an average of 1 yearProportion 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 MeasureTime 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 MeasureTime 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.

Secondary

MeasureTime frameDescription
Intervention FidelityThrough study completion, an average of 1 yearIntervention 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.

Countries

United States

Contacts

CONTACTRachel Webster, PhD
referralinfo@stjude.org888-226-4343
PRINCIPAL_INVESTIGATORRachel Webster, PhD

St. Jude Children's Research Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 4, 2026