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

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 implementing a standardized assessment of substance use and brief substance use reduction intervention in survivorship clinical settings.

Secondary Objective:

- Evaluate the reliability of delivering a brief substance use intervention to reduce substance use behaviors among Adult Survivors of Childhood Cancer (ASCC) followed in the (ACT) Clinic.

Study Overview

• Status: Not yet recruiting
• Conditions: Substance Use; Survivors of Childhood Cancer
• Intervention / Treatment: Behavioral: WHO ASSIST v3.1 Screening with Feedback; Behavioral: ASSIST Linked Brief Intervention (10 Step Motivational interviewing (MI)/FRAMES); Behavioral: WHO ASSIST v3.1 Screening (No Feedback)

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rachel Webster, PhD; Phone Number: 888-226-4343; Email: referralinfo@stjude.org

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • St. Jude Children's Research Hospital
      • Contact: Rachel Webster, PhD; Phone Number: 888-226-4343; Email: referralinfo@stjude.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Followed in the ACT Clinic at St. Jude Children's Research Hospital
• Greater than or equal to 18 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ASSIST Screening with Feedback and Brief Intervention; 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	Behavioral: WHO 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; Behavioral: 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.
Active Comparator: ASSIST Screening Without 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enrollment Feasibility	Proportion of participants approached that enroll in the study	Through study completion, an average of 1 year
Screener Feasibility	Proportion of participants enrolled that completed the substance use screener with their social worker	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	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	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.	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.	Time 2 (3 months post baseline assessment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Through study completion, an average of 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Care Coordination Preliminary Efficacy	Proportion of participants referred to care that enrolled in follow-up care	Time 2 (3 months post baseline visit)
Substance Use Reduction Attempt	Proportion of participants that self-reported attempts to reduce substance use	Time 2 (3 months post baseline visit)
Substance Use Reduction Amount	Average extent substance use was reduced	Time 2 (3 months post baseline visit)
Substance Use Reduction Duration	Average number of days substance use was reduced	Time 2 (3 months post baseline visit)

Collaborators and Investigators

• Sponsor: St. Jude Children's Research Hospital
• Investigators: Principal Investigator: Rachel Webster, PhD, St. Jude Children's Research Hospital

Publications and helpful links

Helpful Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: March 25, 2026
• First Submitted That Met QC Criteria: April 2, 2026
• First Posted (Actual): April 7, 2026

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Cancer Survivorship; Adult childhood cancer survivors (ACCS)
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: ASSIST

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No