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NCT Number: NCT07516301

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 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.

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Key information

Conditions

Survivors of Childhood Cancer Chemically-Induced Disorders Mental Disorders Substance Use Substance-Related Disorders

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location status: Recruiting

Location contact

Rachel Webster, PhD

CONTACT

[email protected]

888-226-4343

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

WHO ASSIST v3.1 Screening with Feedback

Behavioral

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)

Behavioral

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)

Behavioral

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.

Primary outcomes

  1. Enrollment Feasibility

    Time frame: Through study completion, an average of 1 year

    Proportion of participants approached that enroll in the study

  2. 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

  3. 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

  4. 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

  5. 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.

  6. 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.

Secondary outcomes

  1. Intervention Fidelity

    Time frame: Through study completion, an average of 1 year

    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.

Other outcomes

  1. Care Coordination Preliminary Efficacy

    Time frame: Time 2 (3 months post baseline visit)

    Proportion of participants referred to care that enrolled in follow-up care

  2. Substance Use Reduction Attempt

    Time frame: Time 2 (3 months post baseline visit)

    Proportion of participants that self-reported attempts to reduce substance use

  3. Substance Use Reduction Amount

    Time frame: Time 2 (3 months post baseline visit)

    Average extent substance use was reduced

  4. Substance Use Reduction Duration

    Time frame: Time 2 (3 months post baseline visit)

    Average number of days substance use was reduced

Study contacts

Contact information is provided by the study sponsor or research team.

Rachel Webster, PhD

CONTACT

[email protected]

888-226-4343

Sponsors and collaborators

Lead sponsor

St. Jude Children's Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 7, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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