NCT07516301

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 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
29mo left

Started May 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
May 2026Oct 2028

First Submitted

Initial submission to the registry

March 25, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 7, 2026

Completed
24 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

1.4 years

First QC Date

March 25, 2026

Last Update Submit

April 21, 2026

Conditions

Keywords

Adult childhood cancer survivors (ACCS)Cancer Survivorship

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (1)

  • Intervention Fidelity

    Through study completion, an average of 1 year

Other Outcomes (4)

  • Care Coordination Preliminary Efficacy

    Time 2 (3 months post baseline visit)

  • Substance Use Reduction Attempt

    Time 2 (3 months post baseline visit)

  • Substance Use Reduction Amount

    Time 2 (3 months post baseline visit)

  • +1 more other outcomes

Study Arms (2)

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

Behavioral: WHO ASSIST v3.1 Screening with FeedbackBehavioral: 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.

Behavioral: WHO ASSIST v3.1 Screening (No Feedback)

Interventions

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 Screening with Feedback and Brief Intervention

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.

ASSIST Screening Without Feedback

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.

ASSIST Screening with Feedback and Brief Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Rachel Webster, PhD

    St. Jude Children's Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Webster, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2026

First Posted

April 7, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2028

Last Updated

April 23, 2026

Record last verified: 2026-04

Locations