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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15+
SponsorSt. Jude Children's Research Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: ASSIST Screening with Feedback and Brief InterventionExperimental treatment 2 interventions
Group B: ASSIST Screening Without FeedbackActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Enrollment Feasibility

Proportion of participants approached that enroll in the study

Time frame
Through study completion, an average of 1 year
2

Screener Feasibility

Proportion of participants enrolled that completed the substance use screener with their social worker

Time frame
Through study completion, an average of 1 year
3

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

Time frame
Through study completion, an average of 1 year
4

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

Time frame
Through study completion, an average of 1 year

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.

Time frame
Through study completion, an average of 1 year

Other outcomes

1

Care Coordination Preliminary Efficacy

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

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

Substance Use Reduction Attempt

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

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

Substance Use Reduction Amount

Average extent substance use was reduced

Time frame
Time 2 (3 months post baseline visit)
4

Substance Use Reduction Duration

Average number of days substance use was reduced

Time frame
Time 2 (3 months post baseline visit)

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