On-Trac: Online training to manage anxiety after cancer

Online Training After Cancer (On-Trac): Developing An Online Intervention for Cancer Survivors Managing Anxiety

This program will try an online CBT- and ACT-based education plus brief coaching to help adult cancer survivors manage ongoing anxiety.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Dana-Farber Cancer Institute (other)
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT07305740 on ClinicalTrials.gov

What this trial studies

This minimal-risk behavioral optimization trial refines On-Trac, an online education program based on Cognitive-Behavioral Therapy (CBT) and Acceptance and Commitment Therapy (ACT) for adult cancer survivors with anxiety. About 80 participants will be recruited into four age-based cohorts and will complete a 120-minute online group session, 1–2 individual coaching calls, web-based questionnaires, and telephone interviews at 4 and 8 weeks. Eligibility screening uses diagnostic screener items and an OASIS score, and all intervention and follow-up procedures are conducted via videoconference and web-survey platforms. Participants receive modest gift card incentives for completing evaluations.

Who should consider this trial

Good fit: Adults (≥18) with a non-melanoma-skin-cancer diagnosis at least 12 months earlier, no active cancer therapy in the past 4 months and none planned, clinically significant anxiety (positive SCID screener items and OASIS ≥6), regular internet access, and English literacy.

Not a fit: People with recent or planned active cancer treatment, prominent panic disorder or obsessive-compulsive symptoms as defined in the exclusions, limited internet access, or insufficient English reading/writing skills are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, On-Trac could reduce anxiety symptoms and teach survivors practical CBT/ACT skills to manage worry and avoidance.

How similar studies have performed: Previous digital CBT and ACT programs for anxiety, including interventions for cancer survivors, have shown modest-to-moderate benefits, so this approach builds on existing evidence.

Eligibility criteria

Inclusion Criteria:

* Age ≥ 18
* A diagnosis of cancer (except non-melanoma skin cancer) ≥ 12 months prior.
* No active cancer therapy (excluding chemoprevention) in the past 4 months, and no further therapy planned.
* Significant anxiety as evidenced by both of the following

  * Endorsement of the SCID ( Structured Clinical Interview for the DSM-5) Screener Items for Social Anxiety Disorder, Generalized Anxiety Disorder, Agoraphobia, Specific Phobia, or Illness Anxiety Disorder.
  * A score ≥ 6 on the Overall Anxiety Severity and Impairment Scale (OASIS).
* Regular access to the internet.
* Ability to read and write in English.

Exclusion Criteria:

* Significant symptoms of Panic Disorder in the prior month, including anticipatory anxiety of having a future panic attack or avoidance symptoms associated with panic attacks, as assessed by three SCID-5 items from the panic attack disorder module.
* Significant symptoms of Obsessive Compulsive Disorder, as evidenced by any obsessions over the past 3 months, as assessed by three SCID items from the Obsessive Compulsive Disorder module.
* Psychiatric hospitalizations or emergency room visits for psychiatric care in the prior 2 years.
* In the next two months, intention to use or likelihood of using emergent or "rescue" anxiety medication (e.g., Ativan, Xanax, Valium) or self-prescribed substances (i.e., marijuana) at the onset of anxiety symptoms or when entering a situation where they expect to experience anxiety.
* Any significant marijuana use which could impact anxiety symptoms, as evidenced by one of the following:

  * 4 days of marijuana use in any week in the last month
  * 20 milligrams of THC (Tetrahydrocannabinol) products in any week in the last month.
* Participation in any CBT or ACT-based behavioral or education intervention for anxiety in the past 2 years. This includes in-person, asynchronous, and synchronous online anxiety programs, and therapy that includes these skills. This does not include independent use of any self-help materials (i.e., workbooks, books).
* Any impairment (e.g., hearing, visual, cognitive) that interferes with the ability to complete all parts of the study independently.

Where this trial is running

Boston, Massachusetts

• Dana Farber Cancer Institute — Boston, Massachusetts, United States (RECRUITING)

Study contacts

• Principal investigator: Christopher J Recklitis, PhD, MPH — Dana-Farber Cancer Institute
• Study coordinator: On-Trac Study Coordinator

Conditions: Cancer, Survivorship, Anxiety, Cancer Survivorship