On-Trac: An Online Intervention for Cancer Survivors Managing Anxiety
Recruiting · NCT07305740 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
ON-TRAC CoachingON-TRAC Education session
What this trial is about
This study is evaluating On-Trac (Online Training After Cancer), an online educational intervention to teach adult cancer survivors strategies to address anxiety based on Cognitive-Behavioral Therapy (CBT) and Acceptance Commitment Therapy (ACT) The name of the study intervention is Online Training After Cancer (On-Trac)
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed across 1 US state.
- Dana Farber Cancer Institute - Boston, Massachusetts, United States