On-Trac: An Online Intervention for Cancer Survivors Managing Anxiety

Official title

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

Overview

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)

Detailed description

This is a minimal-risk behavioral optimization trial to optimize and refine On-Trac (Online Training After Cancer), an online educational intervention designed to help adult cancer survivors.

The research study procedures include screening for eligibility, questionnaires and interviews.

Participation in the study involves:

* Completing online survey using using a web-based survey platform for baseline assessment * Taking part in an online, 120 minute, group session via video conference platform and completing an online questionnaire. * Completing 1-2, 30-40 minute, individual coaching sessions 1-7 days after group educational video session. * Completing follow-up questionnaire using a web-based survey platform and telephone interview at 4, and 8 weeks after the group education session. * Participants will receive gift card incentives for completing the brief post-session evaluation and the longer follow-up questionnaires and interview, with a maximum total of $90.

It is expected about 80 people will participate in this research study and will be grouped in four aged based cohorts of 15-20 participants.

Interventions

• Behavioral ON-TRAC Education session
  120 minute educational session on strategies for anxiety delivered via synchronous videoconference session
• Behavioral ON-TRAC Coaching
  30-40 minute individual coaching sessions on implementation of strategies for anxiety

Primary outcome measures

• Change in OASIS (Overall Anxiety Severity and Impairment Scale) from baseline to 4 weeks [Time frame: Anxiety measures will be collected once at baseline prior to receiving On-Trac intervention, and at follow-up 4 and 8 weeks post-baseline.]
• Change in OASIS (Overall Anxiety Severity and Impairment Scale) from baseline to 8 weeks [Time frame: Anxiety measures will be collected once at baseline prior to receiving On-Trac intervention, and at follow-up 4 and 8 weeks post-baseline.]
• Change in AAQ-2 (Acceptance and Action Questionnaire - Version 2) from baseline to 4 weeks [Time frame: Anxiety measures will be collected once at baseline prior to receiving On-Trac intervention, and at follow-up 4 and 8 weeks post-baseline.]
• Change in AAQ-2 (Acceptance and Action Questionnaire - Version 2) from baseline to 8 weeks [Time frame: Anxiety measures will be collected once at baseline prior to receiving On-Trac intervention, and at follow-up 4 and 8 weeks post-baseline.]
• Change in PROMIS-Anxiety from baseline to 4 weeks [Time frame: Anxiety measures will be collected once at baseline prior to receiving On-Trac intervention, and at follow-up 4 and 8 weeks post-baseline.]
• Change in PROMIS-Anxiety Short Form 7a (SF-7a) from baseline to 8 weeks [Time frame: Anxiety measures will be collected once at baseline prior to receiving On-Trac intervention, and at follow-up 4 and 8 weeks post-baseline.]
• Change in IAQ (Illness Anxiety Questionnaire) from baseline to 4 weeks [Time frame: Anxiety measures will be collected once at baseline prior to receiving On-Trac intervention, and at follow-up 4 and 8 weeks post-baseline.]
• Change in IAQ ( Illness Anxiety Questionnaire) from baseline to 8 weeks [Time frame: Anxiety measures will be collected once at baseline prior to receiving On-Trac intervention, and at follow-up 4 and 8 weeks post-baseline.]
• Change in PROMIS-Self Efficacy from baseline to 4 weeks [Time frame: Anxiety measures will be collected once at baseline prior to receiving On-Trac intervention, and at follow-up 4 and 8 weeks post-baseline.]
• Change in PROMIS-Self Efficacy from baseline to 8 weeks [Time frame: Anxiety measures will be collected once at baseline prior to receiving On-Trac intervention, and at follow-up 4 and 8 weeks post-baseline.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• Dana Farber Cancer Institute — Boston

Identifiers

NCT: NCT07305740 · 25-521

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗