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

Dana-Farber Cancer Institute

Status: Begins enrollment in 3 months

Conditions: Survivorship; Cancer; Anxiety

Treatments: Behavioral: ON-TRAC Coaching; Behavioral: ON-TRAC Education session

Study type: Interventional

Funder types: Other

Identifiers

NCT07305740

25-521

Details and patient eligibility

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)

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 3 months, 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.

• Any use in the last month of 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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 4 patient groups

Cohort 1: CANCER SURVIVORS AGE 18-39 ON-TRAC SMALL GROUP

Experimental group

Description:

Participants ages 18-39 will receive a group educational intervention via synchronous video conference that provides strategies for managing anxiety. 1-7 days after attending the educational session, participants will receive a 30- 45 minute individual coaching session by telephone to help them implement strategies to manage anxiety. After the first coaching session each participant will be offered a second (optional) coaching session.

Treatment:

Behavioral: ON-TRAC Education session

Behavioral: ON-TRAC Coaching

Cohort 2: CANCER SURVIVORS AGE 18-39 ON-TRAC INDIVIDUAL SESSIONS

Experimental group

Description:

Participants ages 18-39 will receive an individual, 1 on 1, educational intervention via synchronous video conference that provides strategies for managing anxiety. 1-7 days after attending their educational session, participants will receive a 30- 45 minute individual coaching session by telephone to help them implement strategies to manage anxiety. After the first coaching session each participant will be offered a second (optional) coaching session.

Treatment:

Behavioral: ON-TRAC Education session

Behavioral: ON-TRAC Coaching

Cohort 3: CANCER SURVIVORS AGE 40+ ON-TRAC SMALL GROUP

Experimental group

Description:

Participants ages 40+ will receive a group educational intervention via synchronous video conference that provides strategies for managing anxiety. 1-7 days after attending the educational session, participants will receive a 30-45 minute individual coaching session by telephone to help them implement strategies to manage anxiety. After the first coaching session each participant will be offered a second (optional) coaching session.

Treatment:

Behavioral: ON-TRAC Education session

Behavioral: ON-TRAC Coaching

Cohort 4: CANCER SURVIVORS AGE 40+ ON-TRAC INDIVIDUAL SESSIONS

Experimental group

Description:

Participants ages 18-39 will receive an individual, 1 on 1, educational intervention via synchronous video conference that provides strategies for managing anxiety. 1-7 days after attending their educational session, participants will receive a 30-45 minute individual coaching session by telephone to help them implement strategies to manage anxiety. After the first coaching session each participant will be offered a second (optional) coaching session.

Treatment:

Behavioral: ON-TRAC Education session

Behavioral: ON-TRAC Coaching