Recruiting

On-Trac

Sponsor:

Dana-Farber Cancer Institute

Code:

NCT07305740

Conditions

Cancer

Survivorship

Anxiety

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ON-TRAC Education session

ON-TRAC Coaching

Study Details

Brief summary:

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)

Conditions

Cancer

Survivorship

Anxiety

Study ID

NCT07305740

Start date

Mar 11, 2026

Status verified date

May, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Oct 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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

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.

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

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.

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

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.

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

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.

Interventions

ON-TRAC Education session

120 minute educational session on strategies for anxiety delivered via synchronous videoconference session

ON-TRAC Coaching

30-40 minute individual coaching sessions on implementation of strategies for anxiety

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

On-Trac Study Coordinator

617-582-8260ontrac@dfci.harvard.edu

Cheryl Medeiros-Nancarrow

617-632-5798cheryl_nancarrow@dfci.harvard.edu

Locations

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Christopher J Recklitis, Phd, MPH

617-632-3839christopher_recklitis@dfci.harvard.edu

Principal Investigator:

Christopher J Recklitis, Phd, MPH

More Information

Sponsor

Dana-Farber Cancer Institute

Last update posted

May 13, 2026

Last verified

May, 2026

Keywords

  • Cancer Survivorship
  • Anxiety

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dana-Farber Cancer Institute on 2026-05-13.