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NCT Number: NCT07305740

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

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)

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Key information

Conditions

Cancer Anxiety Anxiety Disorders Mental Disorders Neoplasms Survivorship

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location status: Recruiting

Location contact

Christopher J Recklitis, Phd, MPH

CONTACT

[email protected]

617-632-3839

Christopher J Recklitis, Phd, MPH

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ON-TRAC Education session

Behavioral

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

ON-TRAC Coaching

Behavioral

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

Primary outcomes

  1. 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.

    OASIS is a 5-item self-report measure, where the total score is obtained as a sum of the individual items. Higher scores are indicative of more severe and impairing anxiety symptoms.

  2. 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.

    OASIS is a 5-item self-report measure, where the total score is obtained as a sum of the individual items. Higher scores are indicative of more severe and impairing anxiety symptoms.

  3. 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.

    AAQ-2 is a 7-item self report measure, where the total score is obtained as a sum of the individual items. Higher scores are indicative of higher psychological inflexibility.

  4. 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.

    AAQ-2 is a 7-item self report measure, where the total score is obtained as a sum of the individual items. Higher scores are indicative of higher psychological inflexibility.

  5. 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.

    PROMIS-Anxiety is a 7-item self report measure, where the total score is obtained as a sum of the individual items. Higher scores are indicative of greater severity of anxiety symptoms.

  6. 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.

    PROMIS-Anxiety SF-7 is a 7-item self report measure, where the total score is obtained as a sum of the individual items. Higher scores are indicative of greater severity of anxiety symptoms.

  7. 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.

    IAQ is a 7-item self report measure, with all items adapted from the Short Health Anxiety Inventory (SHAI). The total score is obtained as a sum of the individual items.

  8. 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.

    IAQ is a 7-item self report measure, with all items adapted from the Short Health Anxiety Inventory (SHAI). The total score is obtained as a sum of the individual items.

  9. 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.

    SIx PROMIS-Self Efficacy items were selected from the PROMIS item bank for managing chronic conditions - managing emotions. A total score is obtained as a sum of the individual items. Higher scores are indicative of greater self-efficacy for managing emotions.

  10. 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.

    Six PROMIS-Self Efficacy items were selected from the PROMIS item bank for managing chronic conditions - managing emotions. A total score is obtained as a sum of the individual items. Higher scores are indicative of greater self-efficacy for managing emotions.

Study contacts

Contact information is provided by the study sponsor or research team.

Cheryl Medeiros-Nancarrow

CONTACT

[email protected]

617-632-5798

On-Trac Study Coordinator

CONTACT

[email protected]

617-582-8260

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Official study title

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

Acronym: On-Trac

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 26, 2025
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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