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

Online Training After Cancer (On-Trac): Developing 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)

Study Overview

• Status: Recruiting
• Conditions: Cancer; Anxiety; Survivorship
• Intervention / Treatment: Behavioral: ON-TRAC Education session; Behavioral: ON-TRAC Coaching

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cheryl Medeiros-Nancarrow; Phone Number: 617-632-5798; Email: cheryl_nancarrow@dfci.harvard.edu
• Study Contact Backup: Name: On-Trac Study Coordinator; Phone Number: 617-582-8260; Email: ontrac@dfci.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Dana Farber Cancer Institute
      • Contact: Christopher J Recklitis, Phd, MPH; Phone Number: 617-632-3839; Email: christopher_recklitis@dfci.harvard.edu
      • Principal Investigator: Christopher J Recklitis, Phd, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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
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.	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
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.	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
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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in OASIS (Overall Anxiety Severity and Impairment Scale) from baseline to 4 weeks	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.	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	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.	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	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.	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	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.	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	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.	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	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.	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	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.	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	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.	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	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.	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	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.	Anxiety measures will be collected once at baseline prior to receiving On-Trac intervention, and at follow-up 4 and 8 weeks post-baseline.

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Investigators: Principal Investigator: Christopher J Recklitis, PhD, MPH, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 12, 2025
• First Submitted That Met QC Criteria: December 12, 2025
• First Posted (Actual): December 26, 2025

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Anxiety; Cancer Survivorship
• Additional Relevant MeSH Terms: Mental Disorders; Neoplasms; Anxiety Disorders
• Other Study ID Numbers: 25-521

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: On-Trac Study Coordinator at; ontrac@dfci.harvard.edu. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No