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

NCT ID: NCT07305740

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-05-01

Study Completion Date

2027-12-31

Brief Summary

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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

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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.

Conditions

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Cancer Survivorship Anxiety

Keywords

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Cancer Survivorship Anxiety

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

ON-TRAC Education session

Intervention Type BEHAVIORAL

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

ON-TRAC Coaching

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

ON-TRAC Education session

Intervention Type BEHAVIORAL

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

ON-TRAC Coaching

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

ON-TRAC Education session

Intervention Type BEHAVIORAL

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

ON-TRAC Coaching

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

ON-TRAC Education session

Intervention Type BEHAVIORAL

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

ON-TRAC Coaching

Intervention Type BEHAVIORAL

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

Interventions

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ON-TRAC Education session

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

Intervention Type BEHAVIORAL

ON-TRAC Coaching

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dana-Farber Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Christopher Recklitis, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christopher J Recklitis, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

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Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Countries

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United States

Central Contacts

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On-Trac Study Coordinator

Role: CONTACT

Phone: 617-582-8260

Email: [email protected]

Cheryl Medeiros-Nancarrow

Role: CONTACT

Phone: 617-632-5798

Email: [email protected]

Facility Contacts

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Christopher J Recklitis, Phd, MPH

Role: primary

Other Identifiers

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25-521

Identifier Type: -

Identifier Source: org_study_id