On-Trac: An Online Intervention for Cancer Survivors Managing Anxiety
NCT ID: NCT07305740
Last Updated: 2025-12-26
Study Results
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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NOT_YET_RECRUITING
NA
80 participants
INTERVENTIONAL
2026-05-01
2027-12-31
Brief Summary
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The name of the study intervention is Online Training After Cancer (On-Trac)
Detailed Description
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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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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
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.
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
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.
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
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.
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
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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Dana-Farber Cancer Institute
OTHER
Responsible Party
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Christopher Recklitis, PhD
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
Countries
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Central Contacts
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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