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CancerOn-TracNCT07305740

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

A study testing ON-TRAC Education session and ON-TRAC Coaching in people with Cancer and Survivorship, run by Dana-Farber Cancer Institute at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer, Survivorship, Anxiety
What is being tested?
ON-TRAC Education session and ON-TRAC Coaching
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteUnited States
Study dates
11 Mar 2026to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

On-Trac Study Coordinator contact

617-582-8260

ontrac@dfci.harvard.edu

Cheryl Medeiros-Nancarrow contact

617-632-5798

cheryl_nancarrow@dfci.harvard.edu

United States1 site, 1 recruiting
  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

    Christopher J Recklitis, Phd, MPH, 617-632-3839, christopher_recklitis@dfci.harvard.edu

    Christopher J Recklitis, Phd, MPH

    Recruiting

Other trials in United States

About this study

Official title: 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)

Read the 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.

Being tested
ON-TRAC Education session, ON-TRAC Coaching
Keywords
Cancer Survivorship, Anxiety
Medical subject headings
Neoplasms, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ON-TRAC Education sessionBehavioural

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

  • ON-TRAC CoachingBehavioural

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

Study groups in NCT07305740
Study groupRoleWhat they receive
Cohort 1: CANCER SURVIVORS AGE 18-39 ON-TRAC SMALL GROUPExperimentalParticipants 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.
Receives: Behavioral: ON-TRAC Education session; Behavioral: ON-TRAC Coaching
Cohort 2: CANCER SURVIVORS AGE 18-39 ON-TRAC INDIVIDUAL SESSIONSExperimentalParticipants 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.
Receives: Behavioral: ON-TRAC Education session; Behavioral: ON-TRAC Coaching
Cohort 3: CANCER SURVIVORS AGE 40+ ON-TRAC SMALL GROUPExperimentalParticipants 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.
Receives: Behavioral: ON-TRAC Education session; Behavioral: ON-TRAC Coaching
Cohort 4: CANCER SURVIVORS AGE 40+ ON-TRAC INDIVIDUAL SESSIONSExperimentalParticipants 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.
Receives: Behavioral: ON-TRAC Education session; Behavioral: ON-TRAC Coaching

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Anxiety measures will be collected once at baseline prior to receiving On-Trac intervention, and at follow-up 4 and 8 weeks post-baseline.

  2. 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.

    Measured: Anxiety measures will be collected once at baseline prior to receiving On-Trac intervention, and at follow-up 4 and 8 weeks post-baseline.

  3. 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.

    Measured: Anxiety measures will be collected once at baseline prior to receiving On-Trac intervention, and at follow-up 4 and 8 weeks post-baseline.

  4. 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.

    Measured: Anxiety measures will be collected once at baseline prior to receiving On-Trac intervention, and at follow-up 4 and 8 weeks post-baseline.

  5. 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.

    Measured: Anxiety measures will be collected once at baseline prior to receiving On-Trac intervention, and at follow-up 4 and 8 weeks post-baseline.

  6. 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.

    Measured: Anxiety measures will be collected once at baseline prior to receiving On-Trac intervention, and at follow-up 4 and 8 weeks post-baseline.

  7. 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.

    Measured: Anxiety measures will be collected once at baseline prior to receiving On-Trac intervention, and at follow-up 4 and 8 weeks post-baseline.

  8. 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.

    Measured: Anxiety measures will be collected once at baseline prior to receiving On-Trac intervention, and at follow-up 4 and 8 weeks post-baseline.

  9. 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.

    Measured: Anxiety measures will be collected once at baseline prior to receiving On-Trac intervention, and at follow-up 4 and 8 weeks post-baseline.

  10. 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.

    Measured: Anxiety measures will be collected once at baseline prior to receiving On-Trac intervention, and at follow-up 4 and 8 weeks post-baseline.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Dec 2025
  2. Study start11 Mar 2026
  3. Primary completion31 Oct 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07305740
Sponsor's protocol ID
25-521
Acronym
On-Trac
Status last verified
May 2026
First submitted
12 Dec 2025
Last updated
13 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A study testing ON-TRAC Education session and ON-TRAC Coaching in people with Cancer and Survivorship, run by Dana-Farber Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact On-Trac Study Coordinator (617-582-8260, ontrac@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.

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