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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)
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: CANCER SURVIVORS AGE 18-39 ON-TRAC SMALL GROUP | Experimental | 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. |
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| Cohort 2: CANCER SURVIVORS AGE 18-39 ON-TRAC INDIVIDUAL SESSIONS | Experimental | 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. |
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| Cohort 3: CANCER SURVIVORS AGE 40+ ON-TRAC SMALL GROUP | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ON-TRAC Education session | Behavioral | 120 minute educational session on strategies for anxiety delivered via synchronous videoconference session |
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| 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. |
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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
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:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| On-Trac Study Coordinator | Contact | 617-582-8260 | ontrac@dfci.harvard.edu | |
| Cheryl Medeiros-Nancarrow | Contact | 617-632-5798 | cheryl_nancarrow@dfci.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Christopher J Recklitis, PhD, MPH | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02115 | United States |
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.
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Data can be shared no earlier than 1 year following the date of publication
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| Cohort 4: CANCER SURVIVORS AGE 40+ ON-TRAC INDIVIDUAL SESSIONS | Experimental | 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 Coaching | Behavioral | 30-40 minute individual coaching sessions on implementation of strategies for anxiety |
|
| 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. |