On-Trac: An Online Intervention for Cancer Survivors Managing Anxiety
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDana-Farber Cancer Institute
About this trial
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)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
ON-TRAC Education session
Behavioral120 minute educational session on strategies for anxiety delivered via synchronous videoconference session
ON-TRAC Coaching
Behavioral30-40 minute individual coaching sessions on implementation of strategies for anxiety
Treatment groups
80 Participants
are divided into 4 treatment groupsGroup A: Cohort 1: CANCER SURVIVORS AGE 18-39 ON-TRAC SMALL GROUPExperimental treatment 2 interventions
Group B: Cohort 2: CANCER SURVIVORS AGE 18-39 ON-TRAC INDIVIDUAL SESSIONSExperimental treatment 2 interventions
Group C: Cohort 3: CANCER SURVIVORS AGE 40+ ON-TRAC SMALL GROUPExperimental treatment 2 interventions
Group D: Cohort 4: CANCER SURVIVORS AGE 40+ ON-TRAC INDIVIDUAL SESSIONSExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
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.
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.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.
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.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.
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.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.
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov