Acceptance and Commitment Therapy (ACT) for Anxious Cancer Survivors

Study Overview
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Brief Summary
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This randomized clinical trial compares group acceptance and commitment therapy (ACT) to usual care for cancer survivors experiencing anxiety following the end of cancer treatment.

Official Title
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A Novel Acceptance-Based Intervention for Anxious Cancer Survivors

Conditions
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Cancer

Intervention / Treatment
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* Behavioral: Acceptance and Commitment Therapy (ACT) Group
* Behavioral: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults in the Greater Boulder/ Denver, Colorado area who had cancer and completed primary cancer treatment (surgery, chemotherapy, and/or radiation) within the previous 18 months For solid tumor cancers: Show no current evidence of disease for solid-tumor cancers (of any cancer type or initial stage). For lymphoproliferative disorders such as chronic lymphocytic leukemia and indolent non-Hodgkin's lymphoma: In remission or asymptomatic after initial treatment and are followed with active surveillance. Screen positive for anxiety symptoms on the study screener Able to speak, read, and write English fluently Willing and able to participate in an ACT group once a week for 7 weeks Willing and able to complete online questionnaires and phone interviews at designated assessment points Exclusion Criteria: Current moderate to high suicide risk History of chronic untreated trauma (unrelated to their cancer) Psychiatric hospitalization or suicide attempt in the past 5 years

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acceptance and Commitment Therapy Group<br> | Behavioral: Acceptance and Commitment Therapy (ACT) Group<br>* A 7-session Acceptance and Commitment Therapy (ACT) group intervention<br>|
| Active Comparator: Usual Care<br> | Behavioral: Usual Care<br>* Check in with clinical social worker at oncology care site and obtain list of supportive resources<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety symptoms | Method of assessment: questionnaire | Baseline to Post and (3- and 6-month) Follow Up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive symptoms | Method of assessment: questionnaire | Baseline to Post and (3- and 6-month) Follow Up | 
| Medical resource use | Method of assessment: survey of medical care use | Baseline to Post and (3- and 6-month) Follow Up | 
| Fear of cancer recurrence | Method of assessment: questionnaire | Baseline to Post and (3- and 6-month) Follow Up | 
| Sense of life meaning | Method of assessment: questionnaire | Baseline to Post and (3- and 6-month) Follow Up | 
| Fatigue / Vitality | Method of assessment: questionnaire | Baseline to Post and (3- and 6-month) Follow Up | 
| Anxiety disorder severity | Method of assessment: diagnostic interview | Baseline to Post and 6-month Follow Up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer survivors