Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
NCT Number: NCT05643027
This research study is being done to develop an intervention for psychological symptoms that patients diagnosed with cancer may experience. Psychological symptoms may include thoughts, feelings, emotions, and memories
The names of the study intervention and research activities involved in this study are/is:
* Acceptance & Commitment Therapy (ACT) for Cancer (involving 6 sessions with a licensed clinical psychologist) * Questionnaires * Post-study interview
Consistent with the NIH Stage Model for Behavioral Intervention Development, the investigators have adapted an existing, empirically-validated intervention, Acceptance and Commitment Therapy (ACT), to address substance use disorder risk during cancer care. The core components of ACT are particularly well-suited to address the psychological processes underlying opioid misuse in individuals treated for cancer pain. The overarching aim is to assess the feasibility and acceptability of the intervention by conducting a randomized pilot trial of the revised intervention ("ACTION") for cancer patients on opioid therapy, and at risk for SUD.
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Notify Me18 year–99 year
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02215, United States
This research study is a Feasibility Study, which is the first-time investigators are examining this psychological intervention in patients with cancer who are prescribed opioids and are receiving palliative care. This study is being conducted to develop a psychological intervention designed specifically for individuals with cancer. The purpose of this study is to determine how practical this intervention is, to determine patient satisfaction, and test the study procedures. The aims are to:
This research study involves a psychological intervention for thoughts, feelings, emotions, and memories that individuals diagnosed with cancer may have.
The names of the study intervention and research activities involved in this study are/is:
The research study procedures include: screening for eligibility and study treatment including evaluations, 6 visits, and a post-study interview.
Participants will be on this research study for up to 2 months.
It is expected that about 10 people will take part in this research study
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Six-session, skills-based behavioral intervention targeting risk factors for opioid use disorder in the context of cancer
Time frame: 1 year
enrollment rate of at least 60% and retention rate of at least 75%
Time frame: 1 year
Acceptability of the intervention, measured by CSQ-8 scores and patient reported feedback during exit interviews. On the CSQ-8, some items are reverse scored but higher scores mean greater satisfaction. Min value = 8, max value = 32
Time frame: 1 year
patient reported depression symptoms, as measured by the PHQ-9; higher scores represent a worse outcome (i.e., more depression); min value = 1; max value = 27
Time frame: 1 year
anxiety, as measured by the GAD-7; higher scores indicate a worse outcome (i.e., greater anxiety); min value = 0; max value = 21
Time frame: 1 year
opioid misuse behaviors and consequences, as measured by the COMM; with a sum of questions that is less than 9 reflecting no misuse and greater or equal to 9 reflecting misuse
Dana-Farber Cancer Institute
Other
A Novel Intervention for Avoidance-Related Opioid Misuse in Patients With Cancer
Acronym: ACTION
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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