Cancer, Psychological, Substance Use
Conditions
Keywords
feasibility, acceptability
Brief summary
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.
Detailed description
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: 1. determine whether this intervention will be appropriate for further testing; 2. identify which parts of the protocol and procedures need to be modified; and 3. assess patients' reactions to this intervention. 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: * Acceptance & Commitment Therapy (ACT) for Cancer (involving 6 sessions with a licensed clinical psychologist) * Questionnaires * Post-study interview 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
Interventions
BEHAVIORALAcceptance and Commitment Therapy
Six-session, skills-based behavioral intervention targeting risk factors for opioid use disorder in the context of cancer
Sponsors
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* at least 18 years old * have an estimated survival time of at least 6 months (as estimated by palliative care provider) * score at least 4 on the Opioid Risk Tool (ORT) * have been diagnosed with any cancer, including hematologic malignancies * performance status criterion of 0, 1, or 2 \[ with 0 indicating that the patient is asymptomatic, 1 that the patient is symptomatic but fully ambulatory, and 2 that the patient is symptomatic and in bed \<50% of the day\]
Exclusion criteria
* Patients with a score at least 3 to ensure that all enrolled patients are able to participate in the intervention, complete assessments, ensure that no patients who are too sick to participate are enrolled; this will enhance the rigor of the study) * currently be on opioid therapy * not meet criteria for current substance use disorder * assessed by the Diagnostic \& Statistical Manual of mental disorders; DSM-5 or be receiving substance use disorder treatment; and speak and comprehend English sufficiently to be able to participate in psychotherapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the intervention, defined as an enrollment rate of at least 60% | 1 year | enrollment rate of at least 60% and retention rate of at least 75% |
| Acceptability of the intervention, measured by Client Satisfaction Questionnaire (CSQ-8) scores | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression, measured by the Patient Health Questionnaire (PHQ-9) | 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 |
| anxiety, as measured by the Generalized Anxiety Disorder questionnaire (GAD-7) | 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 |
| opioid misuse behaviors and consequences, as measured by the Current Opioid Misuse Measure (COMM) | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMiryam Yusufov, PhD
Dana-Farber Cancer Institute
Outcome results
None listed