Clinical trial NCT05643027: A Novel Intervention for Patients With Cancer
Official title: A Novel Intervention for Avoidance-Related Opioid Misuse in Patients With Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Substance Use
Cancer
Psychological
Keywords: feasibility
acceptability
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-12-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of the intervention, defined as an enrollment rate of at least 60%
timeFrame: 1 year
measure: Acceptability of the intervention, measured by Client Satisfaction Questionnaire (CSQ-8) scores
timeFrame: 1 year
Secondary outcomes:
measure: Depression, measured by the Patient Health Questionnaire (PHQ-9)
timeFrame: 1 year
measure: anxiety, as measured by the Generalized Anxiety Disorder questionnaire (GAD-7)
timeFrame: 1 year
measure: opioid misuse behaviors and consequences, as measured by the Current Opioid Misuse Measure (COMM)
timeFrame: 1 year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Miryam Yusufov, PhD
role: PRINCIPAL_INVESTIGATOR
References: