Training in Evidence-based Treatments in Psycho-Oncology
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
The goal of this research study is to train psychotherapists to administer individualized evidence-based psychotherapies in a cancer care setting to patients and caregivers with elevated levels of distress.
The intervention will mirror clinical care in psycho-oncology in which the therapist, collaboratively with their supervisor, will choose specific components of the following evidence-based treatments to administer based on the clinical presentation of the patient or caregiver and referring problem.
* Cognitive Behavioral Therapy (CBT) * Acceptance Commitment Therapy (ACT) * Mindfulness-Based Cognitive Therapy (MBCT) * Mindfulness-Based Stress Reduction (MBSR) * Meaning-Centered Psychotherapy (MCP) * Cognitive Behavioral Therapy for Insomnia (CBT-I) * CBT for other cancer-related physical symptoms like pain, fatigue, and nausea.
Participation in this research study is expected to last about 26 weeks.
It is expected that about 75 patients, 25 caregivers, and 15 therapists will take part in this research study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults > 18 years of age.
Currently receiving oncology treatment/care at the MGH Cancer Center, including active treatment and/or surveillance.
Reports elevated levels of distress on the National Comprehensive Cancer Network (NCCN) Distress Thermometer > 3.
Reports distress or presenting problem is related to patients' illness and/or treatment (e.g., cancer treatment).
Disqualifiers
Has uncontrolled psychosis, active suicidal ideation, or psychiatric hospitalization within the past year (assessed through EHR review and screening session using the QuickSCID-5), indicating the need for tailored treatment referral to specialty mental healthcare outside of psycho-oncology or to a higher level of care such as an intensive outpatient program (IOP).
Has a cognitive impairment that prohibits participation in the study (assessed through EHR review and screening session).
Currently participating in group or individual evidence-based psychotherapy treatment or other psychosocial intervention trial.
Has an alcohol or substance dependence (other than nicotine dependence) in the past 8 weeks (assessed through EHR review and screening session using the QuickSCID-5), indicating the need for tailored treatment referral to specialty mental healthcare outside of psycho-oncology or to a higher level of care such as an intensive outpatient program (IOP).
Trial design
Design model
Parallel
Treatments tested in this trial
Individualized Evidence-Based Therapy in Cancer (Patients and Caregivers)
BehavioralThe intervention will mirror clinical care in psycho-oncology in which the therapist, collaboratively with their supervisor, will choose specific components of the following evidence-based treatments to administer based on the clinical presentation of the patient or caregiver and referring problem. * Cognitive Behavioral Therapy (CBT) * Acceptance Commitment Therapy (ACT) * Mindfulness-Based Cognitive Therapy (MBCT) * Mindfulness-Based Stress Reduction (MBSR) * Meaning-Centered Psychotherapy (MCP) * Cognitive Behavioral Therapy for Insomnia (CBT-I) * CBT for pain * CBT for fatigue * CBT for nausea
Training in Individualized Evidence-Based Therapy in Cancer (Therapists)
BehavioralEnrolled therapist participants will receive training in evidence-based therapies and deliver therapy to patient and caregiver participants.
Treatment groups
115 Participants
are divided into 2 treatment groupsGroup A: Individualized Evidence-Based Therapy in Cancer (Patients and Caregivers)Experimental treatment 1 intervention
Group B: Training in Individualized Evidence-Based Therapy in Cancer (Therapists)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Evidence-Based Treatment Acceptability
Patients and caregivers will report acceptability of evidence-based treatment delivered by therapists receiving training in psycho-oncology on the Client Satisfaction Questionnaire (acceptability criteria: \>75% of patients score ≥ the CSQ's midpoint \[3\]). Defined by the Client Satisfaction Questionnaire (CSQ), a 3-item, validated measure to assess satisfaction with services provided to the participant. Each item is answered on a scale of 1-4 with a total score range of 3-12. Acceptability criteria is \> 75% of participants with a score ≥ the CSQ's midpoint.
Time frame
up to 26 weeksSecondary outcomes
1
Coping Self-Efficacy
Defined by the Measures of Current Status Part A (MOCS-A), a 13-item scale which measures participants' current self-perceived ability on several skills. Each of the 13 items is answered on a scale of 0 (I cannot do this at all) to 4 (I can do this extremely well).
Time frame
up to 26 weeks2
Patient Quality of Life (FACT-G)
Defined by the Functional Assessment of Cancer Therapy General (FACT-G), a 27-item questionnaire designed to measure four domains of health-related QOL in cancer participants. Items are rated on 5-item Likert scale.
Time frame
up to 26 weeks3
Caregiver Quality of Life (CarGOQoL)
Defined by the CareGiver Quality of Life Questionnaire (CarGOQoL), a 29-item questionnaire designed to measure ten dimensions of caregivers of patients with cancer's QOL. Items are rated on a 5-item Likert scale.
Time frame
up to 26 weeksSponsors and contacts
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Source ClinicalTrials.gov