Training in Evidence-based Treatments in Psycho-Oncology
NCT ID: NCT05674357
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
115 participants
INTERVENTIONAL
2023-01-09
2029-01-01
Brief Summary
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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.
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Detailed Description
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Research procedures include screening for eligibility, completion of surveys and questionnaires, and virtual or in-person therapy sessions.
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.
Patient or caregiver participants will be those who a) are currently receiving oncology care, including active treatment and/or surveillance, or caring for someone currently receiving oncology care, b) report elevated levels of distress (≥ 3 on the NCCN Distress Thermometer), c) report that their distress or presenting concerns are related to their illness, their treatment(s), and/or their caregiving experience and d) have a clinical presentation that matches an evidence-based treatment (e.g., CBT-I for insomnia/sleep disturbance) for cancer-related distress per the therapist and the supervising therapist's discretion. The investigators aim to recruit up to 75 patient and 25 caregiver participants to this study over the course of 5 years. Therapist participants will be fellows or residents in the Mass General's Center for Psychiatric Oncology \& Behavioral Sciences. The investigators aim to include up to 15 therapist participants over the course of this 5-year study. The study period for therapist participation would be up to 3 years, and would end either at a) 3 years, b) the point at which the therapist obtains licensure and transitions to faculty member, c) the time the therapist leaves MGH.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Individualized Evidence-Based Therapy in Cancer (Patients and Caregivers)
This arm will enroll patient and caregiver participants receiving evidence-based therapy as part of the protocol.
Participants will complete:
* 6-16 sessions of therapy 1x/week. Sessions are virtual or in-person at the Massachusetts General Hospital Cancer Center.
* Surveys and questionnaires pre- and post-treatment.
At the discretion of the therapist and the supervising therapist, the participant may receive up to 4 booster sessions after completion of the specific treatment protocol.
Individualized Evidence-Based Therapy in Cancer (Patients and Caregivers)
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 pain
* CBT for fatigue
* CBT for nausea
Training in Individualized Evidence-Based Therapy in Cancer (Therapists)
This arm will enroll therapist participants as part of the protocol. Therapists participants will enroll in the study and receive training in delivering evidence-based therapy to patients in the cancer center. Therapists will complete pre and post-measures of therapist self-efficacy and competence, as well as a semi-structured exit interview.
Training in Individualized Evidence-Based Therapy in Cancer (Therapists)
Enrolled therapist participants will receive training in evidence-based therapies and deliver therapy to patient and caregiver participants.
Interventions
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Individualized Evidence-Based Therapy in Cancer (Patients and Caregivers)
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 pain
* CBT for fatigue
* CBT for nausea
Training in Individualized Evidence-Based Therapy in Cancer (Therapists)
Enrolled therapist participants will receive training in evidence-based therapies and deliver therapy to patient and caregiver participants.
Eligibility Criteria
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Inclusion Criteria
* 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).
* Has a clinical presentation that matches an evidence-based treatment (e.g., CBT-I for insomnia/sleep disturbance) for cancer-related distress per therapist and supervising therapist discretion.
* Located in the state of Massachusetts for the duration of sessions.
* Adults \> 18 years of age
* Currently caring for someone 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 caregiving
* Has a clinical presentation that matches an evidence-based treatment (e.g., CBT-I for insomnia/sleep disturbance) for caregiving-related distress per therapist and supervising therapist discretion
* Located in the state of Massachusetts for the duration of sessions
-Current appointment as a clinical psychology fellow or psychiatry resident at the Massachusetts General Hospital or equivalent designation.
Exclusion Criteria
* 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).
-Obtained licensure as a clinical psychologist in any state.
18 Years
ALL
No
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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Jamie Jacobs
Principal Investigator
Principal Investigators
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Jamie Jacobs, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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22-517
Identifier Type: -
Identifier Source: org_study_id
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