Training in Evidence-based Treatments in Psycho-Oncology

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.

Study Overview

• Status: Recruiting
• Conditions: Pain; Fatigue; Insomnia; Depression, Anxiety; Distress, Emotional
• Intervention / Treatment: Behavioral: Individualized Evidence-Based Therapy in Cancer (Patients and Caregivers); Behavioral: Training in Individualized Evidence-Based Therapy in Cancer (Therapists)

Detailed Description

This is a single-arm, behavioral intervention study to train psychotherapists to administer individualized evidence-based psychotherapies in a cancer care setting to patients and caregivers with elevated levels of distress related to their illness, treatment and/or caregiving responsibilities. For participants with cancer and their caregivers, common treatment goals include improving health behaviors, reducing psychological symptoms that may exacerbate medical disability, and/or improving functional status.

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.

• Study Type: Interventional
• Enrollment (Estimated): 115
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jamie Jacobs, Ph.D; Phone Number: 617-643-1777; Email: jjacobs@mgh.harvard.edu
• Study Contact Backup: Name: Amy Clara, PsyD; Phone Number: 617-643-1777; Email: aclara@partners.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Massachusetts General Hospital Cancer Center
      • Contact: Jamie Jacobs, Ph.D; Phone Number: 617-643-1777; Email: jjacobs@mgh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Patient Inclusion Criteria:

• 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).
• 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.

Caregiver Inclusion criteria:

• 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

Patient Exclusion Criteria:

• 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).

Therapist Inclusion criteria:

-Current appointment as a clinical psychology fellow or psychiatry resident at the Massachusetts General Hospital or equivalent designation.

Therapist Exclusion criteria:

-Obtained licensure as a clinical psychologist in any state.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
Experimental: 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.	Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 26 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	up to 26 weeks
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.	up to 26 weeks
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.	up to 26 weeks

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Jamie Jacobs, Ph.D, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2023
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: December 21, 2022
• First Submitted That Met QC Criteria: December 21, 2022
• First Posted (Actual): January 6, 2023

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Depression; Anxiety; CBT; Emotional Distress; Cognitive-Behavioral Therapies; Symptom-Related Distress
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Pain; Anxiety Disorders; Depression; Fatigue; Sleep Initiation and Maintenance Disorders; Health Care Facilities Workforce and Services; Health Personnel; Caregivers
• Other Study ID Numbers: 22-517

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication.
• IPD Sharing Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No