Recruiting

Psycho-Oncology Training

Sponsor:

Massachusetts General Hospital

Code:

NCT05674357

Conditions

Distress, Emotional

Depression, Anxiety

Fatigue

Pain

Insomnia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Individualized Evidence-Based Therapy in Cancer (Patients and Caregivers)

Training in Individualized Evidence-Based Therapy in Cancer (Therapists)

Study Details

Brief summary:

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.

Conditions

Distress, Emotional

Depression, Anxiety

Fatigue

Pain

Insomnia

Study ID

NCT05674357

Start date

Jan 9, 2023

Status verified date

Jun, 2026

Completion date

Jan 1, 2029

Anticipated

Primary completion date

Jan 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

115 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Primary outcome measure

  • Evidence-Based Treatment Acceptability [ Time Frame: up to 26 weeks ]

Central Contacts and Locations

Central contacts

Jamie Jacobs, Ph.D

617-643-1777jjacobs@mgh.harvard.edu

Amy Clara, PsyD

617-643-1777aclara@partners.org

Locations

Massachusetts General Hospital Cancer Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Jamie Jacobs, Ph.D

617-643-1777jjacobs@mgh.harvard.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Keywords

  • CBT
  • Cognitive-Behavioral Therapies
  • Emotional Distress
  • Anxiety
  • Depression
  • Symptom-Related Distress

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-06-15.