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NCT Number: NCT05674357

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02215, United States

Location status: Recruiting

Location contact

Jamie Jacobs, Ph.D

CONTACT

[email protected]

617-643-1777

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Behavioral

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)

Behavioral

Enrolled therapist participants will receive training in evidence-based therapies and deliver therapy to patient and caregiver participants.

Primary outcomes

  1. Evidence-Based Treatment Acceptability

    Time frame: up to 26 weeks

    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.

Secondary outcomes

  1. Coping Self-Efficacy

    Time frame: up to 26 weeks

    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).

  2. Patient Quality of Life (FACT-G)

    Time frame: up to 26 weeks

    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.

  3. Caregiver Quality of Life (CarGOQoL)

    Time frame: up to 26 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amy Clara, PsyD

CONTACT

[email protected]

617-643-1777

Jamie Jacobs, Ph.D

CONTACT

[email protected]

617-643-1777

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2028
Study completion
2029
First posted
Jan 6, 2023
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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