Distress, EmotionalNCT05674357
Training in Evidence-based Treatments in Psycho-Oncology
A study testing Individualized Evidence-Based Therapy in Cancer (Patients and Caregivers) and Training in Individualized Evidence-Based Therapy in Cancer (Therapists) in people with Distress, Emotional and Depression, Anxiety, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distress, Emotional, Depression, Anxiety, Fatigue
- What is being tested?
- Individualized Evidence-Based Therapy in Cancer (Patients and Caregivers) and Training in Individualized Evidence-Based Therapy in Cancer (Therapists)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2023to 1 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02215
Jamie Jacobs, Ph.D, 617-643-1777, jjacobs@mgh.harvard.edu
About this study
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.
Read more
- 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.
Read the 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.
- Conditions
- Distress, Emotional, Depression, Anxiety, Fatigue, Pain, Insomnia
- Being tested
- Individualized Evidence-Based Therapy in Cancer (Patients and Caregivers), Training in Individualized Evidence-Based Therapy in Cancer (Therapists)
- Keywords
- CBT, Cognitive-Behavioral Therapies, Emotional Distress, Anxiety, Depression, Symptom-Related Distress
- Medical subject headings
- Depression, Anxiety Disorders, Fatigue, Pain, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized Evidence-Based Therapy in Cancer (Patients and Caregivers)Behavioural
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)Behavioural
Enrolled therapist participants will receive training in evidence-based therapies and deliver therapy to patient and caregiver participants.
| Study group | Role | What they receive |
|---|---|---|
| Individualized Evidence-Based Therapy in Cancer (Patients and Caregivers) | Experimental | 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. Receives: Behavioral: Individualized Evidence-Based Therapy in Cancer (Patients and Caregivers) |
| Training in Individualized Evidence-Based Therapy in Cancer (Therapists) | Experimental | 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. Receives: Behavioral: Training in Individualized Evidence-Based Therapy in Cancer (Therapists) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 26 weeks
Secondary outcomes (3)
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).
Measured: 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.
Measured: 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.
Measured: up to 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start9 Jan 2023
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distress, EmotionalStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- There will be two groups in this study- one is patient and caregiver participants (n=100) and the other is therapist participants (n=15). Therapist participants will deliver evidence-based therapy treatments to patients participants. Outcomes in each group will not be compared to each other.
- Masking
- None (open label)
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamie Jacobs, Massachusetts General Hospital
- Investigators
- Jamie Jacobs, Ph.D, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05674357
- Sponsor's protocol ID
- 22-517
- Status last verified
- Jun 2026
- First submitted
- 21 Dec 2022
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training in Evidence-based Treatments in Psycho-Oncology
- ClinicalTrials.gov ID
- NCT05674357
- Acronym / sponsor ID
- 22-517
- Conditions
- Distress, Emotional, Depression, Anxiety, Fatigue, Pain, Insomnia
- Keywords
- CBT, Cognitive-Behavioral Therapies, Emotional Distress, Anxiety, Depression, Symptom-Related Distress
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 6 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There will be two groups in this study- one is patient and caregiver participants (n=100) and the other is therapist participants (n=15). Therapist participants will deliver evidence-based therapy treatments to patients participants. Outcomes in each group will not be compared to each other.
| Arm | Type | Receives |
|---|---|---|
| Individualized Evidence-Based Therapy in Cancer (Patients and Caregivers) | Experimental | Behavioral: 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. |
| Training in Individualized Evidence-Based Therapy in Cancer (Therapists) | Experimental | Behavioral: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | Individualized Evidence-Based Therapy in Cancer (Patients and Caregivers) |
| 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. | Behavioural | Training in Individualized Evidence-Based Therapy in Cancer (Therapists) |
Primary outcome
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.
3 secondary outcomes
Coping Self-Efficacy
Time frame: up to 26 weeks
Patient Quality of Life (FACT-G)
Time frame: up to 26 weeks
Caregiver Quality of Life (CarGOQoL)
Time frame: up to 26 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jamie Jacobs, Ph.D principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized Evidence-Based Therapy in Cancer (Patients and Caregivers) and Training in Individualized Evidence-Based Therapy in Cancer (Therapists) in people with Distress, Emotional and Depression, Anxiety, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jamie Jacobs, Ph.D (617-643-1777, jjacobs@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence-Based Treatment Acceptability (time frame: up to 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.