Training in Evidence-based Treatments in Psycho-Oncology
1 other identifier
interventional
115
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 21, 2022
CompletedFirst Posted
Study publicly available on registry
January 6, 2023
CompletedStudy Start
First participant enrolled
January 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2029
January 12, 2026
December 1, 2025
5 years
December 21, 2022
January 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Coping Self-Efficacy
up to 26 weeks
Patient Quality of Life (FACT-G)
up to 26 weeks
Caregiver Quality of Life (CarGOQoL)
up to 26 weeks
Study Arms (2)
Individualized Evidence-Based Therapy in Cancer (Patients and Caregivers)
EXPERIMENTALThis 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)
EXPERIMENTALThis 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
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
Enrolled therapist participants will receive training in evidence-based therapies and deliver therapy to patient and caregiver participants.
Eligibility Criteria
You may qualify if:
- 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.
- 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
You may not qualify if:
- 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).
- Current appointment as a clinical psychology fellow or psychiatry resident at the Massachusetts General Hospital or equivalent designation.
- Obtained licensure as a clinical psychologist in any state.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jamie Jacobs, Ph.D
Massachusetts General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Masking Details
- 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.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 21, 2022
First Posted
January 6, 2023
Study Start
January 9, 2023
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
January 1, 2029
Last Updated
January 12, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication.
- Access Criteria
- Contact the Partners Innovations team at http://www.partners.org/innovation
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.