Training in Evidence-based Treatments in Psycho-Oncology

Pain Clinical Trial

Official title:

Training in Evidence-based Treatments in Psycho-Oncology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05674357
• Other study ID #: 22-517
• Status: Recruiting
• Phase: N/A
• Start date: January 9, 2023
• Est. completion date: January 1, 2029

Study information

• Verified date: February 2024
• Source: Massachusetts General Hospital
• Contact: Jamie Jacobs, Ph.D
• Phone: 617-643-1777
• Email: jjacobs[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this research study is to train psychotherapists to administer individualized evidence-based psychotherapies in a cancer care setting to participants with elevated levels of distress due to their illness and/or treatment.

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 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 100 people and 15 therapists will take part in this research study.

Description:

This is a single-arm, behavioral intervention study to train psychotherapists to administer individualized evidence-based psychotherapies in a cancer care setting to participants with elevated levels of distress related to their illness and/or treatment. For participants with cancer, 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 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 100 people and 15 therapists will take part in this research study.

Patient participants will be those who a) are currently receiving oncology care, including active treatment and/or surveillance, 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 and/or their treatment(s), 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 100 patient 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 115
• Est. completion date: January 1, 2029
• Est. primary completion date: January 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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 MINI), 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 MINI), 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.

Related Conditions & MeSH terms

• Depression
• Depression, Anxiety
• Distress, Emotional
• Fatigue
• Insomnia
• Pain

Intervention

Behavioral:
• Individualized Evidence-Based Therapy in Cancer (Patients)
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 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 participants.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence-Based Treatment Acceptability	Patients' 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	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
Secondary	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