Depression, Anxiety, Distress, Emotional, Fatigue, Insomnia, Pain
Conditions
Keywords
CBT, Cognitive-Behavioral Therapies, Emotional Distress, Anxiety, Depression, Symptom-Related Distress
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.
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.
Interventions
BEHAVIORALIndividualized 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
BEHAVIORALTraining 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.
Sponsors
Massachusetts General Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking 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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evidence-Based Treatment Acceptability | 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
| Measure | Time frame | Description |
|---|---|---|
| Coping Self-Efficacy | 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). |
| Patient Quality of Life (FACT-G) | 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. |
| Caregiver Quality of Life (CarGOQoL) | 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. |
Countries
United States
Contacts
CONTACTJamie Jacobs, Ph.D
CONTACTAmy Clara, PsyD
PRINCIPAL_INVESTIGATORJamie Jacobs, Ph.D
Massachusetts General Hospital
Outcome results
None listed