New study trains therapists to tackle Cancer's hidden toll: anxiety, pain, and insomnia
NCT ID NCT05674357
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aims to train psychotherapists to deliver personalized, evidence-based therapies to cancer patients and their caregivers who are experiencing high levels of distress. Therapists will choose from treatments like cognitive behavioral therapy and mindfulness-based stress reduction based on each person's needs. About 75 patients, 25 caregivers, and 15 therapists will take part over 26 weeks. The goal is to see if this approach is acceptable and helpful for managing emotional and physical symptoms.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 115 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2023
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Massachusetts General Hospital Cancer Center
RECRUITINGBoston, Massachusetts, 02215, United States
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