Evidence-Based Psychotherapy Training for Cancer-Related Distress
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Massachusetts General Hospital
Disqualifiers: Uncontrolled psychosis, Suicidal ideation, Cognitive impairment, Alcohol dependence, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.
What data supports the effectiveness of the treatment Evidence-Based Psychotherapy for Cancer-Related Distress?
Research shows that cognitive-behavioral interventions, a type of evidence-based psychotherapy, are effective in reducing psychological distress in cancer patients. These interventions are well-accepted by patients and have been shown to improve emotional functioning and manage anxiety and depression.
12345Is evidence-based psychotherapy safe for cancer patients?
Psychotherapy, including evidence-based approaches, is generally considered safe for cancer patients and can help reduce psychological distress. Various types of psychotherapy, such as cognitive behavioral therapy and supportive psychotherapy, have been used effectively without significant safety concerns.
16789How is the Evidence-Based Psychotherapy Training for Cancer-Related Distress treatment different from other treatments for cancer-related distress?
This treatment is unique because it uses evidence-based psychotherapy specifically tailored for cancer patients, focusing on reducing psychological distress through cognitive-behavioral interventions, which have been shown to be effective and well-accepted by patients. It emphasizes individualized care and training for cancer care staff to improve their psychological assessment and intervention skills.
210111213Eligibility Criteria
This trial is for adults over 18 in Massachusetts with cancer-related distress, who are receiving care at MGH Cancer Center. They must report significant distress related to their illness or treatment and be a clinical psychology fellow or psychiatry resident. Excluded are those with uncontrolled psychosis, recent psychiatric hospitalization, cognitive impairments that prevent participation, current psychotherapy involvement, or recent substance dependence.Inclusion Criteria
My symptoms match a known treatment for cancer-related stress.
Located in the state of Massachusetts for the duration of sessions
Reports elevated levels of distress on the National Comprehensive Cancer Network (NCCN) Distress Thermometer > 3
+3 more
Exclusion Criteria
Has a cognitive impairment that prohibits participation in the study (assessed through EHR review and screening session)
I have not had uncontrolled psychosis, suicidal thoughts, or psychiatric hospitalization in the past year.
I have not had alcohol or substance dependence (except for nicotine) in the last 8 weeks.
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (virtual or in-person)
Treatment
Participants receive individualized evidence-based psychotherapies, including CBT, ACT, MBCT, MBSR, MCP, CBT-I, and CBT for other cancer-related symptoms
26 weeks
6-16 sessions (1x/week, virtual or in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment, with optional booster sessions
4 weeks
Up to 4 booster sessions (at therapist's discretion)
Participant Groups
The study trains therapists to provide personalized evidence-based psychotherapies like CBT and ACT to cancer patients experiencing distress. Therapists will choose treatments based on the patient's specific issues such as insomnia or pain. The goal is to see how well these therapies help reduce emotional and physical symptoms caused by cancer.
2Treatment groups
Experimental Treatment
Group I: Training in Individualized Evidence-Based Therapy in Cancer (Therapists)Experimental Treatment1 Intervention
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.
Group II: Individualized Evidence-Based Therapy in Cancer (Patients)Experimental Treatment1 Intervention
This arm will enroll patient 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.
Evidence-Based Therapy is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Evidence-Based Psychotherapy for:
- Cancer-related distress
- Anxiety
- Depression
- Insomnia
- Pain management
- Fatigue management
- Nausea management
🇪🇺 Approved in European Union as Evidence-Based Psychotherapy for:
- Cancer-related distress
- Anxiety
- Depression
- Insomnia
- Pain management
- Fatigue management
- Nausea management
🇨🇦 Approved in Canada as Evidence-Based Psychotherapy for:
- Cancer-related distress
- Anxiety
- Depression
- Insomnia
- Pain management
- Fatigue management
- Nausea management
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Massachusetts General Hospital Cancer CenterBoston, MA
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Who Is Running the Clinical Trial?
Massachusetts General HospitalLead Sponsor
References
Effects of Psychotherapy on Hope/Hopelessness in Adults with Cancer: a Systematic Review and Meta-analysis. [2022]Although psychotherapy is a common treatment for hopelessness and hope, the effectiveness remains controversial. The purpose of this study was to quantitatively synthesize available evidence related to the effect of a broad range of psychotherapy interventions on hope/hopelessness in cancer patients.
Are psychological interventions effective and accepted by cancer patients? II. Using empirically supported therapy guidelines to decide. [2018]We begin our discussion of the efficacy of psychological interventions for cancer patients by defining basic terms. We define efficacy using evidence-based medicine guidelines. According to these guidelines, an intervention is considered efficacious if two or more randomized clinical trials report positive and significant outcomes. Using this guideline as well as other evidence-based medicine criteria, we rate five recent intervention studies published in top-tier journals. The results of this review suggested that there is sufficient evidence to conclude that cognitive-behavioral interventions are effective in reducing and managing psychological distress in cancer patients and are accepted by these patients.
Cancer, emotional responses and cognitive behavioural psychotherapy. [2019]Cancer and its treatment is known to have a substantial psychological morbidity and, while adjuvant psychological therapy (APT) is well established, relatively little work has been done to investigate the effectiveness of psychotherapy, particularly cognitive behaviour therapy (CBT), for patients with cancer. This article focuses initially on emotional responses to the diagnosis of cancer, individual vulnerability and the prevalence of psychological problems in patients with cancer. The use of cognitive behaviour therapy is then described, together with key issues in its application and specific problems. The work concludes by considering differences in applying CBT to patients with cancer compared to patients with other physical illnesses and the notion of 'relapse inoculation'.
Evidence-based psychosocial treatment in the community: considerations for dissemination and implementation. [2018]In psycho-oncology care, steps toward dissemination and implementation of evidence-based treatments (EBTs) have not been made. For this to change, factors associated with real-world dissemination and implementation must be identified. In the community, providers, their organizations, and patients are key stakeholders.
Impact of two supportive care interventions on anxiety, depression, quality of life, and unmet needs in patients with nonlocalized breast and colorectal cancers. [2022]Patients with cancer experience considerable symptom burden, psychological morbidity, and unmet psychosocial needs. Research suggests that feedback of patient-reported outcomes to clinicians or caseworkers, alongside management strategies, may result in improved patient functioning. Two intervention models were developed to test this effect in a randomized, controlled trial against usual care (UC): a telephone caseworker (TCW) model and an oncologist/general practitioner (O/GP) model. Primary end points included anxiety, depression, physical/emotional functioning, and unmet supportive care needs.
[RCT about mindfulness-based cognitive therapy for psychological distress in cancer patients]. [2019]Cancer patients may experience psychological distress, like anxiety and depressive symptoms. Mindfulness-based cognitive therapy (MBCT) has been shown to alleviate this psychological distress. However, patients experience barriers in participating in face-to-face MBCT. Individual internet-based MBCT (eMBCT) could be an alternative. AIM: To compare MBCT and eMBCT to treatment as usual (TAU) for psychological distress in cancer patients. METHOD: 245 cancer patients with psychological distress were randomly allocated to MBCT (n = 77), eMBCT (n = 90) or TAU (n = 78). Patients completed baseline (T0) and post-intervention (T1) assessments. The primary outcome was psychological distress on the Hospital Anxiety and Depression Scale. Outcomes were analyzed using linear mixed modeling on the intention-to-treat sample. Since both interventions were compared to TAU, the type I error rate was set to p RESULTS: Compared to TAU, patients reported significantly less psychological distress after both MBCT (Cohen's d = 0.43, p CONCLUSION: Compared to TAU, MBCT and eMBCT were similarly effective in reducing psychological distress in a sample of distressed heterogeneous cancer patients.
[Practice of psychotherapy for cancer patients]. [2011]Cancer is a threat to life and to the psychological well-being of patients. Previous studies have demonstrated that several patients with cancer have suffered from psychological distress. Psychotherapy for cancer patients is effective against psychological distress. There are several kinds of psychotherapy for these patients, such as supportive psychotherapy, cognitive behavioral psychotherapy including relaxation techniques and cognitive restructuring, and supportive-expressive group psychotherapy. Supportive psychotherapy is feasible for many clinicians. Psychotherapists develop a trustful relationship with patients, provide an empathic posture, and use various types of psychotherapeutic treatments. It is important for psychotherapists to understand the psychological background of such patients from various viewpoints.
Consolidation and prediction of long-term treatment effect of group and online mindfulness-based cognitive therapy for distressed cancer patients. [2019]Group face-to-face and individual internet-based mindfulness-based cognitive therapy (MBCT and eMBCT) have been demonstrated to reduce psychological distress for distressed cancer patients in a randomized controlled trial (RCT). This study focused on the long-term effects of this RCT during the nine-month follow-up period, and on possible predictors, moderators and working mechanisms.
Psychosocial interventions in breast cancer survivorship care. [2018]Cancer distress screening and subsequent referral for psychosocial intervention has been mandated for continued cancer center accreditation. Increasing emphasis is being placed on the referral component of this mandate, ensuring that patient distress is not only identified but also effectively treated. Many evidence-based interventions exist for cancer distress. Specific interventions can effectively target biopsychosocial impacts of stress and promote adaptive coping, focusing on problem-solving, social support utilization, assertive communication, sexual health and intimacy, adherence to medical and supportive care recommendations, health behavior change, and emotional processing and expression. In randomized clinical trials, specific interventions have also been associated with biological improvements, including neuroendocrine and immune functioning, decreased rates of breast cancer recurrence, and improved survival rates. As cancer treatments advance and patients live longer, it is pertinent to treat the impacts of breast cancer with evidence-based interventions.
Are psychological interventions effective and accepted by cancer patients? I. Standards and levels of evidence. [2018]Different standards and levels of evidence for evaluating the effectiveness of psychological interventions for managing distress in cancer patients are presented and discussed. We conclude that the strongest evidence comes from systematic qualitative and quantitative (i.e., meta-analyses) reviews of the relevant literature and that the most appropriate standard of evidence is the "preponderance of evidence" rather than "beyond a reasonable doubt." Results of four selected qualitative and quantitative systematic reviews of the literature are described. The preponderance of evidence furnished by these systematic reviews, particularly that gleaned from meta-analyses, suggests that psychological interventions are effective in managing distress in cancer patients. Although effectiveness may vary as a function of the specific nature of the intervention, overall, effectiveness appears strongest for anxiety-related outcomes and when participants are prescreened for distress. Different standards and indexes for evaluating evidence regarding the acceptability of psychological interventions with cancer patients are presented and discussed. The use of simple study accrual rates as an index of intervention acceptability is deemed inappropriate. We suggest alternative indexes of acceptability and conclude that sufficient information does not exist at the present time to draw the conclusion that contemporary psychological interventions for managing distress in cancer patients are unacceptable.
Brief training in psychological assessment and interventions skills for cancer care staff: a mixed methods evaluation of deliberate practice techniques. [2021]Unaddressed anxiety and depression is common among cancer patients and has significant adverse consequences. Cancer staff training is recommended for psychological assessment and interventions to address depression and anxiety, to increase access to psycho-social oncology care. However, psychological skills training has a poor track-record for improving clinical effectiveness. "Deliberate practice", receiving feedback on therapeutic micro-skills and rehearsing modifications, can enhance clinical effectiveness. This study applied deliberate practice to maximise benefits of brief psychological skills training for cancer care staff.
Psychological treatment outcomes for cancer patients: what do meta-analyses tell us about distress reduction? [2018]The effectiveness of psychological treatment for distress reduction in cancer patients has been frequently studied and reviewed in systematic reviews but reviewer conclusions vary considerably. Clear and consistent evidence is needed to assist clinicians and administrators with their decision-making. We hypothesized that uneven handling of confounding methodological features are at least partly the reason for disagreements and reviewed the literature in this light.
Achieving oncology mental health providers' usage of an empirically supported treatment: Lessons learned. [2023]There is a need for oncology mental health providers to receive training to use empirically supported psychological treatments (ESTs) with their patients. The purpose of this editorial is to describe "lessons learned" from disseminating-conducting EST trainings-and supporting providers' capacity and confidence to use the EST.