Evidence-Based Psychotherapy Training for Cancer-Related Distress

Overseen By Amy Clara, PsyD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Uncontrolled psychosis, Suicidal ideation, Cognitive impairment, Alcohol dependence, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

Duration: 26 weeks

115 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how specially trained therapists can assist people with cancer in managing distress related to their illness or treatment. Therapists will employ various methods, such as Cognitive Behavioral Therapy (CBT) and mindfulness, to address issues like stress, insomnia, and pain. This approach is part of an Evidence-Based Therapy program specifically designed for cancer-related distress. The trial seeks participants who are receiving treatment for cancer at the Massachusetts General Hospital Cancer Center and experiencing high levels of distress. Participants will engage in therapy sessions, either online or in person, over approximately 26 weeks. As an unphased trial, this study provides a unique opportunity to access innovative therapy methods tailored to individual needs.

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 prior data suggests that this psychotherapy training is safe for cancer patients and therapists?

Studies have shown that evidence-based therapy is safe for cancer patients. These therapies help reduce stress and improve mental health. Common treatments include Cognitive Behavioral Therapy (CBT), Acceptance Commitment Therapy (ACT), and Mindfulness-Based Cognitive Therapy (MBCT). Research indicates that these therapies are well-tolerated and do not cause serious side effects. They help manage distress, pain, and other symptoms related to cancer. Participants typically feel stronger and less anxious after treatment. Overall, these therapies offer a safe way to support mental health during cancer care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to refine and improve therapy for cancer-related distress by tailoring treatment specifically to individual patient needs. Unlike standard therapies that may follow a one-size-fits-all approach, this individualized evidence-based therapy allows for flexibility, offering between 6 to 16 sessions that can be virtual or in-person, and even includes additional booster sessions if needed. The trial also focuses on enhancing the skills of therapists, providing them with specialized training to deliver more effective care. This dual focus on patient-centered treatment and therapist training could lead to more personalized and effective support for those experiencing distress during cancer treatment.

What evidence suggests that this trial's treatments could be effective for cancer-related distress?

Research has shown that certain therapies can reduce stress and emotional distress in cancer patients. Cognitive Behavioral Therapy (CBT), for instance, effectively manages symptoms like pain, tiredness, and nausea. Other therapies, such as Acceptance Commitment Therapy (ACT) and Mindfulness-Based Stress Reduction (MBSR), also help with stress and emotional challenges. Meaning-Centered Psychotherapy (MCP) aids patients in finding meaning in their experiences, easing distress. In this trial, one arm will provide Individualized Evidence-Based Therapy to cancer patients, aiming to improve mood and reduce stress. Another arm will train therapists to deliver these evidence-based therapies, enhancing their competence and self-efficacy in cancer care settings. ^{1 6 7 8 9}

Who Is on the Research Team?

Jamie M Jacobs, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Evidence-Based Therapy
• Individualized Evidence-Based Therapy in Cancer (Patients)
• Training in Evidence-based Treatments in Psycho-Oncology
• Training in Individualized Evidence-Based Therapy in Cancer (Therapists)

Trial Overview

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.

How Is the Trial Designed?

Group I: Training in Individualized Evidence-Based Therapy in Cancer (Therapists) Experimental Treatment 1 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 and Caregivers) Experimental Treatment 1 Intervention

This 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.

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

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

In a study involving 245 cancer patients, both mindfulness-based cognitive therapy (MBCT) and individual internet-based MBCT (eMBCT) significantly reduced psychological distress compared to treatment as usual (TAU), with effect sizes of 0.43 and 0.63 respectively.

Both MBCT and eMBCT were found to be equally effective in alleviating anxiety and depressive symptoms in cancer patients, suggesting that eMBCT could be a viable alternative for those facing barriers to traditional face-to-face therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[RCT about mindfulness-based cognitive therapy for psychological distress in cancer patients]. Compen, F., Bisseling, EM., Schellekens, M., et al.[2019]

Psychological issues are common among cancer patients, and while adjuvant psychological therapy (APT) is recognized, there is limited research on the effectiveness of cognitive behavior therapy (CBT) specifically for this group.

CBT can be adapted for cancer patients, addressing unique emotional responses and vulnerabilities, and may help in preventing relapse of psychological issues, highlighting the need for tailored therapeutic approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer, emotional responses and cognitive behavioural psychotherapy. Farrington, A.[2019]

Psychotherapy has a moderate positive effect on reducing hopelessness and improving hope in cancer patients, based on a synthesis of 27 studies involving 1,998 participants with an average age of 57.6 years.

The effectiveness of psychotherapy was higher when conducted in hospital settings (g=0.63) compared to community settings (g=0.05), and when participants were enrolled alone rather than with partners or caregivers, indicating that the context and structure of therapy can significantly influence outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Psychotherapy on Hope/Hopelessness in Adults with Cancer: a Systematic Review and Meta-analysis. Luo, J., Li, L., Reangsing, C., et al.[2022]

Psychological treatments for distress in cancer patients show consistently positive effects, but the magnitude of these effects varies significantly, especially when patients are not screened for high levels of distress before treatment.

When patients are screened for elevated distress, the effectiveness of these treatments increases dramatically, with observed treatment effect sizes being approximately three times greater, highlighting the importance of targeted recruitment in psycho-oncology studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological treatment outcomes for cancer patients: what do meta-analyses tell us about distress reduction? Linden, W., Girgis, A.[2018]

Early-career providers are more open and positive towards implementing evidence-based treatments (EBTs) in psycho-oncology, indicating a potential target group for training and support.

Current continuing education methods for teaching EBTs are not very effective, suggesting a need for more interactive and tailored educational strategies, along with post-education consultation, to improve implementation in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based psychosocial treatment in the community: considerations for dissemination and implementation. Andersen, BL., Dorfman, CS.[2018]

A one-day training program for 263 cancer care staff significantly boosted their confidence in assessing anxiety and depression and delivering brief psychological interventions, using a method called 'deliberate practice' instead of traditional lectures.

Participants appreciated the focus on practical skills, which may lead to changes in their practice, although some suggested that extending the training duration could enhance its effectiveness even further.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief training in psychological assessment and interventions skills for cancer care staff: a mixed methods evaluation of deliberate practice techniques. Barrett-Naylor, R., Malins, S., Levene, J., et al.[2021]

A training program for 166 oncology mental health providers over six 3-day institutes successfully improved their ability to implement empirically supported psychological treatments (ESTs) for at least 12 months after training.

Key lessons learned from the training included the importance of using theory-based educational strategies to enhance therapists' confidence and adaptability in using ESTs, as well as the value of patient-reported outcomes to measure clinical effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Achieving oncology mental health providers' usage of an empirically supported treatment: Lessons learned. Andersen, BL., Dorfman, CS., Conley, CC.[2023]

Both group face-to-face mindfulness-based cognitive therapy (MBCT) and individual internet-based mindfulness-based cognitive therapy (eMBCT) led to long-term reductions in psychological distress and increases in mental health-related quality of life over a nine-month follow-up period for 245 distressed cancer patients.

Patients who participated in eMBCT reported lower psychological distress compared to those in MBCT, particularly benefiting those with lower baseline mindfulness and conscientiousness, suggesting that eMBCT may be a more effective option for certain individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consolidation and prediction of long-term treatment effect of group and online mindfulness-based cognitive therapy for distressed cancer patients. Cillessen, L., Schellekens, MPJ., Van de Ven, MOM., et al.[2019]

Cognitive-behavioral interventions have been shown to effectively reduce psychological distress in cancer patients, based on evidence from multiple randomized clinical trials.

The review of five recent studies published in top-tier journals indicates that these interventions are not only effective but also well-accepted by patients undergoing cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are psychological interventions effective and accepted by cancer patients? II. Using empirically supported therapy guidelines to decide. Manne, SL., Andrykowski, MA.[2018]

In a study involving 356 cancer patients, the telephone caseworker (TCW) model showed a significant improvement in physical functioning at 3 months compared to usual care, suggesting potential benefits of this intervention.

Participants in the TCW model reported better communication with their healthcare team and were more likely to have their needs addressed, indicating that this model may help in managing psychosocial needs, although no overall intervention effect was observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of two supportive care interventions on anxiety, depression, quality of life, and unmet needs in patients with nonlocalized breast and colorectal cancers. Girgis, A., Breen, S., Stacey, F., et al.[2022]

Psychotherapy has been shown to effectively reduce psychological distress in cancer patients, highlighting its importance in their overall care.

Different types of psychotherapy, including supportive and cognitive behavioral therapies, can be tailored to meet the unique psychological needs of cancer patients, emphasizing the role of trust and empathy in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Practice of psychotherapy for cancer patients]. Oba, A., Yoshikawa, E.[2011]

Systematic reviews, especially meta-analyses, provide strong evidence that psychological interventions are effective in managing distress among cancer patients, particularly for anxiety-related outcomes.

Effectiveness of these interventions tends to be higher when participants are pre-screened for distress, indicating that tailored approaches may enhance treatment success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are psychological interventions effective and accepted by cancer patients? I. Standards and levels of evidence. Andrykowski, MA., Manne, SL.[2018]

Screening for cancer-related distress and referring patients for psychosocial interventions is crucial for cancer center accreditation, emphasizing the importance of not just identifying distress but also effectively treating it.

Evidence-based interventions for cancer distress have shown to improve not only psychological well-being but also biological outcomes, such as enhanced immune functioning and reduced breast cancer recurrence rates, highlighting their efficacy in supporting long-term patient health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychosocial interventions in breast cancer survivorship care. Gudenkauf, LM., Ehlers, SL.[2018]

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