Clinical Trials and Mental Health

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Clinical Trials Focused on Mental Health and Colorectal Cancer

Colorectal cancer and mental health are two topics that make people extremely uncomfortable to talk about, but there shouldn’t be shame or stigma attached to either. 

This month Maia and Manju discuss clinical trials promoting taking care of your mental health while dealing with colorectal cancer. The trials below span from using old-fashioned pen and paper to virtual reality to mindfulness.

Maia, what are some clinical trials to help people feel stress relief or pain relief while they are being treated or have been treated for colorectal cancer?

Virtual Trial to Compare Two Digital Therapeutics as Interventions for Physical and Mental Health in People with Cancer (RESTORE) (NCT05227898)

This trial is for stage I through stage III cancer patients with elevated anxiety symptoms. It is for those who are receiving systemic treatment or have received it within the past six months. Eligible patients from anywhere in the United States can enroll in it, since it is a virtual study – they will participate from home, without having to visit a clinic.

During 12 weeks, patients will receive access to one of the two apps, on their smartphone or tablet, and use it to complete 10 informational sessions, each approximately 60 minutes in length. The app also includes guided exercises and other interactive opportunities. More details about this trial with these software-based approaches to support cancer patient well-being are available here.

Expressive Writing for the Management of Stress in Cancer Survivors (NCT04776941)

This clinical trial at MD Anderson evaluates the effect of expressive writing (EW) for the management of stress in cancer survivors. It is a virtual study, which enrolls adults with a diagnosis of any type of cancer who were diagnosed within the past three years. These participants must be able to speak and read in English, and have access to a computer or smartphone with internet connection.

All of the patients complete questionnaires (which take more than 30 minutes) about their mood, health, and income at the start of the study, and at one, three, and six months. Half of the patients read brief neutral messages and write essays about neutral topics over 30 minutes (nonstop) once weekly, for three weeks. The other half of the patients read brief messages with positive content and write essays, too, in the same conditions, but about their own experiences.Previous clinical trials support the use of expressive writing to improve quality of life in breast cancer survivors and favored improvements in cancer-related symptoms and fatigue levels in renal cell carcinoma. The current study investigates the effect of expressive writing specifically related to stress and aims to find out if this approach is equally effective as virtual, not in-person intervention. The researchers observe that the stress that most cancer survivors face “can be further exacerbated by social upheavals, such as the COVID-19 pandemic. For safety reasons, many patients are isolated with restricted access to in-person health care and reduced social interaction with family and friends. Together, with the economic uncertainties that come with this pandemic, these factors are likely to increase cancer survivors' stress levels. Expressive writing may provide a medium through which cancer survivors confront stressors and find meaning in their experience.”

Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes (NCT04907643)

While the first trial listed involves mainly paper and pen, a really low-tech intervention, this study at Cedars-Sinai Medical Center (Los Angeles, CA) evaluates how a novel technology, virtual reality (VR), might help patients to manage gastrointestinal (GI) cancer pain.

Experiencing severe abdominal pain negatively affects physical, emotional, and social function, and overall quality of life for many cancer patients. Therapeutic use of VR has emerged as a promising and evidence-based treatment modality for management of cancer pain. Users of VR wear a pair of goggles with a close-proximity screen in front of the eyes that creates a sensation of being transported into lifelike, 3D worlds. To date, VR has been limited to short-term clinical trials for cancer pain. In addition, limited research exists on theory-based VR modalities beyond mere distraction.

With the goal of effectively improving quality of life/easing pain with this intervention, this study will measure patient-reported outcomes (PROs) and opioid use among three groups of users.

All participants will be provided with a VR audio and visual headset that comes with an orientation-tracked controller, supports three degrees of freedom (3DOF) head tracking, has best-in-class optics, and a wide field of view. It does not require a smartphone or personal computer to operate. Participants will be asked to actively use the headset for four weeks on a daily basis, following the specific instructions for their assigned intervention: 1. Immersive skills-based VR therapy; 2. Immersive distraction VR therapy; and 3. Non-immersive sham VR using 2D videos displayed in a VR headset.

The skills-based treatment will use virtual healing environments to teach patients about meditation, breathing exercises, and pain management. The distraction treatment will use immersive videos that are designed to take the mind off of pain. The sham VR will use VR goggles, but patients will only watch a 2D video rather than a 3D, immersive experience.

Manju, what interesting mental health clinical trials do you want to share with us this month?

Mindfulness-Based Intervention for Latino Cancer Patients and Their Caregivers (NCT04870788)

This 60 participant interventional clinical trial conducted at the MD Anderson Cancer Center develops effective and appropriate mindfulness-based interventions that help meet the needs of Latino cancer patients and their family caregivers. Mindfulness-based interventions focus on building awareness of thoughts, emotions/feelings, and sensations. This study may help improve mental well-being and reduce stress and anxiety associated with having cancer or with a family member's cancer diagnosis. The primary objectives of the trial are to adapt a mindfulness-based intervention to improve psychological well-being in Latino patients with advanced cancer and their family caregivers, and to evaluate its feasibility in Latino patient-family caregiver dyads.The secondary objectives are to find out the effects of the adapted mindfulness techniques on patient and caregiver psychological distress, quality of life, and patient cancer symptoms, compared to a waitlist control.

In the study, patients with stage III or stage IV solid tumors and their caregivers will be randomized into one of two groups. In group one, patients and caregivers will receive mindfulness coaching for 60 minutes a week for four weeks. In group two patients and their caregivers will receive mindfulness coaching for 60 minutes a week for four weeks at 12 weeks after starting the study. Participants get a quality-of-life assessment and a questionnaire at six and 12 weeks.

Psychotherapy Intervention for Latinos With Adv Cancer (NCT04537936)

The purpose of this 285 participant study is to adapt a counseling intervention called Meaning Centered Psychotherapy to make it culturally relevant for Latinos. This study will try to understand factors that affect Latino patients' quality of life and how to improve it. Latinos often experience greater challenges due to cancer,  yet few studies and interventions focus on this group of patients.

This project has five phases. In phase one and phase two, the study team will work to understand the sources of meaning, hope, legacy, and identity in Latino patients with advanced cancer, and to explore Meaning Centered Psychotherapy to Latinos diagnosed with advanced cancer. Patients will be recruited from Memorial Sloan Kettering Cancer Center (MSKCC), and Lincoln Medical and Mental Health Center (LMC), a public hospital in a Latino-dense region. Eligible cancer patients will also be recruited through Dr. Gany’s Integrated Cancer Care Access Network (ICCAN) of MSKCC’s Immigrant Health and Cancer Disparities Service. ICCAN uses bilingual access facilitators to assist patients in identifying their needs.

In phase three, mental health providers will be interviewed to find out what else may be helpful to patients. Phase four will include patient interviews to learn about patient feedback. Phase five is a randomized pilot study, which will collect preliminary data on the feasibility of recruitment, retention, adherence, and acceptability of the content of the intervention and key outcomes. This part will include 60 Spanish-speaking advanced cancer patients enrolled and randomized to the intervention or control arm, which is the enhanced usual care arm.

The primary outcome is measurement of spiritual well-being, and the secondary outcomes include measurement of depression, anxiety, hopelessness, and quality of life.

To learn more about clinical trials, be sure to follow our blog series highlighting various trials each month. You can also sign up for Fight CRC’s patient eGuide each month at FightCRC.org. Also be sure to check the IG Live with Ryan Shadle on mental health, IG Live with Yla Flores on mental health stigma surrounding Latina women and the podcast, Don’t Tell Me How the F*$% to Feel, with Jana Bolduan Lomax, PsyD, Director of Cancer Support Services at Saint Joseph Hospital in Colorado.

Stay Tuned for More!

Once a month, Maia and Manju will spend time unpacking important research trials, tips, and advice for our community. Be sure to subscribe to sign up with Fight CRC and join COLONTOWN’s online community to continue receiving the most relevant updates in the CRC world!

You can also follow Maia (@sassycell) and Manju (@manjuggm) to stay updated on research and trials and visit ClinicalTrials.gov for more information on trials.

Be sure to check out these Fight CRC resources:

More Clinical Trial Conversations:

Clinical trials are critical to finding a cure for colorectal cancer. As an advocacy organization dedicated to supporting and empowering a community of patients, caregivers and families, Fight CRC has partnered with COLONTOWN to deliver a monthly blog series highlighting everything patients need to know about clinical trials and the best treatment options available. 

In this series, we hope to cover promising trials that are enrolling, lessons learned from past research, logistics and resources to joining a clinical trial, and provide relevant and timely updates for our colon and rectal cancer community. 

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