Patient case: 68-year-old male with colon cancer; genetic feature: MLH1 methylation suppression (microsatellite instability)

Clinical trial: Leveraging Mindsets to Improve Health & Wellbeing in Patients With Cancer

Summary: Mindsets are lenses or frames of mind that orient individuals to a particular set of expectations and associations. This study aims to leverage specific and empirically supported mindsets (i.e., 'cancer is manageable' and 'the body is capable') to reduce distress and improve physical health and psychological wellbeing in patients with cancer being treated with curative intent. This intervention will take the form of several brief documentary style film segments which feature both cancer survivors and experts in the fields of Oncology, Psychology, and Psychiatry.
  Although no mindset-targeted interventions have been studied in cancer patients to date, other psychosocial interventions have demonstrated efficacy in treating emotional distress and improving quality of life in this population. However, compared with these standard interventions, mindset interventions need not be lengthy, complex, or costly to yield major effects. Thus, this project aims to lay the groundwork for future scalable and efficient interventions that can meaningfully reduce distress and improve health and wellbeing in this population.

Detailed description: A diagnosis of cancer causes significant emotional distress in a substantial proportion of patients. This distress impacts physical and mental health outcomes and often goes unrecognized and untreated. Psychosocial interventions have been proven effective in ameliorating cancer related distress. While the literature supports the use of standard psychosocial interventions like Mindfulness Based Stress Reduction (MBSR) and Cognitive Behavioral Therapy (CBT) for cancer patients, effects are typically only found in interventions lasting longer than 12 weeks. This constraint represents a considerable time commitment on the part of the patient and large financial commitment on the part of the healthcare system. As such, there is a need for brief, scalable, cost-effective interventions that are informed by psychological theory but do not require access to trained mental health professionals and could potentially be delivered by oncology clinicians during cancer treatment without specialized referrals. This may also facilitate better comprehensive care for patients without insurance covering mental health services.
  Interventions that target mindsets may be well suited to fill this need. A mindset is a lens or frame of mind that orients an individual to a particular set of associations and expectations. Mindsets may serve as an important psychosocial variable that can be leveraged to improve health outcomes. The impact of mindsets has been documented extensively in the context of stress, diet, and exercise. Mindsets also likely play a large role in shaping other clinical outcomes including blood pressure and hormone response as well. Because mindset interventions target specific mindsets rather than more general cognitive or affective processes, they can effectively shape downstream targets like attention, motivation, affect, and physiology despite their apparent brevity.
  Mindsets in clinical populations have been relatively understudied. However, preliminary findings indicate that mindsets about the body, illness, and medications are significantly related to critical health outcomes and quality of life in individuals with chronic illness. For instance, patients with cancer who endorsed the mindset that cancer is a catastrophe reported lower levels of physical and social functioning, worse quality of life, and poorer perceived health. Conversely, patients who adopted the mindset that cancer is manageable or the mindset that cancer can be an opportunity to make important life changes or pursue goals reported better physical functioning, social functioning, perceived health, and quality of life.
  This study aims to understand patient mindsets and quantify the impact of a highly targeted mindset intervention in a diverse population of patients with cancer. The investigators hypothesize that mindsets will also impact treatment efficacy, reporting and management of adverse events, physiological markers of health and disease, global functioning, quality of life, and fear of recurrence in individuals diagnosed with cancer and treated with curative intent.

Eligibility: Inclusion Criteria:
  -  Patients diagnosed with lung cancer (small cell, non-small cell), breast cancer (any), GI/Colorectal cancer (colon, rectal), or Lymphoma (Hodgkins, Low Grade, Diffuse Large B-Cell, Mantle Cell, T-Cell) to be treated with curative intent.
  -  Receiving at least one course of systemic treatment.
  -  Age ≥ 18 years who are fluent in English and are without cognitive impairment.
  -  Ability to understand and willingness to sign a written informed consent document.
  Exclusion Criteria:
  -  Failure to meet any of the inclusion criteria.
  -  Surgical procedures, if applicable, must take place either before the initiation of systemic treatment or after the last infusion.
  -  Patients who have major comorbidities that would substantially reduce life expectancy despite successful cancer treatment (i.e., comorbid end stage heart disease or kidney disease) will not be included in this study.
  -  No active major mental health diagnoses including severe depression, severe anxiety, bipolar / manic depressive disorder, post-traumatic stress disorder, schizophrenia, or any psychotic disorder. Patients with mild depression or anxiety, or depression or anxiety that is well managed with treatment, will not be excluded .
  -  Patients with a previous diagnosis of cancer (cancer survivors) will be excluded from this study. Cancer survivors may already have preconceived notions about the nature of a cancer diagnosis and the course of treatment, and therefore may not respond to our intervention in the same way as individuals who are encountering a cancer diagnosis for the first time.

Relevance to patient case: not relevant