Leveraging Mindsets to Improve Health and Wellbeing in Patients With Cancer

Leveraging Mindsets to Improve Health and Wellbeing in Cancer Patients

Primary Objectives:

Mindsets have been rigorously studied in the domains of development, education, and more recently, in health and disease. However, there are no large-scale longitudinal studies of the mindsets held by cancer patients and how they may affect treatment outcomes, physical health, and psychological well-being. This randomized, single-blind, treatment-as-usual (TAU) control study aims to assess (1) mindsets at four time points spanning from the point of diagnosis to six weeks post-treatment to patients who are newly diagnosed with cancer and undergoing treatment with curative intent, and (2) the impact of a brief but targeted mindset intervention to help instill more useful mindsets about the nature of cancer and the role of the body on patient reported measures of physical and psychological health. This study aims to add to the existing literature on psychosocial interventions for cancer patients and survivors while addressing the substantial time and cost limitations of traditional interventions. It also contributes to the body of research indicating that mindsets play an important role in both health and wellbeing.

Secondary Objectives:

This study has two secondary objectives. First, we aim to determine the impact of patient mindsets on measures of treatment (treatment efficacy and treatment related adverse events) and psychosocial health (stress, coping, mood, emotions). Second, we aim to understand the relationship between patient mindsets and biomarkers of immune and inflammatory processes in patients undergoing cancer treatment

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer
• Intervention / Treatment: Other: Mindset; Other: Reflection activities

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sean R Zion; Phone Number: 650-725-2418; Email: szion@stanford.edu

Study Locations

• United States
  • California
    • Stanford, California, United States, 94304
      • Stanford University
      • Contact: Sean R Zion
      • Principal Investigator: Alia Crum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• We will only recruit patients ≥ 18 years who are fluent in English and are without cognitive impairment. We have no gender, race, or ethnicity restrictions. Diagnosis of cancer (breast, lung, GI or colorectal, or lymphoma) and treatment given with curative intent.
• Patients diagnosed with lung cancer, breast cancer, GI/Colorectal cancer, or Lymphoma to be treated with curative intent will be eligible for this study.
• Participants will be recruited if they are receiving at least one course of systemic treatment. As we are recruiting participants near the point of diagnosis, we will target individuals who have not received prior therapy for cancer.
• Neither ECOG or Karnofsky Performance Status will be employed
• Ability to understand and willingness to sign a written informed consent document is required for participation in this study.
• Treatment plan includes course of systemic treatment involving no less than 4 and no more than 12 infusions.

Exclusion Criteria:

• Surgical procedures, if applicable, must take place either before the initiation of systemic treatment or after the last infusion.
• There are no restrictions regarding the use of other investigational agents; however, use of any investigational agents will be recorded.
• 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
• Pregnant / nursing patients will not be excluded from the study
• 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.
• Patients who are HIV-positive will not be excluded.
• 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 be excluded from this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindset Intervention; Mindset Intervention will include watching three brief ~10-25 minute films and respond to a number of short reflection activities after viewing the films.	Other: Mindset; Mindset Intervention will include watching three brief ~10-25 minute films; Other: Reflection activities; Reflection activity include exercises to internalize the message
Active Comparator: Treatment As Usual (TAU); TAU Control Arm will complete the same assessments as those participants in the Mindset Intervention Arm, but will not view the short films or complete the corresponding response activities.	Other: Reflection activities; Reflection activity include exercises to internalize the message

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life Survey	Quality of life will be assessed using the Functional Assessment of Cancer Therapy (FACT-G), a widely used patient reported health outcome measure. The FACT-G consists of 27 questions. Each question is answered on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Higher scores on the FACT-G indicate better quality of life. Questions fall into four subscales measuring four domains of quality of life: physical wellbeing (7 questions), social/family well-being (7 questions), emotional well-being (6 questions), and functional well-being (7-questions).	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measuring mindsets	Patient mindsets will be measured using the Illness Mindset Inventory (IMI). The IMI is a 20-item measure of mindsets about chronic illness. The Cancer version of the IMI consists of two subscales: mindsets about the nature of cancer and mindsets about the role of the body. Each item is rated on a 6 point Likert scale ranging from strongly disagree (1) to strongly agree (6).	6 weeks
Fear of Cancer Recurrence	Fear of Cancer Recurrence will be measured using the Cancer Worry Scale (CWS). The CWS is a 6-item measure that assesses worry about the risk of developing cancer in cancer survivors. All items use a 4-point scale of frequency, ranging from 1 (not at all) to 4 (almost all the time). The CWS will be measured at only one time-point (CP-7), 6 weeks after the completion of treatment	6 weeks
Biomarker Analyses	Blood samples will be analyzed for the following biomarkers of interest.; C-reactive protein (CRP); -6 / Interleukin (IL) IL-8; Tumor necrosis factor-alpha (TNF-a)	6 weeks
Measuring stress with cancer	Stress will be measured using the Perceived Stress Scale (PSS). This 10-item measure is the most commonly used measure of perceptions of stress.	6 weeks
Measuring coping with cancer	Coping will be measured using the Cancer Behavior Inventory (CBI). The CBI is a 27-item measure of self-efficacy for coping with cancer.	6 weeks
Measuring affect with cancer	Affect will be measured using the Positive and Negative Affect Scale (PANAS). The PANAS is a 20 item scale measuring positive and negative affect.	6 weeks
Measuring emotional regulation with cancer	Emotion Regulation will be measured using the Emotion Regulation Questionnaire (ERQ). The ERQ is a 10-item self-report scale designed to measure use of strategies to alter emotion: reappraisal of cognitions and suppression of expressions.	6 weeks

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Alia Crum, Stanford University

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: July 11, 2019
• First Submitted That Met QC Criteria: July 11, 2019
• First Posted (Actual): July 15, 2019

Study Record Updates

• Last Update Posted (Actual): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IRB-43605 (Other Identifier: Stanford IRB); VAR0174 (Other Identifier: OnCore)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No