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Leveraging Mindsets to Improve Health and Wellbeing in Patients With Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04020029
Recruitment Status : Not yet recruiting
First Posted : July 15, 2019
Last Update Posted : February 24, 2023
Sponsor:
Information provided by (Responsible Party):
Stanford University

Study Description
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Brief Summary:

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


Condition or disease Intervention/treatment Phase
Cancer Other: Mindset Other: Reflection activities Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Leveraging Mindsets to Improve Health and Wellbeing in Cancer Patients
Estimated Study Start Date : November 2023
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : September 2025
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Quality of Life Survey [ Time Frame: 6 weeks ]
    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).


Secondary Outcome Measures :
  1. Measuring mindsets [ Time Frame: 6 weeks ]
    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).

  2. Fear of Cancer Recurrence [ Time Frame: 6 weeks ]
    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

  3. Biomarker Analyses [ Time Frame: 6 weeks ]

    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)

  4. Measuring stress with cancer [ Time Frame: 6 weeks ]
    Stress will be measured using the Perceived Stress Scale (PSS). This 10-item measure is the most commonly used measure of perceptions of stress.

  5. Measuring coping with cancer [ Time Frame: 6 weeks ]
    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. Measuring affect with cancer [ Time Frame: 6 weeks ]
    Affect will be measured using the Positive and Negative Affect Scale (PANAS). The PANAS is a 20 item scale measuring positive and negative affect.

  7. Measuring emotional regulation with cancer [ Time Frame: 6 weeks ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04020029


Contacts
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Contact: Sean R Zion 650-725-2418 szion@stanford.edu

Locations
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United States, California
Stanford University
Stanford, California, United States, 94304
Contact: Sean R Zion         
Principal Investigator: Alia Crum         
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Alia Crum Stanford University
More Information
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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT04020029    
Obsolete Identifiers: NCT03910283
Other Study ID Numbers: IRB-43605
VAR0174 ( Other Identifier: OnCore )
IRB-43605 ( Other Identifier: Stanford IRB )
First Posted: July 15, 2019    Key Record Dates
Last Update Posted: February 24, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No