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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

Tracking Information
First Submitted Date  ICMJE July 11, 2019
First Posted Date  ICMJE July 15, 2019
Last Update Posted Date February 24, 2023
Estimated Study Start Date  ICMJE November 2023
Estimated Primary Completion Date September 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2019)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2019)
  • 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).
  • 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
  • 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)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Leveraging Mindsets to Improve Health and Wellbeing in Patients With Cancer
Official Title  ICMJE Leveraging Mindsets to Improve Health and Wellbeing in Cancer Patients
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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Condition  ICMJE Cancer
Intervention  ICMJE
  • Other: Mindset
    Mindset Intervention will include watching three brief ~10-25 minute films
  • Other: Reflection activities
    Reflection activity include exercises to internalize the message
Study Arms  ICMJE
  • 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.
    Interventions:
    • Other: Mindset
    • Other: Reflection activities
  • 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.
    Intervention: Other: Reflection activities
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 11, 2019)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2025
Estimated Primary Completion Date September 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sean R Zion 650-725-2418 szion@stanford.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04020029
Other Study ID Numbers  ICMJE IRB-43605
VAR0174 ( Other Identifier: OnCore )
IRB-43605 ( Other Identifier: Stanford IRB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Stanford University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Stanford University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alia Crum Stanford University
PRS Account Stanford University
Verification Date February 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP