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 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 : | December 2020 |
| Estimated Primary Completion Date : | December 2022 |
| Estimated Study Completion Date : | December 2023 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Other: Mindset
Mindset Intervention will include watching three brief ~10-25 minute films
Other: Reflection activities Reflection activity include exercises to internalize the message
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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.
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Other: Reflection activities
Reflection activity include exercises to internalize the message
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Blood samples will be analyzed for the following biomarkers of interest.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| Contact: Sean R Zion | 650-725-2418 | szion@stanford.edu |
| United States, California | |
| Stanford University | |
| Stanford, California, United States, 94304 | |
| Contact: Sean R Zion | |
| Principal Investigator: Alia Crum | |
| Principal Investigator: | Alia Crum | Stanford University |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 11, 2019 | ||||
| First Posted Date ICMJE | July 15, 2019 | ||||
| Last Update Posted Date | August 21, 2020 | ||||
| Estimated Study Start Date ICMJE | December 2020 | ||||
| Estimated Primary Completion Date | December 2022 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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).
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| 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 |
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| 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 |
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| Condition ICMJE | Cancer | ||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE |
120 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | December 2023 | ||||
| Estimated Primary Completion Date | December 2022 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
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| 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 ) |
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| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Stanford University | ||||
| Study Sponsor ICMJE | Stanford University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | Stanford University | ||||
| Verification Date | August 2020 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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