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Leveraging Mindsets to Improve Health & Wellbeing in Patients With Cancer

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ClinicalTrials.gov Identifier: NCT03910283
Recruitment Status : Not yet recruiting
First Posted : April 10, 2019
Last Update Posted : April 10, 2019
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Sean Raymond Zion, Stanford University

Brief 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.


Condition or disease Intervention/treatment Phase
Cancer, Breast Cancer, Lung Cancer of Colon Cancer of Rectum Lymphoma, Large B-Cell, Diffuse Lymphoma, Hodgkin Lymphoma, Low-Grade Lymphoma, Mantle-Cell Lymphoma, T-Cell Behavioral: Cancer Mindset Intervention Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized via a stratified block randomization design to either the cancer mindset intervention arm (CMI) or the treatment as usual arm (TAU). Both arms of the study will occur in parallel. Blocks of n=10 will be used across four strata of disease category (breast cancer, lung cancer, GI/colorectal cancer, lymphoma).This randomization pattern will be set before the initiation of the study, and the randomization schedule will be maintained by the study coordinator.
Masking: Double (Participant, Care Provider)
Masking Description:

This study will employ a modified single blind masking as follows:

Patients will be told they are participating in "a study of thoughts and feelings as you undergo treatment for cancer". Therefore they will not be aware of the fact that they are, or are not, in the treatment group of interest. The purpose of this "blinding" is to reduce the likelihood that patients assigned to the control arm will be discouraged by their group assignment and seek out supplemental information / learn about mindsets or mindset related concepts on their own.

Care providers (medical oncologist, nurse practitioner, etc) will not be informed of the assignment of their patients.

Primary Purpose: Supportive Care
Official Title: Leveraging Mindsets to Improve Health & Wellbeing in Patients With Cancer
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : December 31, 2020


Arm Intervention/treatment
Experimental: Cancer Mindset Intervention

Participants who are enrolled in the Cancer Mindset Intervention (CMI) will be asked to view three brief 8-10 minute films and respond to a number of short reflection activities after viewing the films. These films were planned and produced specifically for this study and have been designed to target specific mindsets relevant to patients with chronic or life altering illness.

Participants will also be asked to complete assessments before the start of systemic (baseline), 25% of the way through treatment, 75% of the way through treatment; and 6 weeks after the completion of treatment.

Behavioral: Cancer Mindset Intervention

The intervention used in this study takes the form of three short documentary style film segments that target specific mindsets about cancer and the body. The design of the intervention was guided by the large body of empirical research on the design and implementation of precise and targeted psychosocial interventions (Walton, 2014).

Film 1 will be shown to participants at the initiation of systemic treatment and targets the mindset that 'cancer is a catastrophe' by demonstrating ways of thinking about cancer that are less catastrophic. It aims to help participants adopt more adaptive mindsets, like the mindset that cancer is manageable. Film 2, viewed midway through treatment, teaches patients to adopt mindset-based strategies for overcoming treatment related challenges. Film 3, viewed after the completion of systemic treatment, aims to help cancer patients foster adaptive mindsets about the capability and healing capacity of the human body as they transition into survivorship.


No Intervention: Treatment as Usual
Participants who are randomized to the Treatment as Usual (TAU) control arm will complete the same assessments as those participants in the Mindset Intervention Arm: before beginning systemic treatment (baseline), 25% of the way through treatment, 75% of the way through treatment, and 6 weeks after the completion of treatment.



Primary Outcome Measures :
  1. Change in FACT-G Total Score [ Time Frame: Pre-treatment (week 0), Early Treatment (week 2), Late Treatment (week 6), Post Treatment (6 weeks after the completion of treatment) ]

    The Functional Assessment of Cancer Therapy - General (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).

    For participant within each group, the change in FACT-G total score will be calculated at each of the four timepoints to calculate a time course trajectory of change (slope) for each group. Our primary outcome measure is the difference in slopes between groups.



Secondary Outcome Measures :
  1. Change in Patient Mindsets [ Time Frame: Pre-treatment (week 0), Early Treatment (week 2), Late Treatment (week 6), Post Treatment (6 weeks after the completion of treatment) ]

    Change in Patient Mindsets Mindsets will be measured using The Illness Mindset Inventory (IMI). The IMI is a 20-item measure of mindsets about chronic illnesses. The inventory has two sub-scales: mindsets about the nature of cancer and mindsets about the role of the body. Each item is rated on a scale from 1 (strongly disagree) - 6 (strongly agree), with higher scores indicating greater agreement with the respective mindsets.

    For participant within each group, the change in IMI subscores will be calculated at each of the four timepoints to calculate a time course trajectory of change (slope) for each group. This outcome measures the difference in slopes between groups.


  2. Fear of Cancer Recurrence [ Time Frame: Post-treatment (6 weeks after the completion of treatment) ]

    Fear of cancer recurrence will be measured using the Cancer Worry Scale (CWS). The CWS is the gold-standard for measuring fear of cancer recurrence. The scale consists of 6 items that respondents report on a 4-point scale of frequency, ranging from 1 (not at all) to 4 (almost all the time), with higher scores indicating more worry.

    We will compare the mean total score on the CWS between patients assigned to the intervention arm and those assigned to the TAU control arm. This outcome will be measured once, at follow up.


  3. Change in Body Vigilance [ Time Frame: Pre-treatment (week 0), Early Treatment (week 2), Late Treatment (week 6), Post Treatment (6 weeks after the completion of treatment) ]

    Body Vigilance will be measured using the Body Vigilance Scale (BVS). The BVS is a 4 item scale, assessing the degree of attentional focus, perceived sensitivity to change in bodily sensations, the average amount of time spent attending to bodily sensations, and a rating for 15 sensations individually. Items are rated on an 11 point Likert-like scale ranging from 0 (Not at all like me) to 10 (Extremely like me), with higher values indicating higher degree of body vigilance, which can be maladaptive in patients with chronic illnesses.

    For participants within each group, the change in BVS total score will be calculated at each of the four timepoints to calculate a time course trajectory of change (slope) for each group. This outcome measures the difference in slopes between groups.


  4. Change in Self-Efficacy: Cancer Behavior Inventory [ Time Frame: Pre-treatment (week 0), Early Treatment (week 2), Late Treatment (week 6), Post Treatment (6 weeks after the completion of treatment) ]

    Self-efficacy for coping with cancer will be measured using the Cancer Behavior Inventory (CBI). The CBI is a 27-item measure of self-efficacy for coping with cancer. Items are rated on a 9 point Likert scale from 1 (not at all confident) - 9 (totally confident). Mean scores can be calculated for each of the factors, which include: Maintaining Activity/Independence, Seeking & Understanding Medical Information, Emotion Regulation, Coping With Side Effects, Acceptance/Positive Attitude, Seeking Social Support, and Spiritual Coping. A total score can be calculated by finding the sum of subscale scores. Higher scores indicate greater self-efficacy, which can be beneficial for patients with chronic illnesses.

    For participants within each group, the change in CBI total score will be calculated at each of the four timepoints to calculate a time course trajectory of change (slope) for each group. This outcome measures the difference in slopes between groups.


  5. Change in Emotion Regulation Strategies [ Time Frame: Pre-treatment (week 0), Early Treatment (week 2), Late Treatment (week 6), Post Treatment (6 weeks after the completion of treatment) ]

    Emotion Regulation will be measured using The Emotion Regulation Questionnaire (ERQ). This 10-item self-report scale designed to measure use of strategies to alter emotion: reappraisal of cognitions and suppression of expressions. Items are rated on a Likert scale from 1 (strongly disagree) - 7 (strongly agree), with higher scores indicating greater use of the respective regulation strategy (reappraisal and suppression).

    For participants within each group, the change in ERQ sub-scores for reappraisal and suppression will be calculated at each of the four timepoints to calculate a time course trajectory of change (slope) for each group. This outcome measures the difference in slopes between groups for each of the two strategies.


  6. Change in Affect (Mood) [ Time Frame: Pre-treatment (week 0), Early Treatment (week 2), Late Treatment (week 6), Post Treatment (6 weeks after the completion of treatment) ]

    Affect will be measured using the Positive and Negative Affect Scale (PANAS). The PANAS is a 20 item scale measuring positive and negative affect. Participants are asked to rank, based on a 5-point Likert scale, the extent to which they have felt each item from 1 (vey slightly or not at all) to 5 (extremely) over the past week. The scale yields sub-scores for positive affect and negative affect. Higher scores on each subscale represent more frequent positive affect or negative affect, respectively.

    For participants within each group, the change in PANAS sub-score for positive affect and negative affect will be calculated at each of the four timepoints to calculate a time course trajectory of change (slope) for each group. This outcome measures the difference in slopes between groups for each of the two types of affect.


  7. Change in Perception of Stress [ Time Frame: Pre-treatment (week 0), Early Treatment (week 2), Late Treatment (week 6), Post Treatment (6 weeks after the completion of treatment) ]

    Stress will be measured using The Perceived Stress Scale (PSS). The PSS is a 10-item measure asks respondents to report on the frequency with which they have experienced levels of stress in the past month. Items are rated on a Likert Scale from 0 (Never) - 4 (Very Often). The scale yields one total score. A higher score on the PSS indicates greater perceived stress.

    For participants within each group, the change in PSS total score will be calculated at each of the four timepoints to calculate a time course trajectory of change (slope) for each group. This outcome measures the difference in slopes between groups.


  8. Change in Symptom Related Distress [ Time Frame: Pre-treatment (week 0), Early Treatment (week 2), Late Treatment (week 6), Post Treatment (6 weeks after the completion of treatment) ]

    Symptom related distress will be measured by the Rotterdam Symptom Checklist (RSCL). The RSCL is a widely accepted symptom measurement instrument for patients with cancer. It covers four domains: physical symptom distress, psychological distress, activity level, and overall global life quality. Items are rated on a 4 point Likert Scale, ranging from 1 (not at all) - 4 (very much). Each sub-scale will be analyzed separately. Higher scores on the physical and psychological sub-scales indicate greater distress (a worse outcome), whereas higher scores on activity and life quality sub-scales indicate a better outcome.

    For participants within each group, the change in RSCL total score for will be calculated at each of the four timepoints for each sub-scale to calculate a time course trajectory of change (slope) for each group. This outcome measures the difference in slopes between groups for each of the four sub-scales of the RSCL.




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:

  • 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.

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): NCT03910283


Contacts
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Contact: Sean R Zion, MA (585) 298-3887 szion@stanford.edu
Contact: Alia J Crum, PhD (650) 725-2418 crum@stanford.edu

Locations
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United States, California
Stanford University Not yet recruiting
Stanford, California, United States, 94305
Contact: Alia J Crum, PhD    650-725-2418    crum@stanford.edu   
Sub-Investigator: Lidia Schapira, MD         
Sponsors and Collaborators
Stanford University
National Center for Complementary and Integrative Health (NCCIH)

Publications:
Walton, G. M. (2014). The new science of wise psychological interventions. Current Directions in Psychological Science, 23(1), 73-82.

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Responsible Party: Sean Raymond Zion, PhD Candidate, Stanford University
ClinicalTrials.gov Identifier: NCT03910283     History of Changes
Other Study ID Numbers: 43605
1DP2AT009511-01 ( U.S. NIH Grant/Contract )
First Posted: April 10, 2019    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by Sean Raymond Zion, Stanford University:
Cancer
Chemotherapy
Intervention
Psychosocial
Quality of Life

Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Large B-Cell, Diffuse
Lymphoma, T-Cell
Lymphoma, Mantle-Cell
Breast Neoplasms
Hodgkin Disease
Lung Neoplasms
Colonic Neoplasms
Lymphoma, Non-Hodgkin
Rectal Neoplasms
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Neoplasms by Site
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases