Exploring Mindsets, Beliefs and Resilience Across the Cancer Experience

Not Applicable

Not yet recruiting

• Conditions: Cancer

• Registration Number: NCT06705218
• Lead Sponsor: Stanford University

Brief Summary

The goal of this clinical trial is to test the effect of digitally delivered programs on the health, wellbeing, and functioning of newly diagnosed cancer patients.

Participants will be randomized to one of two digital programs. Both groups are equally important for the study.

Participants will be asked to complete:
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Detailed Description

A cancer diagnosis and its subsequent treatment affects whole patient health -- disrupting the full spectrum of physical, social, emotional, and functional quality of life. An estimated 83% of cancer patients report low to very low quality of life. Individuals receiving chemotherapy report experiencing over 13 concurrent symptoms, including fatigue, sleep di...

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-22
• Study First Submitted QC: 2024-11-22
• Last Update Submitted: 2024-11-25
• Study First Posted: 2024-11-26
• Last Update Posted: 2024-11-27
• Study Start: 2025-01-30
• Primary Completion: 2027-04-30
• Study Completion: 2028-01-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 440

Inclusion Criteria

• Initial (non-recurrent) diagnosis of non-metastatic (stage I-III) or hematological malignancy.

Diagnosis in the past 150 days. Currently receiving active systemic treatment or with a planned systemic treatment (including chemotherapy, immunotherapy or other targeted therapies).

Eighteen years of age or older. Fluent in English. Currently reside in the United States. Access to a computer, tablet, or smartphone (a mobile phone that performs many of the functions of a computer, typically including a touchscreen interface, internet access, and an operating system capable of running downloaded applications, or tablet that runs iOS or Android software, with cellular data service or wifi access).

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Exclusion Criteria

• Failure to meet inclusion criteria. Currently participating in any other investigative psychotherapeutic or behavioral intervention or supportive care trial.

Psychiatric conditions including schizophrenia, bipolar disorder, substance use disorder, severe depression as indicated by PHQ-9 score of 15 or above, or other mental health disorder requiring psychiatric hospitalization in the preceding 2 years.

Cognitive impairment or dementia. Cancer of another primary site within the last 5 years (except for non-melanoma skin cancer).

Current pregnancy. Current medical conditions with known effects on the immune system, specifically HIV/AIDs, Lupus, multiple sclerosis, Crohn's disease, ulcerative colitis, vasculitis, and temporal arteritis.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Functional Assessment of Cancer Therapy - General (FACT-G)	Treatment Phase: Weeks 0 (Baseline), 2, 4, 6, 10 Follow Up: Months 3, 6	Physical, emotional, social and functional quality of life will be assessed using the FACT-G questionnaire. The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item questionnaire designed to measure four domains of quality of life in cancer patients: Physical, social, emotional, and functional well being. Original development and validatio...

Secondary Outcome Measures

Name	Time	Method
Patient-Reported Outcomes Measurement Information System - Anxiety Short Form 8a (PROMIS-A)	Treatment Phase: Weeks 0 (Baseline), 2, 4, 6, 10 Follow Up: Months 3, 6	Anxiety will be measured using the 8 item Patient-Reported Outcomes Measurement Information System - Anxiety Short Form 8a (PROMIS-A). The PROMIS-A measures fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart,dizziness). The items in the PROMIS nega...
Patient-Reported Outcomes Measurement Information System - Depression Short Form 8b (PROMIS-D)	Treatment Phase: Weeks 0 (Baseline), 2, 4, 6, 10 Follow Up: Months 3, 6	Depression will be measured using the 8 item the Patient-Reported Outcomes Measurement Information System - Depression Short Form 8b (PROMIS-D). The PROMIS-D content focuses on negative mood (sadness, guilt), views of self (self- criticism, worthlessness), and social cognition (loneliness, interpersonal alienation), as well as decreased positive affect and e...
Positive and Negative Affect (I-PANAS-SF)	Treatment Phase: Weeks 0 (Baseline), 2, 4, 6, 10 Follow Up: Months 3, 6	Positive and negative affect will be measured by the International version of the Positive and Negative Affect Schedule-Short Form (PANAS-SF). This is a cross-culturally validated version of the widely affect measure that consists of 10 items; 5 items measuring negative affect and 5 items measuring positive affect.