Expressive Writing for the Management of Stress in Cancer Survivors

Study Overview
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Brief Summary
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This clinical trial evaluates the effect of expressive writing for the management of stress in cancer survivors. Cancer diagnosis and treatment are associated with increased stress in cancer survivors related to concerns about family, career, relationships, finances, side effects of treatment, and death. This stress can be further exacerbated by social upheavals such as the COVID-19 pandemic. For safety reasons, many patients are isolated with restricted access to in-person health care and reduced social interaction with family and friends. Together with the economic uncertainties that come with this pandemic, these factors are likely to increase cancer survivors' stress levels. Expressive writing may provide a medium through which cancer survivors confront stressors and find meaning in their experience. The goal of this trial is to learn more about the experiences of cancer survivors during stressful times.

Detailed Description
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PRIMARY OBJECTIVES: I. To evaluate the feasibility of the virtual study for cancer survivors. II. To preliminarily assess the impact of the intervention for cancer survivors. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I (INTERVENTION): Patients complete questionnaires over 30 minutes about their mood, health, and income at baseline, and 1, 3, and 6 months. Patients also read brief positive messages and write essays about their experiences over 30 minutes (non-stop) once weekly (QW) for 3 weeks. ARM II (CONTROL): Patients complete questionnaires over 30 minutes about their mood, health, and income at baseline, and 1, 3, and 6 months. Patients also read brief neutral messages and write essays about neutral topics over 30 minutes (non-stop) QW for 3 weeks.

Official Title
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COVID-19: A Virtual Feasibility Study to Manage Stress

Conditions
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Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm

Intervention / Treatment
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* Behavioral: Behavioral Intervention
* Behavioral: Behavioral Intervention
* Behavioral: Behavioral Intervention
* Behavioral: Behavioral Intervention
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years old Have a diagnosis of cancer within the past 3 years Are able to speak and read in English Have access to a computer or smart phone with internet connection All disease sites and all cancer stages are eligible for enrollment Exclusion Criteria: Inability to provide informed consent Non-English speakers will be excluded because this is a feasibility study that will enroll only a limited number of participants

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (questionnaires, messages, writing)<br>Patients complete questionnaires over 30 minutes about their mood, health, and income at baseline, and 1, 3, and 6 months. Patients also read brief positive messages and write essays about their experiences over 30 minutes (non-stop) QW for 3 weeks. | Behavioral: Behavioral Intervention<br>* Read positive messages<br>* Other names: Behavioral Treatments;Behavioral: Behavioral Intervention<br>* Write about positive experiences<br>* Other names: Behavioral Treatments;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Complete questionnaires<br>|
| Active Comparator: Arm II (questionnaires, messages, writing)<br>Patients complete questionnaires over 30 minutes about their mood, health, and income at baseline, and 1, 3, and 6 months. Patients also read brief neutral messages and write essays about neutral topics over 30 minutes (non-stop) QW for 3 weeks. | Behavioral: Behavioral Intervention<br>* Write about neutral topics<br>* Other names: Behavioral Treatments;Behavioral: Behavioral Intervention<br>* Read neutral messages<br>* Other names: Behavioral Treatments;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Complete questionnaires<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant response rate |  | 1 month | 
| Study completion rate |  | 1 month | 
| Intervention adherence rate |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in stress | Perceived stress will be measured with the 4-item Perceived Stress Scale. Scale scores range from 0-16, with low scores indicating low perceived stress and high scores indicating high perceived stress | Baseline and 1-, 3-, and 6-month follow-up | 
| Change in quality of life | Quality of life will be measured with the 7-item Functional Assessment of Cancer Therapy (FACT-G7). The items are rated on a 5-point scale from 0 - not at all, to 4 - very much. Scores range from 0-28, with higher scores indicating better quality of life. | Baseline and 1-, 3-, and 6-month follow-up | 
| Change in physical health (sleep, fatigue, and cancer related morbidities) | Sleep will be measured with the 19-item Pittsburgh Sleep Quality Index (PSQI). The PSQI global score ranges from 0 to 21, with a cut-off score of 5 or greater indicating poor sleep quality. Fatigue will be measured with the 4-item PROMIS Fatigue Short Form. This measure assesses the magnitude of fatigue in the past 7 days. Items are measured on a five-point scale (1= not at all; 5 = very much) and summed. Higher scores indicate greater fatigue. Cancer related morbidities will be self-reported by participants and verified through medical record review. . | Baseline and 1-, 3-, and 6-month follow-up | 
| Change in psychological health (depressive symptoms, anxiety, and fear of cancer recurrence) | Depressive symptoms will be measured with the 4-item PROMIS Depression Short Form. This measure assesses the frequency of depressive symptoms in the past 7 days. Items are measured on a five-point scale (1= never; 5 = always) and summed. Higher scores indicate more depressive symptoms. Anxiety will be measured with the 4-item PROMIS Anxiety Short Form. This measure assesses the frequency of anxiety in the past 7 days. Items are measured on a five-point scale (1= never; 5 = always) and summed. Higher scores indicate greater anxiety. Fear of cancer recurrence will be measured with a single item added to the quality of life measure (F | Baseline and 1-, 3-, and 6-month follow-up |