Positive Activities Intervention to Improve Quality of Life in Collectivist Culture Cancer Patients and Their Caregivers

Study Overview
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Brief Summary
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This clinical trial studies the feasibility of two positive activities in improving quality of life in collectivist culture cancer patients and their caregivers. Cancer patients of collectivist cultures (e.g., Latinos, Asian Americans, African Americans) have been found to experience lower quality of life and more distress and depression when compared to those of individualist cultures, such as European Americans. Following a cancer diagnosis, collectivist patients may experience a change in their relationships with other family members and their roles within the family. The cancer diagnosis may lead to changes in roles and responsibilities, such as when a male breadwinner is no longer able to work due to hospital treatments. The two positive activities are designed to increase a sense of competence, autonomy, and connectedness, including contributing to household responsibilities (an act of kindness) and writing a letter of gratitude. Performing certain simple activities may improve quality of life in cancer patients and their caregivers.

Detailed Description
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PRIMARY OBJECTIVE: I. To evaluate the feasibility of conducting a study of two positive activities intended to improve the psychological and interpersonal well-being of cancer patients from collectivist cultures. SECONDARY OBJECTIVES: I. To preliminarily assess changes in psychological, interpersonal, and physical well-being of the intervention patients and caregivers compared to control patients and caregivers. II. To preliminarily assess changes in psychological, interpersonal, and physical well-being of patients and caregivers who are members of collectivist cultures (African American, Asian American, or Latino/Hispanic) compared to patients and caregivers who are members of individualist (European American) cultures. EXPLORATORY OBJECTIVE: I. To explore mechanisms through which the interventions may improve psychological and interpersonal well-being. OUTLINE: Participants are randomized to 1 of 3 conditions. CONDITION I (CONTRIBUTION): Patients do 1 nice thing (can be as large or as small as they wish) 2 times per week (BIW) for 4 weeks for their caregivers while at home. CONDITION II (GRATITUDE): Patients write a letter or note of gratitude BIW for 4 weeks to their caregivers who have helped with their treatment or recovery. CONDITION III (CONTROL): Participants keep track of their daily activities. After completion of study, participants are followed up for 28 days.

Official Title
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Feasibility of a Positive Activity Intervention in Cancer Patients From Collectivist Cultures

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
* Other: Interview
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PATIENTS: Between 35 -70 years of age PATIENTS: Within 1-5 years of diagnosis and actively undergoing systemic therapy, including chemotherapy, immunotherapy, endocrine and radiation therapies PATIENTS: Self-identify as ethnically one of the 4 ethnic groups of focus: Asian American, African American, Latino, and European American. For collectivist cultures, will aim to recruit patients of who are first- (i.e., immigrated to United States [US]) or second-generation (i.e., children of US residents who immigrated to US) immigrants PATIENTS: Diagnosed with any type of cancer PATIENTS: Able to identify a caregiver (e.g., family member) who lives in the same household, and who consents to participate in this study PATIENTS: Able to read, write, and speak in English PATIENTS: Access to internet, computer or phone, and web browser CAREGIVERS: Patient considers them as their caregiver CAREGIVERS: Lives in the same household as patient CAREGIVERS: Able to read, write, and speak in English CAREGIVERS: Access to internet, computer or phone, and web browser CAREGIVERS: Identifies as the same race/ethnicity group as the patient (e.g., European American wife and European American husband, or Asian American wife and Asian American husband would be pairs that are considered eligible) Exclusion Criteria: PATIENTS: Life expectancy less than 6 months in the opinion of the primary physician PATIENTS: Inability to stand and walk on their own or with other physical limitations that preclude them from participating. (3+ on Eastern Cooperative Oncology Group [ECOG] performance status) PATIENTS: Major depression (e.g., as determined by a score of 10 or higher on the 10-item Center for Epidemiologic Studies Depression Scale [CES-D] at baseline, out of 30) or diagnosed prior to study (from patient records and/or self-disclosure by patient) CAREGIVERS: Unwilling or unable to participate in the study for any reason CAREGIVERS: Under the age of 18

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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Accepts Healthy Volunteers

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Condition I (contribution)<br>Patients do 1 nice thing (can be as large or as small as they wish) BIW for 4 weeks for their caregivers while at home. | Behavioral: Behavioral Intervention<br>* Perform 1 nice thing<br>* Other names: Behavioral Treatments;Other: Interview<br>* Ancillary studies<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Experimental: Condition II (gratitude)<br>Patients write a letter or note of gratitude BIW for 4 weeks to their caregivers who have helped with their treatment or recovery. | Behavioral: Behavioral Intervention<br>* Write a letter or note of gratitude<br>* Other names: Behavioral Treatments;Other: Interview<br>* Ancillary studies<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Active Comparator: Condition III (daily activities tracking)<br>Participants keep track of their daily activities. | Behavioral: Behavioral Intervention<br>* Track daily activities<br>* Other names: Behavioral Treatments;Other: Interview<br>* Ancillary studies<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consent rate | Will calculate the 95% confidence intervals (CIs) for the consent rate. | 4 weeks | 
| Study completion rate | The study completion rate is defined as the average proportion of participants who complete follow-up assessments at the end of the study (day 30). Will also calculate the 95% CIs for the study completion rate. | 30 days | 
| Intervention adherence rate | Will calculate the 95% CIs for the intervention adherence rate. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in psychological well-being of the collectivist culture patients | Will calculate appropriate summary statistics and 95% CIs for the means of the Affect-Adjective Scale, Perceived Stress Scale, and Center for Epidemiologic Studies Depression Scale (CES-D) at baseline, midpoint, and end of study and the outcome change score from baseline to end of study in each group. | Baseline up to 28 days | 
| Changes in interpersonal well-being of the intervention patients | Will first calculate appropriate summary statistics and 95% CIs for the means of the Relationship Closeness Inventory at baseline, midpoint, and end of study and the outcome change score from baseline to end of study in each group. | Baseline up to 28 days | 
| Changes in physical well-being of the intervention patients | Will calculate appropriate summary statistics and 95% CIs for the means of the MD Anderson Symptom Inventory (MDASI) at baseline, midpoint, and end of study and the outcome change score from baseline to end of study in each group. | Baseline up to 28 days | 
| Changes in psychological well-being of the intervention caregivers | Will first calculate appropriate summary statistics and 95% CIs for the means of the Affect-Adjective Scale, Perceived Stress Scale, and CES-D at baseline, midpoint, and end of study and the outcome change score from baseline to end of study in each group. | Baseline up to 28 days | 
| Changes in interpersonal well-being of the intervention caregivers | Will calculate appropriate summary statistics and 95% CIs for the means of the Relationship Closeness Inventory at baseline, midpoint, and end of study and the outcome change score from baseline to end of study in each group. | Baseline up to 28 days | 
| Changes in physical well-being of the intervention caregivers | Will first calculate appropriate summary statistics and 95% CIs for the means of the MDASI at baseline, midpoint, and end of study and the outcome change score from baseline to end of study in each group. | Baseline up to 28 days |