Clinical trial NCT04810052: Positive Activities Intervention to Improve Quality of Life in Collectivist Culture Cancer Patients and Their Caregivers
Official title: Feasibility of a Positive Activity Intervention in Cancer Patients From Collectivist Cultures
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-03-22
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Consent rate
timeFrame: 4 weeks
measure: Study completion rate
timeFrame: 30 days
measure: Intervention adherence rate
timeFrame: 4 weeks
Secondary outcomes:
measure: Changes in psychological well-being of the collectivist culture patients
timeFrame: Baseline up to 28 days
measure: Changes in interpersonal well-being of the intervention patients
timeFrame: Baseline up to 28 days
measure: Changes in physical well-being of the intervention patients
timeFrame: Baseline up to 28 days
measure: Changes in psychological well-being of the intervention caregivers
timeFrame: Baseline up to 28 days
measure: Changes in interpersonal well-being of the intervention caregivers
timeFrame: Baseline up to 28 days
measure: Changes in physical well-being of the intervention caregivers
timeFrame: Baseline up to 28 days
Other outcomes:
measure: Potential effectiveness of the intervention
timeFrame: 4 weeks
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Qian Lu, MD
role: PRINCIPAL_INVESTIGATOR
References: