Positive Activities Intervention to Improve Quality of Life in Collectivist Culture Cancer Patients and Their Caregivers
NCT ID: NCT04810052
Last Updated: 2025-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
75 participants
INTERVENTIONAL
2021-05-18
2025-09-19
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Condition I (contribution)
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 Intervention
Perform 1 nice thing
Interview
Ancillary studies
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
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.
Behavioral Intervention
Write a letter or note of gratitude
Interview
Ancillary studies
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Condition III (daily activities tracking)
Participants keep track of their daily activities.
Behavioral Intervention
Track daily activities
Interview
Ancillary studies
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Interventions
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Behavioral Intervention
Perform 1 nice thing
Behavioral Intervention
Write a letter or note of gratitude
Behavioral Intervention
Track daily activities
Interview
Ancillary studies
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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: 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
18 Years
ALL
Yes
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Qian Lu, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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References
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Shin-Cho LJ, Whisenant M, Cohen L, Chen M, Barcenas CH, Li Y, Lu Q. Feasibility, acceptability, and experienced benefits of kind acts and gratitude letter interventions among collectivist and individualist culture cancer patients and caregivers: A pilot study. Eur J Oncol Nurs. 2025 Oct;78:102970. doi: 10.1016/j.ejon.2025.102970. Epub 2025 Aug 25.
Provided Documents
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Document Type: Informed Consent Form
Related Links
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MD Anderson Cancer Center
Other Identifiers
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NCI-2020-14194
Identifier Type: REGISTRY
Identifier Source: secondary_id
2020-0789
Identifier Type: OTHER
Identifier Source: secondary_id
2020-0789
Identifier Type: -
Identifier Source: org_study_id
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