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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-18

Study Completion Date

2025-09-19

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.

Conditions

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Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

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.

Group Type EXPERIMENTAL

Behavioral Intervention

Intervention Type BEHAVIORAL

Perform 1 nice thing

Interview

Intervention Type OTHER

Ancillary studies

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

Behavioral Intervention

Intervention Type BEHAVIORAL

Write a letter or note of gratitude

Interview

Intervention Type OTHER

Ancillary studies

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Condition III (daily activities tracking)

Participants keep track of their daily activities.

Group Type ACTIVE_COMPARATOR

Behavioral Intervention

Intervention Type BEHAVIORAL

Track daily activities

Interview

Intervention Type OTHER

Ancillary studies

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Behavioral Intervention

Perform 1 nice thing

Intervention Type BEHAVIORAL

Behavioral Intervention

Write a letter or note of gratitude

Intervention Type BEHAVIORAL

Behavioral Intervention

Track daily activities

Intervention Type BEHAVIORAL

Interview

Ancillary studies

Intervention Type OTHER

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Behavior Conditioning Therapy Behavior Modification Behavior or Life Style Modifications Behavior Therapy Behavioral Interventions Behavioral Modification Behavioral Therapy Behavioral Treatment Behavioral Treatments Behavior Conditioning Therapy Behavior Modification Behavior or Life Style Modifications Behavior Therapy Behavioral Interventions Behavioral Modification Behavioral Therapy Behavioral Treatment Behavioral Treatments Behavior Conditioning Therapy Behavior Modification Behavior or Life Style Modifications Behavior Therapy Behavioral Interventions Behavioral Modification Behavioral Therapy Behavioral Treatment Behavioral Treatments Quality of Life Assessment

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

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.

Reference Type DERIVED
PMID: 40986989 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Related Links

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http://www.mdanderson.org

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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