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

NCT04810052 | Completed

• 2 other identifiers: 2020-0789NCI-2020-14194
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Changes in psychological well-being of the collectivist culture patients

  Baseline up to 28 days

• Changes in interpersonal well-being of the intervention patients

  Baseline up to 28 days

• Changes in physical well-being of the intervention patients

  Baseline up to 28 days

• Changes in psychological well-being of the intervention caregivers

  Baseline up to 28 days

• Changes in interpersonal well-being of the intervention caregivers

  Baseline up to 28 days

Other Outcomes (1)

• Potential effectiveness of the intervention

  4 weeks

Study Arms (3)

Condition I (contribution)

EXPERIMENTAL

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

Condition II (gratitude)

EXPERIMENTAL

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

Condition III (daily activities tracking)

ACTIVE COMPARATOR

Participants keep track of their daily activities.

Behavioral: Behavioral Intervention; Other: Interview; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Behavioral Intervention BEHAVIORAL

Perform 1 nice thing

Also known as: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Interventions, Behavioral Modification, Behavioral Therapy, Behavioral Treatment, Behavioral Treatments

Condition I (contribution)

Interview OTHER

Ancillary studies

Condition I (contribution); Condition II (gratitude); Condition III (daily activities tracking)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Condition I (contribution); Condition II (gratitude); Condition III (daily activities tracking)

Questionnaire Administration OTHER

Ancillary studies

Condition I (contribution); Condition II (gratitude); Condition III (daily activities tracking)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 40986989 DERIVED

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Behavior Therapy; Interviews as Topic

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Qian Lu, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: March 22, 2021
• Study Start: May 18, 2021
• Primary Completion: September 19, 2025
• Study Completion: September 19, 2025
• Last Updated: September 30, 2025

Record last verified: 2025-09

Locations

US (1)