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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm
• Intervention / Treatment: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Interview; Behavioral: Behavioral Intervention; Behavioral: Behavioral Intervention; Behavioral: Behavioral Intervention

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.

• Study Type: Interventional
• Enrollment (Estimated): 104
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qian Lu, MD; Phone Number: 713-745-5715; Email: QLu@mdanderson.or

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • M D Anderson Cancer Center
      • Contact: Qian Lu, MD; Phone Number: 713-745-5715; Email: QLu@mdanderson.org
      • Principal Investigator: Qian Lu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Other: Interview; Ancillary studies; Behavioral: Behavioral Intervention; Perform 1 nice thing; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments; Behavioral: Behavioral Intervention; Write a letter or note of gratitude; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments; Behavioral: Behavioral Intervention; Track daily activities; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments
Experimental: 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.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Other: Interview; Ancillary studies; Behavioral: Behavioral Intervention; Perform 1 nice thing; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments; Behavioral: Behavioral Intervention; Write a letter or note of gratitude; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments; Behavioral: Behavioral Intervention; Track daily activities; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments
Active Comparator: Condition III (daily activities tracking); Participants keep track of their daily activities.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Other: Interview; Ancillary studies; Behavioral: Behavioral Intervention; Perform 1 nice thing; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments; Behavioral: Behavioral Intervention; Write a letter or note of gratitude; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments; Behavioral: Behavioral Intervention; Track daily activities; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Potential effectiveness of the intervention	Will explore potential effects of the intervention by taking "compliance" into consideration, with compliance being defined as, e.g., completing a specified proportion of the intervention activities, so that each intervention group could be split into two or more groups based on different levels of compliance.	4 weeks

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Qian Lu, MD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 24, 2021
• First Submitted That Met QC Criteria: March 18, 2021
• First Posted (Actual): March 22, 2021

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 2020-0789 (Other Identifier: M D Anderson Cancer Center); NCI-2020-14194 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No