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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-14194 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2020-0789 | Other Identifier | M D Anderson Cancer Center |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Condition III (daily activities tracking) | Active Comparator | Participants keep track of their daily activities. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Intervention | Behavioral | Perform 1 nice thing |
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| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qian Lu, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40986989 | Derived | 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. |
| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 22, 2021 | Sep 24, 2025 |
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| Behavioral Intervention | Behavioral | Write a letter or note of gratitude |
|
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| Behavioral Intervention | Behavioral | Track daily activities |
|
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| Interview | Other | Ancillary studies |
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| Quality-of-Life Assessment | Other | Ancillary studies |
|
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| Questionnaire Administration | Other | Ancillary studies |
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| 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 |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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