Hematopoietic and Lymphoid Cell NeoplasmNCT04810052
Positive Activities Intervention to Improve Quality of Life in Collectivist Culture Cancer Patients and Their Caregivers
A study testing Behavioral Intervention, Interview and Quality-of-Life Assessment in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Behavioral Intervention, Interview and Quality-of-Life Assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2021to 19 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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:
- 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.
- Being tested
- Behavioral Intervention, Interview, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral InterventionBehavioural
Also called Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy
Perform 1 nice thing
Behavioral InterventionBehavioural
Also called Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy
Write a letter or note of gratitude
Behavioral InterventionBehavioural
Also called Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy
Track daily activities
InterviewOther
Ancillary studies
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Behavioral Intervention; Other: Interview; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consent rate
Will calculate the 95% confidence intervals (CIs) for the consent rate.
Measured: 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.
Measured: 30 days
Intervention adherence rate
Will calculate the 95% CIs for the intervention adherence rate.
Measured: 4 weeks
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start18 May 2021
- Primary completion19 Sep 2025
- Study completion19 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hematopoietic and Lymphoid Cell NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qian Lu, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04810052
- Sponsor's protocol ID
- 2020-0789
- Other IDs
- NCI-2020-14194, 2020-0789
- Status last verified
- Sep 2025
- First submitted
- 24 Feb 2021
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40986989
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Positive Activity Intervention in Cancer Patients From Collectivist Cultures
- ClinicalTrials.gov ID
- NCT04810052
- Acronym / sponsor ID
- 2020-0789
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 18 May 2021 (actual)
- Primary completion
- 19 Sep 2025 (actual)
- Study completion
- 19 Sep 2025 (actual)
- First posted
- 22 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
PRIMARY OBJECTIVE:
- 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:
- 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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Condition I (contribution) | Experimental | Behavioral: Behavioral Intervention, Other: Interview, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients do 1 nice thing (can be as large or as small as they wish) BIW for 4 weeks for their caregivers while at home. |
| Condition II (gratitude) | Experimental | Behavioral: Behavioral Intervention, Other: Interview, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients write a letter or note of gratitude BIW for 4 weeks to their caregivers who have helped with their treatment or recovery. |
| Condition III (daily activities tracking) | Active comparator | Behavioral: Behavioral Intervention, Other: Interview, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationParticipants keep track of their daily activities. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral InterventionAlso: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior TherapyPerform 1 nice thing | Behavioural | Condition I (contribution) |
| Behavioral InterventionAlso: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior TherapyWrite a letter or note of gratitude | Behavioural | Condition II (gratitude) |
| Behavioral InterventionAlso: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior TherapyTrack daily activities | Behavioural | Condition III (daily activities tracking) |
| InterviewAncillary studies | Other | Condition I (contribution), Condition II (gratitude), Condition III (daily activities tracking) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Condition I (contribution), Condition II (gratitude), Condition III (daily activities tracking) |
| Questionnaire AdministrationAncillary studies | Other | Condition I (contribution), Condition II (gratitude), Condition III (daily activities tracking) |
Primary outcome
Consent rate
Time frame: 4 weeks
Will calculate the 95% confidence intervals (CIs) for the consent rate.
Study completion rate
Time frame: 30 days
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.
Intervention adherence rate
Time frame: 4 weeks
Will calculate the 95% CIs for the intervention adherence rate.
6 secondary outcomes
Changes in psychological well-being of the collectivist culture patients
Time frame: Baseline up to 28 days
Changes in interpersonal well-being of the intervention patients
Time frame: Baseline up to 28 days
Changes in physical well-being of the intervention patients
Time frame: Baseline up to 28 days
Changes in psychological well-being of the intervention caregivers
Time frame: Baseline up to 28 days
Changes in interpersonal well-being of the intervention caregivers
Time frame: Baseline up to 28 days
Changes in physical well-being of the intervention caregivers
Time frame: Baseline up to 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Derived from this study: PubMed 40986989Shin-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.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qian Lu, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Intervention, Interview and Quality-of-Life Assessment in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consent rate (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04810052, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.