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

M.D. Anderson Cancer Center logo

M.D. Anderson Cancer Center

Status

Completed

Conditions

Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04810052
NCI-2020-14194 (Registry Identifier)
2020-0789 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

75 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

75 participants in 3 patient groups

Condition I (contribution)
Experimental group
Description:
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.
Treatment:
Other: Interview
Behavioral: Behavioral Intervention
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
Behavioral: Behavioral Intervention
Behavioral: Behavioral Intervention
Condition II (gratitude)
Experimental group
Description:
Patients write a letter or note of gratitude BIW for 4 weeks to their caregivers who have helped with their treatment or recovery.
Treatment:
Other: Interview
Behavioral: Behavioral Intervention
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
Behavioral: Behavioral Intervention
Behavioral: Behavioral Intervention
Condition III (daily activities tracking)
Active Comparator group
Description:
Participants keep track of their daily activities.
Treatment:
Other: Interview
Behavioral: Behavioral Intervention
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
Behavioral: Behavioral Intervention
Behavioral: Behavioral Intervention

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Qian Lu, MD

Data sourced from clinicaltrials.gov

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