Clinical trial NCT06782581: CARE Study: Cancer, Asian Americans, and Relationship Enrichment
Official title: Positive Activities for Asian American Cancer Patients and Caregivers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neoplasm
Keywords: Asian American
Cancer
Patient
Positive Activities
Well-being
Caregiver
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2025-01-20
Enrollment: 186
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The overarching goal of the current study is to reduce the burden Asian American patients may feel are on their caregivers by designing and testing the feasibility and efficacy of a positive activity intervention designed to increase a sense of autonomy, competence, and connectedness, each of which have been shown to be associated with psychological benefits according to self-determination theory.

Detailed description: This study will introduce two new positive activities, household contribution and outside contribution, which have been specifically created for AA cancer patients and have not been previously investigated. These interventions have been developed with consideration of culture-related challenges, Hofstede's concept of collectivist cultures, and self-determination theory. This study will be the first randomized controlled trial to assess the impact of these new positive activities on Asian-American cancer patients.

Eligibility criteria: Inclusion Criteria for Patients:

1. self-identifies as Asian American or Asian
2. males or females ages 21-80 years
3. within 1 year of any cancer diagnosis or stage 4 cancer diagnosis
4. actively undergoing surgery or systemic therapy (e.g., chemotherapy, radiation, immunotherapy) or within the past 6 months,
5. able to identify a caregiver (e.g., spouse) who lives in the same household or see at least 3 times per week
6. able to read, write, and speak English (i.e., English proficient; EP) or Mandarin/simplified Chinese.

Exclusion Criteria for patients:

1. life expectancy less than 6 months in the opinion of the primary physician
2. inability to stand or walk on their own or other physical limitations that preclude them from participating (3+ on ECOG performance status),
3. major thought disorder (e.g., schizophrenia or bipolar \[patient records or self-disclosure\]).

Inclusion Criteria for Caregivers:

1. identifies as Asian American or Asian,
2. patient considers them to be caregiver
3. English proficient or Mandarin Chinese proficient
4. access to computer/phone, internet, and web browser.

Exclusion Criteria for Caregivers:

1. unwilling or unable to participate in the study for any reason,
2. under the age of 18.

Primary outcomes:
measure: Affect-Adjective Scale (modified) (AAS)
timeFrame: Baseline/pre-intervention, midpoint/during the intervention (2 weeks), immediately after the intervention (4 weeks), and follow-up 4 weeks after the intervention (8 weeks)
measure: Patient-Reported Outcomes Measurement Information System Global Health (PROMIS G10)
timeFrame: Baseline/pre-intervention, midpoint/during the intervention (2 weeks), immediately after the intervention (4 weeks), and follow-up 4 weeks after the intervention (8 weeks)
Secondary outcomes:
measure: Balanced Measure of Psychological Needs (BMPN)
timeFrame: Baseline/pre-intervention, midpoint/during the intervention (2 weeks), immediately after the intervention (4 weeks), and follow-up 4 weeks after the intervention (8 weeks)
measure: Self-Perceived Burden Scale
timeFrame: Baseline/pre-intervention, midpoint/during the intervention (2 weeks), immediately after the intervention (4 weeks), and follow-up 4 weeks after the intervention (8 weeks)
Other outcomes:
measure: Perceived Stress Scale (PSS)
timeFrame: Baseline/pre-intervention, midpoint/during the intervention (2 weeks), immediately after the intervention (4 weeks), and follow-up 4 weeks after the intervention(8 weeks)
measure: PROMIS Patient-Reported Outcomes Measurement Information System Depression 4a (PROMIS Depr4a)
timeFrame: Baseline/pre-intervention, midpoint/during the intervention (2 weeks), immediately after the intervention (4 weeks), and follow-up 4 weeks after the intervention(8 weeks)
measure: MD Anderson Symptom Inventory (MDASI)
timeFrame: Baseline/pre-intervention, midpoint/during the intervention (2 weeks), immediately after the intervention (4 weeks), and follow-up 4 weeks after the intervention(8 weeks)
measure: Getting Along Scale
timeFrame: Baseline/pre-intervention, midpoint/during the intervention (2 weeks), immediately after the intervention (4 weeks), and follow-up 4 weeks after the intervention(8 weeks)
Locations:
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center - Philadelphia
state: Pennsylvania
Study officials:
References: