CARE Study: Cancer, Asian Americans, and Relationship Enrichment

NCT06782581 | Recruiting

• 2 other identifiers: 24-10065R00CA267678-04
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasm

Keywords

Asian American; Cancer; Patient; Positive Activities; Well-being; Caregiver

Outcome Measures

Primary Outcomes (2)

• Affect-Adjective Scale (modified) (AAS)

  Primary Outcome Measure: affective well-being scores range from 0-6, with 6 indicating higher negative or positive affect

  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)

• Patient-Reported Outcomes Measurement Information System Global Health (PROMIS G10)

  Primary Outcome Measure: health-related quality of life scores range from 3 to 15, with higher scores indicating better physical health scores range from 4 to 20, with high scores indicating better mental health

  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 (2)

• Balanced Measure of Psychological Needs (BMPN)

  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)

• Self-Perceived Burden Scale

  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 (4)

• Perceived Stress Scale (PSS)

  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)

• PROMIS Patient-Reported Outcomes Measurement Information System Depression 4a (PROMIS Depr4a)

  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)

• MD Anderson Symptom Inventory (MDASI)

  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)

Study Arms (2)

Contribution

EXPERIMENTAL

Contribution to caregiver wellbeing via household tasks. If the household contribution condition is chosen, participants will be given instructions and examples/list of things they could do to contribute to the well-being of their caregiver (e.g., cook a meal, take pet for a walk, water the plants). If the outside contribution condition is chosen, participants will be given instructions and examples/list of things they could do to contribute to the world outside of their own home (e.g., pick up litter in neighborhood, buy coffee for stranger, donate food/clothing to homeless)

Behavioral: Contribution to Caregivers Well-Being

Control Group

PLACEBO COMPARATOR

Participants in the control group will be asked to factually describe either (1) immediate environment, (2) the weather, or (3) organization of closet

Behavioral: Control

Interventions

Control BEHAVIORAL

factually describe either (1) immediate environment, (2) the weather, or (3) organization of closet

Also known as: Experimental Arm, Control Group

Control Group

Contribution to Caregivers Well-Being BEHAVIORAL

Contribute to caregiver's well-being via household tasks.

Also known as: Household Contribution, Internal Contribution

Contribution

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• life expectancy less than 6 months in the opinion of the primary physician
• inability to stand or walk on their own or other physical limitations that preclude them from participating (3+ on ECOG performance status),
• major thought disorder (e.g., schizophrenia or bipolar \[patient records or self-disclosure\]).
• identifies as Asian American or Asian,
• patient considers them to be caregiver
• English proficient or Mandarin Chinese proficient
• access to computer/phone, internet, and web browser.
• unwilling or unable to participate in the study for any reason,
• under the age of 18.

Sponsors & Collaborators

• Fox Chase Cancer Center: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, 19111, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Lilian J. Shin-Cho, PhD

CONTACT

267-889-2209; Lilian.Shin-Cho@fccc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Assistant Professor

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: January 20, 2025
• Study Start: August 6, 2024
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): February 15, 2027
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

US (1)