CARE Study: Cancer, Asian Americans, and Relationship Enrichment

Not Applicable

Recruiting

• Conditions: Neoplasm

• Registration Number: NCT06782581
• Lead Sponsor: Fox Chase Cancer Center

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.

Study Timeline

• Study Start: 2024-08-06
• Study First Submitted: 2024-09-06
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-16
• Study First Posted: 2025-01-20
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-24
• Primary Completion: 2026-10-31
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 186

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Affect-Adjective Scale (modified) (AAS)	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)	Primary Outcome Measure: affective well-being; scores range from 0-6, with 6 indicating higher negative or positive affect
Patient-Reported Outcomes Measurement Information System Global Health (PROMIS G10)	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)	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

Secondary Outcome Measures

Name	Time	Method
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)	Secondary Outcome Measure: autonomy, competence, and connectedness; scores range from 1 to 5, with higher scores indicating more autonomy, competence, or connectedness
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)	Secondary Outcome Measure: perceived burdensomeness; scores range from 10 to 50, with higher scores indicating more self-perceived burdensomeness

Trial Locations

Locations (1)

Fox Chase Cancer Center - Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States