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NCT Number: NCT06782581

CARE Study: Cancer, Asian Americans, and Relationship Enrichment

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.

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Key information

Conditions

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, 19111, United States

Location status: Recruiting

Location contact

Lilian Shin-Cho, PhD

CONTACT

[email protected]

2678892209

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for Patients:

  • 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.

Exclusion criteria

for patients:

  • 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]).

Inclusion criteria

for Caregivers:

  • 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.

Exclusion criteria

for Caregivers:

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

Treatment and study plan

Contribution to Caregivers Well-Being

Behavioral

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

Other names: Household Contribution, Internal Contribution

Control

Behavioral

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

Other names: Experimental Arm, Control Group

Primary outcomes

  1. Affect-Adjective Scale (modified) (AAS)

    Time frame: 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

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

    Time frame: 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 outcomes

  1. Balanced Measure of Psychological Needs (BMPN)

    Time frame: 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

  2. Self-Perceived Burden Scale

    Time frame: 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

Other outcomes

  1. Perceived Stress Scale (PSS)

    Time frame: 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 Pre-specified Outcome Measure: patient stres

    PSS: scores range from 0 to 16, with higher scores indicating more stress

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

    Time frame: 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 Pre-specified Outcome Measure: depression

    PROMIS Depr4a: scores range from 4 to 20 with higher scores indicating more depressive symptoms

  3. MD Anderson Symptom Inventory (MDASI)

    Time frame: 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 Pre-specified Outcome Measure: clinical symptoms

    MDASI: scores range from 0 to 10 with higher scores indicating more symptoms or more interference

  4. Getting Along Scale

    Time frame: 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 Pre-specified Outcome Measure: interpersonal well-being

    Getting Along: scores range from 4 to 16, with higher scores indicating getting along better

Study contacts

Contact information is provided by the study sponsor or research team.

Lilian J. Shin-Cho, PhD

CONTACT

[email protected]

267-889-2209

Sponsors and collaborators

Lead sponsor

Fox Chase Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Official study title

Positive Activities for Asian American Cancer Patients and Caregivers

Acronym: CARE

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 20, 2025
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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