CARE Study: Cancer, Asian Americans, and Relationship Enrichment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Contribution to Caregivers Well-Being, Control.
- Who it may be relevant to
- Registry conditions: Neoplasm. Basic parameters: 21 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Positive Activities for Asian American Cancer Patients and Caregivers
Overview
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.
Interventions
- Behavioral Contribution to Caregivers Well-Being
Contribute to caregiver's well-being via household tasks. - Behavioral Control
factually describe either (1) immediate environment, (2) the weather, or (3) organization of closet
Primary outcome measures
- 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)]
- 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)]
Secondary outcome measures (2)
- 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)]
- 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)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Fox Chase Cancer Center - Philadelphia — Philadelphia
Identifiers
NCT: NCT06782581 · 24-1006 · 5R00CA267678-04