CARE Study: Cancer, Asian Americans, and Relationship Enrichment

Temple University Health System (TUHS)

Status: Enrolling

Conditions: Neoplasm

Treatments: Behavioral: Contribution to Caregivers Well-Being; Behavioral: Control

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06782581

5R00CA267678-04 (U.S. NIH Grant/Contract)

24-1006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 186 estimated patients

Sex: All

Ages: 21 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for Patients:

1. self-identifies as Asian American or Asian
2. males or females ages 21-80 years
3. within 2 years 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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186 participants in 2 patient groups, including a placebo group

Contribution

Experimental group

Description:

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)

Treatment:

Behavioral: Contribution to Caregivers Well-Being

Control Group

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Control