Neoplasm
Conditions
Keywords
Asian American, Cancer, Patient, Positive Activities, Well-being, Caregiver
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.
Interventions
BEHAVIORALContribution to Caregivers Well-Being
Contribute to caregiver's well-being via household tasks.
BEHAVIORALControl
factually describe either (1) immediate environment, (2) the weather, or (3) organization of closet
Sponsors
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Fox Chase Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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) | Other Pre-specified Outcome Measure: patient stres PSS: scores range from 0 to 16, with higher scores indicating more stress |
| 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) | Other Pre-specified Outcome Measure: depression PROMIS Depr4a: scores range from 4 to 20 with higher scores indicating more depressive symptoms |
| 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) | Other Pre-specified Outcome Measure: clinical symptoms MDASI: scores range from 0 to 10 with higher scores indicating more symptoms or more interference |
| Getting Along 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 Pre-specified Outcome Measure: interpersonal well-being Getting Along: scores range from 4 to 16, with higher scores indicating getting along better |
Countries
United States
Contacts
Primary ContactLilian J. Shin-Cho, PhD
Outcome results
None listed