CARE Study: Cancer, Asian Americans, and Relationship Enrichment
ConditionNeoplasm
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-80
SponsorFox Chase Cancer Center
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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,
Disqualifiers
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]).
identifies as Asian American or Asian,
Trial design
Design model
Parallel
Treatments tested in this trial
Contribution to Caregivers Well-Being
BehavioralContribute to caregiver's well-being via household tasks.
Control
Behavioralfactually describe either (1) immediate environment, (2) the weather, or (3) organization of closet
Treatment groups
186 Participants
are divided into 2 treatment groupsGroup A: ContributionExperimental treatment 1 intervention
Group B: Control GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Affect-Adjective Scale (modified) (AAS)
Primary Outcome Measure: affective well-being scores range from 0-6, with 6 indicating higher negative or positive affect
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)2
Patient-Reported Outcomes Measurement Information System Global Health (PROMIS G10)
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
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 outcomes
1
Balanced Measure of Psychological Needs (BMPN)
Secondary Outcome Measure: autonomy, competence, and connectedness scores range from 1 to 5, with higher scores indicating more autonomy, competence, or connectedness
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)2
Self-Perceived Burden Scale
Secondary Outcome Measure: perceived burdensomeness scores range from 10 to 50, with higher scores indicating more self-perceived burdensomeness
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 outcomes
1
Perceived Stress Scale (PSS)
Other Pre-specified Outcome Measure: patient stres PSS: scores range from 0 to 16, with higher scores indicating more stress
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)2
PROMIS Patient-Reported Outcomes Measurement Information System Depression 4a (PROMIS Depr4a)
Other Pre-specified Outcome Measure: depression PROMIS Depr4a: scores range from 4 to 20 with higher scores indicating more depressive symptoms
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)3
MD Anderson Symptom Inventory (MDASI)
Other Pre-specified Outcome Measure: clinical symptoms MDASI: scores range from 0 to 10 with higher scores indicating more symptoms or more interference
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)4
Getting Along Scale
Other Pre-specified Outcome Measure: interpersonal well-being Getting Along: scores range from 4 to 16, with higher scores indicating getting along better
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Fox Chase Cancer Center
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov