Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, 19111, United States
Location status: Recruiting
NCT Number: NCT06782581
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.
Interested in participating?
Request Info21 year–80 year
All sexes
Interventional
Not applicable
Philadelphia, Pennsylvania, 19111, United States
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for Patients:
Exclusion criteria
for patients:
Inclusion criteria
for Caregivers:
Exclusion criteria
for Caregivers:
Contribute to caregiver's well-being via household tasks.
Other names: Household Contribution, Internal Contribution
factually describe either (1) immediate environment, (2) the weather, or (3) organization of closet
Other names: Experimental Arm, Control Group
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
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
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
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
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
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
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
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
Contact information is provided by the study sponsor or research team.
Fox Chase Cancer Center
Other
Positive Activities for Asian American Cancer Patients and Caregivers
Acronym: CARE
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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