- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05203614
Positive Activities for Asian American Cancer Patients and Caregivers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Primary Objectives:
The overall objective of this project is to design and test the feasibility of two positive activities, household contribution and outside contribution, to increase quality of life in AA cancer patients.
Secondary Objectives:
Aim 1: To assess the acceptability and feasibility of household and outside contribution positive activities for AAs through a mixed qualitative and exploratory quantitative investigation.
Aim 2: To use the qualitative and quantitative data from Aim 1, in collaboration with the mentorship team, AA community members, and clinicians, to develop one or both positive activity intervention(s) (i.e., household or outside contribution) specifically for AA cancer patients.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- M D Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion criteria for patients will be:
- self-identifies as AA,
- males or females ages 25-75 years
- within 1 year of any cancer diagnosis
- actively undergoing systemic therapy (e.g., chemotherapy, radiation)
- able to identify a caregiver (e.g., spouse) who lives in the same household and consents to participate in the study,
- able to read, write, and speak English (i.e., English proficient; EP),
- access to internet, computer/phone, and web browser.
Exclusion criteria for patients will be:
- 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
Inclusion criteria for caregivers will be:
- identifies as AA,
- patient considers them to be caregiver, -
- EP,
- access to computer/phone, internet, and web browser.
Exclusion criteria for caregivers will be:
- unwilling or unable to participate in the study for any reason,
- under the age of 18.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Household Contribution
Do something thoughtful or nice for your caregiver that would provide them with tangible support
|
Questionnaires
|
|
Other: Outside Contribution
Do something outside your home/household that contributes to the larger society
|
Questionnaires
|
|
Other: Control
Keep track of your daily activities
|
Questionnaires
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Affect-Adjective Scale
Time Frame: End-of-study (4 weeks)
|
Positive and negative affect were measured using a modified 12-item Affect-Adjective Scale (AAS) (Diener & Emmons, 1984) that included low-arousal emotion items (e.g., peaceful/serene, dull/bored).
Participants rated the extent to which they experienced positive and negative emotions over the past week on a scale from 0 ("not at all") to 6 ("extremely").
|
End-of-study (4 weeks)
|
|
Health-Related Quality of Life
Time Frame: End-of-study (4 weeks)
|
HRQOL was measured using the 10-item Patient-Reported Outcomes Measurement Information System Global-10 (PROMIS-10) (Cella et al., 2010), with physical and mental health subscales.
The scale ranges from 5 to 20 with higher scores indicating better health-related quality of life.
|
End-of-study (4 weeks)
|
|
Perceived Stress
Time Frame: End-of-study (4 weeks)
|
Perceived stress was measured using the 4-item Perceived Stress Scale (PSS) (Cohen & Willliamson, 1988), which assessed the frequency of stressful experiences over the past month.
The scale ranges from 0 to 16 with higher scores indicating greater perceived stress.
|
End-of-study (4 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Psychological Needs
Time Frame: End-of-study (4 weeks)
|
Psychological needs were measured with a 9-item version of the Balanced Measure of Psychological Needs (BMPN) (Sheldon & Hilpert, 2012), which includes subscales for autonomy, competence, and connectedness.
The subscales range from 1 to 5 with higher scores indicating greater satisfaction of the respective need.
|
End-of-study (4 weeks)
|
|
Self-Perceived Burden
Time Frame: End-of-study (4 weeks)
|
Self-perceived burden was measured using the 10-item Self-Perceived Burden Scale (SPBS) (Cousineau et al., 2003), which assessed the extent to which patients felt that they were a burden on caregivers.
The scale ranges from 10 to 50 with higher scores indicating greater self=perceived burden.
|
End-of-study (4 weeks)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: LI Qian, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-0998
- NCI-2021-12848 (Other Identifier: NCI-CTRP Clinical Trials Reporting Registry)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.