Cancer
Conditions
Brief summary
Positive Activities for Asian American Cancer Patients and Caregivers
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.
Interventions
BEHAVIORALHousehold Contribution
Questionnaires
BEHAVIORALOutside Contribution
Questionnaires
BEHAVIORALControl
Questionnaires
Sponsors
M.D. Anderson Cancer Center
National Institutes of Health (NIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Affect-Adjective Scale | 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"). |
| Health-Related Quality of Life | 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. |
| Perceived Stress | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Psychological Needs | 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. |
| Self-Perceived Burden | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLI Qian
M.D. Anderson Cancer Center
Participant flow
Recruitment details
Data were collected from August 2022 to October 2023, Participants were recruited in person in outpatient clinics or over the phone.
Pre-assignment details
8 participants were excluded from the study before assignment to groups. 3 were excluded due to caregivers not signing informated consent; 5 were excluded due to not completing baseline measures.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous Caregivers | 51.00 years STANDARD_DEVIATION 13.93 |
| Age, Continuous Patients | 53.65 years STANDARD_DEVIATION 12.35 |
| Race (NIH/OMB) Caregivers American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Caregivers Asian | 5 Participants |
| Race (NIH/OMB) Caregivers Black or African American | 0 Participants |
| Race (NIH/OMB) Caregivers More than one race | 0 Participants |
| Race (NIH/OMB) Caregivers Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Caregivers Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Caregivers White | 0 Participants |
| Race (NIH/OMB) Patients American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Patients Asian | 11 Participants |
| Race (NIH/OMB) Patients Black or African American | 0 Participants |
| Race (NIH/OMB) Patients More than one race | 0 Participants |
| Race (NIH/OMB) Patients Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Patients Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Patients White | 0 Participants |
| Region of Enrollment United States | 14 participants |
| Sex: Female, Male Caregivers Female | 4 Participants |
| Sex: Female, Male Caregivers Male | 2 Participants |
| Sex: Female, Male Patients Female | 4 Participants |
| Sex: Female, Male Patients Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 19 | 0 / 14 |
| other Total, other adverse events | 0 / 15 | 0 / 19 | 0 / 14 |
| serious Total, serious adverse events | 0 / 15 | 1 / 19 | 0 / 14 |
Outcome results
None listed