CancerNCT05203614
Positive Activities for Asian American Cancer Patients and Caregivers
A study testing Household Contribution and Outside Contribution in people with Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Positive Activities for Asian American Cancer Patients and Caregivers Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Cancer
- What is being tested?
- Household Contribution and Outside Contribution
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2021to 19 Nov 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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),
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- access to internet, computer/phone, and web browser.
- identifies as AA,
- patient considers them to be caregiver, -
- EP,
- access to computer/phone, internet, and web browser.
Who cannot join
- 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
- unwilling or unable to participate in the study for any reason,
- under the age of 18.
Trial locations and contacts
1 site in 1 country.
About this study
Positive Activities for Asian American Cancer Patients and Caregivers
Read the 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.
- Conditions
- Cancer
- Being tested
- Household Contribution, Outside Contribution, Control
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Household ContributionBehavioural
Questionnaires
Outside ContributionBehavioural
Questionnaires
ControlBehavioural
Questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Household Contribution | Other | Do something thoughtful or nice for your caregiver that would provide them with tangible support Receives: Behavioral: Household Contribution |
| Outside Contribution | Other | Do something outside your home/household that contributes to the larger society Receives: Behavioral: Outside Contribution |
| Control | Other | Keep track of your daily activities Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Affect-Adjective Scale
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").
Measured: End-of-study (4 weeks)
Health-Related Quality of Life
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.
Measured: End-of-study (4 weeks)
Perceived Stress
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.
Measured: End-of-study (4 weeks)
Secondary outcomes (2)
Psychological Needs
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.
Measured: End-of-study (4 weeks)
Self-Perceived Burden
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.
Measured: End-of-study (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start30 Nov 2021
- Primary completion19 Nov 2024
- Study completion19 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- LI Qian, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05203614
- Sponsor's protocol ID
- 2021-0998
- Other IDs
- NCI-2021-12848
- Status last verified
- Aug 2026
- First submitted
- 11 Nov 2021
- Last updated
- 13 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No