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CompletedNCT05203614Updated Aug 13, 2026Results posted

Positive Activities for Asian American Cancer Patients and Caregivers

An interventional study of Household Contribution and Outside Contribution in Cancer, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 25 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by M.D. Anderson Cancer Center · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
25 Years to 75 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Cancer

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03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 60 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

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Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.

Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Other
    Household Contribution

    Do something thoughtful or nice for your caregiver that would provide them with tangible support

    Behavioral: Household Contribution

  • Other
    Outside Contribution

    Do something outside your home/household that contributes to the larger society

    Behavioral: Outside Contribution

  • Other
    Control

    Keep track of your daily activities

    Behavioral: Control

Interventions

  • BehavioralHousehold Contribution

    Questionnaires

  • BehavioralOutside Contribution

    Questionnaires

  • BehavioralControl

    Questionnaires

06

What researchers measure

Primary outcomes

  1. 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").

    Time frame: End-of-study (4 weeks)

  2. 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.

    Time frame: End-of-study (4 weeks)

  3. 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.

    Time frame: End-of-study (4 weeks)

Secondary outcomes

  1. 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.

    Time frame: End-of-study (4 weeks)

  2. 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.

    Time frame: End-of-study (4 weeks)

07

Results

Posted Aug 13, 2026

Participant flow

Data were collected from August 2022 to October 2023, Participants were recruited in person in outpatient clinics or over the phone.

Participant flow — Overall Study
MilestoneHousehold ContributionOutside ContributionControl
Started151914
Patients101210
Caregivers574
Completed141314
Not completed160
Withdrew: Withdrawal by subject140
Withdrew: Lost to follow-up020

Outcome measures

PrimaryAffect-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").

Time frame:
End-of-study (4 weeks)
Reported as:
Mean · score on a scale
Affect-Adjective Scale
score on a scaleHousehold ContributionOutside ContributionControl
Positive Affect Patients3.44 ± 1.143.57 ± 1.043.83 ± 1.23
Positive Affect Caregivers3.6 ± 0.993.21 ± 1.014.25 ± 1.02
Negative Affect Patients0.96 ± 3.140.87 ± 1.060.77 ± 0.7
Negative Affect Caregivers1.2 ± 1.051.46 ± 0.630.96 ± 0.57
PrimaryHealth-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.

Time frame:
End-of-study (4 weeks)
Reported as:
Mean · score on a scale
Health-Related Quality of Life
score on a scaleHousehold ContributionOutside ContributionControl
Physical QOL - Patients13.67 ± 214.67 ± 2.8714.3 ± 1.57
Mental QOL - Patients12.56 ± 3.1713.22 ± 2.3313.5 ± 2.07
PrimaryPerceived 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.

Time frame:
End-of-study (4 weeks)
Reported as:
Mean · score on a scale
Perceived Stress
score on a scaleHousehold ContributionOutside ContributionControl
Patients5.11 ± 2.215.56 ± 2.565.1 ± 2.73
Caregivers6.8 ± 1.927.5 ± 2.085.25 ± 3.86
SecondaryPsychological 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.

Time frame:
End-of-study (4 weeks)
Reported as:
Mean · score on a scale
Psychological Needs
score on a scaleHousehold ContributionOutside ContributionControl
Autonomy - Patients4.07 ± 0.74.11 ± 0.784.1 ± 0.74
Autonomy - Caregivers3.73 ± 0.63.92 ± 1.14.33 ± 0.47
Competence - Patients3.82 ± 0.783.81 ± 1.134 ± 0.85
Competence - Caregivers3.73 ± 0.553.67 ± 1.414 ± 0.72
Connectedness - Patients3.93 ± 0.63.96 ± 0.864.27 ± 0.63
Connectedness - Caregivers3.87 ± 0.33.58 ± 1.454.5 ± 0.43
SecondarySelf-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.

Time frame:
End-of-study (4 weeks)
Reported as:
Mean · score on a scale
Self-Perceived Burden
score on a scaleHousehold ContributionOutside ContributionControl
Self-Perceived Burden20.44 ± 9.8917.33 ± 4.5819.3 ± 4.74

Adverse events

Collected over baseline to study completion, an average of 5 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Household Contribution0/15 (0%)0/15 (0%)0/15 (0%)
Outside Contribution0/19 (0%)1/19 (5.3%)0/19 (0%)
Control0/14 (0%)0/14 (0%)0/14 (0%)
Most frequent serious events
Most frequent serious events
EventHousehold ContributionOutside ContributionControl
Patient did not feel well enough to do study activitiesGeneral disorders0/151/190/14

Baseline characteristics

Age, Continuous
Age, Continuous(years)Household ContributionOutside ContributionControlTotal
Patients53.0 ± 14.8755.8 ± 12.7655.10 ± 12.2653.65 ± 12.35
Caregivers57.0 ± 11.4948.0 ± 9.4751.00 ± 13.9353.65 ± 12.35
Sex: Female, Male
Sex: Female, Male(Participants)Household ContributionOutside ContributionControlTotal
Patients — Female49720
Patients — Male63312
Caregivers — Female45211
Caregivers — Male1225
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Household ContributionOutside ContributionControlTotal
Patients — American Indian or Alaska Native0000
Patients — Asian10111031
Patients — Native Hawaiian or Other Pacific Islander0101
Patients — Black or African American0000
Patients — White0000
Patients — More than one race0000
Patients — Unknown or Not Reported0000
Caregivers — American Indian or Alaska Native0000
Caregivers — Asian57416
Caregivers — Native Hawaiian or Other Pacific Islander0000
Caregivers — Black or African American0000
Caregivers — White0000
Caregivers — More than one race0000
Caregivers — Unknown or Not Reported0000
Region of Enrollment
Region of Enrollment(participants)Household ContributionOutside ContributionControlTotal
United States15191448
08

Study locations

1 site
  • M D Anderson Cancer Center
    Houston, Texas 77030, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Oct 31, 2022
  • Informed consent form · Nov 11, 2022

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05203614
Lead sponsor
M.D. Anderson Cancer Center
Collaborators
National Institutes of Health (NIH)
Responsible party
Sponsor
First posted
Jan 24, 2022
Start date
Nov 30, 2021
Primary completion
Nov 19, 2024
Completion
Nov 19, 2024
Results posted
Aug 13, 2026
Last update
Aug 13, 2026

Study contacts

LI Qian
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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