NeoplasmCARENCT06782581
CARE Study: Cancer, Asian Americans, and Relationship Enrichment
A study testing Contribution to Caregivers Well-Being in people with Neoplasm, run by Fox Chase Cancer Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Neoplasm
- What is being tested?
- Contribution to Caregivers Well-Being
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 186 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2024to 15 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- self-identifies as Asian American or Asian
- males or females ages 21-80 years
- within 2 years of any cancer diagnosis or stage 4 cancer diagnosis
- actively undergoing surgery or systemic therapy (e.g., chemotherapy, radiation, immunotherapy) or within the past 6 months,
- able to identify a caregiver (e.g., spouse) who lives in the same household or see at least 3 times per week
- able to read, write, and speak English (i.e., English proficient; EP) or Mandarin/simplified Chinese.
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- identifies as Asian American or Asian,
- patient considers them to be caregiver
- English proficient or Mandarin Chinese proficient
- 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 self-disclosure]).
- 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. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, 19111
Lilian Shin-Cho, PhD, 2678892209, lilian.shin-cho@fccc.edu
About this study
Official title: Positive Activities for Asian American Cancer Patients and Caregivers
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.
Read the detailed description
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.
- Conditions
- Neoplasm
- Being tested
- Contribution to Caregivers Well-Being, Control
- Keywords
- Asian American, Cancer, Patient, Positive Activities, Well-being, Caregiver
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contribution to Caregivers Well-BeingBehavioural
Also called Household Contribution, Internal Contribution
Contribute to caregiver's well-being via household tasks.
ControlBehavioural
Also called Experimental Arm, Control Group
factually describe either (1) immediate environment, (2) the weather, or (3) organization of closet
| Study group | Role | What they receive |
|---|---|---|
| Contribution | Experimental | Contribution to caregiver wellbeing via household tasks. If the household contribution condition is chosen, participants will be given instructions and examples/list of things they could do to contribute to the well-being of their caregiver (e.g., cook a meal, take pet for a walk, water the plants). If the outside contribution condition is chosen, participants will be given instructions and examples/list of things they could do to contribute to the world outside of their own home (e.g., pick up litter in neighborhood, buy coffee for stranger, donate food/clothing to homeless) Receives: Behavioral: Contribution to Caregivers Well-Being |
| Control Group | Placebo comparator | Participants in the control group will be asked to factually describe either (1) immediate environment, (2) the weather, or (3) organization of closet Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Affect-Adjective Scale (modified) (AAS)
Primary Outcome Measure: affective well-being
scores range from 0-6, with 6 indicating higher negative or positive affect
Measured: 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)
Patient-Reported Outcomes Measurement Information System Global Health (PROMIS G10)
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
Measured: 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 outcomes (2)
Balanced Measure of Psychological Needs (BMPN)
Secondary Outcome Measure: autonomy, competence, and connectedness
scores range from 1 to 5, with higher scores indicating more autonomy, competence, or connectedness
Measured: 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)
Self-Perceived Burden Scale
Secondary Outcome Measure: perceived burdensomeness
scores range from 10 to 50, with higher scores indicating more self-perceived burdensomeness
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start6 Aug 2024
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmStudies of the same condition, open and under way.
- More trials run by Fox Chase 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Lilian Shin-Cho, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06782581
- Sponsor's protocol ID
- 24-1006
- Other IDs
- 5R00CA267678-04
- Acronym
- CARE
- Status last verified
- Dec 2025
- First submitted
- 6 Sep 2024
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positive Activities for Asian American Cancer Patients and Caregivers
- ClinicalTrials.gov ID
- NCT06782581
- Acronym / sponsor ID
- CARE / 24-1006
- Conditions
- Neoplasm
- Keywords
- Asian American, Cancer, Patient, Positive Activities, Well-being, Caregiver
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- 6 Aug 2024 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 20 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contribution | Experimental | Behavioral: Contribution to Caregivers Well-BeingContribution to caregiver wellbeing via household tasks. If the household contribution condition is chosen, participants will be given instructions and examples/list of things they could do to contribute to the well-being of their caregiver (e.g., cook a meal, take pet for a walk, water the plants). If the outside contribution condition is chosen, participants will be given instructions and examples/list of things they could do to contribute to the world outside of their own home (e.g., pick up litter in neighborhood, buy coffee for stranger, donate food/clothing to homeless) |
| Control Group | Placebo comparator | Behavioral: ControlParticipants in the control group will be asked to factually describe either (1) immediate environment, (2) the weather, or (3) organization of closet |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- self-identifies as Asian American or Asian
- males or females ages 21-80 years
- within 2 years of any cancer diagnosis or stage 4 cancer diagnosis
- actively undergoing surgery or systemic therapy (e.g., chemotherapy, radiation, immunotherapy) or within the past 6 months,
- able to identify a caregiver (e.g., spouse) who lives in the same household or see at least 3 times per week
Key exclusion criteria (5 listed)
- 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 self-disclosure]).
- unwilling or unable to participate in the study for any reason,
- under the age of 18.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contribution to Caregivers Well-BeingAlso: Household Contribution, Internal ContributionContribute to caregiver's well-being via household tasks. | Behavioural | Contribution |
| ControlAlso: Experimental Arm, Control Groupfactually describe either (1) immediate environment, (2) the weather, or (3) organization of closet | Behavioural | Control Group |
Primary outcome
Affect-Adjective Scale (modified) (AAS)
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
Patient-Reported Outcomes Measurement Information System Global Health (PROMIS G10)
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
2 secondary outcomes
Balanced Measure of Psychological Needs (BMPN)
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)
Self-Perceived Burden Scale
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contribution to Caregivers Well-Being in people with Neoplasm, run by Fox Chase Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lilian J. Shin-Cho, PhD (267-889-2209, Lilian.Shin-Cho@fccc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Affect-Adjective Scale (modified) (AAS) (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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.