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| ID | Type | Description | Link |
|---|---|---|---|
| 5R00CA267678-04 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contribution to Caregivers Well-Being | Behavioral | Contribute to caregiver's well-being via household tasks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Affect-Adjective Scale (modified) (AAS) | Primary Outcome Measure: affective well-being scores range from 0-6, with 6 indicating higher negative or positive affect | 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 | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived Stress Scale (PSS) | Other Pre-specified Outcome Measure: patient stres PSS: scores range from 0 to 16, with higher scores indicating more stress | 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) |
Inclusion Criteria for Patients:
Exclusion Criteria for patients:
Inclusion Criteria for Caregivers:
Exclusion Criteria for Caregivers:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lilian J. Shin-Cho, PhD | Contact | 267-889-2209 | Lilian.Shin-Cho@fccc.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fox Chase Cancer Center - Philadelphia | Recruiting | Philadelphia | Pennsylvania | 19111 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| Control | Behavioral | factually describe either (1) immediate environment, (2) the weather, or (3) organization of closet |
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| Self-Perceived Burden Scale | Secondary Outcome Measure: perceived burdensomeness scores range from 10 to 50, with higher scores indicating more self-perceived burdensomeness | 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) |
| PROMIS Patient-Reported Outcomes Measurement Information System Depression 4a (PROMIS Depr4a) |
Other Pre-specified Outcome Measure: depression PROMIS Depr4a: scores range from 4 to 20 with higher scores indicating more depressive symptoms |
| 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) |
| MD Anderson Symptom Inventory (MDASI) | Other Pre-specified Outcome Measure: clinical symptoms MDASI: scores range from 0 to 10 with higher scores indicating more symptoms or more interference | 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) |
| Getting Along Scale | Other Pre-specified Outcome Measure: interpersonal well-being Getting Along: scores range from 4 to 16, with higher scores indicating getting along better | 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) |
| D008722 | Methods |