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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05203614
Other study ID # 2021-0998
Secondary ID NCI-2021-12848
Status Recruiting
Phase N/A
First received
Last updated
Start date November 30, 2021
Est. completion date December 31, 2026

Study information

Verified date April 2024
Source M.D. Anderson Cancer Center
Contact LI Qian
Phone (713) 745-8324
Email qlu@mdanderson.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Positive Activities for Asian American Cancer Patients and Caregivers


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 31, 2026
Est. primary completion date December 31, 2026
Accepts healthy volunteers No
Gender All
Age group 25 Years to 75 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Household Contribution
Questionnaires
Outside Contribution
Questionnaires
Control
Questionnaires

Locations

Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of Life Questionnaires(HRQOL & interpersonal well-being ) Hedonic well-being (positive and negative emotions) will be measured using a modified 12-item Affect-Adjective Scale (AAS)42 that includes low-arousal emotion items (e.g., peaceful/serene, dull/bored). through study completion, an average of 1 year
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