City of Hope Medical Center
Duarte, California, 91010, United States
Location status: Recruiting
NCT Number: NCT07664579
This study evaluates how useful and acceptable the components of the "Couples Coping Together Against Cancer", referred to as "The Program", are to the participants with cancer.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Duarte, California, 91010, United States
Location status: Recruiting
PRIMARY OBJECTIVES:
I. Establish feasibility of The Program and its central components. II. Investigate the acceptability of The Program and its central components.
EXPLORATORY OBJECTIVE:
I. Assess the preliminary efficacy of The Program in the domain of patients' and partners' biopsychosocial distress and longitudinal impact of the program on them.
OUTLINE: This is an observational study.
Patient and partners receive access to the Connecting Care App tool and undergo biopsychosocial screening and psychoeducation sessions over 30-45 minutes and complete surveys on study. Patients and partners may also receive counseling sessions over 30-45 minutes for up to 4 sessions on study.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Non-interventional study
Other names: Non-Interventional Observational Study, Noninterventional (Observational) Study
Time frame: Up to 12 months
Defined as number of enrolled dyads/number of eligible dyads x 100. Recruitment rate along with 95% confidence interval (CI) will be calculated. Program will be considered feasible with ≥ 70% recruitment rate.
Time frame: At 3 month and 6 month follow up
Defined as percentage of dyads retained at the 3-month follow-up. Retention rate along with 95% CI will be calculated. Program will be considered feasible with ≥ 70% retention rate.
Time frame: Up to 3 month follow up
Defined as percentage of dyads who completed all core components of the study at the 3-month follow-up. Adherence rate along with 95% CI will be calculated. Program will be considered feasible with ≥ 70% adherence rate.
Time frame: Up to 6 month follow up
Defined by the percentage of respondents (patients, partners, providers and staff) who scored positively on various surveys assessing study satisfaction (e.g. agree to strongly agree or helpful to very helpful). A rate of 70% will be considered acceptable Acceptability will be measured using a survey on study satisfaction. Acceptability rate will be computed with 95% CI.
Time frame: At baseline and up to 6 months post program
Efficacy will be evaluated via paired t-test. Linear mixed models will also be used to explore the change in distress measures from baseline to 3 and 6 months.
City of Hope Medical Center
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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