About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Have received a diagnosis of a primary brain tumor (glioblastoma), or other cancers (breast, lung, etc.)
Are new patients to City of Hope (COH) (all sites) or receive at least some of their care at City of Hope- Duarte Campus (care is defined as: procedures, consults, laboratories, imaging, surgery, and/or treatment)
The patient is in a committed relationship/partnership with a partner and the partner is available and willing to participate
Are English or Spanish speaking
Disqualifiers
Significant cognitive impairment
Inpatient psychiatric treatment for severe mental illness or overt signs of severe psychopathology (e.g., psychosis)
Visual, hearing, voice, or motor impairment that prevents completion of study procedures as evidenced by clinical judgment
Refuse to complete informed consent
Trial population
Patients with glioblastoma, breast cancer, lung cancer, or other cancer, their partners, and their providers
Trial design
Cohort
Prospective
Treatments tested in this trial
Non-Interventional Study
Other interventionNon-interventional study
Treatment groups
Trial outcomes
Primary outcomes
Accrual rate (AR)
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.
Retention rate (RR)
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.
Adherence rate (AdR)
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.
Study Satisfaction (SS)
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.
Secondary outcomes
Change in distress scores
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.
Sponsors and contacts
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City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator