Anatomic Stage IV Breast Cancer AJCC v8, Glioblastoma, Lung Carcinoma, Malignant Solid Neoplasm, Metastatic Breast Carcinoma
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERNon-Interventional Study
Non-interventional study
Sponsors
City of Hope Medical Center
National Cancer Institute (NCI)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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 * ≥ 18 years of age * Have access to a smartphone, computer/laptop or internet connection to complete all study procedures
Exclusion criteria
* 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 * Committed partners will be excluded from the study if they: * Refuse to complete informed consent * Have cognitive impairment * Have severe mental illness that would prevent informed consent and completion of study activities as evidenced by clinical judgment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accrual rate (AR) | 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. |
| Retention rate (RR) | 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. |
| Adherence rate (AdR) | 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. |
| Study Satisfaction (SS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in distress scores | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORWilliam Dale
City of Hope Medical Center
Outcome results
None listed