Investigating the Feasibility and Acceptability of an Innovative Interdisciplinary Supportive Care Program: Couples Coping Together Against Cancer

City of Hope Medical Center160 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

160

Conditions

Anatomic Stage IV Breast Cancer AJCC v8 Glioblastoma Lung Carcinoma Malignant Solid Neoplasm Metastatic Breast Carcinoma

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

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.

Time frame: Up to 12 months

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.

Time frame: At 3 month and 6 month follow up

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.

Time frame: Up to 3 month follow up

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.

Time frame: Up to 6 month follow up

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.

Time frame: At baseline and up to 6 months post program