Investigating the Feasibility and Acceptability of an Innovative Interdisciplinary Supportive Care Program: Couples Coping Together Against Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Non-Interventional Study.
- Who it may be relevant to
- Registry conditions: Anatomic Stage IV Breast Cancer AJCC v8, Glioblastoma, Lung Carcinoma, Malignant Solid Neoplasm. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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.
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
- Other Non-Interventional Study
Non-interventional study
Primary outcome measures
- Accrual rate (AR) [Time frame: Up to 12 months]
- Retention rate (RR) [Time frame: At 3 month and 6 month follow up]
- Adherence rate (AdR) [Time frame: Up to 3 month follow up]
- Study Satisfaction (SS) [Time frame: Up to 6 month follow up]
Secondary outcome measures (1)
- Change in distress scores [Time frame: At baseline and up to 6 months post program]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- City of Hope Medical Center — Duarte
Identifiers
NCT: NCT07664579 · 23430 · NCI-2024-04490 · 23430 · P30CA033572