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

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.

Study Overview

• Status: Recruiting
• Conditions: Malignant Solid Neoplasm; Glioblastoma; Anatomic Stage IV Breast Cancer AJCC v8; Lung Carcinoma; Metastatic Breast Carcinoma
• Intervention / Treatment: Other: Non-Interventional Study

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.

• Study Type: Observational
• Enrollment (Estimated): 160

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • Recruiting
      • City of Hope Medical Center
      • Principal Investigator: William Dale
      • Contact: William Dale; Phone Number: 85153 626-256-4673; Email: wdale@coh.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with glioblastoma, breast cancer, lung cancer, or other cancer, their partners, and their providers

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational; 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.	Other: Non-Interventional Study; Non-interventional study; Other Names: Non-Interventional Observational Study; Noninterventional (Observational) Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Up to 6 month follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At baseline and up to 6 months post program

Collaborators and Investigators

• Sponsor: City of Hope Medical Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: William Dale, City of Hope Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2024
• Primary Completion (Estimated): November 16, 2026
• Study Completion (Estimated): November 16, 2026

Study Registration Dates

• First Submitted: June 16, 2024
• First Submitted That Met QC Criteria: June 18, 2026
• First Posted (Actual): June 24, 2026

Study Record Updates

• Last Update Posted (Actual): June 24, 2026
• Last Update Submitted That Met QC Criteria: June 18, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Neoplasms by Histologic Type; Lung Diseases; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Skin Diseases; Breast Diseases; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Skin and Connective Tissue Diseases; Lung Neoplasms; Breast Neoplasms; Glioblastoma
• Other Study ID Numbers: 23430 (Other Identifier: City of Hope Medical Center); P30CA033572 (U.S. NIH Grant/Contract); NCI-2024-04490 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No