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

NCT07664579 | Recruiting DMC

• 3 other identifiers: 23430NCI-2024-04490P30CA033572
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Change in distress scores

  At baseline and up to 6 months post program

Study Arms (1)

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

Interventions

Non-Interventional Study OTHER

Non-interventional study

Also known as: Non-Interventional Observational Study, Noninterventional (Observational) Study

Observational

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

RECRUITING

MeSH Terms

Conditions

Glioblastoma; Lung Neoplasms; Breast Neoplasms

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• William Dale

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2024
• First Posted: June 24, 2026
• Study Start: July 5, 2024
• Primary Completion (Estimated): November 16, 2026
• Study Completion (Estimated): November 16, 2026
• Last Updated: June 24, 2026

Record last verified: 2026-06

Locations

US (1)