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

June 18, 2026 updated by: City of Hope Medical Center
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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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)
Time Frame: 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.
Up to 12 months
Retention rate (RR)
Time Frame: 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.
At 3 month and 6 month follow up
Adherence rate (AdR)
Time Frame: 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.
Up to 3 month follow up
Study Satisfaction (SS)
Time Frame: 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.
Up to 6 month follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in distress scores
Time Frame: 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.
At baseline and up to 6 months post program

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: William Dale, City of Hope Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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