Anatomic Stage IV Breast Cancer AJCC v8NCT07664579
Investigating the Feasibility and Acceptability of an Innovative Interdisciplinary Supportive Care Program: Couples Coping Together Against Cancer
An observational study of Anatomic Stage IV Breast Cancer AJCC v8 and Glioblastoma, run by City of Hope Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anatomic Stage IV Breast Cancer AJCC v8, Glioblastoma, Lung Carcinoma
- What is being tested?
- Non-Interventional Study
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2024to 16 Nov 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with glioblastoma, breast cancer, lung cancer, or other cancer, their partners, and their providers
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
City of Hope Medical Center
Duarte, California, 91010
William Dale, 626-256-4673 ext. 85153, wdale@coh.org
William Dale
About this study
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.
Read the detailed description
PRIMARY OBJECTIVES:
- Establish feasibility of The Program and its central components. II. Investigate the acceptability of The Program and its central components.
EXPLORATORY OBJECTIVE:
- 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.
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Glioblastoma, Lung Carcinoma, Malignant Solid Neoplasm, Metastatic Breast Carcinoma
- Being tested
- Non-Interventional Study
- Medical subject headings
- Glioblastoma, Lung Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Also called Non-Interventional Observational Study, Noninterventional (Observational) Study
Non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 6 month follow up
Secondary outcomes (1)
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.
Measured: At baseline and up to 6 months post program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start5 Jul 2024
- Primary completion16 Nov 2026 (estimated)
- Study completion16 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage IV Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- William Dale, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07664579
- Sponsor's protocol ID
- 23430
- Other IDs
- NCI-2024-04490, 23430, P30CA033572
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2024
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No