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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Feasibility and Acceptability of an Innovative Interdisciplinary Supportive Care Program: Couples Coping Together Against Cancer
- ClinicalTrials.gov ID
- NCT07664579
- Acronym / sponsor ID
- 23430
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Glioblastoma, Lung Carcinoma, Malignant Solid Neoplasm, Metastatic Breast Carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 5 Jul 2024 (actual)
- Primary completion
- 16 Nov 2026 (estimated)
- Study completion
- 16 Nov 2026 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: Non-Interventional StudyPatient 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with glioblastoma, breast cancer, lung cancer, or other cancer, their partners, and their providers
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Interventional StudyAlso: Non-Interventional Observational Study, Noninterventional (Observational) StudyNon-interventional study | Other | Observational |
Primary outcome
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.
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.
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.
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.
1 secondary outcome
Change in distress scores
Time frame: At baseline and up to 6 months post program
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
William Dale principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accrual rate (AR) (time frame: Up to 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.