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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCity of Hope Medical Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Refuse to complete informed consent

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Non-Interventional Study

    Other intervention

    Non-interventional study

Treatment groups

160 Participants
are divided into 1 treatment group
Group A: Observational1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 12 months
2

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.

Time frame
At 3 month and 6 month follow up
3

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.

Time frame
Up to 3 month follow up
4

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.

Time frame
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.

Time frame
At baseline and up to 6 months post program

Other outcomes

Sponsors and contacts

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City of Hope Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator