Clinical trial NCT02401321: Taking Care of Her Program in Patients With Stage III or IV Ovarian Cancer and Spouse Caregivers
Official title: A Pilot Feasibility Study: Taking Care of Her
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caregiver
Stage IIIA Ovarian Cancer
Stage IIIB Ovarian Cancer
Stage IIIC Ovarian Cancer
Stage IV Ovarian Cancer
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-03-27
Enrollment: 14
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This pilot clinical trial studies the Taking Care of Her program in patients with stage III or IV ovarian cancer and spouse caregivers. This counseling program may equip the spouse caregiver with skills to support and nurture the patient through initial diagnosis and treatment. It may also help patients and spouse caregivers improve communication and coping skills.

Detailed description: PRIMARY OBJECTIVES:

I. Test the feasibility of the study protocol, including recruitment and retention.

II. Assess the short-term impact of the intervention on standardized measures of behavioral-emotional adjustment of spouse caregivers and diagnosed women on depressed mood, anxiety, quality of marital communication, perceived spousal support, and spouse caregivers' skills and self-confidence to manage the emotional toll of the illness on themselves and the ill partner.

OUTLINE:

Patients and spouse caregivers complete the Taking Care of Her Program comprising 5 telephone-delivered intervention sessions over 45-60 minutes every 2 weeks. The intervention sessions are designed to provide training for spouse caregivers and patients to better manage the impact and emotional toll of recently diagnosed ovarian cancer, including its impact on their interpersonal communication and support about the cancer.

Eligibility criteria: Inclusion Criteria:

* Spouses of women with diagnosed within the past 8 months with stage III or IV ovarian cancer will be eligible to participate, as will the diagnosed wife/partner
* Spouses and patients must be married or cohabiting and in intimate relationship for at least 6 months
* Have English as one of their languages of choice (they can be multilingual)
* Have access to a telephone
* Have not been diagnosed with a prior cancer within the recent 5 years, except basal or squamous cell skin carcinoma
* Both heterosexual and same sex couples will be eligible

Exclusion Criteria:

* Women diagnosed with stage IV ovarian cancer and who are hospice eligible
* Spouses/partners could not participate if the patient refused participation

Primary outcomes:
measure: Recruitment
timeFrame: Up to 1 year
measure: Retention
timeFrame: Up to 1 year
measure: Changes in depressed mood assessed by the Center for Epidemiologic Studies- Depression and Patient Health Questionniare-9
timeFrame: Baseline to 3 months
measure: Changes in anxiety assessed by the State-Trait Anxiety Inventory
timeFrame: Baseline to 3 months
measure: Changes in quality of marital communication assessed by the Mutuality & Interpersonal Sensitivity Scale, Total and subscales: Open Communication & Expressing Sad Feelings
timeFrame: Baseline to 3 months
measure: Changes in perceived spousal support assessed by the What My Partner Does for Me Questionnaire
timeFrame: Baseline to 3 months
measure: Changes in spouse caregivers' skills and self-confidence to manage the emotional toll of the illness on themselves and ill partner assessed by the Cancer Self-Efficacy Scale: Total and subscales Self- and Wife/Partner-focused
timeFrame: Baseline to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
name: Frances Lewis
role: PRINCIPAL_INVESTIGATOR
References: