Taking Care of Her Program in Patients With Stage III or IV Ovarian Cancer and Spouse Caregivers

University of Washington

Status: Completed

Conditions: Stage IIIA Ovarian Cancer; Stage IV Ovarian Cancer; Stage IIIB Ovarian Cancer; Caregiver; Stage IIIC Ovarian Cancer

Treatments: Other: Caregiver-Assisted Training; Other: Quality-of-Life Assessment; Behavioral: Telephone-Based Intervention; Other: Questionnaire Administration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02401321

9306 (Other Identifier)

NCI-2015-00325 (Registry Identifier)

P30CA015704 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Supportive care (Taking Care of Her program)

Experimental group

Description:

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.

Treatment:

Other: Quality-of-Life Assessment

Other: Questionnaire Administration

Behavioral: Telephone-Based Intervention

Other: Caregiver-Assisted Training