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

NCT ID: NCT02401321

Last Updated: 2017-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-01

Brief Summary

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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

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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.

Conditions

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Caregiver Stage IIIA Ovarian Cancer Stage IIIB Ovarian Cancer Stage IIIC Ovarian Cancer Stage IV Ovarian Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Supportive care (Taking Care of Her program)

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.

Group Type EXPERIMENTAL

Telephone-Based Intervention

Intervention Type BEHAVIORAL

Complete Taking Care of Her program

Caregiver-Assisted Training

Intervention Type OTHER

Complete Taking Care of Her program

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Interventions

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Telephone-Based Intervention

Complete Taking Care of Her program

Intervention Type BEHAVIORAL

Caregiver-Assisted Training

Complete Taking Care of Her program

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Quality of Life Assessment

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frances Lewis

Role: PRINCIPAL_INVESTIGATOR

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Locations

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Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2015-00325

Identifier Type: REGISTRY

Identifier Source: secondary_id

9306

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA015704

Identifier Type: NIH

Identifier Source: secondary_id

View Link

9306

Identifier Type: -

Identifier Source: org_study_id

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