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

Not Applicable

Completed

• Conditions: Stage IIIC Ovarian Cancer; Caregiver; Stage IV Ovarian Cancer; Stage IIIA Ovarian Cancer; Stage IIIB Ovarian Cancer
• Interventions: Behavioral: Telephone-Based Intervention; Other: Caregiver-Assisted Training; Other: Questionnaire Administration; Other: Quality-of-Life Assessment

• Registration Number: NCT02401321
• Lead Sponsor: University of Washington

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.

Study Timeline

• Study First Submitted: 2015-03-24
• Study First Submitted QC: 2015-03-24
• Study First Posted: 2015-03-27
• Study Start: 2015-04-01
• Primary Completion: 2016-06-23
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-06
• Last Update Posted: 2017-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive care (Taking Care of Her program)	Telephone-Based Intervention	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.
Supportive care (Taking Care of Her program)	Quality-of-Life Assessment	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.
Supportive care (Taking Care of Her program)	Caregiver-Assisted Training	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.
Supportive care (Taking Care of Her program)	Questionnaire Administration	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.

Primary Outcome Measures

Name	Time	Method
Changes in anxiety assessed by the State-Trait Anxiety Inventory	Baseline to 3 months	The short-term impact of the intervention on standardized measures of behavioral-emotional adjustment of spouse caregivers and diagnosed women on anxiety will be assessed. If the distribution of the data are approximately normal, parametric statistics will be used to test the impact of the intervention on post-intervention scores using paired t-tests, 2-tailed, p = .05.
Recruitment	Up to 1 year	To test the feasibility of the study protocol, including recruitment, a detailed spreadsheet will be used to track the relative success of different recruitment channels. The channel through which every eligible patient is recruited will be tracked: self-referral, provider referral, or passive letter referral. The enrollment method that yielded the most accruals will be computed. The proportion of enrolled study participants that came from each channel used for the referral will be reported.
Retention	Up to 1 year	The retention rate for each enrolled study participant will be reported and a detailed log of reasons for attrition will be retained.
Changes in perceived spousal support assessed by the What My Partner Does for Me Questionnaire	Baseline to 3 months	The short-term impact of the intervention on standardized measures of behavioral-emotional adjustment of spouse caregivers and diagnosed women on perceived spousal support will be assessed. If the distribution of the data are approximately normal, parametric statistics will be used to test the impact of the intervention on post-intervention scores using paired t-tests, 2-tailed, p = .05.
Changes in depressed mood assessed by the Center for Epidemiologic Studies- Depression and Patient Health Questionniare-9	Baseline to 3 months	The short-term impact of the intervention on standardized measures of behavioral-emotional adjustment of spouse caregivers and diagnosed women on depressed mood will be assessed. If the distribution of the data are approximately normal, parametric statistics will be used to test the impact of the intervention on post-intervention scores using paired t-tests, 2-tailed, p = .05.
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	Baseline to 3 months	The short-term impact of the intervention on standardized measures of behavioral-emotional adjustment of spouse caregivers and diagnosed women on spouse caregivers' skills and self-confidence to manage the emotional toll of the illness on themselves and ill partner will be assessed. If the distribution of the data are approximately normal, parametric statistics will be used to test the impact of the intervention on post-intervention scores using paired t-tests, 2-tailed, p = .05.
Changes in quality of marital communication assessed by the Mutuality & Interpersonal Sensitivity Scale, Total and subscales: Open Communication & Expressing Sad Feelings	Baseline to 3 months	The short-term impact of the intervention on standardized measures of behavioral-emotional adjustment of spouse caregivers and diagnosed women on the quality of marital communication will be assessed. If the distribution of the data are approximately normal, parametric statistics will be used to test the impact of the intervention on post-intervention scores using paired t-tests, 2-tailed, p = .05.

Trial Locations

Locations (1)

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium; 🇺🇸 Seattle, Washington, United States