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

Caregiver Clinical Trial

Official title:

A Pilot Feasibility Study: Taking Care of Her

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02401321
• Other study ID #: 9306
• Secondary ID: NCI-2015-0032593
• Status: Completed
• Phase: N/A
• First received: March 24, 2015
• Last updated: March 6, 2017
• Start date: April 1, 2015

Study information

• Verified date: March 2017
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. primary completion date: June 23, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Telephone-Based Intervention
Complete Taking Care of Her program

Other:
• Caregiver-Assisted Training
Complete Taking Care of Her program
• Questionnaire Administration
Ancillary studies
• Quality-of-Life Assessment
Ancillary studies

Locations

Country	Name	City	State
United States	Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment	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.	Up to 1 year
Primary	Retention	The retention rate for each enrolled study participant will be reported and a detailed log of reasons for attrition will be retained.	Up to 1 year
Primary	Changes in depressed mood assessed by the Center for Epidemiologic Studies- Depression and Patient Health Questionniare-9	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.	Baseline to 3 months
Primary	Changes in anxiety assessed by the State-Trait Anxiety Inventory	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.	Baseline to 3 months
Primary	Changes in quality of marital communication assessed by the Mutuality & Interpersonal Sensitivity Scale, Total and subscales: Open Communication & Expressing Sad Feelings	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.	Baseline to 3 months
Primary	Changes in perceived spousal support assessed by the What My Partner Does for Me Questionnaire	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.	Baseline to 3 months
Primary	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	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.	Baseline to 3 months