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

University of Washington14 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Caregiver Stage IIIA Ovarian Cancer

Interventions

Telephone-Based InterventionBEHAVIORAL

Complete Taking Care of Her program

Caregiver-Assisted TrainingOTHER

Complete Taking Care of Her program

Questionnaire AdministrationOTHER

Ancillary studies

Quality-of-Life AssessmentOTHER

Ancillary studies

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Up to 1 year

Retention

The retention rate for each enrolled study participant will be reported and a detailed log of reasons for attrition will be retained.

Time frame: Up to 1 year

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.