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

Study Overview
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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.

Official Title
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A Pilot Feasibility Study: Taking Care of Her

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

Intervention / Treatment
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* Behavioral: Telephone-Based Intervention
* Other: Caregiver-Assisted Training
* Other: Questionnaire Administration
* Other: Quality-of-Life Assessment


Participation Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive care (Taking Care of Her program)<br>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. | Behavioral: Telephone-Based Intervention<br>* Complete Taking Care of Her program<br>Other: Caregiver-Assisted Training<br>* Complete Taking Care of Her program<br>Other: Questionnaire Administration<br>* Ancillary studies<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |