Caregiver, Stage IIIA Ovarian Cancer, Stage IIIB Ovarian Cancer, Stage IIIC Ovarian Cancer, Stage IV Ovarian Cancer
Conditions
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.
Interventions
BEHAVIORALTelephone-Based Intervention
Complete Taking Care of Her program
OTHERCaregiver-Assisted Training
Complete Taking Care of Her program
OTHERQuestionnaire Administration
Ancillary studies
OTHERQuality-of-Life Assessment
Ancillary studies
Sponsors
National Cancer Institute (NCI)
University of Washington
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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. |
| 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. |
| 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 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. |
Countries
United States
Outcome results
None listed