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

NCT02401321 | Completed

• 3 other identifiers: 9306NCI-2015-00325P30CA015704
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Caregiver; Stage IIIA Ovarian Cancer; Stage IIIB Ovarian Cancer; Stage IIIC Ovarian Cancer; Stage IV Ovarian Cancer

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (1)

Supportive care (Taking Care of Her program)

EXPERIMENTAL

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; Other: Caregiver-Assisted Training; Other: Questionnaire Administration; Other: Quality-of-Life Assessment

Interventions

Telephone-Based Intervention BEHAVIORAL

Complete Taking Care of Her program

Supportive care (Taking Care of Her program)

Caregiver-Assisted Training OTHER

Complete Taking Care of Her program

Supportive care (Taking Care of Her program)

Questionnaire Administration OTHER

Ancillary studies

Supportive care (Taking Care of Her program)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Supportive care (Taking Care of Her program)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Women diagnosed with stage IV ovarian cancer and who are hospice eligible
• Spouses/partners could not participate if the patient refused participation

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Frances Lewis

  Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2015
• First Posted: March 27, 2015
• Study Start: April 1, 2015
• Primary Completion: June 23, 2016
• Last Updated: March 7, 2017

Record last verified: 2017-03

Locations

US (1)