CaregiverNCT02401321
Taking Care of Her Program in Patients With Stage III or IV Ovarian Cancer and Spouse Caregivers
A study testing Telephone-Based Intervention, Caregiver-Assisted Training and Questionnaire Administration in people with Caregiver and Stage IIIA Ovarian Cancer, run by University of Washington at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Caregiver, Stage IIIA Ovarian Cancer, Stage IIIB Ovarian Cancer
- What is being tested?
- Telephone-Based Intervention, Caregiver-Assisted Training and Questionnaire Administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2015to 23 Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Women diagnosed with stage IV ovarian cancer and who are hospice eligible
- Spouses/partners could not participate if the patient refused participation
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: A Pilot Feasibility Study: Taking Care of Her
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Caregiver, Stage IIIA Ovarian Cancer, Stage IIIB Ovarian Cancer, Stage IIIC Ovarian Cancer, Stage IV Ovarian Cancer
- Being tested
- Telephone-Based Intervention, Caregiver-Assisted Training, Questionnaire Administration, Quality-of-Life Assessment
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone-Based InterventionBehavioural
Complete Taking Care of Her program
Caregiver-Assisted TrainingOther
Complete Taking Care of Her program
Questionnaire AdministrationOther
Ancillary studies
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Telephone-Based Intervention; Other: Caregiver-Assisted Training; Other: Questionnaire Administration; Other: Quality-of-Life Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2015 (estimated)
- Study start1 Apr 2015
- Primary completion23 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CaregiverStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Frances Lewis, Principal investigator, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02401321
- Sponsor's protocol ID
- 9306
- Other IDs
- NCI-2015-00325, 9306, P30CA015704
- Status last verified
- Mar 2017
- First submitted
- 24 Mar 2015
- Last updated
- 7 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Feasibility Study: Taking Care of Her
- ClinicalTrials.gov ID
- NCT02401321
- Acronym / sponsor ID
- 9306
- Conditions
- Caregiver, Stage IIIA Ovarian Cancer, Stage IIIB Ovarian Cancer, Stage IIIC Ovarian Cancer, Stage IV Ovarian Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 23 Jun 2016 (actual)
- First posted
- 27 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (Taking Care of Her program) | Experimental | Behavioral: Telephone-Based Intervention, Other: Caregiver-Assisted Training, Other: Questionnaire Administration, Other: Quality-of-Life AssessmentPatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Women diagnosed with stage IV ovarian cancer and who are hospice eligible
- Spouses/partners could not participate if the patient refused participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telephone-Based InterventionComplete Taking Care of Her program | Behavioural | Supportive care (Taking Care of Her program) |
| Caregiver-Assisted TrainingComplete Taking Care of Her program | Other | Supportive care (Taking Care of Her program) |
| Questionnaire AdministrationAncillary studies | Other | Supportive care (Taking Care of Her program) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Supportive care (Taking Care of Her program) |
Primary outcome
Recruitment
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frances Lewis principal investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone-Based Intervention, Caregiver-Assisted Training and Questionnaire Administration in people with Caregiver and Stage IIIA Ovarian Cancer, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: Up to 1 year). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2017.