Clinical trial NCT03624972: Addressing Sexual Concerns in Breast Cancer: Patient Intervention Study
Official title: Enhancing Patient-Provider Communication About Sexual Concerns in Breast Cancer: Patient Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Female
Keywords: communication
sexual health
menopausal health
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2018-08-10
Enrollment: 153
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this study is to evaluate an educational video intervention (called Starting the Conversation) aimed to enhance breast cancer patients' beliefs about and communication with respect to sexual concerns. In the current study, 128 breast cancer outpatients will be randomized to either participate in the video intervention and to receive a resource guide addressing sexual and menopausal health or to receive the resource guide alone. Patients will be asked to participate in the video and/or read through the resource guide prior to their clinic visit with their breast cancer provider. The investigators will examine effects of the interventions on patients' beliefs about communication about sexual health and on patients' communication about sexual health during clinic visits with their providers. Secondarily, the investigators will examine effects of the interventions on sexual outcomes and other health outcomes, including psychological well-being and health-related QOL.


Eligibility criteria: Inclusion Criteria:

1. Receiving any treatment for breast cancer or have completed acute treatment for breast cancer \< 10 years ago
2. Attending clinic visits in the course of follow-up care (i.e., not an initial consult visit)
3. Willing to have clinic visit audio recorded

Exclusion Criteria:

1. Unable to speak English
2. Eastern Cooperative Oncology Group (ECOG) Performance score \> 2 OR too ill to participate as judged by physician, self-report, or observation of the research team member
3. Overt cognitive dysfunction or psychiatric disturbance or severe mental illness (e.g., dementia, suicidal behavior, or psychosis), as observed or judged by the researcher or referring source.

Primary outcomes:
measure: Self-Reported Self-Efficacy for Communicating About Sexual Health Issues
timeFrame: 2 weeks
measure: Self-Reported Self-Efficacy for Communicating About Sexual Health Issues
timeFrame: 2 months
measure: Self-Reported Outcome Expectancies for Sexual Health Communication
timeFrame: 2 weeks
measure: Self-Reported Outcome Expectancies for Sexual Health Communication
timeFrame: 2 months
measure: Number of Patients Who Asked at Least One Question About Sexual Health at Their Clinic Visit
timeFrame: 2 weeks
measure: Number of Patients Who Initiate Conversation About Sexual Health in Their Clinic Visit
timeFrame: 2 weeks
Secondary outcomes:
measure: Recruitment Rates (Feasibility)
timeFrame: baseline
measure: Retention Rates (Feasibility)
timeFrame: 2 weeks
measure: Retention Rates (Feasibility)
timeFrame: 2 months
measure: Intervention Acceptability
timeFrame: 2 weeks
measure: Sexual Activity
timeFrame: 2 months
measure: Sexual Function
timeFrame: 2 months
measure: General Self-Efficacy for Communication With Provider
timeFrame: 2 months
measure: Barriers to Communicating About Sexual Health
timeFrame: 2 months
measure: Self-Reported Anxiety
timeFrame: 2 months
measure: Self-Reported Depression
timeFrame: 2 months
measure: Self-Reported Quality of Life
timeFrame: 2 months
measure: Self-Reported Self-Efficacy for Communicating About About Treatment Side Effects
timeFrame: 2 weeks
measure: Self-Reported Self-Efficacy for Communicating About About Treatment Side Effects
timeFrame: 2 months
measure: Self-Reported Self-Efficacy for Communicating About About Menopausal Health
timeFrame: 2 weeks
measure: Self-Reported Self-Efficacy for Communicating About About Menopausal Health
timeFrame: 2 months
measure: Self-Reported Outcome Expectancies for Communication About Treatment Side Effects
timeFrame: 2 weeks
measure: Self-Reported Outcome Expectancies for Communication About Treatment Side Effects
timeFrame: 2 months
measure: Self-Reported Outcome Expectancies for Communication About Menopausal Health
timeFrame: 2 weeks
measure: Self-Reported Outcome Expectancies for Communication About Menopausal Health
timeFrame: 2 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
References: