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Addressing Sexual Concerns in Breast Cancer: Patient Intervention Study

15 marca 2021 zaktualizowane przez: Fox Chase Cancer Center

Enhancing Patient-Provider Communication About Sexual Concerns in Breast Cancer: Patient Intervention Study

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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

153

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stany Zjednoczone, 19111
        • Fox Chase Cancer Center

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

21 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Kobieta

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie podtrzymujące
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: Resources Only
Patients will receive a list of resources on sexual and menopausal health in breast cancer. They will be asked to review the resources before their next clinic visit.
Behawioralne: Sexual and Menopausal Health Resources
Patients will receive a resource list that includes both web-based resources on menopausal and sexual health and center-specific resources, such as contact information for a menopausal & sexual health clinic.
Eksperymentalny: Resources + Video
Patients will receive a list of web resources on sexual and menopausal health in breast cancer. In addition to the resources, patients will be asked to view an online video called "Starting the Conversation" and to complete an accompanying workbook. Patients in this arm will be asked to review the resource list, watch the Starting the Conversation video, and complete the workbook before their next clinic visit.
Behawioralne: Sexual and Menopausal Health Resources
Patients will receive a resource list that includes both web-based resources on menopausal and sexual health and center-specific resources, such as contact information for a menopausal & sexual health clinic.
Behawioralne: Starting the Conversation Video
The Starting the Conversation program is designed to increase self-efficacy and outcome expectancies for communicating with providers about sexual health and related issues, reduce barriers to communication, and provide basic training in skills for communicating with providers about these topics, including prioritizing concerns, tips for effective communication, communication practice, and self-feedback.
Brak interwencji: Clinician Arm
Clinicians were consented in order to have their clinic visits audio recorded. No outcomes data were collected from clinician participants.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Self-Reported Self-Efficacy for Communicating About Sexual Health Issues
Ramy czasowe: 2 weeks
Two items assessed patients' self-efficacy (confidence) for communicating with their breast cancer clinician about sexual health concerns in terms of either talking (item 1) or asking (item 2) about sexual health. Response options used an 11-point scale (0=not at all confident/not at all to 10=extremely confident/very much). Mean scores across the two items were used, ranging from 0-10. Higher scores indicate higher self-efficacy.
2 weeks
Self-Reported Self-Efficacy for Communicating About Sexual Health Issues
Ramy czasowe: 2 months
Two items assessed patients' self-efficacy (confidence) for communicating with their breast cancer clinician about sexual health concerns in terms of either talking (item 1) or asking (item 2) about sexual health. Response options used an 11-point scale (0=not at all confident/not at all to 10=extremely confident/very much). Mean scores across the two items were used, ranging from 0-10. Higher scores indicate higher self-efficacy.
2 months
Self-Reported Outcome Expectancies for Sexual Health Communication
Ramy czasowe: 2 weeks
Five items assessed the belief that discussing sexual health with her breast cancer clinician would lead to positive outcomes (e.g., "find a solution to a problem"). Response options used an 11-point scale (0=not at all to 10=very much). Mean scores across the five items were used, ranging from 0-10. Higher scores indicate higher expectancies for positive outcomes.
2 weeks
Self-Reported Outcome Expectancies for Sexual Health Communication
Ramy czasowe: 2 months
Five items assessed the belief that discussing sexual health with her breast cancer clinician would lead to positive outcomes (e.g., "find a solution to a problem"). Response options used an 11-point scale (0=not at all to 10=very much). Mean scores across the five items were used, ranging from 0-10. Higher scores indicate higher expectancies for positive outcomes.
2 months
Number of Patients Who Asked at Least One Question About Sexual Health at Their Clinic Visit
Ramy czasowe: 2 weeks
As coded from clinic visit audio, the number of patients who ask at least one question about sexual health.
2 weeks
Number of Patients Who Initiate Conversation About Sexual Health in Their Clinic Visit
Ramy czasowe: 2 weeks
As coded from clinic visit audio, the number of patients who raise the topic of sexual health during their encounter (out of encounters where a sexual health discussion occurred).
2 weeks

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Recruitment Rates (Feasibility)
Ramy czasowe: baseline
Recruitment rates, as measured by percentage of patients enrolled (i.e., baselined) out of eligible patients approached for the study.
baseline
Retention Rates (Feasibility)
Ramy czasowe: 2 weeks
Retention rates, as measured by percentage of patients who remain on study for 2-week follow-up assessment.
2 weeks
Retention Rates (Feasibility)
Ramy czasowe: 2 months
Retention rates, as measured by percentage of patients who remain on study for 2-month follow-up assessment.
2 months
Intervention Acceptability
Ramy czasowe: 2 weeks
Acceptability of intervention, as measured through the item "Overall, how satisfied were you with this program?". Responses options include Very Satisfied, Satisfied, Dissatisfied, and Very Dissatisfied. Responses of "satisfied" or "very satisfied" indicate acceptability. Number of patients reporting acceptability and number of patients not reporting acceptability are presented.
2 weeks
Sexual Activity
Ramy czasowe: 2 months
Sexual activity was measured by a single item asking (yes/no) whether the participant had any kind of sexual activity in the past 30 days.
2 months
Sexual Function
Ramy czasowe: 2 months
Sexual function was assessed using the Lubrication, Vaginal Discomfort, Satisfaction, and Interest domain scores from the Patient-Reported Outcomes Measurement Information System Sexual Function and Satisfaction scale (PROMIS SexFS) Brief Profile Version 2.0. Scores are converted to a T-score metric where a score of 50 equates to the mean of the U.S. population of sexually active adults (SD=10). Higher scores for all domains except Vaginal Discomfort signify better function.
2 months
General Self-Efficacy for Communication With Provider
Ramy czasowe: 2 months
Patients' self-efficacy for communicating with provider generally, as measured through the Perceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5). The PEPPI-5 is a five-item scale that measures patient confidence in communicating with providers. Response options are on a scale from 1 (Not at All Confident) to 5 (Very Confident) and are summed for a total self-efficacy score (Range: 5-25). Higher scores indicate higher self-efficacy.
2 months
Barriers to Communicating About Sexual Health
Ramy czasowe: 2 months
Patient barriers to communication about sexual health, as measured through a 13-item scale. Scale items cover potential reasons a patient might not want to discuss sexual health concerns with her provider (e.g., "I might become embarrassed"). Items are scored on a 1-5 scale where 1=Strongly Disagree and 5=Strongly Disagree. A total barrier score will be taken from this scale (Range: 13-65). Higher scores indicate more perceived barriers to communication.
2 months
Self-Reported Anxiety
Ramy czasowe: 2 months
Patients self-reported anxiety, as measured through anxiety subscale of the Hospital Anxiety & Depression Scale (HADS). The anxiety subscale consists of 7 items that are scored from 0 to 3. Summed scores range from 0 to 21, with higher scores indicating higher levels of anxiety.
2 months
Self-Reported Depression
Ramy czasowe: 2 months
Patients self-reported depression, as measured through depression subscale of the Hospital Anxiety & Depression Scale (HADS). The depression subscale consists of 7 items that are scored from 0 to 3. Summed scores range from 0 to 21, with higher scores indicating higher levels of depression.
2 months
Self-Reported Quality of Life
Ramy czasowe: 2 months
Quality of life, as measured through the Abbreviated Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) total score. The FACT-B contains 23 items about physical, functional, and emotional well-being in the context of breast cancer. Scale items are scored from 0 to 4. Summed scores run from 0 to 92, with higher scores indicating higher quality of life.
2 months
Self-Reported Self-Efficacy for Communicating About About Treatment Side Effects
Ramy czasowe: 2 weeks
Patients' self-reported self-efficacy for communication about treatment side effects with their breast cancer provider. The items about treatment side effects consist of 2 items within a larger 6-item scale which ask the patient how confident she is in talking to her provider about treatment side effects and asking her provider about treatment side effects. Response options range from 0 (not at all confident) to 10 (extremely confident). Mean scores will be reported.
2 weeks
Self-Reported Self-Efficacy for Communicating About About Treatment Side Effects
Ramy czasowe: 2 months
Patients' self-reported self-efficacy for communication about treatment side effects with their breast cancer provider. The items about treatment side effects consist of 2 items within a larger 6-item scale which ask the patient how confident she is in talking to her provider about treatment side effects and asking her provider about treatment side effects. Response options range from 0 (not at all confident) to 10 (extremely confident). Mean scores will be reported.
2 months
Self-Reported Self-Efficacy for Communicating About About Menopausal Health
Ramy czasowe: 2 weeks
Patients' self-reported self-efficacy for communication about menopausal health with their breast cancer provider. The items about menopausal health consist of 2 items within a larger 6-item scale which ask the patient how confident she is in talking to her provider about menopausal health and asking her provider about menopausal health. Response options range from 0 (not at all confident) to 10 (extremely confident). Mean scores will be reported.
2 weeks
Self-Reported Self-Efficacy for Communicating About About Menopausal Health
Ramy czasowe: 2 months
Patients' self-reported self-efficacy for communication about menopausal health with their breast cancer provider. The items about menopausal health consist of 2 items within a larger 6-item scale which ask the patient how confident she is in talking to her provider about menopausal health and asking her provider about menopausal health. Response options range from 0 (not at all confident) to 10 (extremely confident). Mean scores will be reported.
2 months
Self-Reported Outcome Expectancies for Communication About Treatment Side Effects
Ramy czasowe: 2 weeks
Five items assessed the belief that discussing treatment side effects with her breast cancer clinician would lead to positive outcomes (e.g., "find a solution to a problem"). Response options used an 11-point scale (0=not at all to 10=very much). Mean scores across the five items were used, ranging from 0-10. Higher scores indicate higher expectancies for positive outcomes.
2 weeks
Self-Reported Outcome Expectancies for Communication About Treatment Side Effects
Ramy czasowe: 2 months
Five items assessed the belief that discussing treatment side effects with her breast cancer clinician would lead to positive outcomes (e.g., "find a solution to a problem"). Response options used an 11-point scale (0=not at all to 10=very much). Mean scores across the five items were used, ranging from 0-10. Higher scores indicate higher expectancies for positive outcomes.
2 months
Self-Reported Outcome Expectancies for Communication About Menopausal Health
Ramy czasowe: 2 weeks
Five items assessed the belief that discussing menopausal health with her breast cancer clinician would lead to positive outcomes (e.g., "find a solution to a problem"). Response options used an 11-point scale (0=not at all to 10=very much). Mean scores across the five items were used, ranging from 0-10. Higher scores indicate higher expectancies for positive outcomes.
2 weeks
Self-Reported Outcome Expectancies for Communication About Menopausal Health
Ramy czasowe: 2 months
Five items assessed the belief that discussing menopausal health with her breast cancer clinician would lead to positive outcomes (e.g., "find a solution to a problem"). Response options used an 11-point scale (0=not at all to 10=very much). Mean scores across the five items were used, ranging from 0-10. Higher scores indicate higher expectancies for positive outcomes.
2 months

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Fox Chase Cancer Center

Współpracownicy

American Cancer Society, Inc.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

27 maja 2018

Zakończenie podstawowe (Rzeczywisty)

31 grudnia 2019

Ukończenie studiów (Rzeczywisty)

31 grudnia 2019

Daty rejestracji na studia

Pierwszy przesłany

20 lipca 2018

Pierwszy przesłany, który spełnia kryteria kontroli jakości

7 sierpnia 2018

Pierwszy wysłany (Rzeczywisty)

10 sierpnia 2018

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

16 marca 2021

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

15 marca 2021

Ostatnia weryfikacja

1 marca 2021

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 14-833-02

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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Badania kliniczne na Sexual and Menopausal Health Resources

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