Addressing Sexual Concerns in Breast Cancer: Patient Intervention Study
2021年3月15日 更新者：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.
調査の概要
研究の種類
介入
入学 (実際)
153
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19111
- Fox Chase Cancer Center
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
21年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
女性
説明
Inclusion Criteria:
- Receiving any treatment for breast cancer or have completed acute treatment for breast cancer < 10 years ago
- Attending clinic visits in the course of follow-up care (i.e., not an initial consult visit)
- Willing to have clinic visit audio recorded
Exclusion Criteria:
- Unable to speak English
- 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
- 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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ：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.
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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.
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実験的：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.
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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.
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.
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介入なし：Clinician Arm
Clinicians were consented in order to have their clinic visits audio recorded.
No outcomes data were collected from clinician participants.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Self-Reported Self-Efficacy for Communicating About Sexual Health Issues
時間枠：2 weeks
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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.
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2 weeks
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Self-Reported Self-Efficacy for Communicating About Sexual Health Issues
時間枠：2 months
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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.
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2 months
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Self-Reported Outcome Expectancies for Sexual Health Communication
時間枠：2 weeks
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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.
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2 weeks
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Self-Reported Outcome Expectancies for Sexual Health Communication
時間枠：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.
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2 months
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Number of Patients Who Asked at Least One Question About Sexual Health at Their Clinic Visit
時間枠：2 weeks
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As coded from clinic visit audio, the number of patients who ask at least one question about sexual health.
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2 weeks
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Number of Patients Who Initiate Conversation About Sexual Health in Their Clinic Visit
時間枠：2 weeks
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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).
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2 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Recruitment Rates (Feasibility)
時間枠：baseline
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Recruitment rates, as measured by percentage of patients enrolled (i.e., baselined) out of eligible patients approached for the study.
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baseline
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Retention Rates (Feasibility)
時間枠：2 weeks
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Retention rates, as measured by percentage of patients who remain on study for 2-week follow-up assessment.
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2 weeks
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Retention Rates (Feasibility)
時間枠：2 months
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Retention rates, as measured by percentage of patients who remain on study for 2-month follow-up assessment.
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2 months
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Intervention Acceptability
時間枠：2 weeks
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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.
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2 weeks
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Sexual Activity
時間枠：2 months
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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.
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2 months
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Sexual Function
時間枠：2 months
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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.
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2 months
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General Self-Efficacy for Communication With Provider
時間枠：2 months
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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.
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2 months
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Barriers to Communicating About Sexual Health
時間枠：2 months
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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.
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2 months
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Self-Reported Anxiety
時間枠：2 months
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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.
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2 months
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Self-Reported Depression
時間枠：2 months
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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.
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2 months
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Self-Reported Quality of Life
時間枠：2 months
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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.
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2 months
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Self-Reported Self-Efficacy for Communicating About About Treatment Side Effects
時間枠：2 weeks
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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.
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2 weeks
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Self-Reported Self-Efficacy for Communicating About About Treatment Side Effects
時間枠：2 months
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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.
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2 months
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Self-Reported Self-Efficacy for Communicating About About Menopausal Health
時間枠：2 weeks
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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.
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2 weeks
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Self-Reported Self-Efficacy for Communicating About About Menopausal Health
時間枠：2 months
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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.
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2 months
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Self-Reported Outcome Expectancies for Communication About Treatment Side Effects
時間枠：2 weeks
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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
時間枠：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
|
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Self-Reported Outcome Expectancies for Communication About Menopausal Health
時間枠：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
|
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Self-Reported Outcome Expectancies for Communication About Menopausal Health
時間枠：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.
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2 months
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2018年5月27日
一次修了 (実際)
2019年12月31日
研究の完了 (実際)
2019年12月31日
試験登録日
最初に提出
2018年7月20日
QC基準を満たした最初の提出物
2018年8月7日
最初の投稿 (実際)
2018年8月10日
学習記録の更新
投稿された最後の更新 (実際)
2021年3月16日
QC基準を満たした最後の更新が送信されました
2021年3月15日
最終確認日
2021年3月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
乳がんの女性の臨床試験
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Tianjin Medical University Cancer Institute and...Guangxi Medical University; Sun Yat-sen University; Chinese PLA General Hospital; The First Affiliated... と他の協力者完了
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Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI); Highlight Therapeutics積極的、募集していない平滑筋肉腫 | 悪性末梢神経鞘腫瘍 | 滑膜肉腫 | 未分化多形肉腫 | 骨の未分化高悪性度多形肉腫 | 粘液線維肉腫 | II期の体幹および四肢の軟部肉腫 AJCC v8 | III期の体幹および四肢の軟部肉腫 AJCC v8 | IIIA 期の体幹および四肢の軟部肉腫 AJCC v8 | IIIB 期の体幹および四肢の軟部肉腫 AJCC v8 | 切除可能な軟部肉腫 | 多形性横紋筋肉腫 | 切除可能な脱分化型脂肪肉腫 | 切除可能な未分化多形肉腫 | 軟部組織線維肉腫 | 紡錘細胞肉腫 | ステージ I 後腹膜肉腫 AJCC (American Joint Committee on Cancer) v8 | 体幹および四肢の I 期軟部肉腫 AJCC v8 | ステージ... およびその他の条件アメリカ
Sexual and Menopausal Health Resourcesの臨床試験
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University of BirminghamNational Institute for Health Research, United Kingdomわからない