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Pilot Study of an Intimacy Enhancement Intervention for Couples Facing Breast Cancer

2018년 10월 24일 업데이트: Fox Chase Cancer Center
The central goal of this study is to examine the feasibility, acceptability, and preliminary efficacy of the IE intervention on patient and partner sexual QOL and relationship outcomes, and on patient psychosocial outcomes. We expect that the IE will show adequate feasibility, acceptability, and preliminary efficacy. Secondarily, based on the rationale that barriers exist that limit participation in intensive sexual QOL interventions for breast cancer survivors, an innovative secondary aim will investigate the perspectives of study-eligible patient candidates who opt out of participating in the pilot trial. We expect that we will be able to identify the participation barriers and intervention preferences of breast cancer survivors with sexual concerns who opt out of the intensive trial in order to inform the development of different interventions for future study.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

89

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 미국
    • Pennsylvania
      • Philadelphia, Pennsylvania, 미국, 19111
        • Fox Chase Cancer Center

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

21년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

여성

설명

Inclusion Criteria:

  1. Female
  2. Age > 21 years
  3. Has diagnosis of non-recurrent stage I-III breast cancer
  4. Completed active treatment (e.g., chemotherapy, radiation therapy, surgery) 6 months-5 years ago (current use of endocrine therapy is acceptable)
  5. Has a partner or spouse who is > 21
  6. Lives with a romantic partner > 6 months
  7. Score of > 3 on Patient Care Monitor Sexual Concerns screening item
  8. No hearing impairment in patient or partner

Exclusion Criteria:

  1. Not able to speak English, as stated in medical record or as observed by study team member
  2. ECOG Performance score > 2 OR too ill to participate as judged by physician/in medical record
  3. Overt cognitive dysfunction or psychiatric disturbance such as suicidal ideation or severe mental illness, as observed or judged by the researcher, referring source, or other qualified observer.
  4. Past history of any cancer other than non-melanoma skin cancer
  5. Currently participating in couple/marital therapy
  6. Currently pregnant

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Intimacy Enhancing Intervention
Participants attend 4 intimacy enhancement intervention sessions over 75 minutes every other week for 4 weeks. The intimacy enhancement intervention comprises 4 main sessions: understanding impact of breast cancer on sex and intimacy, communication about sex/intimacy, problem-solving and changing thoughts, and planning ahead and preparing for challenges. Participants are encouraged to participate in written and behavioral activities at home.
행동: Intimacy Enhancing Intervention
Participants attend 4 intimacy enhancement intervention sessions over 75 minutes every other week for 4 weeks. The intimacy enhancement intervention comprises 4 main sessions: understanding impact of breast cancer on sex and intimacy, communication about sex/intimacy, problem-solving and changing thoughts, and planning ahead and preparing for challenges. Participants are encouraged to participate in written and behavioral activities at home.
행동: Partner-Assisted Coping Skills Training
Receive couple-based intimacy enhancement intervention
활성 비교기: Living Healthy Together
Participants receive educational information and support about breast cancer every other week for 4 weeks. The educational information and support comprises topics about breast cancer, its treatments, sleep, energy, stress, stress management, nutrition, and diet. Participants are encouraged to read educational materials.
행동: Living Healthy Together
Participants receive educational information and support about breast cancer every other week for 4 weeks. The educational information and support comprises topics about breast cancer, its treatments, sleep, energy, stress, stress management, nutrition, and diet. Participants are encouraged to read educational materials.
행동: Behavioral, Psychological or Informational Intervention
Receive educational information and support

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Feasibility of the Treatment as Measured Through Study Accrual
기간: Up to 8 weeks
Feasibility is measured through the percentage of study eligible individuals who enrolled in the intervention study (i.e., acceptance rate).
Up to 8 weeks
Feasibility of the Treatment as Measured Through Study Attrition
기간: Up to 8 weeks
Feasibility of treatment is measured through the number of randomized participants who completed the study.
Up to 8 weeks
Feasibility of the Treatment as Measured Through Session Completion by Participant
기간: Up to 8 weeks
Feasibility of the treatment as measured through number of randomized participants who completed all 4 telephone sessions.
Up to 8 weeks
Acceptability Measured Using the Client Satisfaction Questionnaire (CSQ-8)
기간: Up to 8 weeks
Acceptability was measured through the median score on a validated acceptability measure. Item responses run on a scale of 1 to 4, with a total score range of 8-32. Higher scores indicate higher satisfaction with the service (acceptability). A median score of 28 or higher is considered acceptable. This measure was collected for both patients and partners.
Up to 8 weeks

2차 결과 측정

결과 측정
측정값 설명
기간
Change in Sexual Function Measured Using the Female Sexual Function Index (FSFI)
기간: Baseline to up to 8 weeks
Total scale scores range from 2 to 36. Higher scores indicate higher level of functioning. Change in mean patient FSFI score from pre-intervention to post-intervention is reported. Positive mean change scores indicate increase in sexual functioning from pre- to post-intervention.
Baseline to up to 8 weeks
Change in Sexual Function Measured Using the International Index of Erectile Function
기간: Baseline to up to 8 weeks
Total scale scores range from 1 to 75, with higher scores indicating a higher level of sexual functioning. Change in mean male partner IIEF score from pre-intervention to post-intervention is reported. Positive mean change scores indicate increase in sexual functioning from pre- to post-intervention.
Baseline to up to 8 weeks
Change in Sexual Satisfaction Measured Using the Patient-Reported-Outcomes Measurement Information System (PROMIS) Sexual Satisfaction Items
기간: Baseline to up to 8 weeks
The PROMIS uses T-scores that are calculated against U.S. population norms with a M of 50 and SD of 10. Higher T-scores indicate higher levels of sexual satisfaction. Change in sexual satisfaction T-scores from pre-intervention to post-intervention are reported. Positive change scores indicate increase in sexual satisfaction from pre- to post-intervention.
Baseline to up to 8 weeks
Change in Sexual Distress Measured Using the Female Sexual Distress Scale-Revised
기간: Baseline to up to 8 weeks
Total scale scores range from 0 to 52. Higher scores indicate higher levels of sexual distress. Change in patient mean sexual distress score from pre-intervention to post-intervention is reported. Negative mean change scores indicate decrease in sexual distress from pre- to post-intervention.
Baseline to up to 8 weeks
Change in Beliefs (Self-efficacy)
기간: Baseline to up to 8 weeks
Total scale scores range from 0 to 100. Higher scores indicate higher degree of self-efficacy for coping with sexual concerns. Change in mean self-efficacy score from pre-intervention to post-intervention is reported. Positive mean change scores indicate increase in self-efficacy from pre- to post-intervention.
Baseline to up to 8 weeks
Change in Emotional Intimacy Measured Using the Personal Assessment of Intimacy in Relationships (PAIR) Emotional Intimacy Scale
기간: Baseline to up to 8 weeks
Total scale scores range from 1 to 5. Higher scores indicate higher level of emotional intimacy with one's partner. Change in mean emotional intimacy score from pre-intervention to post-intervention is reported. Positive mean change scores indicate increase in emotional intimacy from pre- to post-intervention.
Baseline to up to 8 weeks
Change in Sexual Communication Measured Using the Dyadic Sexual Communication Scale
기간: Baseline to up to 8 weeks
Total scale scores range from 13 to 78. Higher scores indicate more communication. Change in mean sexual communication score from pre-intervention to post-intervention is reported. Positive mean change scores indicate increase in sexual communication from pre- to post-intervention.
Baseline to up to 8 weeks
Change in Relationship Quality Measured Using the Dyadic Adjustment Scale-7 Item
기간: Baseline to up to 8 weeks
Total scale scores range from 0 to 36. Higher scores indicate higher relationship quality. Change in mean relationship quality score from pre-intervention to post-intervention is reported. Positive mean change scores indicate increase in relationship quality from pre- to post-intervention.
Baseline to up to 8 weeks
Change in Body Image Distress Measured Using the Body Image Scale
기간: Baseline to up to 8 weeks
Total scale scores range from 0 to 30. Higher scores indicate higher level of body image distress. Change in mean body image distress score from pre-intervention to post-intervention is reported. Negative mean change scores indicate decrease in body image distress from pre- to post-intervention.
Baseline to up to 8 weeks
Change in Depression Measured Using the Patient Health Questionnaire-9 Item
기간: Baseline to up to 8 weeks
Total scale scores range from 0 to 27. Higher scores indicate higher level of depression. Change in mean depression score from pre-intervention to post-intervention is reported. Negative mean change scores indicate decrease in depression from pre- to post-intervention.
Baseline to up to 8 weeks
Change in Anxiety Measured Using the Generalized Anxiety Disorder 7-item
기간: Baseline to up to 8 weeks
Total scale scores range from 0 to 21. Higher scores indicate higher levels of anxiety. Change in mean anxiety score from pre-intervention to post-intervention is reported. Negative mean change scores indicate decrease in anxiety from pre- to post-intervention.
Baseline to up to 8 weeks
Change in Cancer-related Distress Using the Impact of Events Scale-Revised
기간: Baseline to up to 8 weeks
Total scale scores range from 0 to 88. Higher scores indicate higher levels of distress. Change in mean cancer-related distress score from pre-intervention to post-intervention is reported. Negative mean change scores indicate decrease in distress from pre- to post-intervention.
Baseline to up to 8 weeks

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Fox Chase Cancer Center

협력자

National Cancer Institute (NCI)

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2015년 10월 27일

기본 완료 (실제)

2017년 9월 29일

연구 완료 (실제)

2017년 9월 29일

연구 등록 날짜

최초 제출

2016년 3월 14일

QC 기준을 충족하는 최초 제출

2016년 3월 28일

처음 게시됨 (추정)

2016년 3월 29일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 10월 25일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 10월 24일

마지막으로 확인됨

2018년 10월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 15-8007
  • 1R21CA191354-01 (미국 NIH 보조금/계약)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

유방암에 대한 임상 시험

Intimacy Enhancing Intervention에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Saudi Arabia

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다