이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Enhancing Connections Program in Improving Family Adjustment in Patients With Incurable Cancer

2021년 11월 10일 업데이트: Fred Hutchinson Cancer Center

Family Functioning and Bereavement Outcomes Following the Enhancing Connections Program in Palliative Care

This pilot clinical trial studies how well the Enhancing Connections program improves family adjustment in patients with incurable cancer. Participating in an educational program with a co-parent to learn about ways to talk to a child about cancer may help parents and co-parents support their child with the parent's cancer and may help families communicate and function better.

연구 개요

상태

종료됨

정황

개입 / 치료

상세 설명

PRIMARY OBJECTIVES:

I. Test the feasibility of the study protocol in advanced cancer patients and co-parents (recruitment/retention, dosage and fidelity of the intervention; program acceptability of program; and logistics).

II. Evaluate the short-term impact of the program on the diagnosed parents', co-parents' and children's adjustment and family functioning using a within group design (pre- and posttest design).

III. Compare outcomes from the Enhancing Connections Palliative Program with similar outcomes obtained from the completed phase III trial (between group design) for the patients and children outcomes.

IV. Evaluate the longer term impact of the program on the co-parents' and children's adjustment, including bereavement outcomes when appropriate, using a within and across group design (pre- and posttest design).

OUTLINE:

Patients and co-parents participate in the Enhancing Connections program consisting of 5 sessions over 1 hour each in the clinic or over the telephone. Session topics include managing cancer-related emotions when talking to children, developing deep listening skills, initiating difficult cancer-related conversations with children, interpreting a child's behavior, recognizing newly acquired gains from the program, and identifying available resources that can be used after program completion.

After completion of the study, participants are followed-up at 6 months.

연구 유형

중재적

등록 (실제)

15

단계

  • 해당 없음

연락처 및 위치

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

연구 장소

  • 미국
    • Washington
      • Seattle, Washington, 미국, 98109
        • Fred Hutch/University of Washington Cancer Consortium

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

5년 (어린이, 성인, 고령자)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

설명

Inclusion Criteria:

PATIENTS

  • Ages 25-65 years
  • Have a diagnosis of incurable cancer of any type; at any time in the diagnosis as long as they have at least a 4 month life expectancy based on the opinion of the attending physician
  • Read and write English among their languages of choice
  • Parent must live at least 50% of the time in the home and have a child 5-17 years old living at home who has been told their parent's cancer diagnosis

CO-PARENTS

  • Co-parents must reside with the consenting eligible cancer participant (and child) at least 50% of the time and be actively participating in the care of the child
  • If a biological parent lives in the home, and is physically well themselves, this person must be the co-parent
  • If a biological parent does not live in the home (or has died), the co-parent does not have to be a biological parent; therefore, co-parents may be step-parents, lesbian, gay, bi-sexual or transgender (LGBT) partners, grandparents, aunts, uncles, etc if they otherwise meet eligibility criteria
  • He or she can read and write English among their languages of choice and agrees to attend the patient intervention sessions in person or by telephone

CHILDREN

  • The patient and co-parent must agree to focus on the same child throughout the study and consent to have the child participate before the child's assent will be sought
  • Children aged 5-13 years of age will participate with a waiver of assent
  • Children aged 14-17 will assent to participate in the research study by signing a separate assent form
  • Children of formal assenting age will be eligible to participate if they can read and write English among their languages of choice

ALL PARTICIPANTS

  • Participants must live within 35 miles of the University of Washington, Seattle, WA to receive the in-person version of the intervention
  • Parents and co-parents selecting the telephone version of the intervention may live any distance from the University of Washington

Exclusion Criteria:

  • Patients will be excluded if they are enrolled in hospice at time of enrollment; however, they will be allowed to continue in the study if they enroll in hospice after beginning the study
  • The triad will be ineligible if any member lives in the home less than 50% of the time
  • If any member of the triad retracts consent or assent prior to completion of the post-intervention surveys, then all members will be excluded from the study thereafter
  • The child will be excluded if he or she has learning challenges as assessed by the patient or co-parent; patients and co-parents will be instructed to consider any formal diagnoses of a learning disability of the presence of an Individual Education Plan (IEP) when making this assessment

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: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Supportive Care (Enhancing Connections program)
Patients and co-parents participate in the Enhancing Connections program consisting of 5 sessions over 1 hour each in the clinic or over the telephone. Session topics include managing cancer-related emotions when talking to children, developing deep listening skills, initiating difficult cancer-related conversations with children, interpreting a child's behavior, recognizing newly acquired gains from the program, and identifying available resources that can be used after program completion.
다른: 설문지 관리
보조 연구
다른: Communication Intervention
Complete Enhancing Connections program

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Feasibility of the Enhancing Connections program in advanced cancer patients and co-parents
기간: Up to 2 years
Recruitment and retention of all triads will be monitored. Dosage and fidelity will be monitored for each intervention session. Program acceptability (per session, overall, duration of program, interval between intervention sessions) will be assessed from a debriefing interview. For logistics four areas will be monitored: rate of receipt of mailed materials both to participants and from participants; duration and type (whether telephone or in-person) of intervention sessions; rate of success in scheduling and completing intervention sessions with patient and co-parent; and quality of data on baseline, post-intervention and follow-up measures.
Up to 2 years
Change in adjustment and family functioning
기간: Baseline to 6 months
Descriptive statistics (e.g. means, medians) will be used to describe the Enhancing Connections palliative care population. Parents', co-parents and children's baseline scores [parent-reported] on standardized questionnaires will be compared with post-intervention and 6 month follow-up scores on the same measures.
Baseline to 6 months
Outcomes from the Enhancing Connections Palliative Program as measured by the Child Behavior Check List
기간: Up to 2 years
Linear mixed modeling based on Maximum Likelihood Estimation will be used to test the differences between the Child Behavior Check List results for the Enhancing Connections Palliative Program and the completed phase III trial (EC-R01).
Up to 2 years
Change in adjustment as measured by post-traumatic growth scores
기간: Baseline to 6 months
Enhancing Connection Palliative Program parents', co-parents' and children's post-traumatic growth scores will be compared with follow-up (6 month) scores on the same measure.
Baseline to 6 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Fred Hutchinson Cancer Center

협력자

National Cancer Institute (NCI)

수사관

  • 수석 연구원: Elizabeth Loggers, Fred Hutch/University of Washington Cancer Consortium

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)

2017년 4월 5일

기본 완료 (실제)

2018년 9월 12일

연구 완료 (실제)

2018년 11월 30일

연구 등록 날짜

최초 제출

2017년 2월 8일

QC 기준을 충족하는 최초 제출

2017년 2월 8일

처음 게시됨 (실제)

2017년 2월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2021년 11월 17일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 11월 10일

마지막으로 확인됨

2021년 11월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 9667 (기타 식별자: Fred Hutch/University of Washington Cancer Consortium)
  • P30CA015704 (미국 NIH 보조금/계약)
  • NCI-2016-01640 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
  • RG9218011 (기타 식별자: Fred Hutch/University of Washington Cancer Consortium)

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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. .

진행성 악성 신생물에 대한 임상 시험

설문지 관리에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Jordan

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다