Targeted eHealth Intervention to Reduce Fear of Recurrence Among Breast Cancer Survivors (FoRtitude)
2018년 4월 27일 업데이트: Wake Forest University Health Sciences
Targeted eHealth Intervention to Reduce Fear of Recurrence Among Breast Cancer Survivors: The FoRtitude Trial
The FoRtitude trial aims to evaluate an eHealth intervention designed to teach breast cancer survivors strategies to manage anxiety about cancer recurrence.
The eHealth intervention includes educational content and interactive tools, designed to teach coping strategies and/or inert content, depending on the study participant's randomization assignment.
The FoRtitude study will examine whether three coping strategies (relaxation training, cognitive restructuring, worry practice) are more effective than general health-related content in reducing fear of cancer recurrence.
연구 개요
상태
완전한
상세 설명
The purpose of the FoRtitude trial is to develop and evaluate a targeted eHealth intervention designed to teach breast cancer survivors (BCS) coping strategies to manage fear about cancer recurrence (FoR). FoRtitude, a web-based program with interactive text messaging capabilities, was created to deliver a targeted intervention for BCS with moderate to severe FoR. FoRtitude consists of didactic content presented in written and video-based formats and interactive tools, designed to teach coping strategies. Commonly used cognitive behavior therapy (CBT) techniques were tailored to the management of FoR and included diaphragmatic breathing and relaxation, cognitive restructuring, and scheduled worry practice. Participants are encouraged to use the FoRtitude site several times per week over a period of 4 weeks. The investigators employed principles of user-centered design to create the FoRtitude website and incorporated feedback from 17 BCS to refine site content and improve FoRtitude usability.
After refining the FoRtitude site, the investigators will conduct a randomized controlled trial using the Multiphase Optimization Strategy (MOST) to individually evaluate three coping strategies; each coping strategy will be compared to health management content. Inert content includes general health information and managing comorbid illnesses, information on general nutrition, and information on nutritional topics of interest to BCS. Half of the participants will be randomized to receive telecoaching, which included 3-4 telephone-based brief sessions with a motivational interviewer, aimed at improving adherence to use of the FoRtitude site. Participants will complete questionnaires at baseline, 4 weeks (immediately after completing the FoRtitude site) and at 8 weeks.
Study hypotheses:
- BCS randomized to Relaxation training will report a greater reduction in fear of cancer recurrence from pre-post intervention than BCS randomized to inert (health management) content
- BCS randomized to Cognitive restructuring will report a greater reduction in fear of cancer recurrence from pre-post intervention than BCS randomized to inert (health management) content
- BCS randomized to Scheduled Worry practice will report a greater reduction in fear of cancer recurrence from pre-post intervention than BCS randomized to inert (health management) content
- BCS randomized to receive Telecoaching will demonstrate higher adherence to using the FoRtitude site and will report a greater reduction in fear of cancer recurrence from pre-post intervention compared to BCS randomized to no Telecoaching
- BCS randomized to a higher number of coping strategies will report a greater reduction in fear of cancer recurrence from pre-post intervention than BCS randomized to receive all inert content or fewer coping strategies (dose-response effect)
연구 유형
중재적
등록 (실제)
215
단계
- 해당 없음
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
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
여성
설명
Inclusion Criteria:
- Female
- Diagnosis of breast cancer, non-metastatic, stage I-III
- Completed primary treatment for breast cancer (surgery, chemotherapy and/or radiation therapy, current hormonal treatment allowable)
No current evidence of disease
- Greater than 1 year post treatment (for phase I interviews and usability testing)
- Between 1 and 10 years post-treatment (for Phase I field testing and Phase II)
- Good overall functional status as evidenced by ECOG Performance Status < 3
- At least 18 years of age (for Phase I only)
- At least 19 years of age (for Phase 2 only)
- Able to speak and read English
- Able to provide informed consent
Clinically significant FoR, measured by the 9-item FCRI severity scale using established cut-off
a. Patients may be eligible for Phase I and Phase IV of the study regardless of their FCRI score
- Cellular telephone with SMS messaging capability and access to a computer with broadband Internet access
- Self-reported familiarity with the Internet per Internet Usage Patterns Measure
- For Phase III, participants must have participated in Phase II
- For Phase IV, participants must be a self-identified African American breast cancer survivor that is willing to review site content and provide feedback in addition to meeting inclusion criteria above (with exception of FCRI severity scale score)
Exclusion Criteria:
- Visual, hearing, voice, or motor impairment that would prevent completion of study procedures
- Diagnosed with a psychotic disorder, bipolar disorder, dissociative disorder, or other diagnosis for which participation in this trial is either inappropriate or dangerous
- Hazardous substance or alcohol use
- Suicidal ideation, plan, intent
- Dementia
- Or if the participant is deemed ineligible by the investigators for reasons not otherwise specified.
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: 요인 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Group 1
Participants were exposed to the following conditions: general health for week 1, diet-general information for week 2, and diet-BCSS information (breast cancer survivor-specific) for week 3. Telephone coaching was given.
|
BCS will receive 5 TeleCoaching calls over a period of 4 weeks, to include one introductory phone call, followed by 4 calls focused each week on the current CSM; if the participant is not randomized to a CSM, TeleCoaching will provide reflective listening and encouragement.
Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information.
|
|
실험적: Group 2
Participants were exposed to the one of the following usual care conditions: general health for week 1, diet-general information for week 2, and diet-BCSS information (breast cancer survivor-specific) for week 3.
|
Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information.
|
|
실험적: Group 3
Participants were exposed to the following conditions: cognitive restructuring for week 1, general health for week 2, and diet-general information and diet-BCSS information (breast cancer survivor-specific) for week 3. Telephone coaching was given.
|
BCS will receive 5 TeleCoaching calls over a period of 4 weeks, to include one introductory phone call, followed by 4 calls focused each week on the current CSM; if the participant is not randomized to a CSM, TeleCoaching will provide reflective listening and encouragement.
Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information.
Education on the thought-emotion connection and exercises designed to better understand cognitions associated with increased anxiety and tools to evaluate and replace anxiety-generating cognitions.
Includes an interactive tool (thought record) participants complete to facilitate this process.
|
|
실험적: Group 4
Participants were exposed to the following conditions: cognitive restructuring for week 1, general health for week 2, and diet-general information and diet-BCSS information (breast cancer survivor-specific) for week 3.
|
Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information.
Education on the thought-emotion connection and exercises designed to better understand cognitions associated with increased anxiety and tools to evaluate and replace anxiety-generating cognitions.
Includes an interactive tool (thought record) participants complete to facilitate this process.
|
|
실험적: Group 5
Participants were exposed to the following conditions: scheduled worry practice for week 1, general health for week 2, and diet-general information and diet-BCSS information (breast cancer survivor-specific) for week 3. Telephone coaching was given.
|
BCS will receive 5 TeleCoaching calls over a period of 4 weeks, to include one introductory phone call, followed by 4 calls focused each week on the current CSM; if the participant is not randomized to a CSM, TeleCoaching will provide reflective listening and encouragement.
Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information.
Education on the association between avoidance and increased anxiety, and instructions on actively thinking about feared events to reduce avoidance and engage healthy coping strategies.
Interactive tool includes a video-based guided worry practice session and an interactive worksheet and timer.
|
|
실험적: Group 6
Participants were exposed to the following conditions: scheduled worry practice for week 1, general health for week 2, and diet-general information and diet-BCSS information (breast cancer survivor-specific) for week 3.
|
Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information.
Education on the association between avoidance and increased anxiety, and instructions on actively thinking about feared events to reduce avoidance and engage healthy coping strategies.
Interactive tool includes a video-based guided worry practice session and an interactive worksheet and timer.
|
|
실험적: Group 7
Participants were exposed to the following conditions: cognitive restructuring for week 1, worry practice for week 2, and General Health and Diet (General and BCSS) for week 3. Telephone coaching was given.
|
BCS will receive 5 TeleCoaching calls over a period of 4 weeks, to include one introductory phone call, followed by 4 calls focused each week on the current CSM; if the participant is not randomized to a CSM, TeleCoaching will provide reflective listening and encouragement.
Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information.
Education on the thought-emotion connection and exercises designed to better understand cognitions associated with increased anxiety and tools to evaluate and replace anxiety-generating cognitions.
Includes an interactive tool (thought record) participants complete to facilitate this process.
Education on the association between avoidance and increased anxiety, and instructions on actively thinking about feared events to reduce avoidance and engage healthy coping strategies.
Interactive tool includes a video-based guided worry practice session and an interactive worksheet and timer.
|
|
실험적: Group 8
Participants were exposed to the following conditions: cognitive restructuring for week 1, scheduled worry practice for week 2, and General Health and Diet (General and BCSS) for week 3.
|
Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information.
Education on the thought-emotion connection and exercises designed to better understand cognitions associated with increased anxiety and tools to evaluate and replace anxiety-generating cognitions.
Includes an interactive tool (thought record) participants complete to facilitate this process.
Education on the association between avoidance and increased anxiety, and instructions on actively thinking about feared events to reduce avoidance and engage healthy coping strategies.
Interactive tool includes a video-based guided worry practice session and an interactive worksheet and timer.
|
|
실험적: Group 9
Participants were exposed to the following conditions: Diaphragmatic breathing and relaxation for week 1, general health for week 2, and Diet - General and BCSS for week 3. Telephone coaching was given.
|
BCS will receive 5 TeleCoaching calls over a period of 4 weeks, to include one introductory phone call, followed by 4 calls focused each week on the current CSM; if the participant is not randomized to a CSM, TeleCoaching will provide reflective listening and encouragement.
Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information.
Education on physiological effects of anxiety, instructions in diaphragmatic breathing and relaxation techniques, and audio-recordings 5-15 minutes in length that provide guided relaxation exercises (autogenic, imagery-based and progressive muscle relaxation).
|
|
실험적: Group 10
Participants were exposed to the following conditions: Diaphragmatic breathing and relaxation for week 1, general health for week 2, and Diet - General and BCSS for week 3.
|
Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information.
Education on physiological effects of anxiety, instructions in diaphragmatic breathing and relaxation techniques, and audio-recordings 5-15 minutes in length that provide guided relaxation exercises (autogenic, imagery-based and progressive muscle relaxation).
|
|
실험적: Group 11
Participants were exposed to the following conditions: Diaphragmatic breathing and relaxation for week 1, cognitive restructuring for week 2, and General health and Diet (General and BCSS) for week 3. Telephone coaching was given.
|
BCS will receive 5 TeleCoaching calls over a period of 4 weeks, to include one introductory phone call, followed by 4 calls focused each week on the current CSM; if the participant is not randomized to a CSM, TeleCoaching will provide reflective listening and encouragement.
Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information.
Education on the thought-emotion connection and exercises designed to better understand cognitions associated with increased anxiety and tools to evaluate and replace anxiety-generating cognitions.
Includes an interactive tool (thought record) participants complete to facilitate this process.
Education on physiological effects of anxiety, instructions in diaphragmatic breathing and relaxation techniques, and audio-recordings 5-15 minutes in length that provide guided relaxation exercises (autogenic, imagery-based and progressive muscle relaxation).
|
|
실험적: Group 12
Participants were exposed to the following conditions: Diaphragmatic breathing and relaxation for week 1, cognitive restructuring for week 2, and General health and Diet (General and BCSS) for week 3.
|
Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information.
Education on the thought-emotion connection and exercises designed to better understand cognitions associated with increased anxiety and tools to evaluate and replace anxiety-generating cognitions.
Includes an interactive tool (thought record) participants complete to facilitate this process.
Education on physiological effects of anxiety, instructions in diaphragmatic breathing and relaxation techniques, and audio-recordings 5-15 minutes in length that provide guided relaxation exercises (autogenic, imagery-based and progressive muscle relaxation).
|
|
실험적: Group 13
Participants were exposed to the following conditions: Diaphragmatic breathing and relaxation for week 1, worry practice for week 2, and General health and Diet (General and BCSS) for week 3. Telephone coaching was given.
|
BCS will receive 5 TeleCoaching calls over a period of 4 weeks, to include one introductory phone call, followed by 4 calls focused each week on the current CSM; if the participant is not randomized to a CSM, TeleCoaching will provide reflective listening and encouragement.
Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information.
Education on the association between avoidance and increased anxiety, and instructions on actively thinking about feared events to reduce avoidance and engage healthy coping strategies.
Interactive tool includes a video-based guided worry practice session and an interactive worksheet and timer.
Education on physiological effects of anxiety, instructions in diaphragmatic breathing and relaxation techniques, and audio-recordings 5-15 minutes in length that provide guided relaxation exercises (autogenic, imagery-based and progressive muscle relaxation).
|
|
실험적: Group 14
Participants were exposed to the following conditions: Diaphragmatic breathing and relaxation for week 1, scheduled worry practice for week 2, and General health and Diet (General and BCSS) for week 3.
|
Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information.
Education on the association between avoidance and increased anxiety, and instructions on actively thinking about feared events to reduce avoidance and engage healthy coping strategies.
Interactive tool includes a video-based guided worry practice session and an interactive worksheet and timer.
Education on physiological effects of anxiety, instructions in diaphragmatic breathing and relaxation techniques, and audio-recordings 5-15 minutes in length that provide guided relaxation exercises (autogenic, imagery-based and progressive muscle relaxation).
|
|
실험적: Group 15
Participants were exposed to the following conditions: Diaphragmatic breathing and relaxation for week 1, worry practice for week 2, and cognitive restructuring for week 3. Telephone coaching was given.
|
BCS will receive 5 TeleCoaching calls over a period of 4 weeks, to include one introductory phone call, followed by 4 calls focused each week on the current CSM; if the participant is not randomized to a CSM, TeleCoaching will provide reflective listening and encouragement.
Education on the thought-emotion connection and exercises designed to better understand cognitions associated with increased anxiety and tools to evaluate and replace anxiety-generating cognitions.
Includes an interactive tool (thought record) participants complete to facilitate this process.
Education on the association between avoidance and increased anxiety, and instructions on actively thinking about feared events to reduce avoidance and engage healthy coping strategies.
Interactive tool includes a video-based guided worry practice session and an interactive worksheet and timer.
Education on physiological effects of anxiety, instructions in diaphragmatic breathing and relaxation techniques, and audio-recordings 5-15 minutes in length that provide guided relaxation exercises (autogenic, imagery-based and progressive muscle relaxation).
|
|
실험적: Group 16
Participants were exposed to the following conditions: Diaphragmatic breathing and relaxation for week 1, scheduled worry practice for week 2, and cognitive restructuring for week 3.
|
Education on the thought-emotion connection and exercises designed to better understand cognitions associated with increased anxiety and tools to evaluate and replace anxiety-generating cognitions.
Includes an interactive tool (thought record) participants complete to facilitate this process.
Education on the association between avoidance and increased anxiety, and instructions on actively thinking about feared events to reduce avoidance and engage healthy coping strategies.
Interactive tool includes a video-based guided worry practice session and an interactive worksheet and timer.
Education on physiological effects of anxiety, instructions in diaphragmatic breathing and relaxation techniques, and audio-recordings 5-15 minutes in length that provide guided relaxation exercises (autogenic, imagery-based and progressive muscle relaxation).
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Fear of Cancer Recurrence Inventory (FCRI) total score (minus Coping and Reassurance subscales)
기간: Baseline to Week 8 change score
|
Questionnaire aims to better understand the experience of worries about cancer recurrence.
Scaled from 1-4 with 4 being "all the time" and 1 being "never".
The FCRI is the only FoR measure validated using interview to define 'caseness' and has demonstrated reliability and validity with English speaking survivors.
FCRI total score to be calculated without including the Coping and Reassurance subscales defined a priori and determined by FoR theoretical model.
|
Baseline to Week 8 change score
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Impact of Events Scale - Revised
기간: Baseline to Week 8 change score
|
Questionnaire to assess illness-related distress and post-truamatic type anxiety
|
Baseline to Week 8 change score
|
|
Concerns about Recurrence Scale (CARS) - 4 item severity score
기간: Baseline to Week 8 change score
|
Questionnaire to assess concerns about recurrence among BCS
|
Baseline to Week 8 change score
|
|
PROMIS Anxiety Computer adaptive test
기간: Baseline to Week 8 change score
|
Questions administered using a computer adaptive test-based algorithm to assess overall anxiety
|
Baseline to Week 8 change score
|
|
PROMIS Depression Computer adaptive test
기간: Baseline to Week 8 change score
|
Questions administered using a computer adaptive test-based algorithm to assess depression
|
Baseline to Week 8 change score
|
|
PROMIS Sleep Disturbance Computer adaptive test
기간: Baseline to Week 8 change score
|
Questions administered using a computer adaptive test-based algorithm to assess sleep disturbances
|
Baseline to Week 8 change score
|
|
PROMIS Fatigue Computer adaptive test
기간: Baseline to Week 8 change score
|
Questions administered using a computer adaptive test-based algorithm to assess fatigue
|
Baseline to Week 8 change score
|
|
PROMIS Global Health
기간: Baseline to Week 8 change score
|
Questionnaire to assess overall health and health-related quality of life
|
Baseline to Week 8 change score
|
|
PROMIS Applied Cognition Computer adaptive test
기간: Baseline to Week 8 change score
|
Questions administered using a computer adaptive test-based algorithm to assess patient-reported cognitive impairments
|
Baseline to Week 8 change score
|
|
Breast Cancer Self-Efficacy scale (BCSE)
기간: Baseline to Week 8 change score
|
Questionnaire to assess confidence in one's ability to manage breast cancer
|
Baseline to Week 8 change score
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Lynne Wagner, Ph.D., Wake Forest University Health Sciences
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)
2014년 3월 1일
기본 완료 (실제)
2015년 12월 5일
연구 완료 (실제)
2015년 12월 5일
연구 등록 날짜
최초 제출
2017년 12월 20일
QC 기준을 충족하는 최초 제출
2017년 12월 20일
처음 게시됨 (실제)
2017년 12월 28일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 4월 30일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 4월 27일
마지막으로 확인됨
2018년 4월 1일
추가 정보
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
-
Georgetown UniversityNational Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen Breast Cancer...완전한
-
University of UtahNational Cancer Institute (NCI)완전한피로 | 좌식 생활 | 전이성 전립선암 | IV기 전립선암 AJCC(American Joint Committee on Cancer) v8 | IVA기 전립선암 AJCC(American Joint Committee on Cancer) v8 | IVB기 전립선암 AJCC(American Joint Committee on Cancer) v8미국
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SB Istanbul Education and Research Hospital아직 모집하지 않음Thryoid cancer | parathyrıoid 선종
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Jonsson Comprehensive Cancer CenterNovartis Pharmaceuticals모병전립선암 | IVB기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
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Jonsson Comprehensive Cancer Center모병전립선 선암종 | 2기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
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Jonsson Comprehensive Cancer Center빼는전립선 선암종 | 2기 전립선암 AJCC v8 | IIC기 전립선암 AJCC v8 | IIA기 전립선암 AJCC v8 | IIB기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
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Jonsson Comprehensive Cancer CenterMiraDX모집하지 않고 적극적으로전립선 선암종 | 2기 전립선암 AJCC v8 | IIC기 전립선암 AJCC v8 | IIA기 전립선암 AJCC v8 | IIB기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
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Society for Endocrinology초대로 등록
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Jonsson Comprehensive Cancer Center모병거세저항성 전립선암 | 전이성 전립선암 | IVA기 전립선암 AJCC v8 | IVB기 전립선암 AJCC v8 | IV기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
Telephone coaching에 대한 임상 시험
-
University of OregonSpecial X Inc.완전한부모-자녀 관계 | 육아 | 아동 행동 | 발달 장애 | 개발 지연 | 발달 장애, 아동미국
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University of PittsburghNational Institute of Nursing Research (NINR); National Institute on Aging (NIA)완전한
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Training and Implementation Associates모병전통적인 대면 교육 | FTTIP(가족 치료 교육 및 구현 플랫폼)미국