Targeted eHealth Intervention to Reduce Fear of Recurrence Among Breast Cancer Survivors (FoRtitude)
2018年4月27日 更新者：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.
調査の概要
状態
完了
詳細な説明
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)
研究の種類
介入
入学 (実際)
215
段階
- 適用できない
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
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
女性
説明
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.
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：階乗代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
|
実験的：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.
|
|
実験的：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.
|
|
実験的：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.
|
|
実験的：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.
|
|
実験的：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.
|
|
実験的：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.
|
|
実験的：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.
|
|
実験的：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).
|
|
実験的：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).
|
|
実験的：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).
|
|
実験的：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).
|
|
実験的：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).
|
|
実験的：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).
|
|
実験的：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).
|
|
実験的：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).
|
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 |
|---|---|---|
|
Fear of Cancer Recurrence Inventory (FCRI) total score (minus Coping and Reassurance subscales)
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Impact of Events Scale - Revised
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：Baseline to Week 8 change score
|
Questionnaire to assess confidence in one's ability to manage breast cancer
|
Baseline to Week 8 change score
|
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。
捜査官
- 主任研究者：Lynne Wagner, Ph.D.、Wake Forest University Health Sciences
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)
2014年3月1日
一次修了 (実際)
2015年12月5日
研究の完了 (実際)
2015年12月5日
試験登録日
最初に提出
2017年12月20日
QC基準を満たした最初の提出物
2017年12月20日
最初の投稿 (実際)
2017年12月28日
学習記録の更新
投稿された最後の更新 (実際)
2018年4月30日
QC基準を満たした最後の更新が送信されました
2018年4月27日
最終確認日
2018年4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。
乳がんの臨床試験
-
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
Telephone coachingの臨床試験
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University of PittsburghNational Institute of Nursing Research (NINR); National Institute on Aging (NIA)完了