Targeted eHealth Intervention to Reduce Fear of Recurrence Among Breast Cancer Survivors

Study Overview
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Brief Summary
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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.

Detailed Description
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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)

Official Title
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Targeted eHealth Intervention to Reduce Fear of Recurrence Among Breast Cancer Survivors: The FoRtitude Trial

Conditions
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Breast Cancer, Fear of Cancer

Intervention / Treatment
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* Other: Diaphragmatic breathing and relaxation
* Other: Cognitive restructuring
* Other: Scheduled worry practice
* Other: Telephone coaching
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: FoRtitude includes three CSMs: (1) diaphragmatic breathing and relaxation, (2) cognitive restructuring, and (3) scheduled worry practice. The fourth intervention component is (4) telephone coaching. We assigned two levels (yes, no) to each component. Evaluating individual and combined intervention components, each with two levels, results in a classic full factorial design with 16 (2 x 2 x 2 x 2) experimental conditions
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>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. | Other: Telephone coaching<br>* 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.<br>Other: Usual care<br>* Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information.<br>|
| Experimental: Group 2<br>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. | Other: Usual care<br>* Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information.<br>|
| Experimental: Group 3<br>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. | Other: Cognitive restructuring<br>* 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.<br>Other: Telephone coaching<br>* 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.<br>Other: Usual care<br>* Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information.<br>|
| Experimental: Group 4<br>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. | Other: Cognitive restructuring<br>* 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.<br>Other: Usual care<br>* Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information.<br>|
| Experimental: Group 5<br>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. | Other: Scheduled worry practice<br>* 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.<br>Other: Telephone coaching<br>* 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.<br>Other: Usual care<br>* Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information.<br>|
| Experimental: Group 6<br>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. | Other: Scheduled worry practice<br>* 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.<br>Other: Usual care<br>* Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information.<br>|
| Experimental: Group 7<br>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. | Other: Cognitive restructuring<br>* 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.<br>Other: Scheduled worry practice<br>* 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.<br>Other: Telephone coaching<br>* 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.<br>Other: Usual care<br>* Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information.<br>|
| Experimental: Group 8<br>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. | Other: Cognitive restructuring<br>* 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.<br>Other: Scheduled worry practice<br>* 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.<br>Other: Usual care<br>* Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information.<br>|
| Experimental: Group 9<br>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. | Other: Diaphragmatic breathing and relaxation<br>* 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).<br>Other: Telephone coaching<br>* 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.<br>Other: Usual care<br>* Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information.<br>|
| Experimental: Group 10<br>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. | Other: Diaphragmatic breathing and relaxation<br>* 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).<br>Other: Usual care<br>* Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information.<br>|
| Experimental: Group 11<br>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. | Other: Diaphragmatic breathing and relaxation<br>* 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).<br>Other: Cognitive restructuring<br>* 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.<br>Other: Telephone coaching<br>* 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.<br>Other: Usual care<br>* Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information.<br>|
| Experimental: Group 12<br>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. | Other: Diaphragmatic breathing and relaxation<br>* 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).<br>Other: Cognitive restructuring<br>* 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.<br>Other: Usual care<br>* Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information.<br>|
| Experimental: Group 13<br>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. | Other: Diaphragmatic breathing and relaxation<br>* 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).<br>Other: Scheduled worry practice<br>* 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.<br>Other: Telephone coaching<br>* 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.<br>Other: Usual care<br>* Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information.<br>|
| Experimental: Group 14<br>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. | Other: Diaphragmatic breathing and relaxation<br>* 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).<br>Other: Scheduled worry practice<br>* 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.<br>Other: Usual care<br>* Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information.<br>|
| Experimental: Group 15<br>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. | Other: Diaphragmatic breathing and relaxation<br>* 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).<br>Other: Cognitive restructuring<br>* 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.<br>Other: Scheduled worry practice<br>* 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.<br>Other: Telephone coaching<br>* 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.<br>|
| Experimental: Group 16<br>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. | Other: Diaphragmatic breathing and relaxation<br>* 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).<br>Other: Cognitive restructuring<br>* 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.<br>Other: Scheduled worry practice<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fear of Cancer Recurrence Inventory (FCRI) total score (minus Coping and Reassurance subscales) | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of Events Scale - Revised | 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 | Questionnaire to assess concerns about recurrence among BCS | Baseline to Week 8 change score | 
| PROMIS Anxiety Computer adaptive test | Questions administered using a computer adaptive test-based algorithm to assess overall anxiety | Baseline to Week 8 change score | 
| PROMIS Depression Computer adaptive test | Questions administered using a computer adaptive test-based algorithm to assess depression | Baseline to Week 8 change score | 
| PROMIS Sleep Disturbance Computer adaptive test | Questions administered using a computer adaptive test-based algorithm to assess sleep disturbances | Baseline to Week 8 change score | 
| PROMIS Fatigue Computer adaptive test | Questions administered using a computer adaptive test-based algorithm to assess fatigue | Baseline to Week 8 change score | 
| PROMIS Global Health | Questionnaire to assess overall health and health-related quality of life | Baseline to Week 8 change score | 
| PROMIS Applied Cognition Computer adaptive test | 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) | Questionnaire to assess confidence in one's ability to manage breast cancer | Baseline to Week 8 change score | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PROMIS, Fear of Cancer Recurrence, ehealth interventions, FoR