An interventional study of Diaphragmatic breathing and relaxation and Cognitive restructuring in Breast Cancer and Fear of Cancer, sponsored by Wake Forest University Health Sciences. Completed. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-30.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Supportive care
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.
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:
No current evidence of disease
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
Exclusion Criteria:
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 · Other: Usual care
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
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 · Other: Telephone coaching · Other: Usual care
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 · Other: Usual care
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 · Other: Telephone coaching · Other: Usual care
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 · Other: Usual care
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 · Other: Scheduled worry practice · Other: Telephone coaching · Other: Usual care
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 · Other: Scheduled worry practice · Other: Usual care
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 · Other: Telephone coaching · Other: Usual care
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 · Other: Usual care
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 · Other: Cognitive restructuring · Other: Telephone coaching · Other: Usual care
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 · Other: Cognitive restructuring · Other: Usual care
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 · Other: Scheduled worry practice · Other: Telephone coaching · Other: Usual care
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 · Other: Scheduled worry practice · Other: Usual care
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 · Other: Cognitive restructuring · Other: Scheduled worry practice · Other: Telephone coaching
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 · Other: Cognitive restructuring · Other: Scheduled worry practice
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).
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.
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.
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.
Time frame: Baseline to Week 8 change score
Impact of Events Scale - Revised
Questionnaire to assess illness-related distress and post-truamatic type anxiety
Time frame: Baseline to Week 8 change score
Concerns about Recurrence Scale (CARS) - 4 item severity score
Questionnaire to assess concerns about recurrence among BCS
Time frame: Baseline to Week 8 change score
PROMIS Anxiety Computer adaptive test
Questions administered using a computer adaptive test-based algorithm to assess overall anxiety
Time frame: Baseline to Week 8 change score
PROMIS Depression Computer adaptive test
Questions administered using a computer adaptive test-based algorithm to assess depression
Time frame: 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
Time frame: Baseline to Week 8 change score
PROMIS Fatigue Computer adaptive test
Questions administered using a computer adaptive test-based algorithm to assess fatigue
Time frame: Baseline to Week 8 change score
PROMIS Global Health
Questionnaire to assess overall health and health-related quality of life
Time frame: 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
Time frame: Baseline to Week 8 change score
Breast Cancer Self-Efficacy scale (BCSE)
Questionnaire to assess confidence in one's ability to manage breast cancer
Time frame: Baseline to Week 8 change score
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Wake Forest University Health Sciences