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

27 april 2018 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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)

Studietype

Ingrijpend

Inschrijving (Werkelijk)

215

Fase

Niet toepasbaar

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

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
1. Greater than 1 year post treatment (for phase I interviews and usability testing)
2. 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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Primair doel: Ondersteunende zorg
Toewijzing: Gerandomiseerd
Interventioneel model: Faculteitstoewijzing
Masker: Verdrievoudigen

Aantal wapens

Wapens en interventies

Deelnemersgroep / Arm	Interventie / Behandeling
Experimenteel: 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.	Ander: Telephone coaching 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. Ander: Usual care Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information.
Experimenteel: 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.	Ander: Usual care Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information.
Experimenteel: 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.	Ander: Telephone coaching 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. Ander: Usual care Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information. Ander: Cognitive restructuring 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.
Experimenteel: 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.	Ander: Usual care Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information. Ander: Cognitive restructuring 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.
Experimenteel: 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.	Ander: Telephone coaching 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. Ander: Usual care Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information. Ander: Scheduled worry practice 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.
Experimenteel: 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.	Ander: Usual care Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information. Ander: Scheduled worry practice 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.
Experimenteel: 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.	Ander: Telephone coaching 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. Ander: Usual care Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information. Ander: Cognitive restructuring 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. Ander: Scheduled worry practice 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.
Experimenteel: 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.	Ander: Usual care Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information. Ander: Cognitive restructuring 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. Ander: Scheduled worry practice 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.
Experimenteel: 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.	Ander: Telephone coaching 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. Ander: Usual care Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information. Ander: Diaphragmatic breathing and relaxation 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).
Experimenteel: 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.	Ander: Usual care Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information. Ander: Diaphragmatic breathing and relaxation 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).
Experimenteel: 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.	Ander: Telephone coaching 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. Ander: Usual care Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information. Ander: Cognitive restructuring 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. Ander: Diaphragmatic breathing and relaxation 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).
Experimenteel: 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.	Ander: Usual care Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information. Ander: Cognitive restructuring 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. Ander: Diaphragmatic breathing and relaxation 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).
Experimenteel: 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.	Ander: Telephone coaching 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. Ander: Usual care Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information. Ander: Scheduled worry practice 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. Ander: Diaphragmatic breathing and relaxation 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).
Experimenteel: 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.	Ander: Usual care Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information. Ander: Scheduled worry practice 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. Ander: Diaphragmatic breathing and relaxation 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).
Experimenteel: 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.	Ander: Telephone coaching 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. Ander: Cognitive restructuring 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. Ander: Scheduled worry practice 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. Ander: Diaphragmatic breathing and relaxation 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).
Experimenteel: 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.	Ander: Cognitive restructuring 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. Ander: Scheduled worry practice 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. Ander: Diaphragmatic breathing and relaxation 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).

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Fear of Cancer Recurrence Inventory (FCRI) total score (minus Coping and Reassurance subscales) Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Impact of Events Scale - Revised Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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) Tijdsspanne: Baseline to Week 8 change score	Questionnaire to assess confidence in one's ability to manage breast cancer	Baseline to Week 8 change score

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Wake Forest University Health Sciences

Medewerkers

National Cancer Institute (NCI)

Onderzoekers

Hoofdonderzoeker: Lynne Wagner, Ph.D., Wake Forest University Health Sciences

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 maart 2014

Primaire voltooiing (Werkelijk)

5 december 2015

Studie voltooiing (Werkelijk)

5 december 2015

Studieregistratiedata

Eerst ingediend

20 december 2017

Eerst ingediend dat voldeed aan de QC-criteria

20 december 2017

Eerst geplaatst (Werkelijk)

28 december 2017

Updates van studierecords

Laatste update geplaatst (Werkelijk)

30 april 2018

Laatste update ingediend die voldeed aan QC-criteria

27 april 2018

Laatst geverifieerd

1 april 2018

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

IRB00036679
1R21CA173193-01A1 (Subsidie/contract van de Amerikaanse NIH)

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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

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

Studie Overzicht

Toestand

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Studietype

Inschrijving (Werkelijk)

Fase

Deelname Criteria

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Accepteert gezonde vrijwilligers

Geslachten die in aanmerking komen voor studie

Beschrijving

Studie plan

Hoe is de studie opgezet?

Ontwerpdetails

Aantal wapens

Wapens en interventies

Deelnemersgroep / Arm

Interventie / Behandeling

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat

Maatregel Beschrijving

Tijdsspanne

Secundaire uitkomstmaten

Uitkomstmaat

Maatregel Beschrijving

Tijdsspanne

Medewerkers en onderzoekers

Sponsor

Medewerkers

Onderzoekers

Studie record data

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