Targeted eHealth Intervention to Reduce Fear of Recurrence Among Breast Cancer Survivors (FoRtitude)
27 de abril de 2018 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
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)
Tipo de estudo
Intervencional
Inscrição (Real)
215
Estágio
- Não aplicável
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Fêmea
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição fatorial
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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).
|
|
Experimental: 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).
|
|
Experimental: 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).
|
|
Experimental: 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).
|
|
Experimental: 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).
|
|
Experimental: 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).
|
|
Experimental: 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).
|
|
Experimental: 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).
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Fear of Cancer Recurrence Inventory (FCRI) total score (minus Coping and Reassurance subscales)
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Impact of Events Scale - Revised
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: Baseline to Week 8 change score
|
Questionnaire to assess confidence in one's ability to manage breast cancer
|
Baseline to Week 8 change score
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Lynne Wagner, Ph.D., Wake Forest University Health Sciences
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de março de 2014
Conclusão Primária (Real)
5 de dezembro de 2015
Conclusão do estudo (Real)
5 de dezembro de 2015
Datas de inscrição no estudo
Enviado pela primeira vez
20 de dezembro de 2017
Enviado pela primeira vez que atendeu aos critérios de CQ
20 de dezembro de 2017
Primeira postagem (Real)
28 de dezembro de 2017
Atualizações de registro de estudo
Última Atualização Postada (Real)
30 de abril de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
27 de abril de 2018
Última verificação
1 de abril de 2018
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IRB00036679
- 1R21CA173193-01A1 (Concessão/Contrato do NIH dos EUA)
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Câncer de mama
-
Turku University HospitalLounais-Suomen SyöpäyhdistysAinda não está recrutandoSobrevivente de cancerFinlândia
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI)RetiradoSobrevivente de cancerEstados Unidos
-
University of Alabama at BirminghamNational Cancer Institute (NCI); Auburn UniversityConcluído
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI)ConcluídoSobrevivente de cancerEstados Unidos
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)ConcluídoSobrevivente de cancerEstados Unidos, Guam
-
Wake Forest University Health SciencesNational Cancer Institute (NCI); National Institute of Mental Health (NIMH)ConcluídoSobrevivente de cancerEstados Unidos
-
Masonic Cancer Center, University of MinnesotaConcluídoSobrevivente de cancerEstados Unidos
-
University of New MexicoNew Mexico State University; University of New Mexico Cancer CenterConcluído
-
Ohio State University Comprehensive Cancer CenterConcluídoSobrevivente de cancerEstados Unidos
-
Abramson Cancer Center of the University of PennsylvaniaConcluídoPlano de cuidados de sobrevivência LIVESTRONG: coleta contínua de dados e pesquisa de acompanhamentoPaciente com cancerEstados Unidos
Ensaios clínicos em Telephone coaching
-
Mayo ClinicConcluídoEstresse | Ansiedade | Liderança | Função Profissional | Metas | Bem-estar | Papel do médico | Esgotamento profissional | Desenvolvimento HumanoEstados Unidos
-
Queen Mary University of LondonBarts & The London NHS TrustConcluídoDoença cardiovascularReino Unido
-
University of Central FloridaAinda não está recrutandoDistúrbios do Movimento | Sensibilidade MuscularEstados Unidos
-
Thomas Jefferson UniversityAmerican Occupational Therapy FoundationRecrutamentoAVC, Agudo | Síndrome de Estresse do Cuidador | Esgotamento do cuidadorEstados Unidos
-
Food and Health Bureau, Hong KongRecrutamento
-
Dana-Farber Cancer InstituteNational Cancer Institute (NCI)RecrutamentoCâncer | Insônia | Insônia devido a condição médicaEstados Unidos
-
University of California, Los AngelesAtivo, não recrutando
-
Aava MedicalUniversity of Helsinki; Finnish Institute for Health and Welfare; Finnish Institute...DesconhecidoEsgotamento | Síndrome metabólica | Distúrbios do metabolismo lipídico | O stress relacionado com o trabalho | Redução de risco de estilo de vidaFinlândia
-
Government of Newfoundland and LabradorAtivo, não recrutando