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Principal Investigator: Shelley A. Johns
Organization: INDIANA UNIVERSITY INDIANAPOLIS
Fiscal Year: 2024
Award: $617,829
Funding agency: National Cancer Institute
PROJECT SUMMARY / ABSTRACT
Following treatment for early-stage cancer, most survivors fear the possibility of a recurrence. While mild and
intermittent for many, these fears become clinically significant for approximately 40% of survivors, adversely
affecting mood, coping, and quality of life while simultaneously increasing healthcare use and associated
costs. Particularly vulnerable are breast cancer survivors (BCS) who are 33% more likely to report clinically
significant fear of cancer recurrence (FCR) than other survivors. Additionally, FCR is the top unmet need
among BCS, yet evidence-based treatments for FCR are lacking. Cognitive Behavioral Therapy (CBT) has
been the most frequently tested intervention for FCR, yielding modest effect sizes. A theoretically distinct
approach that may be better suited to BCS' experiences with FCR is Acceptance and Commitment Therapy
(ACT). The goal of ACT is to increase psychological flexibility so that difficult internal experiences (e.g., fearful
thoughts and feelings) interfere less with meaningful activities and quality of life. Psychological flexibility is
comprised of mindfulness/acceptance processes (i.e., compassionate attention to the present moment) and
commitment/behavior change processes (i.e., identifying and acting in line with personal values). Our team
conducted a 3-arm pilot randomized controlled trial in BCS with clinical FCR comparing group-based ACT to
an attention-matched survivorship education (SE) group and enhanced usual care (EUC; brief coaching with
self-administered readings). Rapid recruitment (91 BCS in 12 weeks) and high retention (94.5% through 6
months) demonstrated outstanding feasibility. Our 6-week ACT intervention was superior to SE and EUC in
reducing FCR and improving several other outcomes at 6 months post-intervention. Based on these promising
pilot trial results, we propose a 3-arm phase III randomized controlled trial of ACT compared to CBT and EUC
for early stage (I-IIIA) BCS 0-5 years post-treatment (N=375) reporting clinically significant FCR. All
interventions will be delivered via videoconferencing. Using the Indiana State Cancer Registry and Indiana
Network for Patient Care database, we will recruit BCS from five oncology facilities, including one that
specializes in the care of racially, ethnically, and economically diverse survivors. Specific aims are to: (1) test
the efficacy of group-based ACT compared to CBT and EUC on FCR (primary outcome) and anxiety,
depressive symptoms, post-traumatic stress, avoidant coping, and quality of life (secondary outcomes) over 12
months; (2) examine change in psychological flexibility as a mediator of ACT's effects on FCR over 12 months;
and (3) perform comparative assessment of ACT, CBT, and EUC to determine the cost-effective intervention
for FCR. Our ability to demonstrate ACT's efficacy will lead to its widespread dissemination to BCS. Findings
will also inform further application and refined testing of ACT with various cancer populations and health-
related outcomes.
Terms: <Acceptance Process><Active Follow-up><Address><Affect><After Care><After-Treatment><Aftercare><Anxiety><Attention><Breast Cancer survivor><Cancer Survivor><Cancers><Caring><Clinical><Cognition Therapy><Cognitive Psychotherapy><Cognitive Therapy><Cognitive treatment><Colon or Rectum><Colorectal><Colorectal Cancer><Comprehensive Health Care><Comprehensive Healthcare><Data Bases><Databases><Disease remission><Distress><Early treatment><Education><Educational aspects><Elements><Eligibility><Eligibility Determination><Emotional Depression><Ethnic Origin><Ethnicity><Evidence based treatment><Fear><Feeling><Fright><Future><Goals><Health><Health Services><Health behavior><Healthcare><Hour><Indiana><Intervention><Intervention Strategies><Malignant Neoplasms><Malignant Tumor><Mediating><Mediator><Meta-Analysis><Moods><Morbidity><Morbidity - disease rate><Oncology><Oncology Cancer><Outcome><Patient Care><Patient Care Delivery><Pattern><Persons><Phase><Population><Process><Prostate><Prostate Gland><Prostatic Gland><Protocol Screening><QOL><Quality of life><Race><Races><Randomization trial><Randomized><Randomized, Controlled Trials><Recurrence><Recurrent><Recurrent Malignant Neoplasm><Recurrent Malignant Tumor><Remission><Reporting><Sampling><Self Administered><Self Administration><Self-Help Groups><Support Groups><Survivors><Testing><Therapeutic Intervention><Thinking><Time><Treatment Efficacy><United States><Videoconferencing><Work><active comparator><active comparison control><active followup><arm><behavior change><cancer recurrence><cancer registry><care as usual><care for patients><care of patients><caring for patients><clinical practice><clinical significance><clinically significant><cognitive behavior intervention><cognitive behavior modification><cognitive behavior therapy><cognitive behavioral intervention><cognitive behavioral modification><cognitive behavioral therapy><cognitive behavioral treatment><colorectum><comparative><comprehensive care><coping><cost><cost effective><cost effective intervention><cost effectiveness><data base><depression symptom><depressive><depressive symptoms><design><designing><early therapy><efficacy testing><evidence base><experience><feelings><flexibility><flexible><follow up><follow-up><followed up><followup><health care><health related behavior><improved><intervention efficacy><intervention therapy><interventional strategy><malignancy><mindfulness><mortality><neoplasm registry><neoplasm/cancer><pilot trial><post intervention><post treatment><post-traumatic stress symptoms><post-traumatic symptoms><posttraumatic stress symptoms><posttraumatic symptoms><primary outcome><psychologic><psychological><racial><racial background><racial origin><randomisation><randomization><randomized control trial><randomized trial><randomly assigned><recruit><relative effectiveness><secondary outcome><self help organization><standard care><standard treatment><stressor><survivorship><therapeutic efficacy><therapy efficacy><thoughts><treatment as usual><usual care><video conferencing>