Behaviors and Mental Disorders

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Anxiety Disorders

Carcinoma

Breast Neoplasms

Recurrence

Mammary Neoplasms, Animal

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Breast Diseases

Skin Diseases

Disease Attributes

All Drugs and Chemicals

Nicotine

The EUC group will meet for a single 90-minute coaching session via Zoom Health.

The ACT group will meet for 90-minute sessions via Zoom Health weekly for 6 weeks.

The CBT group will meet for 90-minute sessions via Zoom Health weekly for 6 weeks.

Interventionists will provide a brief explanation of the intervention and coaching to the group on how to utilize the resources provided. Prior to the single session group, EUC participants will have received a workbook with the National Cancer Institute's "Facing Forward: Life After Cancer Treatment" booklet on maximizing quality of life during cancer survivorship and the American Society of Clinical Oncology's "Guide to Cancer Survivorship."

Enhanced Usual Care

Interventionists will support participants in adopting a psychologically flexible posture toward FCR through six interdependent processes of change - acceptance, cognitive defusion, mindfulness, perspective taking, values, and committed action. During ACT sessions, participants will learn to respond adaptively to FCR by being more fully aware of thoughts, feelings, and bodily sensations without judging or attempting to control or avoid them. Participants will also clarify their deeply-held values and set action goals in alignment with their values.

Acceptance Commitment Therapy

Interventionists will provide psycho-education on the cognitive behavioral model of FCR and assist participants in changing unhelpful thinking patterns and maladaptive behaviors linked to FCR. Session topics will include FCR triggers, behavioral experiments to reduce FCR-perpetuating safety behaviors, and pleasant events scheduling. Interventionists will also provide evidence-based information on behaviors that may reduce recurrence risk (e.g., achieving a healthy weight, physical activity, cancer surveillance).

Cognitive Behavioral Therapy

Shelley A Johns, PsyD

Fear of cancer recurrence (FCR) is a highly prevalent, disruptive, and under-treated problem for breast cancer survivors. This randomized controlled trial will test the efficacy of group-based Acceptance and Commitment Therapy compared to Cognitive Behavioral Therapy and enhanced usual care for breast cancer survivors suffering from FCR while examining its cost-effectiveness and the mechanisms by which the intervention may work. Study findings will guide the future care of breast cancer survivors with FCR.

The primary objective of this 3-arm randomized control trial (RCT) is to build on the investigators' pilot work by testing the impact of Acceptance Commitment Therapy (ACT) on FCR. The investigators will randomly assign up to 375 early-stage Breast Cancer Survivors (BCS; for at least 300 study completers after attrition) who have finished primary cancer treatment and who report clinically significant FCR to: (1) group-based ACT (6 weekly 1.5-hour videoconference sessions), (2) group-based Cognitive Behavioral Therapy (CBT; 6 weekly 1.5-hour videoconference sessions), or (3) Enhanced Usual Care (EUC; a single 90-minute videoconference coaching session with self-administered readings). Outcomes will be assessed at baseline and at 2, 6, and 12 months; additionally, potential theory-driven mediators of the ACT intervention's effects on key outcomes will be analyzed at these time points and at intervention midpoint. Cost-effectiveness of each intervention will be assessed.

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, fatigue, sleep disturbance, and quality of life (secondary outcomes) in BCS with clinical FCR; (2) to examine changes in psychological flexibility as a mediator of ACT's effect on FCR; and (3) to perform comparative assessments of ACT, CBT, and EUC to determine the cost-effective intervention.

An external statistician will create the randomization sequence. An unblinded research manager will maintain the randomization sequence and randomization assignment for each participant in password-protected databases not accessible by the study team. All study personnel, including the study's principal investigator (PI), biostatistician, data manager, research coordinator (RC), and research assistants (RAs), will be blind to the randomization sequence. The PI, research manager, interventionists, and intervention supervisors will be the only individuals privy to participants' randomization assignments. The study RC, RAs (including outcome assessors), and the study biostatistician and data manager will remain blind to participants' random assignments for the trial's duration to enhance rigor and reduce the risk of outcome expectancy and other biases. Participants will be blind to study hypotheses, yet will be aware of their assignment to a 6-session versus single-session intervention.

Facilitating Adaptive Coping With Fear of Recurrence Among Breast Cancer Survivors

Acceptance and Commitment Therapy for Fear of Recurrence in Breast Cancer Survivors

EuroQoL Five Dimensions Questionnaire (EQ-5D-5L) is a standardized non-disease specific instrument used to estimate 'utilities' for cost-effectiveness analyses. Consists of 5 items assessing mobility, self-care, usual activities, pain/discomfort, and anxiety/depression on a 1-5 scale. An additional item asks respondents to assess overall health on a 0 (worst health imaginable) to 100 (best health imaginable) scale. This measure will be used in cost effectiveness analysis.

Medical and non-medical costs are measure over the past 4 weeks using the validated Treatment Inventory of Costs in Patients with Psychiatric Disorders (TiC-P). The first part of the TiC-P assesses frequency of use of various types of health care resources. The second part is an adaptation of the Short Form of the Health and Labor Questionnaire. This measure will be used in cost effectiveness analysis.

The 18-item Cancer Acceptance and Action Questionnaire is a validated measure of cancer-related psychological flexibility, with items rated on a 1 (never true) to 7 (always true) scale. Lower scores indicate greater psychological flexibility. This measure will be used in mediator analysis.

The 10-item Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) comprehensively assesses mindfulness processes including attention, present-focused awareness, and acceptance/non-judgment. Items are rated on a 1 (rarely or not at all) to 4 (almost always) scale, with higher scores indicating greater mindfulness. This measure will be used in mediator analysis.

The 5-item Value Progress subscale of the Valuing Questionnaire assesses progress in living consistently with personal values. Items are rated on a 0 (not at all true) to 6 (completely true) scale, with higher scores indicating greater values-consistent living. This measure will be used in mediator analysis.

The 43-item Fear of Cancer Recurrence Inventory (FCRI) includes triggers, psychological distress, coping strategies, reassurance seeking, insight, severity, and functional impairments subscales. Each item is rated on a scale from 0 (never, not at all, or I don't think about it) to 4 (all the time or a great deal), participants indicate the extent to which they are fearful, with higher scores indicating greater FCR.

The 7-item FCR-7 assesses anxiety, worry, and strong feelings associated with cancer recurrence, coupled with items assessing cognitive and behavioral responses to FCR. The first six items are on a scale from 1 (not at all) to 5 (all the time). The seventh item assesses the extent to which worry about getting cancer again intrudes on thoughts and activities on a 0 (not at all) to 10 (great deal) scale. Higher scores indicate greater FCR.

The 4-item Concerns About Recurrence Scale includes frequency, potential for upset, consistency, and intensity of fears on a 1-4 scale. Higher scores indicate greater FCR.

Participants will be asked "Overall, since starting your assigned study program, is your fear of cancer recurrence worse, about the same, or better?" Those rating their fear of cancer recurrence as "better" are then asked if their fear is "a little better," "somewhat better," "moderately better," "a lot better," or "completely better".

The 7-item Generalized Anxiety Disorder Scale (GAD-7) assesses how often in the past two weeks participants have been bothered by symptoms of anxiety on a 0 (not at all) to 3 (nearly everyday) scale, with higher scores indicating greater anxiety.

The 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety measure assesses how often participants felt various symptoms of anxiety in the past 7 days on a 1 (never) to 5 (always) scale, with higher scores indicating greater anxiety.

The 22-item Impact of Events Scale-Revised (IES-R) assesses post-traumatic distress on a 0 (not at all) to 4 (extremely) scale, with higher scores indicating greater post traumatic distress.

The 8-item Patient Health Questionnaire (PHQ-8) depression scale assesses how often participants have been bothered with symptoms of depression over the past two weeks on a 0 (not at all) to 3 (nearly everyday) scale, with higher scores indicating greater depressive symptomatology.

The 4-item PROMIS Depression measure assesses how often participants felt various symptoms of depression in the past 7 days on a 1 (never) to 5 (always) scale, with higher scores indicating greater depression severity.

The 4-item PROMIS Fatigue measure assesses how often participants felt various symptoms of fatigue in the past 7 days on a 1 (not at all) to 5 (very much) scale, with higher scores indicating greater fatigue severity.

The 4-item PROMIS Sleep Disturbance measure assesses how often participants experienced aspects of sleep disturbance in the past 7 days on a 1 (not at all) to 5 (very much) scale, with higher scores indicating greater sleep disturbance.

The 28-item Brief COPE assesses how often participants have been utilizing a series of coping strategies since their cancer diagnosis on a 1 (I haven't been doing this at all) to 4 (I have been doing this a lot) scale, with higher scores indicating greater use of the coping strategy.

The 10-item PROMIS Global Health measure assesses mental and physical health. The first nine items are on a 1 (poor or not at all) to 5 (excellent or completely) scale. The tenth item assesses average pain on a 0 (no pain) to 10 (worst pain imaginable) scale and is reverse scored. Higher scores are indicative of better global health.

National Cancer Institute (NCI)

Indiana University Health

Eskenazi Health

Indiana University

Associate Professor of Medicine, Research Scientist

Remission, Spontaneous

Neoplasm Regression, Spontaneous

Disease Progression

Neoplastic Processes

6 weeks, the ACT group will meet weekly for 2 hours at one of three facilities.

6 weeks, SE group will meet weekly for 2 hours at one of three facilities.

Continue to meet with their health care team + receive a variety of readings at each data collection point on coping with common survivorship concerns, including a booklet from the National Cancer Institute entitled "Facing Forward: Life After Cancer Treatment."

Acceptance and Commitment Therapy

6-week survivorship education group (SE; n=32)

Survivorship Education

Fear of cancer recurrence (FCR) is one of the most prevalent, persistent, and disruptive sources of distress for adult cancer survivors. Prevalence rates for FCR have been estimated at up to 89%, with approximately half of cancer survivors reporting clinically significant levels of FCR. Despite the recognized prevalence, persistence, and suffering associated with FCR, effective and accessible treatments for FCR are lacking and urgently needed. Our long-term goal is to develop, evaluate, and implement effective behavioral interventions for cancer survivors suffering with FCR.

The proposed randomized pilot study will assess the effects of a novel therapeutic intervention-Acceptance and Commitment Therapy (ACT)-for breast cancer survivors (BCS) with clinically-significant FCR. ACT is a spiritually-sensitive behavioral therapy that has shown efficacy in the treatment of anxiety in non-cancer populations, and preliminary efficacy in improving a variety of outcomes among adults with cancer. ACT uses mindfulness and acceptance processes, along with committed behavior change in service of an individual's deeply held values to enhance psychological flexibility and encourage adaptive coping with life challenges, such as cancer.

The primary objective of the proposed 3-arm randomized controlled pilot trial is to assess the feasibility/acceptability and determine preliminary effect size estimates of ACT in preparation for a fully-powered efficacy trial. To allow for potential drop out (15% attrition) and ensure we have a minimum of 78 completers through the end of the trial, we will enroll approximately 91 BCS with clinically significant FCR (defined by score ≥ 13 on Fears of Cancer Recurrence Inventory-Short Form). Participants will be randomized to one of three groups: (1) a 6-week ACT intervention group (n=26); (2) a 6-week survivorship education group (SE; n=26); or (3) enhanced usual care (EUC; n=26). The impact of ACT, SE, and EUC on survivors' FCR and associated psychological, spiritual, and biological (telomere length) outcomes will be examined at baseline (T1), post-intervention (T2), and at 1-month (T3) and 6-month follow-up (T4) with the following specific aims:

Aim 1: Evaluate feasibility and acceptability of ACT, SE, and EUC according to the:

1. Percentage of eligible BCS who consent to participate in the trial;
2. Attendance rate across 6 sessions of ACT and SE;
3. Retention rate through T4 in the ACT, SE, and EUC arms;
4. Mean ratings across groups for intervention satisfaction and helpfulness for managing FCR.

Aim 2: Determine pairwise effect size estimates of ACT, SE, and EUC effects at each time point (T2, T3, T4) adjusted for T1 on the:

1. Primary outcome: reducing FCR;
2. Secondary psychological outcomes: cancer-related experiential avoidance, cognitive avoidance, anxiety, depression, post-traumatic stress symptoms, vitality, breast cancer self-efficacy, and quality of life;
3. Secondary spiritual outcomes: spiritual well-being and mindfulness;
4. Secondary biological outcome: telomere length.

Participants were blinded to study hypotheses.

Investigation of Three Approaches to Address Fear of Recurrence Among Breast Cancer Survivors

Investigation of Three Approaches to Address Fear of Recurrence Among Breast Cancer Survivors: A Randomized Clinical Pilot Trial

As measured by Fear of Cancer Recurrence Inventory (FCRI)

As measured by Concerns about Recurrence Scale (CARS)

As measured by Acceptance \& Action Questionnaire-Cancer

As measured by Generalized Anxiety Disorder Scale (GAD-7)

As measured by Patient Health Questionnaire Depression Scale (PHQ-8)

As measured by Impact of Events Scale-Revised (IES-R)

As measured by Short Form(SF)-36 Vitality Scale

As measured by Breast Cancer Self-Efficacy Scale

As measured by PROMIS Global Health Scale

As measured by Functional Assessment of Chronic Illness Therapy- Spiritual Well-being (FACIT-Sp) scale

As measured by Five Facet Mindfulness Questionnaire-Short Form

As measured by quantitative telomere length.

As measured by a 5-item investigator-created measure of intervention satisfaction and helpfulness

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Facilitating Adaptive Coping With Fear of Recurrence Among Breast Cancer Survivors	NCT05364450	Breast Neoplasm Breast Cancer Breast Carcinom... Malignant Neopl... Cancer of Breas... Mammary Neoplas... Human Mammary C... Malignant Tumor... Mammary Cancer Mammary Carcino... Anxiety Fear	Enhanced Usual ... Acceptance Comm... Cognitive Behav...	18 Years - 99 Years	Indiana University
Facilitating Adaptive Coping With Fear of Recurrence Among Breast Cancer Survivors	NCT05364450	Breast Neoplasm Breast Cancer Breast Carcinom... Malignant Neopl... Cancer of Breas... Mammary Neoplas... Human Mammary C... Malignant Tumor... Mammary Cancer Mammary Carcino... Anxiety Fear	Enhanced Usual ... Acceptance Comm... Cognitive Behav...	18 Years - 99 Years	Indiana University
Facilitating Adaptive Coping With Fear of Recurrence Among Breast Cancer Survivors	NCT05364450	Breast Neoplasm Breast Cancer Breast Carcinom... Malignant Neopl... Cancer of Breas... Mammary Neoplas... Human Mammary C... Malignant Tumor... Mammary Cancer Mammary Carcino... Anxiety Fear	Enhanced Usual ... Acceptance Comm... Cognitive Behav...	18 Years - 99 Years	Indiana University
Investigation of Three Approaches to Address Fear of Recurrence Among Breast Cancer Survivors	NCT02611544	Breast Neoplasm... Breast Cancer Breast Carcinom... Malignant Neopl... Cancer of Breas... Mammary Neoplas... Human Mammary C... Malignant Tumor... Mammary Cancer Mammary Carcino... Anxiety Fear Neoplasm Remiss... Spontaneous Neo... Regression, Spo... Remission, Spon... Spontaneous Neo...	Acceptance and ... Survivorship Ed... Enhanced Usual ...	18 Years - 99 Years	Indiana University
Investigation of Three Approaches to Address Fear of Recurrence Among Breast Cancer Survivors	NCT02611544	Breast Neoplasm... Breast Cancer Breast Carcinom... Malignant Neopl... Cancer of Breas... Mammary Neoplas... Human Mammary C... Malignant Tumor... Mammary Cancer Mammary Carcino... Anxiety Fear Neoplasm Remiss... Spontaneous Neo... Regression, Spo... Remission, Spon... Spontaneous Neo...	Acceptance and ... Survivorship Ed... Enhanced Usual ...	18 Years - 99 Years	Indiana University

Spots Global Cancer Trial Database for breast cancer remission