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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02611544
• Other study ID #: IUSCC-0563
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: December 1, 2016

Study information

• Verified date: June 2019
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: December 1, 2016
• Est. primary completion date: December 1, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria: Participants in this study will be eligible if they are:

1. =18 years old,

2. have been diagnosed with non-metastatic breast cancer (stages I-III),

3. have completed curative treatment for breast cancer,

4. have not experienced a cancer recurrence, and

5. report a clinically significant level of FCR (Fear of Cancer Recurrence Inventory-Short Form score of = 13)

Exclusion Criteria: Participants in this study will be ineligible if they are:

1. severe depression (PHQ-8 score of = 20),

2. past participation in ACT or formal mindfulness training, and

3. limited English proficiency.

Related Conditions & MeSH terms

• Anxiety
• Breast Cancer
• Breast Carcinoma
• Breast Neoplasms
• Cancer of Breast
• Carcinoma
• Fear
• Human Mammary Carcinoma
• Malignant Neoplasm of Breast
• Malignant Tumor of Breast
• Mammary Cancer
• Mammary Carcinoma
• Mammary Neoplasm, Human
• Neoplasm Regression, Spontaneous
• Neoplasm Remission, Spontaneous
• Neoplasms
• Recurrence
• Regression, Spontaneous Neoplasm
• Remission, Spontaneous Neoplasm
• Spontaneous Neoplasm Regression
• Spontaneous Neoplasm Remission

Intervention

Behavioral:
• Acceptance and Commitment Therapy
6-week ACT intervention group (n=33)
• Survivorship Education
6-week survivorship education group (SE; n=32)
• Enhanced Usual Care
enhanced usual care (EUC; n=26)

Locations

Country	Name	City	State
United States	Indiana University	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Indiana University Health

Country where clinical trial is conducted

United States, 

References & Publications (23)

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* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in fear of recurrence (FCR) at Post-Intervention, 1-month, and 6-month follow-up as assessed by Fear of Cancer Recurrence Inventory (FCRI).	As measured by Fear of Cancer Recurrence Inventory (FCRI)	Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)
Secondary	Change from baseline in fear of recurrence (FCR) at Post-Intervention, 1-month, and 6-month follow-up as assessed by Concerns about Recurrence Scale (CARS).	As measured by Concerns about Recurrence Scale (CARS)	Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)
Secondary	Change from baseline in cancer-related avoidant coping at Post-Intervention, 1-month, and 6-month follow-up as assessed by Acceptance & Action Questionnaire-Cancer	As measured by Acceptance & Action Questionnaire-Cancer	Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)
Secondary	Change from baseline in anxiety at Post-Intervention, 1-month, and 6-month follow-up as assessed Generalized Anxiety Disorder Scale (GAD-7).	As measured by Generalized Anxiety Disorder Scale (GAD-7)	Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)
Secondary	Change from baseline in depression at Post-Intervention, 1-month, and 6-month follow-up as assessed by as measured by Patient Health Questionnaire Depression Scale (PHQ-8).	As measured by Patient Health Questionnaire Depression Scale (PHQ-8)	Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)
Secondary	Change from baseline in post-traumatic stress symptoms at Post-Intervention, 1-month, and 6-month follow-up as assessed by Impact of Events Scale-Revised (IES-R).	As measured by Impact of Events Scale-Revised (IES-R)	Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)
Secondary	Change from baseline in vitality at Post-Intervention, 1-month, and 6-month follow-up as assessed by Short Form(SF)-36 Vitality Scale.	As measured by Short Form(SF)-36 Vitality Scale	Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)
Secondary	Change from baseline in Breast Cancer Self-Efficacy at Post-Intervention, 1-month, and 6-month follow-up as assessed by Breast Cancer Self-Efficacy Scale	As measured by Breast Cancer Self-Efficacy Scale	Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)
Secondary	Change from baseline in quality of life at Post-Intervention, 1-month, and 6-month follow-up as assessed by 10-item PROMIS Global Health Scale	As measured by PROMIS Global Health Scale	Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)
Secondary	Change from baseline in spiritual well-being at Post-Intervention, 1-month, and 6-month follow-up as assessed by Functional Assessment of Chronic Illness Therapy-Spiritual Well-being (FACIT-Sp) scale	As measured by Functional Assessment of Chronic Illness Therapy- Spiritual Well-being (FACIT-Sp) scale	Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)
Secondary	Change from baseline in mindfulness at Post-Intervention, 1-month, and 6-month follow-up as assessed by Five Facet Mindfulness Questionnaire-Short Form	As measured by Five Facet Mindfulness Questionnaire-Short Form	Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)
Secondary	Change from baseline in telomere length at Post-Intervention, 1-month, and 6-month follow-up as assessed by quantitative telomere length.	As measured by quantitative telomere length.	Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)
Secondary	Intervention ratings for satisfaction and helpfulness at Post-Intervention as assessed by a 5-item investigator-created measure.	As measured by a 5-item investigator-created measure of intervention satisfaction and helpfulness	post-intervention/6-weeks (T2)