AzTrials
AzTrials

Breast NeoplasmsNCT02611544

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

A study testing Acceptance and Commitment Therapy and Survivorship Education in people with Breast Neoplasms and Breast Cancer, run by Indiana University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 99 years, women only
Conditions the study is for
Breast Neoplasms, Breast Cancer, Breast Carcinoma
What is being tested?
Acceptance and Commitment Therapy and Survivorship Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
91 participants
Where
1 siteUnited States
Study dates
Dec 2015to 1 Dec 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Indiana University

    Indianapolis, Indiana, 46202

Other trials in United States

About this study

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

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.

Read the detailed 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.
Being tested
Acceptance and Commitment Therapy, Survivorship Education, Enhanced Usual Care
Keywords
Fear of Cancer Recurrence, Fear of Cancer Return, Breast Cancer Survivor, Breast Cancer Remission
Medical subject headings
Breast Neoplasms, Anxiety Disorders, Neoplasm Regression, Spontaneous

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acceptance and Commitment TherapyBehavioural

    Also called ACT

    6-week ACT intervention group (n=33)

  • Survivorship EducationBehavioural

    Also called SE

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

  • Enhanced Usual CareBehavioural

    Also called EUC

    enhanced usual care (EUC; n=26)

Study groups in NCT02611544
Study groupRoleWhat they receive
Acceptance and Commitment TherapyActive comparator6 weeks, the ACT group will meet weekly for 2 hours at one of three facilities.
Receives: Behavioral: Acceptance and Commitment Therapy
Survivorship EducationActive comparator6 weeks, SE group will meet weekly for 2 hours at one of three facilities.
Receives: Behavioral: Survivorship Education
Enhanced Usual CareActive comparatorContinue 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."
Receives: Behavioral: Enhanced Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)

Secondary outcomes (12)

  1. 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)

    Measured: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)

  2. 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

    Measured: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)

  3. 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)

    Measured: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)

  4. 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)

    Measured: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)

  5. 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)

    Measured: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)

  6. 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

    Measured: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)

  7. 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

    Measured: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)

  8. 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

    Measured: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)

  9. 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

    Measured: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)

  10. 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

    Measured: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)

  11. 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.

    Measured: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)

  12. 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

    Measured: post-intervention/6-weeks (T2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2015 (estimated)
  2. Study startDec 2015
  3. Primary completion1 Dec 2016
  4. Study completion1 Dec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
91 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02611544
Sponsor's protocol ID
IUSCC-0563
Status last verified
Jun 2019
First submitted
16 Nov 2015
Last updated
26 Jun 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Simard S, Thewes B, Humphris G, Dixon M, Hayden C, Mireskandari S, Ozakinci G. Fear of cancer recurrence in adult cancer survivors: a systematic review of quantitative studies. J Cancer Surviv. 2013 Sep;7(3):300-22. doi: 10.1007/s11764-013-0272-z. Epub 2013 Mar 10.

    PubMed 23475398

  • Koch L, Jansen L, Brenner H, Arndt V. Fear of recurrence and disease progression in long-term (>/= 5 years) cancer survivors--a systematic review of quantitative studies. Psychooncology. 2013 Jan;22(1):1-11. doi: 10.1002/pon.3022. Epub 2012 Jan 10.

    PubMed 22232030

  • Vickberg SM. The Concerns About Recurrence Scale (CARS): a systematic measure of women's fears about the possibility of breast cancer recurrence. Ann Behav Med. 2003 Winter;25(1):16-24. doi: 10.1207/S15324796ABM2501_03.

    PubMed 12581932

  • Needham BL, Mezuk B, Bareis N, Lin J, Blackburn EH, Epel ES. Depression, anxiety and telomere length in young adults: evidence from the National Health and Nutrition Examination Survey. Mol Psychiatry. 2015 Apr;20(4):520-8. doi: 10.1038/mp.2014.89. Epub 2014 Sep 2.

    PubMed 25178165

  • Duggan C, Risques R, Alfano C, Prunkard D, Imayama I, Holte S, Baumgartner K, Baumgartner R, Bernstein L, Ballard-Barbash R, Rabinovitch P, McTiernan A. Change in peripheral blood leukocyte telomere length and mortality in breast cancer survivors. J Natl Cancer Inst. 2014 Apr;106(4):dju035. doi: 10.1093/jnci/dju035. Epub 2014 Mar 13.

    PubMed 24627273

  • Lengacher CA, Johnson-Mallard V, Post-White J, Moscoso MS, Jacobsen PB, Klein TW, Widen RH, Fitzgerald SG, Shelton MM, Barta M, Goodman M, Cox CE, Kip KE. Randomized controlled trial of mindfulness-based stress reduction (MBSR) for survivors of breast cancer. Psychooncology. 2009 Dec;18(12):1261-72. doi: 10.1002/pon.1529.

    PubMed 19235193

  • Lebel S, Maheu C, Lefebvre M, Secord S, Courbasson C, Singh M, Jolicoeur L, Benea A, Harris C, Fung MF, Rosberger Z, Catton P. Addressing fear of cancer recurrence among women with cancer: a feasibility and preliminary outcome study. J Cancer Surviv. 2014 Sep;8(3):485-96. doi: 10.1007/s11764-014-0357-3. Epub 2014 Apr 23.

    PubMed 24756313

  • Butow PN, Bell ML, Smith AB, Fardell JE, Thewes B, Turner J, Gilchrist J, Beith J, Girgis A, Sharpe L, Shih S, Mihalopoulos C; members of the Conquer Fear Authorship Group. Conquer fear: protocol of a randomised controlled trial of a psychological intervention to reduce fear of cancer recurrence. BMC Cancer. 2013 Apr 23;13:201. doi: 10.1186/1471-2407-13-201.

    PubMed 23617696

  • A-Tjak JG, Davis ML, Morina N, Powers MB, Smits JA, Emmelkamp PM. A meta-analysis of the efficacy of acceptance and commitment therapy for clinically relevant mental and physical health problems. Psychother Psychosom. 2015;84(1):30-6. doi: 10.1159/000365764. Epub 2014 Dec 24.

    PubMed 25547522

  • Feros DL, Lane L, Ciarrochi J, Blackledge JT. Acceptance and Commitment Therapy (ACT) for improving the lives of cancer patients: a preliminary study. Psychooncology. 2013 Feb;22(2):459-64. doi: 10.1002/pon.2083. Epub 2011 Oct 6.

    PubMed 23382134

  • Hulbert-Williams NJ, Storey L, Wilson KG. Psychological interventions for patients with cancer: psychological flexibility and the potential utility of Acceptance and Commitment Therapy. Eur J Cancer Care (Engl). 2015;24(1):15-27. doi: 10.1111/ecc.12223. Epub 2014 Aug 6.

    PubMed 25100576

  • Johns SA, Brown LF, Beck-Coon K, Monahan PO, Tong Y, Kroenke K. Randomized controlled pilot study of mindfulness-based stress reduction for persistently fatigued cancer survivors. Psychooncology. 2015 Aug;24(8):885-93. doi: 10.1002/pon.3648. Epub 2014 Aug 17.

    PubMed 25132206

  • Simard S, Savard J. Fear of Cancer Recurrence Inventory: development and initial validation of a multidimensional measure of fear of cancer recurrence. Support Care Cancer. 2009 Mar;17(3):241-51. doi: 10.1007/s00520-008-0444-y. Epub 2008 Apr 15.

    PubMed 18414902

  • Fischer D, Stewart AL, Bloch DA, Lorig K, Laurent D, Holman H. Capturing the patient's view of change as a clinical outcome measure. JAMA. 1999 Sep 22-29;282(12):1157-62. doi: 10.1001/jama.282.12.1157.

    PubMed 10501119

  • Bond FW, Hayes SC, Baer RA, Carpenter KM, Guenole N, Orcutt HK, Waltz T, Zettle RD. Preliminary psychometric properties of the Acceptance and Action Questionnaire-II: a revised measure of psychological inflexibility and experiential avoidance. Behav Ther. 2011 Dec;42(4):676-88. doi: 10.1016/j.beth.2011.03.007. Epub 2011 May 25.

    PubMed 22035996

Questions about this trial

What is this clinical trial studying?

A study testing Acceptance and Commitment Therapy and Survivorship Education in people with Breast Neoplasms and Breast Cancer, run by Indiana University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). (time frame: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02611544, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in