Investigation of Three Approaches to Address Fear of Recurrence Among Breast Cancer Survivors
NCT ID: NCT02611544
Last Updated: 2019-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
91 participants
INTERVENTIONAL
2015-12-31
2016-12-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Acceptance and Commitment Therapy
6 weeks, the ACT group will meet weekly for 2 hours at one of three facilities.
Acceptance and Commitment Therapy
6-week ACT intervention group (n=33)
Survivorship Education
6 weeks, SE group will meet weekly for 2 hours at one of three facilities.
Survivorship Education
6-week survivorship education group (SE; n=32)
Enhanced Usual Care
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."
Enhanced Usual Care
enhanced usual care (EUC; n=26)
Interventions
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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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
2. past participation in ACT or formal mindfulness training, and
3. limited English proficiency.
18 Years
99 Years
FEMALE
No
Sponsors
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Indiana University Health
OTHER
Indiana University
OTHER
Responsible Party
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Shelley Johns
Assistant Professor of Medicine, Research Scientist
Principal Investigators
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Shelley A Johns, PsyD
Role: PRINCIPAL_INVESTIGATOR
Indiana University School of Medicine; Regenstrief Institute, Inc.
Locations
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Indiana University
Indianapolis, Indiana, United States
Countries
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References
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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.
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.
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.
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Other Identifiers
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IUSCC-0563
Identifier Type: -
Identifier Source: org_study_id
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