Randomized trial of ConquerFear

A novel, theoretically based psychosocial intervention for fear of cancer recurrence

Phyllis N. Butow, Jane Turner, Jemma Gilchrist, Louise Sharpe, Allan Ben Smith, Joanna E. Fardell, Stephanie Tesson, Rachel O'Connell, Afaf Girgis, Val J. Gebski, Rebecca Asher, Cathrine Mihalopoulos, Melanie L Bell, Karina Grunewald Zola, Jane Beith, Belinda Thewes

Research output: Contribution to journalArticle

30 Citations (Scopus)

Abstract

Purpose: Fear of cancer recurrence (FCR) is prevalent, distressing, and long lasting. This study evaluated the impact of a theoretically/empirically based intervention (ConquerFear) on FCR. Methods: Eligible survivors had curable breast or colorectal cancer or melanoma, had completed treatment (not including endocrine therapy) 2 months to 5 years previously, were age > 18 years, and had scores above the clinical cutoff on the FCR Inventory (FCRI) severity subscale at screening. Participants were randomly assigned at a one-to-one ratio to either five face-to-face sessions of ConquerFear (attention training, metacognitions, acceptance/mindfulness, screening behavior, and values-based goal setting) or an attention control (Taking-it-Easy relaxation therapy). Participants completed questionnaires at baseline (T0), immediately post-therapy (T1), and 3 (T2) and 6 months (T3) later. The primary outcome was FCRI total score. Results: Of 704 potentially eligible survivors from 17 sites and two online databases, 533 were contactable, of whom 222 (42%) consented; 121 were randomly assigned to intervention and 101 to control. Study arms were equivalent at baseline on all measured characteristics. ConquerFear participants had clinically and statistically greater improvements than control participants from T0 to T1 on FCRI total (P <.001) and severity subscale scores (P =.001), which were maintained at T2 (P =.017 and P =.023, respectively) and, for FCRI total only, at T3 (P =.018), and from T0 to T1 on three FCRI subscales (coping, psychological distress, and triggers) as well as in general anxiety, cancer-specific distress (total), and mental quality of life and metacognitions (total). Differences in FCRI psychological distress and cancer-specific distress (total) remained significantly different at T3. Conclusion: This randomized trial demonstrated efficacy of ConquerFear compared with attention control (Taking-it-Easy) in reduction of FCRI total scores immediately post-therapy and 3 and 6 months later and in many secondary outcomes immediately post-therapy. Cancer-specific distress (total) remained more improved at 3- and 6-month follow-up.

Original languageEnglish (US)
Pages (from-to)4066-4077
Number of pages12
JournalJournal of Clinical Oncology
Volume35
Issue number36
DOIs
StatePublished - Dec 20 2017
Externally publishedYes

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Fear
Recurrence
Equipment and Supplies
Neoplasms
Survivors
Psychology
Relaxation Therapy
Mindfulness
Therapeutics
Colorectal Neoplasms
Melanoma
Anxiety
Quality of Life
Databases
Breast Neoplasms

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Butow, P. N., Turner, J., Gilchrist, J., Sharpe, L., Smith, A. B., Fardell, J. E., ... Thewes, B. (2017). Randomized trial of ConquerFear: A novel, theoretically based psychosocial intervention for fear of cancer recurrence. Journal of Clinical Oncology, 35(36), 4066-4077. https://doi.org/10.1200/JCO.2017.73.1257

Randomized trial of ConquerFear : A novel, theoretically based psychosocial intervention for fear of cancer recurrence. / Butow, Phyllis N.; Turner, Jane; Gilchrist, Jemma; Sharpe, Louise; Smith, Allan Ben; Fardell, Joanna E.; Tesson, Stephanie; O'Connell, Rachel; Girgis, Afaf; Gebski, Val J.; Asher, Rebecca; Mihalopoulos, Cathrine; Bell, Melanie L; Zola, Karina Grunewald; Beith, Jane; Thewes, Belinda.

In: Journal of Clinical Oncology, Vol. 35, No. 36, 20.12.2017, p. 4066-4077.

Research output: Contribution to journalArticle

Butow, PN, Turner, J, Gilchrist, J, Sharpe, L, Smith, AB, Fardell, JE, Tesson, S, O'Connell, R, Girgis, A, Gebski, VJ, Asher, R, Mihalopoulos, C, Bell, ML, Zola, KG, Beith, J & Thewes, B 2017, 'Randomized trial of ConquerFear: A novel, theoretically based psychosocial intervention for fear of cancer recurrence', Journal of Clinical Oncology, vol. 35, no. 36, pp. 4066-4077. https://doi.org/10.1200/JCO.2017.73.1257
Butow, Phyllis N. ; Turner, Jane ; Gilchrist, Jemma ; Sharpe, Louise ; Smith, Allan Ben ; Fardell, Joanna E. ; Tesson, Stephanie ; O'Connell, Rachel ; Girgis, Afaf ; Gebski, Val J. ; Asher, Rebecca ; Mihalopoulos, Cathrine ; Bell, Melanie L ; Zola, Karina Grunewald ; Beith, Jane ; Thewes, Belinda. / Randomized trial of ConquerFear : A novel, theoretically based psychosocial intervention for fear of cancer recurrence. In: Journal of Clinical Oncology. 2017 ; Vol. 35, No. 36. pp. 4066-4077.
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abstract = "Purpose: Fear of cancer recurrence (FCR) is prevalent, distressing, and long lasting. This study evaluated the impact of a theoretically/empirically based intervention (ConquerFear) on FCR. Methods: Eligible survivors had curable breast or colorectal cancer or melanoma, had completed treatment (not including endocrine therapy) 2 months to 5 years previously, were age > 18 years, and had scores above the clinical cutoff on the FCR Inventory (FCRI) severity subscale at screening. Participants were randomly assigned at a one-to-one ratio to either five face-to-face sessions of ConquerFear (attention training, metacognitions, acceptance/mindfulness, screening behavior, and values-based goal setting) or an attention control (Taking-it-Easy relaxation therapy). Participants completed questionnaires at baseline (T0), immediately post-therapy (T1), and 3 (T2) and 6 months (T3) later. The primary outcome was FCRI total score. Results: Of 704 potentially eligible survivors from 17 sites and two online databases, 533 were contactable, of whom 222 (42{\%}) consented; 121 were randomly assigned to intervention and 101 to control. Study arms were equivalent at baseline on all measured characteristics. ConquerFear participants had clinically and statistically greater improvements than control participants from T0 to T1 on FCRI total (P <.001) and severity subscale scores (P =.001), which were maintained at T2 (P =.017 and P =.023, respectively) and, for FCRI total only, at T3 (P =.018), and from T0 to T1 on three FCRI subscales (coping, psychological distress, and triggers) as well as in general anxiety, cancer-specific distress (total), and mental quality of life and metacognitions (total). Differences in FCRI psychological distress and cancer-specific distress (total) remained significantly different at T3. Conclusion: This randomized trial demonstrated efficacy of ConquerFear compared with attention control (Taking-it-Easy) in reduction of FCRI total scores immediately post-therapy and 3 and 6 months later and in many secondary outcomes immediately post-therapy. Cancer-specific distress (total) remained more improved at 3- and 6-month follow-up.",
author = "Butow, {Phyllis N.} and Jane Turner and Jemma Gilchrist and Louise Sharpe and Smith, {Allan Ben} and Fardell, {Joanna E.} and Stephanie Tesson and Rachel O'Connell and Afaf Girgis and Gebski, {Val J.} and Rebecca Asher and Cathrine Mihalopoulos and Bell, {Melanie L} and Zola, {Karina Grunewald} and Jane Beith and Belinda Thewes",
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T2 - A novel, theoretically based psychosocial intervention for fear of cancer recurrence

AU - Butow, Phyllis N.

AU - Turner, Jane

AU - Gilchrist, Jemma

AU - Sharpe, Louise

AU - Smith, Allan Ben

AU - Fardell, Joanna E.

AU - Tesson, Stephanie

AU - O'Connell, Rachel

AU - Girgis, Afaf

AU - Gebski, Val J.

AU - Asher, Rebecca

AU - Mihalopoulos, Cathrine

AU - Bell, Melanie L

AU - Zola, Karina Grunewald

AU - Beith, Jane

AU - Thewes, Belinda

PY - 2017/12/20

Y1 - 2017/12/20

N2 - Purpose: Fear of cancer recurrence (FCR) is prevalent, distressing, and long lasting. This study evaluated the impact of a theoretically/empirically based intervention (ConquerFear) on FCR. Methods: Eligible survivors had curable breast or colorectal cancer or melanoma, had completed treatment (not including endocrine therapy) 2 months to 5 years previously, were age > 18 years, and had scores above the clinical cutoff on the FCR Inventory (FCRI) severity subscale at screening. Participants were randomly assigned at a one-to-one ratio to either five face-to-face sessions of ConquerFear (attention training, metacognitions, acceptance/mindfulness, screening behavior, and values-based goal setting) or an attention control (Taking-it-Easy relaxation therapy). Participants completed questionnaires at baseline (T0), immediately post-therapy (T1), and 3 (T2) and 6 months (T3) later. The primary outcome was FCRI total score. Results: Of 704 potentially eligible survivors from 17 sites and two online databases, 533 were contactable, of whom 222 (42%) consented; 121 were randomly assigned to intervention and 101 to control. Study arms were equivalent at baseline on all measured characteristics. ConquerFear participants had clinically and statistically greater improvements than control participants from T0 to T1 on FCRI total (P <.001) and severity subscale scores (P =.001), which were maintained at T2 (P =.017 and P =.023, respectively) and, for FCRI total only, at T3 (P =.018), and from T0 to T1 on three FCRI subscales (coping, psychological distress, and triggers) as well as in general anxiety, cancer-specific distress (total), and mental quality of life and metacognitions (total). Differences in FCRI psychological distress and cancer-specific distress (total) remained significantly different at T3. Conclusion: This randomized trial demonstrated efficacy of ConquerFear compared with attention control (Taking-it-Easy) in reduction of FCRI total scores immediately post-therapy and 3 and 6 months later and in many secondary outcomes immediately post-therapy. Cancer-specific distress (total) remained more improved at 3- and 6-month follow-up.

AB - Purpose: Fear of cancer recurrence (FCR) is prevalent, distressing, and long lasting. This study evaluated the impact of a theoretically/empirically based intervention (ConquerFear) on FCR. Methods: Eligible survivors had curable breast or colorectal cancer or melanoma, had completed treatment (not including endocrine therapy) 2 months to 5 years previously, were age > 18 years, and had scores above the clinical cutoff on the FCR Inventory (FCRI) severity subscale at screening. Participants were randomly assigned at a one-to-one ratio to either five face-to-face sessions of ConquerFear (attention training, metacognitions, acceptance/mindfulness, screening behavior, and values-based goal setting) or an attention control (Taking-it-Easy relaxation therapy). Participants completed questionnaires at baseline (T0), immediately post-therapy (T1), and 3 (T2) and 6 months (T3) later. The primary outcome was FCRI total score. Results: Of 704 potentially eligible survivors from 17 sites and two online databases, 533 were contactable, of whom 222 (42%) consented; 121 were randomly assigned to intervention and 101 to control. Study arms were equivalent at baseline on all measured characteristics. ConquerFear participants had clinically and statistically greater improvements than control participants from T0 to T1 on FCRI total (P <.001) and severity subscale scores (P =.001), which were maintained at T2 (P =.017 and P =.023, respectively) and, for FCRI total only, at T3 (P =.018), and from T0 to T1 on three FCRI subscales (coping, psychological distress, and triggers) as well as in general anxiety, cancer-specific distress (total), and mental quality of life and metacognitions (total). Differences in FCRI psychological distress and cancer-specific distress (total) remained significantly different at T3. Conclusion: This randomized trial demonstrated efficacy of ConquerFear compared with attention control (Taking-it-Easy) in reduction of FCRI total scores immediately post-therapy and 3 and 6 months later and in many secondary outcomes immediately post-therapy. Cancer-specific distress (total) remained more improved at 3- and 6-month follow-up.

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