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Cited by 6Cancer survivorship and careMindfulness and Compassion InterventionsCancer-related cognitive impairment studies

Protocol of a randomized trial of acceptance and commitment therapy for fatigue interference in metastatic breast cancer

Open access
Mosher, Catherine E., Krueger, Ellen, Hirsh, Adam T., Miller, Kathy D., Ballinger, Tarah J., Storniolo, Anna Maria, Schneider, Bryan P., Newton, Erin V. +2 more·2020·Contemporary Clinical Trials
DOI 10.1016/j.cct.2020.106168PMC PMC7686157
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Abstract

Fatigue interference with activities, mood, and cognition is one of the most prevalent and distressing concerns of metastatic breast cancer patients. To date, there are no evidence-based interventions for reducing fatigue interference in metastatic breast cancer and other advanced cancer populations. In pilot studies, Acceptance and Commitment Therapy (ACT) has shown potential for reducing symptom-related suffering in cancer patients. The current Phase II trial seeks to more definitively examine the efficacy of telephone-based ACT for women with metastatic breast cancer who are experiencing fatigue interference. In this trial, 250 women are randomly assigned to either the ACT intervention or an education/support control condition. Women in both conditions attend six weekly 50-min telephone sessions. The primary aim of this study is to test the effect of telephone-based ACT on fatigue interference. Secondary outcomes include sleep interference, engagement in daily activities, and quality of life. Outcomes are assessed at baseline, 2 weeks post-intervention, and 3 and 6 months post-intervention. This trial also examines whether increases in psychological flexibility, defined as full awareness of the present moment while persisting in behaviors aligned with personal values, account for the beneficial effect of ACT on fatigue interference. After demonstrating ACT's efficacy, the intervention can be widely disseminated to clinicians who care for metastatic breast cancer patients. Our findings will also inform future ACT trials with various cancer populations and functional outcomes. © 2020 Elsevier Inc.

Integrity signals

Registry

Crossref · 10.1016/j.cct.2020.106168

Cites

69 of 69 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Claims the paper makes

23 of 61 cited sources checked · 9 supported · 0 flagged · accuracy not yet measured

  • Findingcitation

    In the authors' pilot study, the effect of study condition on fatigue interference at 1 month post-intervention was moderate (d = −.30).

    “In our pilot study, we found a moderate effect (d = −.30) of study condition on fatigue interference at 1 month post-intervention [23].”
    Quote in the paperSubstantial claim1 of 1 sources checked
    • cites [23] source

      The Results (Preliminary Efficacy; page unavailable) report small-to-moderate decreases in fatigue interference within the ACT group at the 8- and 12-week follow-ups (d range −.23 to −.31). They do not report d = −.30 as an effect of study condition at one month post-intervention; the mixed-effects analysis found no main effect of study group on fatigue interference. (LLM, conf=0.87)

      Experimental — accuracy not yet measured
  • Findingown data

    In the authors' pilot trial, the retention rate was 83% (39/47) at 8 weeks post-intervention.

    “and the retention rate (83% [39/47] at 8 weeks post-intervention).”
    Quote in the paperSubstantial claim1 of 1 sources checked
    • cites [23] source

      The Results (Feasibility) report that 83% (39/47) completed the 8-week follow-up. The Abstract (Results) specifies that this was 8 weeks post-baseline, not 8 weeks post-intervention, so the claim misstates the timing. (LLM, conf=0.88)

      Experimental — accuracy not yet measured
  • Findingown data

    In the authors' pilot trial, 64% of reached patients agreed to be screened.

    “Feasibility was demonstrated by the eligibility screening rate (64% of reached patients agreed to be screened)”
    Quote in the paperSubstantial claim1 of 1 sources checked
  • Premisecitation

    Evidence-based interventions for managing fatigue in metastatic breast cancer and other advanced cancer populations are lacking.

    “Evidence-based interventions for managing fatigue in MBC and other advanced cancer populations are lacking [7–9].”
    Quote in the paperSubstantial claim1 of 3 sources checked
    • cites [7] source

      The Authors’ conclusions (Implications for practice; page unavailable) say evidence is too weak to support a specific drug for fatigue in palliative care patients, including those with cancer. The review addresses pharmacological treatments, not interventions generally, and does not establish the claim specifically for metastatic breast cancer. (LLM, conf=0.86)

      Experimental — accuracy not yet measured
    • cites [8] source
    • cites [9] source
  • Premisecitation

    Fatigue interference with activities, mood, and cognition is a highly prevalent and distressing problem for patients with metastatic breast cancer.

    “Fatigue interference with activities, mood, and cognition is one of the most prevalent and distressing concerns of metastatic breast cancer patients.”
    Quote in the paperSubstantial claim2 of 3 sources checked
    • cites [1] source
    • cites [2] source

      The Description of the sample reports that 63% of women had elevated fatigue symptoms, supporting the claim that fatigue was highly prevalent. The paper reports physical, emotional and cognitive functioning separately, but does not establish that fatigue interfered with activities, mood or cognition, or rank that interference among the most distressing concerns. Page numbers were not available in our copy. (LLM, conf=0.87)

      Experimental — accuracy not yet measured
    • cites [3] source

      The Abstract reports that fatigue was a top-ranked concern among patients with advanced cancer, including breast cancer, and says it can affect physical, emotional, and cognitive function. The Results associate fatigue with difficulty enjoying usual activities. But the study included stage III and IV patients and did not establish that interference with activities, mood, and cognition specifically was highly prevalent or ranked among the most distressing concerns in metastatic breast cancer patients. (LLM, conf=0.84)

      Experimental — accuracy not yet measured
  • May combine two claims. 13
  • Classified as probably not a substantial claim. 15

  • May combine two claims.

    Premisecitation

    Fatigue often co-occurs with sleep disturbance, cognitive concerns, anxiety, and depressive symptoms, and this co-occurrence impairs daily activities.

    “Fatigue frequently co-occurs with a number of symptoms, such as sleep disturbance, cognitive concerns, anxiety, and depressive symptoms [4, 5], resulting in impaired daily activities [1, 5, 6].”
    Quote in the paperNot a substantial claim3 of 4 sources checked
    • cites [4] source

      The Discussion (page unavailable) says fatigue, sleep problems, and psychological symptoms tended to co-occur in patients with metastatic breast cancer. The Results (page unavailable) link fatigue and poorer sleep quality with worse functional status. The paper does not address cognitive concerns or show that symptom co-occurrence causes impaired daily activities. (LLM, conf=0.88)

      Experimental — accuracy not yet measured
    • cites [5] source

      The Background reports that sleep problems are frequently associated with fatigue in metastatic breast cancer patients. The Results (Preliminary and Primary analyses; page numbers unavailable) link higher symptom levels, including the named symptoms, with reduced activity engagement. The paper reports associations rather than showing that their co-occurrence causes daily activity impairment, and it does not establish how frequently all five symptoms co-occur. (LLM, conf=0.84)

      Experimental — accuracy not yet measured
    • cites [1] source
    • cites [6] source

      The Results and Discussion (page numbers unavailable) report that depressive symptoms, particularly negative affect, predicted later disruption of social and recreational activities in women with metastatic breast cancer. The paper does not establish that fatigue co-occurs with sleep disturbance, cognitive concerns, anxiety, and depression, or that this symptom cluster causes the disruption. (LLM, conf=0.86)

      Experimental — accuracy not yet measured

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    More than half of patients with metastatic breast cancer report moderate-to-severe fatigue.

    “Moderate-to-severe fatigue is reported by over 50% of MBC patients [1, 2].”
    Quote in the paperNot a substantial claim1 of 2 sources checked
    • cites [1] source
    • cites [2] source

  • May combine two claims.

    Findingown data

    In the authors' pilot randomized controlled trial, ACT showed strong evidence of feasibility and promise for fatigue and sleep interference with activities, mood, and cognition.

    “ACT showed strong evidence of feasibility and promise with respect to fatigue and sleep interference with activities, mood, and cognition.”
    Quote in the paperSubstantial claim1 of 1 sources checked

  • May combine two claims.

    Premisecitation

    A Cochrane meta-analysis found the evidence for pharmacologic fatigue interventions in advanced cancer and palliative care inconclusive and noted small, heterogeneous samples.

    “A Cochrane meta-analysis of pharmacologic interventions for fatigue in advanced cancer and other palliative care patients characterized the evidence as inconclusive and highlighted the small, heterogeneous samples in many studies [7].”
    Quote in the paperSubstantial claim1 of 1 sources checked

  • May combine two claims.

    Study design and conductown data

    The estimated attrition is based on the authors' feasibility data for telephone-based ACT, use of telephone assessments to maximize compliance, and metastatic breast cancer survival rates.

    “The estimated attrition is based on our promising feasibility data for telephone-based ACT [23], use of telephone assessments to maximize compliance, and MBC survival rates [54].”
    Quote in the paperSubstantial claim1 of 2 sources checked
    • cites [23] source
    • cites [54]

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  • May combine two claims.

    Premisecitation

    The education/support condition was tested in the authors' pilot feasibility trial and is similar to controls in other cancer trials.

    “The education/support condition was tested in our pilot feasibility trial [23] and is similar to controls in other cancer trials [34, 35].”
    Quote in the paperNot a substantial claim2 of 3 sources checked
    • cites [23]

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

    • cites [34] source
    • cites [35] source

      The Method > Procedures section says participants were randomly assigned to education/support or partner-assisted emotional disclosure, so this paper did test the education/support condition. Our copy describes the study as a randomized controlled trial, but does not identify it as a pilot feasibility trial. The comparison with controls in other cancer trials is attributed to different citations and is not judged here. (LLM, conf=0.82)

      Experimental — accuracy not yet measured

  • Classified as probably not a substantial claim.

    Premisecitation

    According to the ACT model, increased psychological flexibility is the primary mechanism underlying the beneficial health effects of ACT.

    “According to the ACT model, increased psychological flexibility is the primary mechanism underlying the beneficial health effects of ACT [15].”
    Quote in the paperSubstantial claim1 of 1 sources checked

  • May combine two claims.

    Premisecitation

    Among five psychotherapy trials for fatigue in metastatic breast cancer, only year-long supportive-expressive group therapy reduced fatigue, and that result was not replicated.

    “Furthermore, of the five psychotherapy trials for MBC patients targeting fatigue [9], only a trial of year-long supportive-expressive group therapy effectively reduced fatigue [10]; importantly, this finding was not replicated by others [11].”
    Quote in the paperSubstantial claim0 of 3 sources checked
    • cites [9] source
    • cites [10] source
    • cites [11] source

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    Intervention assignments are identifiable to patients, interventionists, and staff mailing intervention materials.

    “Following randomization, intervention assignments are identifiable to patients, interventionists, and staff mailing intervention materials.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductreasoning

    Randomly varying block sizes of 2, 4, 6, and 8 are used to maintain allocation concealment and balanced allocation.

    “Randomly varying block sizes of 2, 4, 6, and 8 are used to maintain allocation concealment and assure balanced allocation to study conditions.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductnone given

    The trial is registered at clinicaltrials.gov (NCT03998618) and approved by the Indiana University Institutional Review Board.

    “This trial was registered in clinicaltrials.gov (NCT03998618) and approved by the Indiana University Institutional Review Board.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Study design and conductcitation

    Patients are randomly assigned to ACT or education/support using stratified block randomization, with stratification by age (<65 vs ≥65 years) and performance status (ECOG 0 or 1 vs 2).

    “Following baseline assessments, patients are randomly assigned to ACT or education/support using stratified block randomization to balance the groups by age (<65 yrs. vs. ≥65 yrs.) and performance status (patient-reported ECOG scores 0 or 1 vs. 2 [27]).”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [27] source

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    Other investigators, data monitoring committee members, outcome assessors, and data analysts are blinded throughout the trial.

    “Other investigators, data monitoring committee members, outcome assessors, and data analysts are blinded throughout the trial.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim.

    Study design and conductreasoning

    Different therapists deliver each intervention to prevent cross-contamination between study conditions.

    “Different therapists deliver each intervention to prevent cross-contamination between study conditions.”
    Quote in the paperSubstantial claim
    • Rests on an assumption: Having different therapists deliver each intervention prevents cross-contamination between study conditions.

  • Probably not a substantial claim: may not pass S4 (based).

    Study design and conductnone given

    All study measures have evidence of reliability and validity in cancer patients.

    “All measures have evidence of reliability and validity in cancer patients.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductown data

    Treatment adherence scores are provided and treatment fidelity issues are discussed during regular supervision with therapists.

    “During regular supervision with therapists, treatment adherence scores (number of required topics and exercises covered in each session/total number of fidelity criteria) are provided and treatment fidelity issues are discussed.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim. May combine two claims.

    Study design and conductnone given

    All sessions are digitally recorded, and licensed psychologists and advanced doctoral students randomly select recordings to review for adherence to the manual using checklists.

    “All sessions are digitally recorded, and licensed psychologists and advanced doctoral students in clinical psychology randomly select recordings to review for adherence to the manual using checklists developed in our pilot work.”
    Quote in the paperSubstantial claim

  • Classified as probably not a substantial claim.

    Study design and conductreasoning

    In the analyses for Aims 1 and 2, all randomized participants will be included in intent-to-treat analyses.

    “In the analyses for Aims 1 and 2 described below, all randomized participants will be included in intent-to-treat analyses [50], as the aims are concerned with the impact of the intervention on outcomes regardless of study completion status.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [50] source

  • Classified as probably not a substantial claim.

    Study design and conductnone given

    The Sidak adjustment for correlated multiple outcomes will be used to control the familywise Type I error rate.

    “The Sidak adjustment for correlated multiple outcomes will be used to control the familywise Type I error rate.”
    Quote in the paperSubstantial claim

  • Classified as probably not a substantial claim.

    Study design and conductcitation

    The random effects pattern-mixture model proposed by Hedeker and Gibbons will be used to address missing data.

    “We plan to use the random effects pattern-mixture model proposed by Hedeker and Gibbons [51] to address missing data.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [51] source

  • May combine two claims.

    Premisecitation

    Minimal clinically important differences for metastatic breast cancer and other cancer patients are 2-point differences on FACT-G subscale scores and a 5-point difference on the FACT-G total score, corresponding to .3 to .5 SDs.

    “MCIDs for MBC and other cancer patients are 2-point differences on the FACT-G subscale scores and a 5-point difference on the FACT-G total score, which fall in the range of .3 to .5 SDs [55, 56].”
    Quote in the paperSubstantial claim0 of 2 sources checked
    • cites [55] source
    • cites [56] source

  • Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based). May combine two claims.

    Interpretationnone given

    Use of the telephone for all assessments and the intervention reduces barriers to participation for rural residents and those with low incomes.

    “Use of the telephone for all assessments and the intervention reduces barriers to participation for rural residents and those with low incomes.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim.

    Premisereasoning

    The ACT intervention is designed for patients who can engage in at least moderate levels of activity.

    “Those with an ECOG score above 2 are excluded, as the ACT intervention is designed for those who can engage in at least moderate levels of activity.”
    Quote in the paperSubstantial claim
    • Rests on an assumption: Patients with an ECOG performance status above 2 cannot engage in the ACT intervention because it requires at least moderate activity.
23 of 23

  • The paper relies on this without support.

    Patients with an ECOG performance status above 2 cannot engage in the ACT intervention because it requires at least moderate activity.

    “Those with an ECOG score above 2 are excluded, as the ACT intervention is designed for those who can engage in at least moderate levels of activity.”

  • The paper relies on this without support.

    Minimal clinically important differences for fatigue interference can be determined by anchoring to established MCIDs on the FACT-G.

    “We will use established minimal clinically important differences (MCIDs) on the FACT-G total score and subscale scores as anchors for determining a MCID in fatigue interference.”

  • The paper relies on this without support.

    Having different therapists deliver each intervention prevents cross-contamination between study conditions.

    “Different therapists deliver each intervention to prevent cross-contamination between study conditions.”
3 of 3

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4 of the 73 references couldn’t be matched to a known paper.

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Authors
Mosher, C. E., Krueger, E., Hirsh, A. T., Miller, K. D., Ballinger, T. J., Storniolo, A. M., Schneider, B. P., Newton, E. V., Champion, V. L., & Johns, S. A.
Affiliations
  • Indiana University Indianapolis (US)
  • Indiana University Health (US)
  • Regenstrief Institute (US)
Corresponding author
Mosher, Catherine E.
ORCID
Venue
Contemporary Clinical Trials
Publisher
Elsevier BV
Published
2020-11
Volume
98
Pages
106168
ISSN
1551-7144 (ISSN-L)
DOI
10.1016/j.cct.2020.106168
PMC
PMC7686157
OpenAlex
W3091804211
Semantic Scholar
769170d1efb17d1b3ecb7e6ad1f8d895d6b5237e
Cited by
6
References
73
Citations by year
2026: 2 · 2024: 3 · 2022: 1
FWCI
0.09
Type
journal article
Language
en
Open access
Licence
Locations
  • Contemporary Clinical Trials (publishedVersion)
  • PubMed (publishedVersion)
  • Europe PMC (PubMed Central) (acceptedVersion)
  • PubMed Central (acceptedVersion)
  • IUScholarWorks (Indiana University) (submittedVersion)
  • Author eBooks
Funders
National Cancer Institute (R01CA230542, T32CA117865)
Topics
  • Health Sciences › Medicine › Oncology › Cancer survivorship and care
  • Social Sciences › Psychology › Clinical Psychology › Mindfulness and Compassion Interventions
  • Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Cancer-related cognitive impairment studies
Keywords
acceptance and commitment therapy, cancer-related fatigue, metastatic breast cancer, telephone-delivered intervention, psychological flexibility, sleep interference, quality of life, psychological distress, advanced cancer
MeSH terms
Anxiety, Breast Neoplasms, Fatigue, Female, Humans, Quality of Life, Randomized Controlled Trials as Topic, Acceptance and Commitment Therapy

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