Acceptance and commitment therapy for patient fatigue interference and caregiver burden in advanced gastrointestinal cancer: Results of a pilot randomized trial
Open accessAbstract
Background: Fatigue often interferes with functioning in patients with advanced cancer, resulting in increased family caregiver burden. Acceptance and commitment therapy, a promising intervention for cancer-related suffering, has rarely been applied to dyads coping with advanced cancer. Aim: To examine the feasibility, acceptability, and preliminary efficacy of acceptance and commitment therapy for patient-caregiver dyads coping with advanced gastrointestinal cancer. Primary outcomes were patient fatigue interference and caregiver burden. Design: In this pilot trial, dyads were randomized to six weekly sessions of telephone-delivered acceptance and commitment therapy or education/support, an attention control. Outcomes were assessed at baseline and at 2 weeks and 3 months post-intervention. Setting/participants: Forty patients with stage III–IV gastrointestinal cancer and fatigue interference and family caregivers with burden or distress were recruited from two oncology clinics and randomized. Results: The eligibility screening rate (54%) and retention rate (81% at 2 weeks post-intervention) demonstrated feasibility. At 2 weeks post-intervention, acceptance and commitment therapy participants reported high intervention helpfulness (mean = 4.25/5.00). Group differences in outcomes were not statistically significant. However, when examining within-group change, acceptance and commitment therapy patients showed moderate decline in fatigue interference at both follow-ups, whereas education/support patients did not show improvement at either follow-up. Acceptance and commitment therapy caregivers showed medium decline in burden at 2 weeks that was not sustained at 3 months, whereas education/support caregivers showed little change in burden. Conclusions: Acceptance and commitment therapy showed strong feasibility, acceptability, and promise and warrants further testing. Trial Registration: ClinicalTrials.gov NCT04010227. Registered 8 July 2019, https://clinicaltrials.gov/ct2/show/NCT04010227?term=catherine+mosher&draw=2&rank=1
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Both prior dyad ACT studies involved relatively small sample sizes ranging from 40 to 50 dyads.
“Both studies involved relatively small sample sizes ranging from 40 to 50 dyads.”
From Effectiveness of a videoconferencing group-based dyad acceptance and commitment therapy on the quality of life of chronic heart failure patients and their family caregivers: A study protocol for a randomized controlled trial (2024) · cites this paper as [59]
The Results (Feasibility and acceptability; page not available) report that 40 dyads were randomized, and the Discussion (Strengths/limitations) describes this trial’s sample as small. These passages support the claim for this study, but our copy does not establish that the other study had 40–50 dyads. (LLM, conf=0.84)
Experimental — accuracy not yet measuredNo statistically significant differences were found in QOL, use of health services, and caregiver distress after the intervention when compared to usual care in the two prior dyad ACT studies.
“Although no statistically significant differences were found in QOL, use of health services, and caregiver distress after the intervention when compared to those who received the usual care”
From Effectiveness of a videoconferencing group-based dyad acceptance and commitment therapy on the quality of life of chronic heart failure patients and their family caregivers: A study protocol for a randomized controlled trial (2024) · cites this paper as [59]
The Results (Preliminary efficacy) report no significant group-by-time differences in quality of life, and the supplemental analyses report no group difference in outpatient visits or prescribed medications. The Discussion (Main findings) also says outcomes did not differ significantly between conditions, including caregiver burden. But this paper reports one dyadic trial, compares ACT with education/support rather than usual care, and measures caregiver burden rather than a distinct caregiver-distress outcome. (LLM, conf=0.88)
Experimental — accuracy not yet measuredOne study showed no improvements in valued living post intervention.
“One study showed no improvements in valued living post intervention. 55”
From Acceptance and Commitment Therapy (ACT) for people with advanced progressive illness, their caregivers and staff involved in their care: A scoping review. (2023) · cites this paper as [55]
The Results (Preliminary efficacy: Multilevel model results; page unavailable) report no group-by-time interaction for values progress, the study’s measure of valued living. That supports a lack of demonstrated improvement relative to the comparison group, but not the broader assertion that valued living did not improve at all after the intervention. (LLM, conf=0.85)
Experimental — accuracy not yet measuredThree studies showed improvements in quality of life, one study reported significant improvements.
“Three studies showed improvements in quality of life add53,55,57, one study reported significant improvements. 53”
From Acceptance and Commitment Therapy (ACT) for people with advanced progressive illness, their caregivers and staff involved in their care: A scoping review. (2023) · cites this paper as [55]
The Results (Preliminary efficacy: Supplemental analyses of survey completers; page unavailable) say most quality-of-life outcomes improved only among acceptance and commitment therapy participants. But the Results (Preliminary efficacy: Multilevel model results; page unavailable) report no significant group-by-time effects for patient or caregiver quality of life, so this source does not support the claim that its improvement was significant. (LLM, conf=0.86)
Experimental — accuracy not yet measuredThe two prior dyad ACT studies had high completion rates and levels of satisfaction among participants.
“high completion rates and levels of satisfaction among the participants in these studies”
To date, only two studies have adopted an ACT intervention for dyads, and in both cases the interventions were delivered via telephone in an individual/dyad format for specific cancer conditions, such as lung cancer or gastrointestinal cancer.
“To date, only two studies have adopted an ACT intervention for dyads, and in both cases the interventions were delivered via telephone in an individual/dyad format for specific cancer conditions, such as lung cancer [58] or gastrointestinal cancer [59].”
High completion rates and levels of satisfaction among participants in the two prior dyad ACT studies provide early support for the use of a remote ACT intervention for patient-FC dyads.
“high completion rates and levels of satisfaction among the participants in these studies provide early support for the use of a remote ACT intervention for patient-FC dyads.”
Eight of the 12 included studies were pilot studies.
“Eight studies were pilot studies [19–26].”
From Third-wave cognitive behavioral therapies for caregivers of cancer patients: a scoping review. (2023) · cites this paper as [24]
In the study that provided ACT, trained clinicians or psychologists provided the intervention.
“In the study that provided ACT, trained clinicians or psychologists provided the intervention [24].”
From Third-wave cognitive behavioral therapies for caregivers of cancer patients: a scoping review. (2023) · cites this paper as [24]
One included study included both gastrointestinal cancer patients in advanced stages and their caregivers.
“There was one study that included both gastrointestinal cancer patients in advanced stages and their caregivers in the intervention [24]”
From Third-wave cognitive behavioral therapies for caregivers of cancer patients: a scoping review. (2023) · cites this paper as [24]
The most common method was a weekly session for a total of 6 weeks or 8 weeks with a length of approximately 60 min per session.
“The most common method was a weekly session for a total of 6 weeks [19, 20, 24, 27] or 8 weeks [25, 28, 29] with a length of approximately 60 min per session [21, 22, 27, 29, 30].”
From Third-wave cognitive behavioral therapies for caregivers of cancer patients: a scoping review. (2023) · cites this paper as [24]
Six of the 15 intervention studies examined feasibility and acceptability as one of their stated outcomes.
“Six of the 15 intervention studies examined feasibility and acceptability as one of their stated outcomes.16,52,55,60,61,63”
From Acceptance and Commitment Therapy (ACT) for people with advanced progressive illness, their caregivers and staff involved in their care: A scoping review. (2023) · cites this paper as [55]
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Fang, P., Tan, L., Cui, J., & Yu, L. (2023) · Journal of Advanced Nursing · doi:10.1111/jan.15543 · Cited by 49 · see citing works
“Compared with the previous review (Li, Wong, et al., 2021 ), the current meta-analysis provided stronger evidence by including four more RCTs (Li et al., 2022 ; Mosher et al., 2022 ; Pan et al., 2020; Zhang et al., 2021 ).”
BackgroundMethodResultInfluentialJiang, X., Sun, J., Song, R., Wang, Y., Li, J., & Shi, R. (2024) · Frontiers in Psychology · doi:10.3389/fpsyg.2023.1253266 · Cited by 43 · see citing works
Gibson Watt, T., Gillanders, D., Spiller, J. A., & Finucane, A. M. (2023) · Palliative Medicine · doi:10.1177/02692163231183101 · Cited by 32 · see citing works
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Burns, M. F., Secinti, E., Johns, S. A., Wu, W., Helft, P. R., Turk, A. A., Loehrer, P. J., Sehdev, A., Al-Hader, A. A., & Mosher, C. E. (2023) · Journal of Contextual Behavioral Science · doi:10.1016/j.jcbs.2023.01.001 · Cited by 14 · see citing works
Self-citationMosher, C. E., Lee, S., Addington, E. L., Park, S., Lewson, A. B., Snyder, S., Hirsh, A. T., Bricker, J. B., Miller, K. D., Ballinger, T. J., et al. (2024) · Journal of Clinical Oncology · doi:10.1200/jco.24.00965 · Cited by 15 · see citing works
“12,13,45 In our education/support condition, QOL may have been maintained through discussion of QOL concerns and referrals to resources.”
InfluentialSelf-citationAl‐Abbadey, M., Tomescu‐Stachie, S., Kaklamanou, D., Jarrett, N., Merwood, A., Tyndall, I. T., & McCracken, L. M. (2025) · British Journal of Health Psychology · doi:10.1111/bjhp.12807 · Cited by 9 · see citing works
“…be particularly useful in the context of oncology services as patients with different diagnoses of cancer will most likely experience a significant degree of suffering that is unavoidable physically and psychologically (Fawson et al., 2023; Mosher et al., 2019, 2022; Rehfeldt & Tyndall, 2022).”
Li, H., Wong, C. L., Jin, X., Chong, Y. Y., & Ng, M. S. N. (2024) · Journal of Contextual Behavioral Science · doi:10.1016/j.jcbs.2024.100758 · Cited by 7 · see citing works
Third-wave cognitive behavioral therapies for caregivers of cancer patients: a scoping review.
Hong, B., Yang, S., Hyeon, S., Kim, S., & Lee, J. (2023) · BMC Complementary Medicine and Therapies · doi:10.1186/s12906-023-04186-3 · Cited by 7 · see citing works
“Among the 12 studies investigated, nine studies targeted patient–caregiver dyads [19–22, 24, 25, 28–30].”
BackgroundMethodInfluentialLi, H., Wong, C. L., Jin, X., Wang, N., & Shi, Z. (2024) · BMJ Open · doi:10.1136/bmjopen-2023-082090 · Cited by 7 · see citing works
Gu, Y., Duan, M., Huang, Y., Hu, M., Bao, M., & Yang, F. (2025) · Scientific Reports · doi:10.1038/s41598-025-07280-3 · Cited by 7 · see citing works
“The main facilitators of the treatment programs were trained professionals, including nursing students 26,45 , social workers 42 , nurses 44,46 , psychiatrists, and psychologists 43,47 .”
Mirzaei, S., Bagherian-Sararoudi, R., Davazdahemami, M. H., Izadi, R., & Sharbafchi, M. R. (2025) · BMC Psychiatry · doi:10.1186/s12888-025-06823-2 · Cited by 6 · see citing works
Zhang, L., Chen, Y., Tang, W., Wang, Q., Zou, L., & Zhou, L. (2025) · BMC Nursing · doi:10.1186/s12912-025-02835-1 · Cited by 7 · see citing works
“…of the intervention over the study period for MHD dyads the intervention program could effectively reduce the burden of caregivers, which is consistent with the results of recent studies on psychoeducational intervention in patients with stroke [44, 54], cancer [55] and cardiovascular disease [56].”
Müller, F., van Dongen, S. I., van Woezik, R., Tibosch, M., Tuinman, M. A., Schellekens, M. P. J., Laurenceau, J., van der Lee, M. L., & Hagedoorn, M. (2023) · JMIR Research Protocols · doi:10.2196/48329 · Cited by 5 · see citing works
“However, of those relevant to the proposed pilot study, most either apply a couple’s mindfulness-based approach [64,65] or target cancer-related fatigue [66].”
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Beasley, E., WHITE, V. M., Ugalde, A., Brooker, J., Skvarc, D., & Mikocka‐Walus, A. A. (2025) · Journal of Psychosomatic Research · doi:10.1016/j.jpsychores.2025.112106 · Cited by 3 · see citing works
Application of Acceptance and Commitment Therapy (ACT) in Hospice and Palliative Care Settings
Park, S.-Y. (2023) · The Journal of Hospice and Palliative Care · doi:10.14475/jhpc.2023.26.3.140 · Cited by 2 · see citing works
“A study by Mosher and colleagues [24] focused on both advanced cancer patients and their care-givers http://www.e-jhpc.org As another example, Finucane and colleagues conducted a study [28] to assess the feasibility and acceptability of an”
Zhang, X., Ho, G. W. K., & Mak, Y. W. (2024) · PLoS ONE · doi:10.1371/journal.pone.0298178 · Cited by 1 · see citing works
Mosher, C. E., Lewson, A. B., Austin-Wright, M., Matthias, M. S., Helft, P. R., Turk, A. A., Loehrer, P. J., Sehdev, A., Al-Hader, A. A., & Johns, S. A. (2025) · BMJ Supportive & Palliative Care · doi:10.1136/spcare-2025-005548 · Cited by 1 · see citing works
“13 In secondary analyses of within-group change, only ACT patients showed moderate reductions in pain severity and interference at 2 weeks post-intervention and moderate reductions in depressive symptoms at 2 weeks and 3 months post-intervention.”
Self-citationThird-wave psychotherapy for caregivers of cancer patients: a scoping reviewPreprint
Hong, B., Yang, S., Hyeon, S., Kim, S., & Lee, J. (2023) · Research Square · doi:10.21203/rs.3.rs-1960441/v1 · Cited by 1 · see citing works
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Chikwe, C., & Zadhasn, Z. (2023) · Journal of Personality and Psychosomatic Research · doi:10.61838/kman.jppr.1.4.2
Wang, T., Lin, Y., Tang, L., Sun, J., Chen, W., Mao, Y., Ge, Y., & Liu, H. (2025) · Research Square · doi:10.21203/rs.3.rs-6905143/v1
Fatigue in Cholestatic Liver Disease: A Review of Mechanisms and Non-Pharmacological Management
Isley, S., Johnson, E., Swain, M. G., & Tandon, P. (2025) · Current Hepatology Reports · doi:10.1007/s11901-025-00706-6
“Unlike CBT, which aims to challenge and change maladaptive thoughts, ACT enhances psychological flexibility [ 98 ].”
Mosher, C. E., Shinn, E. H., Addington, E. L., Wu, W., Bricker, J. B., Helft, P. R., Turk, A. A., Vater, L. B., Masood, A., Jalal, S. I., et al. (2025) · Contemporary Clinical Trials · doi:10.1016/j.cct.2025.108168
“In our pilot RCT, telephone-based ACT was feasible and acceptable to patients with advanced GI cancer and caregivers and showed promise in reducing patient fatigue interference and caregiver burden [21].”
InfluentialSelf-citationHong, B., Yang, S., Hyeon, S., Kim, S., & Lee, J. (2024) · Figshare · doi:10.6084/m9.figshare.26625730
Hagedoorn, M., Müller, F., van Dongen, S. I., van Woezik, R., Tuinman, M. A., Schellekens, M. P. J., & van der Lee, M. L. (2026) · Supportive Care in Cancer · doi:10.1007/s00520-026-10547-8
Macías, J., Lara-Merín, L., & López-Pinar, C. (2026) · Psicothema · doi:10.70478/psicothema.2026.38.12
Li, T., Wu, X., Xu, H., Wang, Y., Luo, T., & Fu, A. (2026) · Medicine · doi:10.1097/md.0000000000050303
“[25,26] Compared with these studies, the present trial extends existing evidence by focusing specifically on primary caregivers of ostomy patients and by simultaneously evaluating psychological flexibility, resilience, caregiving ability, and benefit finding.”
Wang, T., Lin, Y., Tang, L., Sun, J., Chen, W., Mao, Y., Ge, Y., & Liu, H. (2026) · Cancer Medicine · doi:10.1002/cam4.72312
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- Authors
- Mosher, C. E., Secinti, E., Wu, W., Kashy, D. A., Kroenke, K., Bricker, J. B., Helft, P. R., Turk, A. A., Loehrer, P. J., Sehdev, A., Al-Hader, A. A., Champion, V. L., & Johns, S. A.
- Affiliations
- Indiana University – Purdue University Indianapolis (US)
- Department of Psychology, Indiana University-Purdue University Indianapolis, Indianapolis, IN, USA
- Michigan State University (US)
- Indiana University School of Medicine (US)
- University of Washington (US)
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center (US)
- Indiana University Indianapolis (US)
- Regenstrief Institute (US)
- Corresponding author
- Mosher, Catherine E
- ORCID
- Venue
- Palliative Medicine
- Publisher
- SAGE Publications
- Published
- 2022-05-30
- Volume
- 36
- Issue
- 7
- Pages
- 1104-1117
- ISSN
- 0269-2163 (ISSN-L)
- 1477-030X
- PMC
- PMC9396957
- OpenAlex
- W4281634502
- Cited by
- 34
- References
- 70
- Citations by year
- 2026: 5 · 2025: 10 · 2024: 6 · 2023: 12 · 2022: 1
- FWCI
- 6.62
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Palliative Medicine (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- IUScholarWorks (Indiana University) (submittedVersion)
- Funders
- national cancer institute (R21CA235788)
- Topics
- Social Sciences › Psychology › Clinical Psychology › Mindfulness and Compassion Interventions
- Health Sciences › Medicine › Oncology › Cancer survivorship and care
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Palliative Care and End-of-Life Issues
- Keywords
- acceptance and commitment therapy, cancer-related fatigue, fatigue interference, caregiver burden, advanced gastrointestinal cancer, patient-caregiver dyads, telephone-delivered intervention, feasibility and acceptability, family caregivers, palliative care
- MeSH terms
- Caregiver Burden, Fatigue, Gastrointestinal Neoplasms, Humans, Pilot Projects, Quality of Life, Caregivers, Acceptance and Commitment Therapy
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