Effects of exercise in breast cancer patients: implications of the trials within cohorts (TwiCs) design in the UMBRELLA Fit trial

Gal, Roxanne; Monninkhof, Evelyn M.; Gils, Carla H. van; Groenwold, Rolf H H; Elias, Sjoerd G.; Bongard, Desirée H. J. G. van den; Peeters, Petra H.M.; Verkooijen, Helena M.; May, Anne M.

doi:10.1007/s10549-021-06363-9

Cited by 21 publications

(28 citation statements)

References 39 publications

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“…The response rate of this survey was reasonably high (76%). Patients who responded to the questionnaire were comparable to the original trial population in terms of age and gender [14,15]. However, women of the UM-BRELLA Fit control group who had a higher level of education seemed more likely to respond to this questionnaire.…”

Section: Discussionmentioning

confidence: 84%

“…This cross-sectional survey was conducted among patients with breast or rectal cancer who had served as controls in two TwiCs, that is, the UMBRELLA Fit and the RECTAL-BOOST trial [14,15,18,19]. The UMBRELLA Fit trial included 260 patients from the Utrecht cohort for Multiple BREast cancer intervention studies and Longterm evaLuAtion (UMBRELLA) between October 2015 and February 2018 [20].…”

Section: Study Populationmentioning

confidence: 99%

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Most patients reported positively or neutrally of having served as controls in the trials within cohorts design

Verweij

Gal

Burbach

et al. 2022

Journal of Clinical Epidemiology

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Section: Discussionmentioning

confidence: 84%

Section: Study Populationmentioning

confidence: 99%

Most patients reported positively or neutrally of having served as controls in the trials within cohorts design

Verweij

Gal

Burbach

et al. 2022

Journal of Clinical Epidemiology

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“…In post-randomization consent trial designs with individual randomization (i.e., not cluster designs), randomization is done based on eligibility criteria prior to obtaining consent from participants. In most cmRCT trials [ 66 – 68 ], as with SPIN-HAND, cohort participants consent upon enrollment in the cohort to participate in possible future post-randomization consent trials; but, when such a trial is conducted, only those selected for the intervention, which is added to usual care, are approached to provide informed consent. Rather than evaluating an intervention among those who agree to receive it, these trials evaluate the effects of being offered an intervention [ 38 ].…”

Section: Discussionmentioning

confidence: 99%

“…The SPIN-HAND trial and other cmRCT trials [ 66 – 68 ] differ from most, though not all, trials that have successfully used Zelen designs in that they have typically used a post-randomization consent model for testing the offer of an intervention among people not seeking an intervention or in areas like prevention where the effect of combined uptake and effectiveness are of interest. Rather, investigators using the design have generally been interested in evaluating use of the intervention but have randomized participants to an offer of the intervention or no offer.…”

Section: Discussionmentioning

confidence: 99%

“…Rather, investigators using the design have generally been interested in evaluating use of the intervention but have randomized participants to an offer of the intervention or no offer. cmRCT trials that have published results have consistently reported acceptance rates of < 55% [ 66 – 68 ]. In the case of SPIN-HAND, we were interested in the effect of using the intervention, but we hoped that the cmRCT design would facilitate enrollment and reduce disappointment bias.…”

Section: Discussionmentioning

confidence: 99%

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Randomized controlled trial of an internet-based self-guided hand exercise program to improve hand function in people with systemic sclerosis: the Scleroderma Patient-centered Intervention Network Hand Exercise Program (SPIN-HAND) trial

Kwakkenbos

Carrier

Welling³

et al. 2022

Trials

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Background Systemic sclerosis (scleroderma; SSc) is a rare autoimmune connective tissue disease. Functional impairment of hands is common. The Scleroderma Patient-centered Intervention Network (SPIN)-HAND trial compared effects of offering access to an online self-guided hand exercise program to usual care on hand function (primary) and functional health outcomes (secondary) in people with SSc with at least mild hand function limitations. Methods The pragmatic, two-arm, parallel-group cohort multiple randomized controlled trial was embedded in the SPIN Cohort. Cohort participants with Cochin Hand Function Scale (CHFS) scores ≥ 3 and who indicated interest in using the SPIN-HAND Program were randomized (3:2 ratio) to an offer of program access or to usual care (targeted N = 586). The SPIN-HAND program consists of 4 modules that address (1) thumb flexibility and strength; (2) finger bending; (3) finger extension; and (4) wrist flexibility and strength. The primary outcome analysis compared CHFS scores 3 months post-randomization between participants offered versus not offered the program. Secondary outcomes were CHFS scores 6 months post-randomization and functional health outcomes (Patient-Reported Outcomes Measurement Information System profile version 2.0 domain scores) 3 and 6 months post-randomization. Results In total, 466 participants were randomized to intervention offer (N = 280) or usual care (N = 186). Of 280 participants offered the intervention, 170 (61%) consented to access the program. Of these, 117 (69%) viewed at least one hand exercise instruction video and 77 (45%) logged into the program website at least 3 times. In intent-to-treat analyses, CHFS scores were 1.2 points lower (95% CI − 2.8 to 0.3) for intervention compared to usual care 3 months post-randomization and 0.1 points lower (95% CI − 1.8 to 1.6 points) 6 months post-randomization. There were no statistically significant differences in other outcomes. Conclusion The offer to use the SPIN-HAND Program did not improve hand function. Low offer uptake, program access, and minimal usage among those who accessed the program limited our ability to determine if using the program would improve function. To improve engagement, the program could be tested in a group format or as a resource to support care provided by a physical or occupational therapist. Trial registration NCT03419208. Registered on February 1, 2018.

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Hyperbaric Oxygen Therapy and Late Local Toxic Effects in Patients With Irradiated Breast Cancer

Mink van der Molen,

Batenburg,

Maarse

et al. 2024

JAMA Oncol

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ImportanceHyperbaric oxygen therapy (HBOT) is proposed as treatment for late local toxic effects after breast irradiation. Strong evidence of effectiveness is lacking.ObjectiveTo assess effectiveness of HBOT for late local toxic effects in women who received adjuvant radiotherapy for breast cancer.Design, Setting, and ParticipantsThis was a hospital-based, pragmatic, 2-arm, randomized clinical trial nested within the prospective UMBRELLA cohort following the trials within cohorts design in the Netherlands. Participants included 189 women with patient-reported moderate or severe breast, chest wall, and/or shoulder pain in combination with mild, moderate, or severe edema, fibrosis, or movement restriction 12 months or longer after breast irradiation. Data analysis was performed from May to September 2023.InterventionReceipt of 30 to 40 HBOT sessions over a period of 6 to 8 consecutive weeks.Main Outcomes and MeasuresBreast, chest wall, and/or shoulder pain 6 months postrandomization measured by the European Organization for Research and Treatment of Cancer QLQ-BR23 questionnaire. Secondary end points were patient-reported fibrosis, edema, movement restriction, and overall quality of life. Data were analyzed according to intention-to-treat (ITT) and complier average causal effect (CACE) principles.ResultsBetween November 2019 and August 2022, 125 women (median [range] age at randomization, 56 [37-85] years) with late local toxic effects were offered to undergo HBOT (intervention arm), and 61 women (median [range] age at randomization, 60 [36-80] years) were randomized to the control arm. Of those offered HBOT, 31 (25%) accepted and completed treatment. The most common reason for not accepting HBOT was high treatment intensity. In ITT, moderate or severe pain at follow-up was reported by 58 of 115 women (50%) in the intervention arm and 32 of 52 women (62%) in the control arm (odds ratio [OR], 0.63; 95% CI, 0.32-1.23; P = .18). In CACE, the proportion of women reporting moderate or severe pain at follow-up was 32% (10 of 31) among those completing HBOT and 75% (9.7 of 12.9) among control participants expected to complete HBOT if offered (adjusted OR, 0.34; 95% CI, 0.15-0.80; P = .01). In ITT, moderate or severe fibrosis was reported by 35 of 107 (33%) in the intervention arm and 25 of 49 (51%) in the control arm (OR, 0.36; 95% CI, 0.15-0.81; P = .02). There were no significant differences in breast edema, movement restriction, and quality of life between groups in ITT and CACE.Conclusions and RelevanceIn this randomized clinical trial, offering HBOT to women with late local toxic effects was not effective for reducing pain, but was effective for reducing fibrosis. In the subgroup of women who completed HBOT, a significant reduction in pain and fibrosis was observed. A smaller than anticipated proportion of women with late local toxic effects was prepared to undergo HBOT.Trial RegistrationClinicalTrials.gov Identifier: NCT04193722

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Effects of exercise in breast cancer patients: implications of the trials within cohorts (TwiCs) design in the UMBRELLA Fit trial

Cited by 21 publications

References 39 publications

Most patients reported positively or neutrally of having served as controls in the trials within cohorts design

Most patients reported positively or neutrally of having served as controls in the trials within cohorts design

Randomized controlled trial of an internet-based self-guided hand exercise program to improve hand function in people with systemic sclerosis: the Scleroderma Patient-centered Intervention Network Hand Exercise Program (SPIN-HAND) trial

Hyperbaric Oxygen Therapy and Late Local Toxic Effects in Patients With Irradiated Breast Cancer

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