Tradeoffs in Patient Decision Making About Rectal Cancer Treatment: Benefits Compared to Quality Of Life.

Official title

PATHOS Tradeoffs in Patient Decision Making About Rectal Cancer Treatment: Benefits Compared to Quality Of Life.

Overview

This study is aiming to look into patients' treatment preferences and their socio economic background as well as the exploration of thought processes leading to these preferences. It will integrate, in two exploratory questionnaires, the three most common treatment schema (standard of care, non-operative management, surgery alone) all of which have been demonstrated efficacious.

Detailed description

The primary study objective is to evaluate socioeconomic and demographic factors involved in patients' / physicians treatment preferences. The secondary objective is to assess the tradeoff level between the benefits versus quality of life.

This study will evaluate 192 participants: 14 physicians (group A) and 178 patients (group B).

Participants with operable rectal cancer or health professionals will be screened for eligibility. Subsequently, these participants will be offered to participate in this pilot study and provided a consent form. When a participant has consented to participate, he/she will be provided with a first questionnaire (socio-demographic characteristics, some clinical data and medical baseline information as well as details about their current knowledge about treatments).

An informational brochure will be given after answering the first questionnaire describing different treatment regimens, treatment duration, potential side effects and oncologic outcomes.

A second questionnaire will be provided (evaluating patients treatment preferences and tradeoff).

The consent form, brochure and questionnaires will be available only in an electronic format (Microsoft Form).

Interventions

• Behavioral The only intervention will be the information brochure that will be given after the first questionnaire.
  The information brochure will be given to both groups at the same time at 2-3 weeks after the first consultation (patients group) or after answering the first questionnaire (physicians group).

Primary outcome measures

• Socio-economic and demographic characteristics [Time frame: 1 day]

Secondary outcome measures (1)

• Tradeoff level [Time frame: 1 day]

Eligibility criteria

Inclusion criteria

Group A

• New rectal cancer patient
• Operable patients
• Capable adults older than 18 years of age
• Capacity to sign a consent form
• Capacity to answer questionnaires on an online platform Group B
• Treating physician specialists
• Capacity to sign a consent form
• Capacity to answer questionnaires on an online platform

Exclusion criteria

Group A:

• Patient unable to sign a consent form
• Patients with metastasis
• Recurrent tumours
• Inability to answer questionnaires on an online platform
• Inability to communicate in french or english

Group B:

• Participant unable to sign a consent form
• Inability to answer questionnaires on an online platform

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Case-control

Study locations

Canada · 1 center

• Jewish General Hospital — Montreal

Publications

• Pieterse AH, Kunneman M, van den Hout WB, Baas-Thijssen M, Geijsen ED, Ceha HM, Muller KM, van der Linden YM, Marijnen CAM, Stiggelbout AM. Patient explicit consideration of tradeoffs in decision making about rectal cancer treatment: benefits for decision process and quality of life. Acta Oncol. 2019 Jul;58(7):1069-1076. doi: 10.1080/0284186X.2019.1594363. Epub 2019 Apr 11. PMID 30971150
• Saclarides TJ. Transanal Endoscopic Microsurgery. Clin Colon Rectal Surg. 2015 Sep;28(3):165-75. doi: 10.1055/s-0035-1562889. PMID 26491409
• Maggiori L, Panis Y. Transanal endoscopic microsurgery (TEM) for T1 rectal cancer. Acta Chir Iugosl. 2012;59(2):87-90. doi: 10.2298/aci1202087m. PMID 23373364
• Cunningham C. Transanal endoscopic microsurgery. Recent Results Cancer Res. 2014;203:31-8. doi: 10.1007/978-3-319-08060-4_4. PMID 25102997
• Habr-Gama A, Sabbaga J, Gama-Rodrigues J, Sao Juliao GP, Proscurshim I, Bailao Aguilar P, Nadalin W, Perez RO. Watch and wait approach following extended neoadjuvant chemoradiation for distal rectal cancer: are we getting closer to anal cancer management? Dis Colon Rectum. 2013 Oct;56(10):1109-17. doi: 10.1097/DCR.0b013e3182a25c4e. PMID 24022527
• Garant A, Magnan S, Devic S, Martin AG, Boutros M, Vasilevsky CA, Ferland S, Bujold A, DesGroseilliers S, Sebajang H, Richard C, Vuong T. Image Guided Adaptive Endorectal Brachytherapy in the Nonoperative Management of Patients With Rectal Cancer. Int J Radiat Oncol Biol Phys. 2019 Dec 1;105(5):1005-1011. doi: 10.1016/j.ijrobp.2019.08.042. Epub 2019 Aug 30. PMID 31476417
• van der Valk MJM, Marijnen CAM, van Etten B, Dijkstra EA, Hilling DE, Kranenbarg EM, Putter H, Roodvoets AGH, Bahadoer RR, Fokstuen T, Ten Tije AJ, Capdevila J, Hendriks MP, Edhemovic I, Cervantes AMR, de Groot DJA, Nilsson PJ, Glimelius B, van de Velde CJH, Hospers GAP; Collaborative investigators. Compliance and tolerability of short-course radiotherapy followed by preoperative chemotherapy and PMID 32240909
• van der Valk MJM, van der Sande ME, Toebes RE, Breukink SO, Broker MEE, Doornebosch PG, Maliko N, Neijenhuis PA, Marinelli AWKS, Peters FP, Peeters KCMJ, Beets GL, Marang-van de Mheen PJ, Hilling DE. Importance of patient reported and clinical outcomes for patients with locally advanced rectal cancer and their treating physicians. Do clinicians know what patients want? Eur J Surg Oncol. 2020 Sep;4 PMID 32336626

Identifiers

NCT: NCT04925154 · 2021-2517

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗