Understanding how coping strategies and quality of life maintain hope in patients deliberating phase I trial participation

Abstract

Objective: This study aimed to understand how hope and motivation of patients considering phase I trial participation are affected by psychological factors such as coping strategies and locus of control (LoC) and general well-being as measured by the quality of life (QoL).Methods: An exploratory cross-sectional study was performed in patients with incurable cancer (N = 135) referred to our phase I unit for the first time. Patients were potentially eligible for phase I trial participation and participated in our study while deliberating phase I trial participation. We used questionnaires on hope, motivation to participate, coping, LoC, and QoL. To investigate the nature and magnitude of the relationships between the scales, a structural equation modeling (SEM) was fitted to the data.Results: Hope significantly predicted the motivation to participate in phase I trials. Predictors of hope were a combination of flexible and tenacious goal pursuit (both P < .01), internal LoC (P < .01), and QoL (P < .01). The SEM showed an exact fit to the data, using a null hypothesis significance test: chi-square (8) = 9.30, P = .32. Conclusions:Patients considering phase I trial participation seem to use a pact of tenacious and flexible coping and control to stay hopeful. Furthermore, hope and QoL positively affected each other. The psychological pact may promote an adaptation enabling them to adjust to difficult circumstances by unconsciously ignoring information, called dissonance reduction. This mechanism may impair their ability to provide a valid informed consent. We suggest including a systematic exploration of patients' social context and values before proposing a phase I trial. Patients may struggle to decide whether to engage in a treatment with unknown efficacy, benefit, and side effects, or to opt solely for symptom-oriented palliative care.2 During this deliberation, their mindset may help them deal with this choice by setting goals. 3Mindset represents people's personal attitudes that influence their goals and behavior. 4 Equally, physicians face the difficult decision whether to offer a phase I trial to their patients and how to answer patients' questions, not knowing whether the experiment is worthwhile. Additionally, when treatment options are sparse or not available, considering phase I trial participation may represent a health crisis. 21This crisis, facing a life-threatening situation, can trigger 2 modes of coping: tenacious goal pursuit (tenacity) and flexible goal adjustment (flexibility). 21 Patients who use tenacity try to modify their circumstances to fulfill their personal preferences. In contrast, patients who use flexibility adapt their personal preferences to the new situation.In both coping strategies, another psychological factor, the sense of control, can play a role.Locus of control (LoC) refers to the extent to which people believe their lives can be controlled by external factors (such as doctors) or internal factors (themselves). 22 One may assume that palliative patients with cancer, wh...

A Palliative Care Intervention for Patients on Phase 1 Studies

“…Supporting patients as they make decisions regarding treatment options and evaluate goals of care can best be accomplished through the collaboration of oncologists and PC clinicans. [36][37][38][39]…”

Self-reported quality of life and hope in phase-I trial participants: An observational prospective cohort study

“…During trial participation, there was a decrease of hope in all patients. This could be associated with a drop in experienced global health, since global health and hope were correlated at preconsent (Van der Biessen et al, 2018). The maintenance of quality of life is an important factor in staying hopeful.…”

“…Informing patients about the consequences of trial participation on their quality of life, hope and coping may help them make a wellinformed decision. During the discussion of trial participation, it should be kept in mind that hope will influence patients' perception, F I G U R E 4 Overall survival of patients: not participating, started without continuation, and started with continuation after first evaluation since patient' hope is high (Catt, Langridge, Fallowfield, Talbot, & Jenkins, 2011;Godskesen et al, 2013;Moorcraft et al, 2016;Van der Biessen et al, 2018).…”

“…Furthermore, research towards hope at preconsent of phase-I trial participation showed that hope was the central motivator for participation and positively interacted with HRQoL. Hope formed a pact with coping strategies, such as tenacious and flexible coping, and the feeling of being in control (Van der Biessen et al, 2018).…”

Realizing better doctor-patient dialogue about choices in palliative care and early phase clinical trial participation: towards an online value clarification tool (OnVaCT)

“…Although a recent search revealed a 19.8% response rate (both complete and partial responses) in phase I trials from 2014 until mid-2015 [2], it is known that participation can (also) be beneficial for other reasons. Hope for and belief in benefit are for instance important reasons for patients to participate [3, 4], and those factors can positively affect quality of life [5]. However, it is also known that patients can be aware of palliative care services at the end of life but may not consider them for themselves [6], which may especially apply to those who have unrealistic hope for benefit [4].…”