Spirituality in cancer patients on phase 1 clinical trials

Abstract

Objectives Patients with cancer who are at a transition to Phase I investigational treatments have been identified as an underserved population with regard to palliative care. This disease transition is often accompanied by spiritual and existential concerns. The study objective was to conduct a secondary analysis of data from a larger study testing a palliative care intervention. This paper reports the findings of this secondary focus on the spiritual needs of this population. Methods Patients (n = 479) were accrued to this study prior to initiating a Phase I clinical trial with data collected at baseline, and 4, 12, and 24 week follow‐up. Results Qualitative data revealed that the transition to Phase 1 trial participation is a time of balancing hope for extended life with the reality of advancing disease. Quantitative results demonstrated increased spirituality over time in both religious‐ and non‐religious‐affiliated patients. Conclusions Patients entering Phase I trials have important spiritual needs as they face treatment decisions, advancing disease, and often mortality. Spiritual care should be provided to seriously ill patients as a component of quality care.

Hope and meaning-making in phase 1 oncology trials: a systematic review and thematic synthesis of qualitative evidence on patient-participant experiences

“… P1 trial participants are strongly motivated by hope of therapeutic benefit and very few patients understand the purpose of P1 as dose-determination studies. Ferrell, 2019 (USA) [ 43 ], Ferrell, 2020 (USA) [ 44 ] Good quality Capture patient perspectives of P1 trial participation and disease/ treatment options [ 43 ]. Secondary analysis focused on spiritual needs of this population [ 44 ].…”

“… Ferrell, 2019 (USA) [ 43 ], Ferrell, 2020 (USA) [ 44 ] Good quality Capture patient perspectives of P1 trial participation and disease/ treatment options [ 43 ]. Secondary analysis focused on spiritual needs of this population [ 44 ]. Qualitative 30 patients 56.8% female 30.7% ethnic minority Aged: <40 = 3, 50–59 = 8, 60–69 = 9, 70–79 = 8, >80 = 2 Cancer type: lung, bladder, colon, ovarian, prostate, breast, cervical, other Interviews audio-recorded and transcribed.…”

“…These motivations are optimistic not misconceptions [ 43 ]. The transition to phase 1 trial participation is a time of balancing hope for extended life with the reality of disease [ 44 ]. Godskesen.…”

Palliative care provider attitudes toward existential distress and treatment with psychedelic-assisted therapies

“…Further research would be best directed at identifying risk factors for poor response to conventional psychotherapy and spiritual counseling. Alternatively, referral to PAT could be triggered by specific shifts in the course of treatment associated with significant unmet existential needs, such as cancer recurrence, hospice enrollment, or transition from standard cancer therapies to phase I clinical trials [ 35 ].…”

Health Related Quality of Life in Interstitial Lung Disease: Can We Use the Same Concepts Around the World?

“…A systematic review focused on the relationship between religiosity/spirituality and quality of life (QOL) in patients with cardiovascular disease found a positive association between mental and emotional well-being, spiritual well-being, intrinsic religiousness, and frequency of church attendance (49). While it is important to recognize that these factors play an important role in HRQOL, there is controversy over the extent to which patients should be subdivided by spiritual and religious beliefs for clinical and epidemiological research (50). In order to address these differences, one potential approach is to focus on the longitudinal relative changes in each individual's HRQOL score, rather than comparing cross-sectional absolute values between different patients, but more work is needed to better define and operationalize this approach.…”