Study | Aim | Design | Population | Data collection | Key findings |
---|---|---|---|---|---|
Bredart, 2017 (France) [40], Good quality | Describe perceived side-effect tolerance in P1 trials. | Qualitative | 17 patients 12 female, 5 male Aged 41–72 years (median 63) Cancer type: melanoma, breast, nasopharyngeal, cervical, endometrial | Face-to-face semi-structured interviews of open questions. | As trial is last treatment hope, patients accept side effects, resulting in reduced reporting. Patients stop trial treatment if it stops working rather than side effects. Disappointed when it is not effective. |
Cohen, 2007 (USA) [41], Good quality | Describe the burdens and benefits, as well as perceived QoL, of P1 trial patients. | Mixed methods: Survey with some patients interviewed | 16 patients 10 male, 6 female 29–69 years (57 mean) Cancer type: solid tumours (not specified) | Face-to-face interviews audiotaped and transcribed. | Patients’ QoL was good as they were free from cancer symptoms or drug side effects. However, the trial process was a huge burden as they were away from home and had to spend a lot of time at the hospital for treatment. |
Daugherty, 1995 (USA) [42], Low quality | Understand patient perceptions of P1 trials, and issues related to their participation. | Mixed methods: Survey with both open and closed data | 27 patients 19 male, 8 female Aged 32–80 (median 58 years) 70% white; 26% African American Cancer type: 15 different diagnoses (not specified) | Structured interviews of open and closed questions. Responses hand-written. | 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]. | 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. | Doctors, lack of other options, altruism and family motivate patients to join P1 trial. Patients’ expectations of trial are to get better, improve their QoL, and reach remission or cure. 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. 2013 (Sweden) [45], Good quality | Explore patients’ reasons for participation in, and experiences of, P1 trial participation. | Qualitative | 14 patients Male 9, female 5 Age: range 51–81 (median 63) Cancer type; prostate, melanoma, lung, pancreas | Face-to-face semi-structured interviews audio-recorded and transcribed. | Patients had poor understandings of the trial and demonstrated therapeutic misconception. Hope of trial success was good for patient wellbeing and mental health. Trial offers patients extra care and attention which was a positive factor. |
Kohara, 2010 (Japan) [46], Good quality | Understand the decision-making process in participation of P1 trials | Qualitative | 25 patients Male 14, female 11 Age: <50 = 5, 50–59 = 7, 60–69 = 10, >70 = 3 Cancer type; colon, lung, breast, head and neck, renal, oesophageal, pancreas, biliary tract, ovary, liposarcoma, thymoma | Face-to-face semi-structured interviews audio-recorded and transcribed. | Decision-making depends on: doctors’ influence, previous experiences, attitude towards cancer, family (biggest influence) |
Kvale, 2010 (USA) [47], Mixed quality | Appreciate the experiences of older adults in P1 trials | Qualitative | 4 patients Male 3, female 1 Older adults—mean age 63 Cancer type; lung, lymphoma, paraganglioma | Face-to-face semi-structured interviews audio-recorded and transcribed. | Patients use social comparison and hope to aid them through the process |
Moore, 2000 (UK) [48], Mixed quality | Capture patient perceptions of P1 participation | Qualitative | 15 patients 12 female, 3 male Cancer type; 9 different diagnoses (not specified) | Open-questionnaires and an interview audiotaped and transcribed. | Patients felt a need to try everything at any cost. Patients understood the reality of the disease while hoping to be cured. Trial benefits participants and future patients |
Pentz, 2012 (USA) [49], Mixed quality | Determine if patients misunderstand trial info and identify those who suffer therapeutic misconception | Mixed methods: Interviews followed by a survey | 95 patients 53 male, 42 female median age 57 (range 28–85) 67% white Cancer type: not specified | Interviews audio-record and transcribed. | Therapeutic misconception associated with lower income and higher education. Most participated with hope of direct medical benefit, although other motivations also included: altruism, doctor’s recommendation, other collateral benefits of trial. |
Reeder-Hayes, 2017 (USA) [50], Good quality | Understand patient decision- making to enter trial | Qualitative | 18 patients Female Cancer type: metastatic breast cancer | Telephone semi-structured interviews audio-recorded and transcribed. | Family is a powerful motivating factor, patients join trials for therapeutic gains as well as other factors. |
Rodenhuis,1984 (Netherland) [51] Mixed quality | Explore motives to partake or refuse P1 trial and evaluate quality of consent | Qualitative | 10 patients 6 males, 4 female Cancer type: melanoma, head and neck, lung, breast, cervix | Face-to-face interviews. | Many patients did not understand the trial purpose but were motivated by disease improvement and their families. |
Schutta, 2000 (USA) [52], Good quality. | Explore factors which influence the decision to join a P1 trial | Qualitative | 8 patients Female 5, male 3 Range = 42–72 (years) Cancer type: lung, renal, breast, gastrointestinal | 2 focus groups. 1st recorded (n = 6) and 2nd (n = 2) took notes. | Patients understand the trial purpose but choose to focus on hope of medical benefit. |
Sulmasy, 2010 (USA) [53], Good quality. | Explore justifications for estimations of expected therapeutic benefit from p1 trials | Mixed methods | 45 patients 23 female, 22 male Mean age 57 Cancer type: not specified | Face-to-face interviews audio-recorded and transcribed. | High hopes of therapeutic benefit had little to do with knowledge and more to do with expressions of optimism. |