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Table 2 Included Study Characteristics

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

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.