Table 2 Clinical trials on smoking cessation from 2000 to 2014
From: Helping patients to reduce tobacco consumption in oncology: a narrative review
CLINICAL TRIALS 2000–2014 | ||||||||
|---|---|---|---|---|---|---|---|---|
Year | Authors | Design study | Aim | Sample | Smoking cessation intervention | Follow-up | Disease | Outcome |
Gritz et al. | Randomized controlled study | Assessing a provider-delivered smoking cessation counseling program in cancer patients | 186 | Group 1: usual care including information on the risks of continued smoking and benefits of cessation and physician advice to quit Group 2: usual care advice plus discussion of the person’s readiness to quit, provision of informational booklets, and the physician’s expressions of confidence in the patient’s ability to quit (plus booster sessions during six monthly appointments) | 12 months | Head and neck cancers | 60 % patients was abstinent (confirmed by cotinine) and among the remaining smokers, consumption dropped by 50 % (12/cigarettes/day). No differences between groups. 39 % of the sample was not assessed at 12 month due to health conditions, death and dropout | |
Stanislaw, Wewers | Randomized controlled study | To examine the effect of a structured smoking cessation intervention during hospitalization on short-term smoking abstinence | 26 | Structured counseling smoking cessation treatment during hospitalization followed by five weekly phone calls after discharge | 6 weeks (first post discharge visit) | Mix cancer sites | abstinence rates confirmed by cotinine were 75 % for the intervention and 40 % for usual care | |
Griebel, Wewers, Baker | Prospective, two-group, randomized clinical trial | Assessing the effectiveness of a nurse-managed minimal smoking-cessation intervention among hospitalized patients with cancer | 28 | During hospitalization, subjects were assigned to a minimal counseling smoking-cessation intervention group (n = 14) or to usual care treatment (n = 14) | 6 weeks post intervention | Mix cancer sites | 21 % and 14 % of the intervention and usual care group, respectively, were abstinent at 6 weeks | |
Schnoll et al. | Randomized controlled trial | Assessing physician-based smoking intervention comparing to usual care | 432 | Control Group (N = 218) Usual care: minimal advice. Intervention Group (N = 217) Intervention: quitting advice; nicotine replacement therapy; self-help smoking cessation guide; telephone number for additional assistance and/or referral to a cessation program; assessed cessation progress during subsequent medical visits | 6 months–12 months | Breast, prostate, or testicular cancer or lymphoma | No association found between physician-based smoking intervention and long-term (6 months follow up and 12 months follow up) quit rates | |
Wakefield et al. | Randomized controlled trial | Evaluating whether motivational interviewing intervention increases quit rates | 137 | Control Group (N = 63): minimal advice. Intervention Group (N = 74): motivational interviewing intervention (over at 3-months period); nicotine replacement therapy (in patients who smoked more than 15 cigarettes per day), family advice to quit, and an in-person or telephone follow-up conversation. Follow-up at 6-months | 6 months | Mixed cancer sites | No evidence to support efficacy of the motivational interviewing intervention | |
Croghan et al. | Method no stated | Assessing individual counseling intervention comparing to physician advice alone | 30 | Control Group (N = 11): minimal advice. Intervention Group (N = 19): individual counseling intervention (1 session for 45 min) plus individualized nicotine replacementtherapy | No information available | Lung or Esophageal cancer | No evidence to support efficacy of the individual counseling intervention | |
Schnoll et al. | Randomized controlled trial | Assessing cognitive-behavioral therapy plus Nicotine ReplacementTherapy (CBT) comparing to General Health Education (GHE) | 109 | No indication about dimension of control and experimental group. Control group: minimal advice plus transdermal nicotine patches (8 weeks). Intervention group: individual counseling intervention (4 counseling sessions, 1 in-person and 3 over the phone) plus transdermal nicotine patches (8 weeks) | 1 month–3 months | Headand neck, lung cancer | No evidence to support efficacy of the tailored CBT intervention both at 1 month and at 3 months follow-up | |
Thomsen et al. | Randomized controlled multicentre trial | Primary aim: Evaluating the impact of brief smoking cessation interventions on post-surgery complications. Secondary aim: Assessing the efficacy of brief smoking cessation interventions on quit rates | 130 | Control group (N = 65): minimal advice. Experimental group (N = 65): brief smoking intervention (motivational interviewing plus personalized nicotine replacement therapy) | No information available | Breast cancer | Primary outcome: No observed clinical impact on postoperative complications. Secondary outcome: Brief smoking intervention administered shortly before breast cancer surgery modestly increased preoperative smoking cessation | |
Schnoll et al. | Double-blind placebo-controlled trial randomized | Assessing the efficacy of bupropion for treating tobacco dependence among cancer patients | 246 | Control group (N = 132): counseling (5 sessions), transdermal nicotine patches (8 weeks) plus placebo (9 weeks). Experimental group (N = 114): counseling (5 sessions), transdermal nicotine patches (8 weeks) plus Bupropion (9 weeks) | 3 months–6 months | Mixed cancer sites | Bupropion has a low impact on quitting rate on patients with depression symptoms, but not in cancer patients without depression symptoms. Bupropion is safe for cancer patients who smoke (in terms of bupropion-related side effects) and may increase QOL for patients with depression symptoms | |
Park et al. | Pilot study | Assessing the efficacy of a smoking interventions based on behavioral counseling plus varenicline | 49 | Control group (N = 17): no information available. Experimental group (N = 32): varenicline (12 weeks) plus counseling (9 sessions) | 2 weeks–2 months | Thoracic cancer | Varenicline plus counseling increased quitting rate | |
de Bruin-Visser et al. | Method not stated | Examining the efficacy of nursing-delivered smoking cessation intervention | 145 | Nursing-delivered smoking cessation program (counseling plus nicotine replacement therapy) | 6 months–12 months | Head-and-neck; Lung; Breast; Sarcoma; Bladder cancer | Counseling plus nicotine replacement therapy seem to improve smoking cessation rate both 6 months and 12 months | |
Bastian et al. | Randomized controlled trial | Assessing the efficacy of proactive telephone counseling combined with a tailored self-directed intervention comparing to tailored self-directed intervention alone | 596 | Control group (N = 251): transdermal nicotine patches. Experimental group (N = 245): proactive telephone counseling plus transdermal nicotine patches | 2 weeks–6 months–12 months | Lung cancer | No difference | |
Hawari et al. | Prospective observational study | Evaluating the abstinence rates in cancer patients that they underwent to smoking cessation program | 210 | Tobacco Intervention: medical counselling, pharmacologic management (varenicline or bupropion), plus NRT | 3- 6 and 12- months | lung, urinary bladder, head and neck cancers and myeloid leukemia | Abstinence rates declined with time 3 months: relapse related to withdrawal 6 months: relapse rated to personal and professional stressful 12 months: relapse rated to personal and professional stressful | |
Ostroff et al. | Randomized controlled trial | Assessing the efficacy of short smoking intervention pre-surgical | 185 | Control group: counseling plus pharmacotherapy. Experimental group: short smoking intervention pre-surgical plus counseling and pharmacotherapy | 3 months–6 months | Mixed cancer sites | Short smoking intervention pre-surgical does not increase quit rates both in short term (hospital admission and 3 months) and in long term (6 months) | |
Price et al. | Randomized controlled trial | Assessing the feasibility, safety, and effect on cessation of varenicline combined with counseling for smoking cessation in patients with cancer | 132 | Group 1: 12 weeks of varenicline followed by 12 weeks of placebo Group 2: 24 weeks of varenicline All Participants also received behavioral counseling consisting of one 60-min in-person pre-quit counseling visit at week 0 and further in-person counseling sessions at weeks 1, 4, 8, and 12 | 12 weeks | Mixed cancer cites | 40.1 % of patients self-reported to be abstinent at 12 weeks. Abstinence correlated with improvement in cognitive functions | |